TMI Blog2012 (9) TMI 1129X X X X Extracts X X X X X X X X Extracts X X X X ..... for the purpose of research and development, the said plaintiff engages inter alia into collaborative agreements and alliances with numerous partners and invests approximately 7 billion Swiss Francs in such activities. 2. It is averred in the plaint that the plaintiff No. 2 jointly owns a patent with Pfizer Products Inc. in respect of a small drug molecule medically termed as a Human Epidermal Growth Factor Type-I/Epidermal Growth Factor Receptor (HER/EGFR) inhibitor which is popularly known as 'Erlotinib' (pronounced as err-lot-i-nib). This drug marked a major breakthrough and innovation in the treatment of cancer and is used to destroy some types of cancer cells while causing little harm to the normal human cells. Various tests conducted on this drug have shown a marked increased in the survival benefit in the patients suffering from advanced or metastatic non small cell lung cancer, the metastatic NSLC is most prevalent form of NSLC being the most prevalent form of this cancer. 3. This drug is administered in the form of a tablet. The tablet formulation of Erlotinib is sold by the plaintiffs under the trademark and name of 'Tarceva', which is registered in ..... X X X X Extracts X X X X X X X X Extracts X X X X ..... 6. The case of the plaintiffs against the defendant is that the defendant is also engaged in manufacture and marketing of pharmaceutical and health care products in India and the plaintiffs had learnt that the defendant is involved in several actions for violation of intellectual property rights including patent rights as the plaintiffs noticed from various news reports appearing in the print as well as electronic media about the plans of the defendant to launch a generic version of the drug Tarceva (Erlotinib) in India and also for exporting the same to various countries. One of such reports appeared on 11th January, 2008 in an English daily Mint published by the Hindustan Times Group and from the aforesaid report, for the first time the plaintiffs came to know about the plans of defendant to infringe and violate legal rights of the plaintiffs with regard to patent. 7. The claim of the plaintiffs is that provision of Section 48 of the Patent Act, 1970 provides for exclusive right of the patentee of a product or a process to prevent any third parties from non-consensual usage of the product or the process. Section 68 provides that an assignment inter alia by way of a licence ..... X X X X Extracts X X X X X X X X Extracts X X X X ..... t the suit patent is a mixture of Polymorph A and B and Tarceva is Polymorph B version of the compound namely Erlotinib Hydrochloride. Time was sought by the plaintiffs to file the reply. 10. In the written statement, the following defences are raised by the defendant: a) The plaintiffs have not filed the copy of the specification. b) The patent of the plaintiffs has been granted under suspicious circumstances, c) No documents which vest any right in plaintiff No.1 of ownership or right to sue have been placed on record, d) The patent in question is liable to be revoked, It only sought to improve from the existing prior art as Quinazoline compounds are known to inhibit growth have been used as anti cancer treatment and are available in the market for treatment of various cancers, Thus, it is a derivative of a known compound and hence not patentable under Section 3(d) of the Indian Patent Act. e) The plaintiffs in a subsequent patent filed in the United States Patent Office have admitted the short comings in the patent in issue. The details of the same are mentioned in the counter claim filed by the defendant. f) The plaintiff has engaged in Bio-isosterism proce ..... X X X X Extracts X X X X X X X X Extracts X X X X ..... eptember, 2008 replication to the written statement of the defendant was filed by the plaintiff. 13. The order was reserved in I.A. No. 642/2008 under Order XXXIX, Rule 1 2 CPC. The injunction application of the plaintiffs was dismissed vide order dated 19th March, 2008. The operative para-87 of the order reads as under: 87. The result of the above discussion is that the plaintiff is not entitled to claim an ad-interim injunction, in the terms sought. However, this Court is not unmindful of the fact that if no equitable balancing order protecting its interest is made at this stage, there is a likelihood of the plaintiff being prejudiced at the final stage. Therefore, the defendant is hereby directed to: i) Furnish an undertaking to this Court, within two weeks, to pay damages in the event of the suit being decreed. A director or other person, on behalf of the Defendant duly authorized by a specific resolution of its Board of Directors, shall execute the undertaking. The undertaking shall also include a stipulation that it would continue to bind the Defendant, regardless of its change in composition. ii) Towards effectuating direction (i) above, maintain faithful accou ..... X X X X Extracts X X X X X X X X Extracts X X X X ..... ties shall complete their pleadings. The plaintiffs were given four weeks time to file the replication to the written statement in the suit and written statement to the counter claim. The defendant was given two weeks time thereafter to complete its pleadings. 18. In the plaintiffs' application, being I.A. No. 12872/2008, the Court also extended the time to file the documents within eight weeks on behalf of both the parties. The matter was listed before the Joint Registrar on 13th January, 2009 for admission/denial of the documents and before Court on 24th February, 2009. On 13th January, 2009, two documents were admitted by the defendant, being Ex.P-1 and Ex.P-2. The documents of the defendant were admitted by the plaintiffs which were exhibited as Ex.D-1 to Ex.D-14 at the time of admission/denial of the documents. 19. When the matter was listed before this Court on 24th February, 2009, the order was passed in I.A. No. 12762/2008 with the consent of the parties that the evidence be got recorded by a retired Additional District Judge Sh. S.N. Chopra as a Commissioner and the matter was sent to him on 1st April, 2009 for fixing dates for cross-examination of witnesses. Par ..... X X X X Extracts X X X X X X X X Extracts X X X X ..... on Certificate Ex PW1/13 Tarceva carton and product insert (dt. 15.4.2009 Ex PW1/19 Decision on 25 Aug 2008 b/w OSI Pharmaceuticals V. CIPLA Ex PW1/20 Form-3 Statement Undertaking under Section 8 Ex PW1/21 Declaration to the effect that the commercial form of Erlotinib hydrochloride sold under the trademark name Tarceva in India is covred by the claims of Indian Patent No.196774 (537/DEL/96) Ex PW1/X1 Phase 1 - Pharmacologic Study of USI 774, an epidesmal GFR Tyrosine Kinase Inhibitor, Journal of clinical Oneology Vol 19, No.13 (July 1), 2001 PP 3267- 3279 Ex PW1/X2 Pfizer Investigators brochure Ex PW1/X3 Journal of clinical oneology Vol. 25, No.18, June 20, 2007 Phase II study of Erlotinib in Adv non small cell lung cancer..... Ex PW1/X4 Cancer research 57, 4838 4848, Nov 1, 1997 Induction of Apoptosis Cell cycle arr ..... X X X X Extracts X X X X X X X X Extracts X X X X ..... Dated 25.3.2010 Power of attorney of Gopalkrishnan Ex DW1/2 Tax Invoice of Mahaveer Medicare Chennai of 31.12.2007 Ex DW1/3 Invoice Mahaveer of 16.1.2008 Ex DW1/4 Copy of Invoice dated 31.12.2007 Ex DW1/5 Mark X claims filed by Remfry and Sagar dated 13.3.1996 Ex DW1/6 Original letter duly signed by Rachna Nandwai + copies of doc. issued with original letter of prosecution file IN 774 Ex DW1/7 Decision of 18 July, 2006 b/w Astrazeneca V. Natco Ex DW1/8 Dated 25.3.2010 decision 21.3.2007 b/w Astrazeneca V. G M Pharma Ex DW1/9 US 6900 221 B1 Ex DW1/10 True copy of decision of Controller in respect of hearing held on 27 June, 2007 for 537/DEL/96 dated 25.3.2010 Ex DW1/11 True copy of written arguments made on 27 th Jne, 2007 filed on 5 July, 2007 for 537/DEL/96 dated 25.3.2010 ..... X X X X Extracts X X X X X X X X Extracts X X X X ..... Pregrant Opp by b/w OSI Vs CIPLA Ex.D-14 Complete Specification 537/DEL/96 between Pfizer and OSI Pharmaceutical 24. The following are marked documents: Mark PX1 Financial Profile downloaded from cipla.com Mark PX2 Copy of patent 2004/026879 A1 Mark PX3 Copy of patent WO 2004/099119 A1 Mark PX4 Copy of patent WO 2005/21541 A2 Mark PX5 Copy of article from the Business World magazine, Feb 2010 Mark PX6 73 rd Annual Report of Cipla (2008-2009) Mark PX7 Copy of article Cipla eyeing copies of 20 patented drugs Mark PX8 US CBO Study Research Development in the Pharmaceutical Industry Mark PX9 Copy of article from The Economist Mark PX10 Copy of article Mukesh, LNM in richest of rich club , Economic Times ..... X X X X Extracts X X X X X X X X Extracts X X X X ..... DW4/2 Information US 146/27 Patent 196774 Statement of working of patent Mark DW 4/3 Examination Sheet Mark DW4/4 Patent 537/Del/96 PFIZER. Application reply Statement US 25(1) Mark DW 4/5 Opp. to 537/Del/96 written arguments of (Majumdar) Opponent Mark DW4/6 Written arguments held on 27.6.2007 PFIZER applicant Mark DW4/7 Decision (27.6.2007 hearing) dated 4.7.2007 Mark DW 4/8 Depenning letters hearing confirmation for 19.3.2008 etc. Mark DW4/9 US Certificate App. No.08/413300 filing dated 30.3.1995 Mark DW4/10 Pregrant Opp. IP for Natco Mark DW4/11 Withdrawal of the compulsory license at 15.1.2008 patent 196774 Decision 22.7.2008, Hearings etc. Mark DW4/12 Complete Specification of 537/D/96 A novel [ ... ..... X X X X Extracts X X X X X X X X Extracts X X X X ..... Mark DW4/35 Written arguments App. Mark DW4/36 Close structural similarity bw Chem compound art. Mark DW4/37 Consideration of Applicant s Rebuttal Arguments Patent ability (R3) 2100 Mark DW4/38 Patent 196774 PFIZER filed Chinese evd. for refusal of Natco Pharma s Patent Mark DW4/39 Letter to Assistant Controller of Patents and Designs of S. Majumdar Mark DW4/40 EPO boards 17.7.1986 of appeal decisions Mark DW4/41 EPO boards 10.2.1984 of appeal decisions Mark DW4/42 EPO boards 28.2.1984 of appeal decisions Mark DW4/43 International search report PCT/EP 2004/0012 Mark XX Table of comparison of Background of invention Mark YY Chart with structures 25. ..... X X X X Extracts X X X X X X X X Extracts X X X X ..... mplete specification are not by themselves sufficient to enable a person in India possessing average skill in, and average knowledge of, the art to which the invention relates, to work the invention, or that it does not disclose the best method of performing it which was known to the patentee for the patent and for which he was entitled to claim protection. f) That the scope of any claim of the complete specification is not sufficiently and clearly defined or that any claim of the complete specification is not fairly based on the matter disclosed in the specification. g) That the patent was obtained on false suggestion or representation. h) That the subject of any claim of the complete specification is not patentable under this Act. i) That the patentee for the patent has failed to disclose to the Controller the information required by Section 8 or has furnished information which in any material particular was false to his knowledge. Re: Obviousness or lack of inventive step 29. The defendant has explained the concept of lack of inventive step in detail by contending that the patent IN'196774 (Ex.PW1/5) (hereinafter referred to as the 'Suit Patent) lacks i ..... X X X X Extracts X X X X X X X X Extracts X X X X ..... tion. In these circumstances, as per the defendant, it would be safe to infer that the suit patent was obvious to the person skilled in the art. 5) It is contended that Example 51 of the EP'226 is the closest prior art: - From the analysis of the specification it is clear that IN'774 is a patent which relates Quinazoline derivative. It is established in the art and known art that Quinazoline derivative has anti cancer properties. From the perusal of all the relevant patents EP'534, EP'507, US'498, EP'226 it is clear that they all belong to a family of patents which are related to similar compound having identical/similar characteristics and similar effect. Any person who is working on Quinazoline derivative would obviously look at these patents. The compounds disclosed in EP'226 (patent which is an admitted prior art in the complete specification of suit patent) are compounds which are obvious to try permutations and combinations on. There is sufficient motivation to do further developments in the preferred compound which are disclosed in EP'226. EP'226 explains and shortlists preferred compounds and thereafter specific preferred compounds. EP ..... X X X X Extracts X X X X X X X X Extracts X X X X ..... interchangeably. It is deposed that there is no fixed pattern can be laid down as to the superiority of one over the other as a matter of rule. In some cases methyl is found to be superior to ethynyl and in some cases vice versa. 9) It is deposed in the said affidavit of DW 3 that that when the said EP' 700 is referred, there are three tables namely Table -1 2 and 3. It is stated in the affidavit that in table 2, the properties of compounds having methyl and ethynyl substituents are shown to have identical MIC value, but Table 3 shows that methyl and ethynyl substitutents have substantially similar properties with ethynyl showing showing marginal higher value. It is therefore stated in the affidavit that the said patent teaches as how the methyl and ethynyl can be used interchangeably as antiviral agents. 10) Likewise, it is stated in the affidavit that US 4138590 (Ex.DW3/3) in column 10 provides that the comparative data in the table indicating that methyl substitution gives a better blood platlet aggregate than the compound having ethynyl substitutent. Thus, the US' 590 goes on to teach that one may use methyl, ethynyl or phenyl interchangeably. Similarly, US 766 (E ..... X X X X Extracts X X X X X X X X Extracts X X X X ..... d of DW-1 and DW-2 which are mainly not relating to aspect of revocation and are discussed later on in another head. 31. Per contra, the plaintiffs have filed the written statement to the counter claim, adduced the evidence of PW-3 and PW-2, Mr. Nick Thatcher and Mr. Robert Griffin, in support of the same thereof and proceeds to answer the grounds of the counter claim by contending the following: a) It is contended by the plaintiffs that the defendant has not discharged the onus casted on the same by not explaining as to how the said EP'226 will act as a motivation towards arriving at the suit patent invention. The same has been explained by the plaintiffs in the following manner: (1) It is submitted The Defendant merely relies upon the prior arts stated by the Plaintiffs in their own patent specification of the suit patent, IN'774, namely, EP0520722A1 (EP'722), EP0566226A1 (EP'226), EP0602851A1 (EP'851), EP0635498A1 (EP'498) and EP0635507A1 (EP'507) - all of which disclose '4-anilinoquinazoline' derivative compounds possessing anti-cancer properties. Each of these prior arts, EP'722, EP'226, EP'851, EP'507, and EP'49 ..... X X X X Extracts X X X X X X X X Extracts X X X X ..... laintiffs to contend that when it comes to possibilities, then any one compound can be out of many can be a starting point for further development. (7) In fact, this is conclusively established by DW3, the defendant's own witness who states in paragraph 4(a) of his Evidence Affidavit that was directed to the specific prior art document, EP'226. b) It has been orally argued and countered by the plaintiffs that there is no formal proof on record to show as to how the plaintiffs had taken Example 51 of EP'226 patent as a lead compound and treated the same as base to arrive at the suit patent. It has been stated that EP' 226 patent discloses numerous formulae and several structures of the quinazolines derivatives, it cannot assumed by the Court at the behest of the defendant's saying that the same would act as prior art solely by looking at one of the several depictions cited in the EP'226. c) The plaintiffs have countered depositions made in the affidavit of Mr. Nangia where under he has deposed about the process of arriving at the suit patent by treating EP'226 as a base is obvious to the person skilled in art. The plaintiffs criticized the said d ..... X X X X Extracts X X X X X X X X Extracts X X X X ..... Para 4 and 6, Evidence Affidavit of DW3; Question nos. 5, 7, 8, 14, 52, 60, 83, 84, PW2,). He has neither provided any reason for selecting Example 51 as the starting point nor has he independently evaluated whether Example 51 was the best starting point as compared to other compounds of EP'226. Thus, the Defendant has completely failed to provide any reason/ motivation for a person skilled in the art to select Example 51 of EP'226 as the lead compound over the 5 prominent compounds for which defined biological data (IC50 values) is provided in EP'226. e) It is further argued orally as well as contended in writing that even if it is admitted for the sake of argument that Example 51 is the correct lead compound for the obviousness enquiry, it is submitted that the Defendant has failed to prove that there was any motivation for a person skilled in the art to modify the 3'-prime position in Example 51 of EP'226. This has been explained by the plaintiffs in the following manner: It is submitted that there are ten positions available in the 4-anilinoquinazoline core structure where substitutions can be done i.e. five positions in the phenyl ring and five p ..... X X X X Extracts X X X X X X X X Extracts X X X X ..... g empirical studies. As an illustration, the core of the enzyme, here being EGFR kinase, is considered a lock and the claimed compound, here being Erlotinib Hydrochloride, which acts on the enzyme, is considered as the key. In pharmaceutical sciences, the researcher in order to make a key for the lock has to perform empirical studies to arrive at a particular conclusion. The researcher cannot make arbitrary choices and do further development without any reasons to do so. One has to apply the reasoned approach for further development of compounds since a small change anywhere in the molecule may alter activity of the compound for a particular target, such as EGFR kinase, and therefore it is not possible to predict activity of the compound in advance without performing the empirical studies. In the case of the methyl and ethynyl group, the difference in the physical properties such as bond angle, bond length and bond strength of the methyl group [-CH3] and ethynyl group , affect the manner in which Example 51 and Erlotinib Hydrochloride interact with the target protein, EGFR kinase, and the differences in the chemical properties of the methyl group [-CH3] and ethynyl group ..... X X X X Extracts X X X X X X X X Extracts X X X X ..... replaces Methyl group at 3'-position with Cyano group. The Defendant has provided absolutely no teaching/suggestion/motivation for a person skilled in the art to change Methyl to Cyano. EP'226 describes that _R2' i.e. 3'-position in Markush structure stands for 45 different substituents. Therefore, EP'226 provides for 43 substituents other than Methyl or Cyano for 3' position. The Defendant has not provided any teaching/suggestion/ motivation that a person skilled in the art will substitute Methyl with only Cyano group and not the other 43 functional groups disclosed for R2 position. It is submitted that none of the 32 specific preferred compounds or the 18 claimed compounds or the 5 prominent compounds in EP'226 include the Cyano substitution at the 3' position. Instead this position is largely dominated by Methyl as stated above. Thus, the Defendant has failed to provide any reason as to why a person skilled in the art would substitute the Methyl group with Cyano group. The Plaintiffs submit that the same is done only on the basis of 'Hindsight' after knowing the structure of Erlotinib Hydrochloride II Methyl to Ethynyl Direct ..... X X X X Extracts X X X X X X X X Extracts X X X X ..... WO1993/04047; US5,427,766; US5,736,534) are cited by the Defendant in the Replication. Of these five patent documents, two patent documents US5,427,766 and US5,736,534 are not valid prior arts under Section 64(1)(f) because they were published subsequent to the priority date of the Suit Patent. The Plaintiffs submit that out of the 2 cited patent documents, which are not valid prior arts, one document US'534 belongs to the same inventor as the suit patent. US'534 was filed prior to the suit patent but was published almost 3 years after the priority date of suit patent. Additionally, US'534 does not even disclose 4-anilino quinazoline compounds. Instead US'534 discloses 4-heterocyclic substituted quinazoline compounds. Therefore, no structural similarity exists between the compounds of the US'534 and the suit patent. The Defendant has erroneously contended that since the inventor was common and he already had knowledge of including Ethynyl in 3'-position, the claimed compound of suit patent becomes obvious. h) It has been contended orally as well as in writing that the inference of non obviousness can be drawn by the Court on t ..... X X X X Extracts X X X X X X X X Extracts X X X X ..... n patients with advanced pancreatic cancer: a phase III trial of the National Cancer Institute of Canada Clinical Trials Group. iv. Ex. PW2/D2: Gefitinib plus best supportive care in previously treated patients with refractory advanced non-small-cell lung cancer: results from a randomised, placebo-controlled, multicentre study (Iressa(r) Survival Evaluation in Lung Cancer) v. Ex. PW3/1: Does potency predict clinical efficacy? Illustration through an antihistamine model vi. Ex. PW3/2: Salvage Therapy for advance Non-Small Cell Lung Cancer: Factors Influencing Treatment Selection vii. Ex. PW3/3: Smoking History and Epidermal Growth Factor Receptor Expression as Predictors of Survival Benefit from Erlotinib for Patents with Non-Small Cell Lung Cancer in the National Cancer Institute of Canada Trials Group Study BR.21 viii. Ex. PW3/5: ?US FDA Public Health Advisory: New Labelling and Distribution Program for Gefitinib 33. By placing reliance on the aforementioned reply, submissions, evidence, anomalies in relation to the case of the counter claimant, it has been argued by the learned senior counsel for the plaintiffs that there is no case made out for obviou ..... X X X X Extracts X X X X X X X X Extracts X X X X ..... as governing in India in form of Patents Act 1970 in order to find out the true test on basis of which the obviousness or inventive step in the patent is required to be tested. 38. Indian Patents Act 1970 has been amended in the year 2005 where under the concept of the product patent in relation to pharmaceuticals has been introduced. The definition of inventive step is the defined under Section 2 (1) (ja) of the patents Act. The definition of inventive step in The Patents (Amendment) Act which is inserted by way of amendment of 2005 u/s 2(ja) reads as under:- 2(1) (ja) inventive step means a feature of an invention that involves technical advance as compared to the existing knowledge or having economic significance or both and that makes the invention not obvious to a person skilled in the art; 39. The provisions relating to revocation of Patents which are statutorily engrafted u/s 64(1) (f) provides specifically a ground of lack of inventive step for the purposes of revocation. The said provision reads as under:- 64. Revocation of patents 1) Subject to the provisions contained in this Act, a patent, whether granted before or after the commencement of this Act, ..... X X X X Extracts X X X X X X X X Extracts X X X X ..... plete specification is not fairly, based on the matter disclosed in the specification; (j) that the patent was obtained on a false suggestion or representation; (k) that the subject of any claim of the complete specification is not patentable under this Act; (l) that the invention so far as claimed in any claim of the complete specification was secretly used in India, otherwise than as mentioned in sub-Section (3), before the priority date of the claim; (m) that the applicant for the patent has failed to disclose to the Controller the information required by Section 8 or has furnished information which in any material particular was false to his knowledge; (n) that the applicant contravened any direction for secrecy passed under Section 35 or made or caused to be made an application for the grant of a patent outside India in contravention of Section 39;] (o) that leave to amend the complete specification under Section 57 or Section 58 was obtained by fraud. [(p) that the complete specification does not disclose or wrongly mentions the source or geographical origin of biological material used for the invention; (q) that the invention so far as claimed in any ..... X X X X Extracts X X X X X X X X Extracts X X X X ..... r, it lays down the general test which is indicative towards technological advancement and the non obviousness of an invention to a person skilled in art. Besides the same, the said definition of inventive step u/s 2(ja) which has been newly inserted in the Patents Act (Amendment) 2005 once read with grounds of revocation u/s 64 nowhere indicate any special treatment or different tests to be applied for any particular type of invention more specifically medicinal, chemical, industrial, etc. 41. On conjoint reading of the Section 64 read with Section 2(ja), it is clearly discernible that there are certain essential ingredients of Section 2(ja) in order to call any invention to qualify the threshold of inventive step. The said ingredients are:- a) That the said invention involves a technical advancement as compared to existing knowledge or economic significance or both; and b) That makes the invention non obvious to the persons skilled in art. 42. These are conjunctive requirements u/s 2(ja) which means that not merely there should be a technical advancement in the invention but at the same time, it should not be obvious to the person skilled in art. Therefore, both the r ..... X X X X Extracts X X X X X X X X Extracts X X X X ..... ain broad criteria can be indicated. Whether the manner of manufacture patented, was publicly known, used and practised in the country before or at the date of the patent ? If the answer to this questseion is 'yes', it will negative novelty or 'subject matter'. Prior public knowledge of the alleged invention which would disqualify the grant of a patent can be by word of mouth or by publication through books or other media. If the public once becomes possessed of an invention , says Hindmarch on Patents (quoted with approval by Fry L. J. in Humpherson v. Syer, by any means whatsoever, no subsequent patent for it can be granted either to the true or first inventor himself or any other person; for the public cannot be deprived of the right to use the invention... the public already possessing everything that he could give. 25. The expression does not involve any inventive step used in Section 26(1) (a) of the Act and its equivalent word obvious , have acquired special significance in the terminology of Patent Law. The 'obviousness' has to be strictly and objectively judged. For this determination several forms of the question have been suggested. T ..... X X X X Extracts X X X X X X X X Extracts X X X X ..... preme Court. 48. The said observations relied upon by the parties are judicially created tests depending upon the nature of the case and the subjective satisfaction of the Judge in the given case. As there is no such requirement which exists at least in Indian Patent Act defining the further qualities of a person skilled in art, therefore, one has to leave the said point there and then which is that what is required to be seen is the obviousness from the standpoint of a person who is skilled in art. 49. Normal and grammatical meaning of the said person who is skilled in art would presuppose that the said person would have the knowledge and the skill in the said field of art and will not be unknown to a particular field of art and it is from that angle one has to see that if the said document which is prior patent if placed in the hands of the said person skilled in art whether he will be able to work upon the same in the workshop and achieve the desired result leading to patent which is under challenge. If the answer comes in affirmative, then certainly the said invention under challenge is anticipated by the prior art or in other words, obvious to the person skilled in art a ..... X X X X Extracts X X X X X X X X Extracts X X X X ..... nowhere provides such requirement. 54. Therefore, it would be wise to say that there exists a jurisprudential difference between the countries like India where the patent law is still at the nascent stage vis- -vis the European countries where the law has developed uptil one level and far away in US where the patent law is operating at the advanced stage. The tests shall accordingly vary as per the prevalent conditions of the respective countries. 55. In the country like India where we have followed the Product Patent Regime relating to medicines and pharmaceuticals reluctantly after 10 years since 1995 as phase by phase basis as against the US where the said regime is preexisting for a healthy passage of time, it is but natural that the tendency of the Courts in such countries to protect the patents and to lay down the tests for measuring the obviousness, novelty shall vary and will certainly be at the advanced stage than that of what has been existing in India. 56. One must also not forget that the tests are carved out by also considering the language of the Statute, coupled with other factors including avowed object of the Act and constitutional goals to be achieved an ..... X X X X Extracts X X X X X X X X Extracts X X X X ..... such as these is consistent and clear and it is based on its general approach to patent validity on novelty and obviousness. There is nothing in the 1977 Act (any more than there was in the 1949 Act, it is fair to say) which recognizes, or even implies, a special approach to, or even the existence of, selection patents as a special category of patent, which require a different approach when determining validity from other patents. Indeed, although it involves a slightly different analysis, it seems to me that the point at issue is not dissimilar from the enantiomer/ racemate issue, in relation to which this court and the House of Lords adopted the approach which had been taken by the Board - See Generics (UK) Ltd. V H. Lundbeck A/S [2008] UKHL 12; [2008] EWCA Civ 311 [2008] RPC 19, at para 9 (where Lord Hoffmann specifically referred to and followed the Board's reasoning in T 0296/87 HOECHST/ Enantiomers). Quite apart from this, as Jacob L.J. points out in para 39, there may be some difficulty in applying Maugham J.'s three stage approach where the prior class of compounds is very large (Emphasis Supplied) 59. It has also been recognized by the author in the Book ti ..... X X X X Extracts X X X X X X X X Extracts X X X X ..... of Bishwanath Prasad which were established on record in that case are the 6 points mentioned in the judgments which are established on the record in that case. 63. Therefore, one has to immediately advert to the question as to what chain of events is necessary in order to establish obviousness to the person skilled in art in relation to chemical compounds. Is it only the establishment of the fact that there is depiction of the similar looking compound in the examples in the cited prior art and coupled with the further experimentation which may find somehow common place after the priority date of the patent or something more. I think for the same, some guidance from English authorities or the books can be taken only to the limited extent of finding out as to what are the essential facts or material facts necessary to establish the obviousness should be proved by the applicant for revocation. 64. The chain of events which are necessary for the purposes of finding obviousness in relation to selection of chemical compounds from the larger formula or molecule are discussed in the book titled as The Modern Law of Patents by Roughton, Johnson, Cook Fysh, 2011 Edition, (Lexis N ..... X X X X Extracts X X X X X X X X Extracts X X X X ..... d tests are some broad criterion on the basis of which, it can be tested that the whether the onus of the counterclaimant is discharged so far as it relates to revocation of the patent by establishing the material facts necessary for the same. The existence of the said events is essentially a question of the fact and shall vary from case to case basis as noted by Modern Law of Patents (supra). These factors are also inclusive and not exhaustive as there may exists some more chain of events which may prove helpful in arriving at the finding of obviousness to the person skilled in art as attending circumstances peculiar to the said case. 66. It is also necessary to examine the legal aspect of onus of proof involved in the revocation proceedings. It is well settled principle of law that the onus of proof in the revocation proceedings is akin to the principle of onus of proof involved in the civil cases which is on balance of probabilities. 67. Sh. P. Narayanan in his book titled Patent Law Fourth Edition, published by Eastern Law House, has observed in relation to standard of proof required in the revocation proceedings by citing English authorities that the said standard of p ..... X X X X Extracts X X X X X X X X Extracts X X X X ..... lack of inventive step of the suit patent IN'774. In order to support the ground, it is stated and documents to the effect have been filed that the suit patent is anticipated by EP'226. The said document depicts the structure of the compound as example 51 which seems to be similar in structure and look with that suit patent but the same does not coincide with the suit patent as it contains certain further treatments by way of substitution of ethynyl at the third position with that of methyl. 2. The defendant has also filed documents containing the specifications of EP 477700, US 4138590, US 5427766, US 5736534, WO 193004047though objected to that they are after replication, which showed that in the field of derivative compounds, it is not uncommon or unusual to substitute the treatment of ethyl or ethynyl with that of methyl components. The said documents are filed and marked as Exhibit DW 3/ 2 to 3/6 respectively. I think the said documents have been filed by the defendant after the replication to the counterclaim has been filed after framing of issues. The admissibility of the said documents have been questioned by the learned counsel for the plaintiffs that they are ..... X X X X Extracts X X X X X X X X Extracts X X X X ..... ce by way of affidavit is completely silent about the same. 7. The defendant has been able to cross-examine the plaintiffs' witnesses which reveal that the plaintiffs' witnesses inform that they were not involved in the research of quinazoline derivatives with the owners namely OSI which is answer to question Nos. 15 and 16, the said witness PW2 Roger Griffin informs that he is not into the field of quinazoline derivatives but into quinazolinone. Though he denies the suggestion that he does not have the knowledge about the same. The said witness further states on being asked that the he is not aware the name of the scientists who have invented the suit patent. Accordingly if the said expert witness does not properly know about the derivatives in question, nor himself worked upon the invention, not is even aware of the said scientists who are involved in the invention, not even consulted with the plaintiffs at the relevant time of 1995 when the invention was made and the said witness deposes in the affidavit everything relating to experimentation and working on of the invention on the might have been basis or would have been basis, it can be safely said that the said ..... X X X X Extracts X X X X X X X X Extracts X X X X ..... changed to the present title which is A novel [6,7-bis(2-methoxyethoxy)quinazolin-4-yl]-(3-ethynylphenyl) amine hydrochloride and a process for preparing the same . 73. It is submitted that it is important to note the fact that this change took place in February, 2007 i.e. 14th February, 2007 when the original 27 claims were replaced with 2 claims i.e. One Product Claim and One Process Claim. The reading of the specification does not disclose any connection whatsoever with the Claims as granted except for one Example i.e. Example 20. 74. Counsel for defendant also submits that after analysis of the specification reveals that this is nothing but cut and paste job done by alleged inventor. He relied upon the following:- A. Background of Invention: The entire Background of the Invention has been copied word to word from EP566226 (Exhibit D-6) and WO 1995023141 (Exhibit No. PW2/D1 and Exhibit P2/DA). B. Summary of Invention: Coming to the Summary of the Invention, it deals with the Markush Formula consisting of several compounds and the possible substitution thereof. The purpose of the Invention merely mentions the various substitution and does not give any reason whatsoe ..... X X X X Extracts X X X X X X X X Extracts X X X X ..... line Derivatives have been altered by substituting Methyl/ Flouro with Ethynyl in order to arrive at the IN'774. If not for this explanation, there could be no other explanation whatsoever as to how the same very substitution using Ethynyl has been made in so many compounds. There is also no discussion whatsoever in the entire specification as to what are the effects of such substitution the efficiency of each of the compounds disclosed. There is also no comparative data or any data relating to studies. 76. The closest prior art for this case in comparison with the Claim 1 is Example 51 of EP'226. The said example 51 is one of the preferred compounds in EP'226 and even by applying the test of obviousness the compound preferred in EP'226 is a good starting point. There is no disclosure in the specification as to how claimed compound in Claim 1 is a technical advancement of example 51 of EP'226. 77. EP'226 patent related to quinazoline derivatives, or pharmaceutically acceptable salts thereof, which possess anti-cancer activity, as well as their methods of manufacture, pharmaceutical compositions containing them, and the compounds' use in mammals ..... X X X X Extracts X X X X X X X X Extracts X X X X ..... of lying upon him. This could have been done by the defendant by showing clinically that the substitution of the compound containing ethynyl component are not far removed from that of the methyl component. There should have been depositions to this effect which are not there in the affidavit of PW3. The said finding of far removed of the range cannot be simply arrived at by mere look of the structure and assuming the state of the affairs that it is so simple to the substitute the ethynyl with the methyl at the particular position. Therefore, the defendant has not able to demonstrate as to how the said suit patent compound or range is not far removed from the one depicted in EP'226. 80. As recorded above in the defendant's submissions, where in comparison is done by defendant relating to compounds of EP'226 with that of the suit patent compound, it is clear that some range of compounds is selected from the earlier range already contained in EP'226 wherein ethynyl position has been replaced at third position with that of the methyl or cyno and others. The said argument has been considered but cannot be said to be solely aiding the defendant towards the discharging ..... X X X X Extracts X X X X X X X X Extracts X X X X ..... by the inventor. 82. The said submissions are neither present in the written-statement nor in the counter claim nor same are deposed in the affidavit of DW1, 2 and 3 towards establishment of the fact that the said working on the compounds is arbitrary and based on trial and error. I find that the said submissions cannot be believed in the abstract in the absence of the any positive evidence coming from the defendant's end showing some tenability of the same clinically as to how the said invention could be arrived at on trial and error method or selection is arbitrary. This could have been done by the defendant by going step by step. Firstly to show the example from the known compound, which the defendant has done, secondly to show as to how the said selection is not far removed not merely by relying upon the structural similarity or generally saying that the ethynyl or methyl could reap the similar results but by clinically showing what is the effect of the said working of ethynyl at the several positions and how it is not far removed from EP'226 and lastly by showing that the entire selection is arbitrary. All this could have been done by the defendant in the affidavit ..... X X X X Extracts X X X X X X X X Extracts X X X X ..... id characteristic of curing the cancer emerges from the said very compound which is a quinazoline derivatives. The plaintiff's inventor being a conscious person is equally aware of the defects in the pre-existing medicine or compound and its inability to cure the disease properly and therefore would select the range from the point from where the last research ended. Therefore, there is no harm so far as taking the compounds from the previous state of the art is concerned unless it is further backed by the evidence that the said selection and the working thereupon is not far removed from the known range, further that the said selection and the working is arbitrary in nature. On the other hand, it indicates that inventor was conscious about the existing state of art. Accordingly, even if the range from EP'226 is selected by the plaintiffs to conduct the further workings upon the same, unless shown contrary, it cannot be said that the said selection to be an arbitrary one. 86. Another reason which persuades me to infer to the contrary in the absence of the evidence is that there is a commercial success of the medicine worldwide which has been widely recognized and the sa ..... X X X X Extracts X X X X X X X X Extracts X X X X ..... aid change in the reaction is bare minimal or the said reactants are known to the person skilled in the art. It is also not established on record clinically to show as to how the suit patent compound is not far removed from the selection or example 51 of EP'226 by positive evidence in the form of depositions and I find the structural similarity on the look and perusal is not the decisive of this establishment of the far removed material fact. 90. The said material fact goes into the root of the matter and affects the case of the defendant, consequently must be given the treatment prescribed in the law as per the stages of the suit. To sum up, the bundle of facts or chain of events leading towards inference as to the obviousness of the patent are not clearly established on record as per the evidence of the defendant. The similar is the case with the plaintiffs but the same remains inconsequential as the initial onus by satisfying the three requirements was on the defendant which the defendant failed. 91. Again, it is reiterated that what has been stated in Biswanath Prasad (supra) that the inventive step is a mixed question of fact and law and not a pure question of law wh ..... X X X X Extracts X X X X X X X X Extracts X X X X ..... st informed person about the matter in issue, Purshottam was not a stranger. He was a partner of the patentee firm and a brother of Sotam Singh (D.W. 3). He was the best informed person who might have answered the charge of lack of novelty levelled by the opponent side, by explaining what was the novelty of the alleged invention and how and after, what research, if any, he made this alleged 'discovery'. Being a partner of the respondent-firm and personally knowing all the circumstances of the case, it was his duty as well as of the respondent-firm, to examine him as a witness so that the story of the particular invention being a new manufacture or improvement involving novelty, could, in all its aspects, be subjected to cross-examination. By keeping Purshottam away from the witness-box, the respondent-firm, therefore, took the heavy risk of the trial Court accepting the charge of lack of novelty made by the appellant herein. 94. Thereafter, the Hon'ble Supreme Court affirmed the finding of the learned trial judge by observing that they do not find any piece of evidence as misread and overlooked or omitted from the consideration and view expressed by the trial judge a ..... X X X X Extracts X X X X X X X X Extracts X X X X ..... t agree with submissions of the defendant that the mere fact that there were commonality in the wordings of the specification of EP'226 with that of US 498, there can be any inference which can be drawn as to non obviousness as that the specification is copied from EP'226. It needs to be emphasized that the chemical research requires lots of experimentation on the existing compounds. Therefore, the background of the inventions arising out of the same molecule or compound may be same, may have similar properties which may be expressed in the limited ways, therefore the reading of the same may look similar in grammatically. But that does not testify the fact that chemical compounds are the same nor the structural similarities are decisive factor. The structural similarities may be one of the indicators that the said invention or compound is derived from particular compound or set of the compounds, but may not be sole criteria as per settled law. Unless the other factors like selection of range, arbitrary nature of selection, are established. 99. The defendant has sought to rely upon 5 patent documents namely EP 477700, US 4138590, US 4138590, US 5427766, US 5736734, WO 193 ..... X X X X Extracts X X X X X X X X Extracts X X X X ..... pleader shall produce, on or before the settlement of issues, all the documentary evidence of in original where the copies thereof have been filed along with plaint or written statement. (2) The Court shall receive the documents so produced Provided that they are accompanied by an accurate list thereof prepared in such form as the High Court directs. (3) Nothing in sub-rule (1) shall apply to documents,- (a) produced for the cross-examination of the witnesses of the other party, or (b) handed over to a witness merely to refresh his memory.] 100. On the plain reading of order 8 rule 1A(3), it is manifest that there is legislative command engrafted in the said provision which is not to receive the documents in evidence which ought to have been filed and produced by the defendant under this but has not been produced. The Court's discretion to receive such document is conditional of the fact of defendant seeking to leave from the Court to produce the said document on the record. The said leave is thus a jurisdictional fact which enables the Court to exercise such discretion as to the reception of the document in evidence which has not been produced in the manner p ..... X X X X Extracts X X X X X X X X Extracts X X X X ..... which took effect on 1.7.2002. While considering the effect of this deletion the Supreme Court observed: 13. In Salem Advocate Bar Assn. v. Union of India, it has been clarified that on deletion of Order 18 Rule 17A which provided for leading of additional evidence, the law existing before the introduction of the amendment i.e. 1-7-2002, would stand restored. The Rule was deleted by Amendment Act of 2002. Even before insertion of Order 18 Rule 17A, the court had inbuilt power to permit parties to produce evidence not known to them earlier or which could not be produced in spite of due diligence. Order 18 Rule 17A did not create any new right but only clarified the position. Therefore, deletion of Order 18 Rule Order 18 Rule 17A does not disentitle production of evidence at a later stage. On a party satisfying the court that after exercise of due diligence that evidence was not within his knowledge or could not be produced at the time the party was leading evidence, the court may permit leading of such evidence at a later stage on such terms as may appear to be just. Thus, the Supreme Court held that the insertion of Rule 17-A was only clarificatory of the in-built power of t ..... X X X X Extracts X X X X X X X X Extracts X X X X ..... y objected to taking these documents on record and its admissibility at the time of recording of the evidence of DW3 Mr. Nangia and the said objection has been categorically recorded by the learned LC Mr. S.M. Chopra leaving it to this Court to decide. In the absence of any leave sought from the Court which leaves no room for the Court to exercise any such discretion, I upheld the objection raised by the learned counsel for the plaintiffs as no steps have been taken by the defendant to cure such objection till date by seeking a permission of this Court. Therefore, the question of taking the documents on record at such belated stage after the commencement of trial does not arise unless the leave of the Court is sought in the prescribed manner providing the sufficient reasons for non-filing at the earlier stage. In fact these documents were filed along with replication in counter-claim filed by the defendant and after production of evidence of plaintiffs. In case, these documents are taken on record, I am of the considered view that a great injustice would be done to the plaintiffs as no chance of rebuttal at present would be available. 103. Even if the said documents in the form ..... X X X X Extracts X X X X X X X X Extracts X X X X ..... her, the said invention provides again some references to methyl, ethynyl at 6 and 7 position and the said compound was structure wise is totally different though it has common quinazole core. Accordingly, the mere presence of methyl and ethynyl reactions at the different place would not make the patent obvious. If the defendant is argument is to be believed that the methyl and ethynyl reactions are so common and was present in EP 534, then it is noteworthy to mention that EP'226 is mentioned as prior art even in US 534, If it was so obvious to the person skilled in the art, then why the inventor who is Mr. Arnold and the owner of US 534 which is Pfizer, who was also the stakeholder in US 498 and IN'774 in the instant case earlier with the plaintiff No. 2 herein had to wait to apply for US 498 for months together, then the same very patentee as the defendant states that he was aware of methyl and Ethynyl substitution could have easily arrived this successful compound even prior to arriving at US 534 but in fact it is not so in the instant case. What follows from the same is that it is not so easy to assume that the mere fact that there is ethynyl or methyl reactions are kno ..... X X X X Extracts X X X X X X X X Extracts X X X X ..... aid reactions, where to react, why not to react with phenyl and at what position. Therefore, the similar prior arts are rejected. So far as the emphasized prior art US 534 is concerned, my answers in specific are recorded above. In view of the same, I find that the documents which are marked as DW 3/2 to 3/6 are not relevant for the purposes of showing the obviousness of the suit patent compound on the basis of EP'226. And these cannot be considered otherwise an opportunity has to be given to the plaintiffs to rebut the same in evidence and a great injustice and prejudice would be caused if the same are taken on record. 104. There is a related argument raised relating to technique of Bioisosteres which as per the defendant is groups or substituents having similar chemical or physical properties that impart similar biological properties to a chemical compound. As per the defendant, the suit patent could have been arrived at by using the said technique and therefore the suit patient is obvious. The said argument in other words means the substitution of ethynyl with that of methyl being a component of the same group which can make the suit patent obvious by knowing about the ..... X X X X Extracts X X X X X X X X Extracts X X X X ..... pp.2d 359 at pages 14-15 d. Eli Lilly Co. v. Zenith Goldline Pharm., Inc., Nos. 2005-1396, -1429, -1430 (Fed. Cir. 2006), at pages 9 [reported as 471 F.3d 1369] e. Star Scientific v. RJ Reynolds, No. 2010-1183 (Fed. Cir. 2011) at Pg 17, 19-20 [reported as 537 F.3d 1357] f. Apotex v. Sanofi, 2008 SCC 61 at paras 79, 87, 90 and 92. Eisai Co. v. Dr. Reddy's Laboratories, 2007-1397, -1398 (Fed. Cir. 2008) at pages 8, 9 [reported as 533 F.3d 1353]. g. Genetics Institute v. Novartis Vaccines and Diagnostics, 2010-1264 (Fed. Cir. 2011) at pages 22-23, 25-26, 28- 29, 34-35 [reported as 655 F3d 1291] h. Sabaf v. Meneghetti, 2003 RPC 14 para 43 i. Generics UK v. Daiichi, 2009 RPC 23 at para 22, 23 - Will not pursue every avenue relentlessly if there is only the mildest motive for doing so; must be obvious to try. 107. I may however notice that the said test of motivation, suggestion and teaching seems to be one of the facets of the theory of the person skilled in the art. However, its application of the same by the US Courts and sometimes in EU in the distinct circumstances is such cases somehow leads to the conclusion that challenge to the patents in the pharmaceu ..... X X X X Extracts X X X X X X X X Extracts X X X X ..... ne 15). Line 15: ?It was common ground that when the validity of a patent is attacked under the relevant provisions of Section 32(1) of the 1949 Act, the onus of proof lies, as regards each allegation, on the party launching attack. Who is a Person skilled in the Art? i. General Tire Rubber Company v. Firestone, 1972 RPC 457 at p. 498 (lines 15-27) - Obviousness adjudged by the person of ordinary skills in the art and not the inventor (or his rival). Hindsight is impermissible in an obviousness enquiry. i. FH B v. Unichem , AIR 1969 Bom 255 at Para 16 ii. Technograph v. Mills Rockley, 1972 RPC 346 at pages 353 (line 40), 362 (line 35). iii. General Tire Rubber Company v. Firestone, 1972 RPC 457 at p. 505 (line 35). iv. Sabaf v. Menenghetti, 2003 RPC 14 at p. 279-280 (Para 43,44) - Dangers of hindsight are notorious; v. Daiichi Sankyo v. Matrix Laboratories Ors., 2009-1511 (Fed. Cir. 2010) at pages 14, 15, 18 [reported as 670 F. Supp.2d 359] Structural Similarity: a. Takeda v. Alphapharm, No. 2006-1329 (Fed. Cir. 2007)at p. 9, 19 [reported as 492 F.3d 1350]- Generalization should be avoided insofar as specific chemical structures are alleged ..... X X X X Extracts X X X X X X X X Extracts X X X X ..... inability of the defendant to discharge the onus casted upon it. Re: Patent violating Section 3(d) of Patents Act 1970 (as amended in 2005) 110. Now, I shall be proceeding to discuss the challenge which has been set up the defendant in relation to Section3(d)of Patents Act. 111. The defendant has raised in the counter claim a ground that the suit patent violates Section3(d) of the Patents Act by urging that the patent applied by the plaintiffs is another form of the EP' 226 and therefore is an attempt by the inventors like the plaintiffs to renew the patent of the invention which has already pre existing in the art. Learned counsel for the defendant in order to set up the said challenge has explained the concept of the evergreening as well as the provisions of Section 3(d) by making the submissions in the following manner: 112. It is submitted that prior to the introduction of Product Patents in India, the country could derive and consider the vast experiences of global markets where Product Patents have been granted with respect to medicines/drugs. The experience of other countries revealed that there was a practice in the pharmaceutical industry to increase the t ..... X X X X Extracts X X X X X X X X Extracts X X X X ..... ller held as follows: On the basis of the arguments and evidence given by both parties I am of the opinion that the basic skeleton of the prior art compound and the present invention are same. The prior art also teaches chloro fluoro substituent in the aniline attached to the 4th position of the quinozoline molecule and a methoxy group at the 7th position of the quinozoline. But I find that none of the compound disclosed in the prior art is identical to the compound disclosed or claimed in the proposed claim-1 in the present application with respect to the 3, 4 and 7th position of the quinozoline molecule. The prior art does not teach exclusively the claimed compound. Therefore the said selected compound of the present invention is novel over the prior art. Regarding closest prior art issue I find that in the present application following substitution has been claimed. (a) 3' 4' position; could be chloro or fluoro (b) 7th position of quinozoline ring; Methoxy and (c) .position of the quinozoline ring; a basic group. Following the above basis, I find that the compound of Table 3 within example 34 comes structurally closure to the claimed compounds than ..... X X X X Extracts X X X X X X X X Extracts X X X X ..... patent ability under Section 3(d), I find that the test data provided by the applicant does not substantiate the applicant's claim or significant enhanced potency residing in the selection of a basic group at 6-position of the quinazoline ring. The applicant has attempted to claim enhanced efficacy by demonstrating that the compounds of the claimed invention possess 4 to 16 fold potency compared to the compounds of the prior art. Based on my findings under the ground of obviousness and lack of inventive step wherein I concluded that the claim of the applicant that the compounds of the present invention are 4 to 16 times more potent than the prior art compounds, are not persuasive, I conclude that all the compounds claimed in the present invention do not significantly differ in efficacy compared to the prior art which is the explicit requirement under Section 3(d) and therefore is not patentable under Section 3(d) of the Patent Act. For conclusion the Controller holds as follows: - In view of my findings in the preceding paragraphs, I conclude that the present invention as claimed in revised claim 1 to 12 of the application number 841/DEL/1996 is; (a) Novel over the pri ..... X X X X Extracts X X X X X X X X Extracts X X X X ..... ;s expert witness that the Erlotinib compound was not known as a drug or a compound in the year 1995 from which is the date that the patent claims priority. ii. Furthermore, it is pertinent to note that Quinazoline Derivatives have diverse uses that are not targeted to anti-cancer activity or even limited to pharmaceutical uses. Quinazoline Derivatives are also used as dyes, etc. Therefore, merely to infer from the term 'Quinazoline Derivatives' that a newly invented compound is a 'derivative' and hence have similar activity, obvious/non-inventive/non-novel, would be illogical. iii. Lastly, it is submitted that the Defendant's averment that no efficacy data has been provided is completely erroneous. It is submitted that the suit patent has specifically mentioned IC50 values for the patented compounds. 115. The plaintiffs have also filed the evidence by way of affidavit of Mr. Thatcher PW3 in order to substantiate that there exist some kind of efficacy which has been deposed by the witness in his affidavit in the form of reference to the clinical trial and other aspects of efficacy. The said efficacy is deposed in the form of clinical trials conducted by ..... X X X X Extracts X X X X X X X X Extracts X X X X ..... art but does not deposes as to how the IN'774 is the new form of same substance based on EP'226. 118. The defendant, however, has set up the challenge as to the clinical trials relating to efficacy as relied by the PW3 Nick Thatcher. Learned counsel for the Defendant did cross examination of Mr. Thatcher where under, there were questions asked as to on whether the clinical trials relied upon by the defendant are conducted on Tarceva or the suit patent, the witness answered that the trials are conducted on both. No clear picture has emerged so as to say with certainty from the cross examination as the said clinical trials are either bad or were never conducted. It is correct that the PW3 states that clinical trials were conducted in the years 2004 and 2005, but that by itself is not conclusive of the fact that the clinical trials were not related to the IN'774 except to presume that by that time Polymorph B version was in existence and therefore the said trials may or may not relate to the suit patent compound. Besides this I find number of questions on Polymorphism but no specific question or suggestion relating to the Section 3(d) or evergreening is put to the plai ..... X X X X Extracts X X X X X X X X Extracts X X X X ..... re are some more facts which may be required to be proved which include the complete analysis as to what was actually the old substance, how it can be said to be same as that of the subject invention or new use of the same substance. In the present case, though the defendant has stated in the affidavit that there was a preexisting patent of EP'226, but the defendant at the same time could not provide any positive evidence as to whether the suit patent coincides with the said compound which was the subject matter of EP'226 or new form of what is contained in EP'226. There is an attending circumstance which is that the suit patent specification corresponded with EP'226 which somehow seems to provide a hint that the plaintiffs had worked on the EP'226, but the presence of the same by itself nowhere establish that the said compound is the new form of the same compound as stated in EP'226. I have already noticed and observed that there may be a cases in chemical substances where the research is common and the same is represented in a very limited manner, accordingly it is not safe to assume that mere fact that there is grammatical similarity in the description of ..... X X X X Extracts X X X X X X X X Extracts X X X X ..... d rather the said order finds that the said IN'507 is Polymorphic form of Erlotinib Hydrochloride which is IN'774 compound. Therefore, the said finding of the controller will not enable this Court to infer that the suit patent is hit by Section 3(d) of the Act. The said order was passed in the application filed by the plaintiffs for registration of Polymorph-B. The defendant's stands in the said opposition and in the counter-claim filed in the present suit are different. In case, the defendant's admissions made in the opposition to IN'507 are applied here, the prayer made in the counter-claim is liable to be rejected. 124. Accordingly in relation to aspect of Section 3(d), I find that the defendant has not able to discharge the onus casted upon it. Thus, the impugned patent is not hit by Section 3(d) of the Patents Act. 125. I therefore reject the submissions of the learned counsel for the defendant on the count of Section 3(d). I think there is no reason to further advert to case laws and legislative intendment relating to Section 3(d) when I find that the defendant has not discharged the onus of proof on balance of the probabilities on the count of the v ..... X X X X Extracts X X X X X X X X Extracts X X X X ..... quire. 129. As the said Section 8 has been raised as a ground of challenge in the revocation, it would be necessary to also reproduce Section 64 relating to revocation where clause sub clause (m) reads as under:- 64(1) (m) that the applicant for the patent has failed to disclose to the Controller the information required by Section 8 or has furnished information which in any material particular was false to his knowledge; 130. On the conjoint reading of both the above Sections, it is clear that there is a mandatory provision provided u/s 8 where under the applicant for patent is under obligation to disclose the information to the Controller of Patents regarding any patent application which is pending in the country outside India in respect of the same or substantially the same invention or where to his knowledge such application is being prosecuted by some person through whom he claims title, he shall file along with the same or subsequently a statement setting out the detailed particulars of such application and also give an undertaking to that effect. 131. It is also manifest from the collective reading of Section 64(m) with that of Section 8 that the consequences of ..... X X X X Extracts X X X X X X X X Extracts X X X X ..... nt or his predecessors in the foreign countries at the time of preferring the patent applications in India. 136. It is also seen from the reading of said Section that Section 8(1) covers within its sweep not merely the applications which are being prosecuted at the time of filing of patent, but also the other applications which are filed subsequently during the time when the prosecution before the Indian Patents Office is underway. This is clear from the undertaking which the applicant for patent has to give under clause 8 (b) relating to the applications preferred in countries outside India subsequently to the filing of statement referred to in clause (a). 137. Careful examination of entire scheme of Section 8(1) of the Act would reveal that the Section - 8 is aimed at to provide the Controller true and faithful disclosure of all the information relating to the applications for patents which are same or substantially the same invention and also to provide the information to the Controller in relation to the title of the said Patent owned by the applicant and the other persons in the foreign countries. 138. Thus, the twin requirements of ascertainment of the foreign applic ..... X X X X Extracts X X X X X X X X Extracts X X X X ..... relating to the same. 141. Let us see whether in the instant case provisions of Section 8 gets attracted. It has been said by the defendant that the plaintiffs as Patentee has not disclosed before the Indian Patent Office while prosecuting IN'774 about the patent namely US'221 which was filed subsequently in 2000 in US which relates to the same or substantially the same invention. This ground is raised in the instant case as it is the case of the plaintiffs that the compound which is involved in the suit patent IN'774 and the compound which was filed subsequently in India in the form of IN'507 as well as in US'221 are one and the same and the subsequent ones being the derivative of previous one would not have any impact on the enforceability of the previous one in the instant suit. This has also assailed by the Defendant by stating what has been in actual use in the market is the Polymorphic version B which was filed subsequently and not the one claimed in IN'774 which is the suit patent. 142. Essentially, the challenge of the defendant is that had the full and faithful disclosure relating to the filing of the substantially same patent been made before ..... X X X X Extracts X X X X X X X X Extracts X X X X ..... pound and it is Polymorph form considering the impact of US'221. Therefore, there is no need for this Court to go into the question now as to whether such disclosure is warranted or not. It is urged that the said decision of the Controller otherwise came on 15.12.2008. However, IN'774 was granted in February 2007. Consequently, the plaintiffs who were always under the belief prior to the said order of the controller that the suit patent IN'774 and US'221 are different could not have filed the said description of US'221 prior to the order dated 15.12.2008. The alleged similarity or substantial similarity has been held by the Controller in the opposition proceedings later in point of time and till that time the plaintiffs were under the belief that both the compounds are distinct and therefore the disclosure was not warranted. 145. By submitting all of the aforenoted in response, it has been said that no disclosure was required to be made when it comes to US'221 subsequently relating to Polymorphic version B of the compound. Even otherwise Natco in its pre-grant opposition lost the objection of Section 8. The opposition of Natco was filed by the same patent ..... X X X X Extracts X X X X X X X X Extracts X X X X ..... the existence of Polymorph version B and the usage of the same in the market of the said version is immaterial as suit patent IN'774 and its subsequent Polymorphic versions are the same, then it does not lie in the mouth of same very plaintiffs to urge to the contrary while filing two applications for patents in India as IN'774 and In 507 to contend that they are distinct from each other. If the said patent was relating to the same field which is of the same compound or derivative of the same compound, the same could have been disclosed to the Patent Office that the Polymorph version of the same has been filed in 2000 in US patent office. This is more so, when the specification of subsequently filed patent as US'221 exhibited as DW 1/9 contained the same information relating to efficacy and the stability of the earlier patent whatever inference the Patent Controller could have drawn either in favor of the patentee or against him, that by itself does not absolve the responsibility of the plaintiffs as applicant for patent to disclose such information before the Controller. 149. It is legally untenable to say that the plaintiffs were under the belief that US'221 w ..... X X X X Extracts X X X X X X X X Extracts X X X X ..... plaintiffs now that both the versions are of the same nature and non grant of one in India is inconsequential, The defendant is able to discharge the onus which lied on him to show that there was an obligation to disclose. Thereafter, it was upon the plaintiff to displace the onus and justify as to how the said disclosure was not required or the said disclosure was actually made. The responses which are coming forth from the plaintiffs for filing of Form-3 twice in 1996 and 2006 nowhere relates to foreign application and does not satisfy as to how the disclosure was properly made of the developments which happened in the year 2000. The fact that the Controller incidentally dealt with such application filed in US'221 while testing the opposition with the third party does not absolve the responsibility of the plaintiffs as applicant for patent to disclose the said information before the Controller which could have impacted the decision making of the Controller. 153. Likewise, the stand of the plaintiffs that both the inventions are different also seems unjustifiable in the light of their present stand before this Court and no other response has been made except what has been ..... X X X X Extracts X X X X X X X X Extracts X X X X ..... abroad and in India; No witness was produced who had knowledge of the patent filings in India or abroad; Concealment about the true form of TARCEVA; TARCEVA was launched after the Polymorph B patent was filed; No product was ever launched by the Plaintiffs which was a combination of Polymorph A+B; Contradictory stands as to the second patent being an independent or a selection patent before the patent office; Creation of backdated agreements and over-reaching this Court without disclosing later agreements and getting recordals done behind the back of the Court; No clinical trials record has been filed or produced or pleaded; Witnesses were specifically briefed not to answer questions on Polymorphism. 157. By placing reliance upon the aforementioned concealments, learned counsel for the defendant urged that the plaintiffs are guilty of non disclosure of material facts which may have bearing upon the decision of the present case as stated above. It is also argued that the plaintiffs have deliberately withheld the documents of this Court which are title documents and also from the patent office, therefore, the adverse inference may be drawn ..... X X X X Extracts X X X X X X X X Extracts X X X X ..... to the facts which are material or non material can draw an inference by analyzing as to which of the concealments would have material bearing while securing the patent. 161. So far as concealments relating to title are concerned, it has been stated that there are deficiencies in the documents relating to title. Number of inconsistencies has been pointed out in order to state that the title of the patent is defeated and does not inure in favor of the plaintiffs. It is stated that the agreements are created as an afterthought and have been recorded later on in the back of the party in order to deprive them the chance of disputing the said documents. 162. The response given by the plaintiffs in this respect is that the plaintiffs are the true owner of the patent in question and even if there are certain documents which have been executed by them subsequently, the same do not affect the passing of the title as the same may amount to feeding the grant of estoppel. The said principle enunciates that even a person at the time of effecting the grant did not have the title but subsequently attains the title or his title subsequently becomes perfect, then the said perfection of title ..... X X X X Extracts X X X X X X X X Extracts X X X X ..... rt. The objection about the title and ownership was not proved by the defendant in its evidence. Since the patent has been granted in favour of the plaintiffs and no issue has been framed by the Court, this Court is not inclined to go into the objection raised by the defendant with regard to the lack of title/ownership. In case any discrepancy with regard to chain of documents/deeds as well as on stamp duty or other objection raised by the defendant is there, I am of the view that the defendant would have pressed for framing of issue in this regard at the appropriate time and ought to have proved the same before Court. The said discrepancies whatsoever are otherwise too trivial and do not material affect the case as to title unless shown otherwise. 166. Therefore, it cannot be said that the titles of patent is defective solely by pointing out certain defects which are intermittent in the chain of title relating to patent. Therefore, the said concealments will not strictly fall within the purview of Section 64(1) (j) and may not be relevant for the purposes of discussion chapter of revocation. 167. There is another aspect which has been raised by the Defendant that the grant o ..... X X X X Extracts X X X X X X X X Extracts X X X X ..... mendments which were made were already falling within the scope of the patent specification which was originally filed and the said amendment was permissible and therefore no useful purpose would have been served by re advertising the said amendments in the patent. 171. So far as the improper examination of the patent as a ground is concerned, there is no need for any specific mention of the said expression is covered in the grounds of revocation when there is a ground of revocation in para-4 which provides that the patent is obtained on false suggestion and representation which can include any aspect relating to prosecution of the patent application which can materially affect the decision making or the grant of the patent. 172. The said improper examination may arise either on the default of the controller or examiner by overreaching the process of the law and not following the provisions of the Act or on the basis of misrepresentation of the applicant for the patent. The complaint of the defendant when it criticizes the examination process is based on two fold grounds which include both the defaults at the controller's end and consequent contravention of the provisions ..... X X X X Extracts X X X X X X X X Extracts X X X X ..... e invention, so far as claimed in any claim of the complete specification, has been anticipated by publication in India or elsewhere in any document other than those mentioned in sub-Section (1) before the date of filing of the applicant's complete specification. (3) Where a complete specification is amended under the provisions of this Act before [the grant of a patent], the amended specification shall be examined and investigated in like manner as the original specification . (Emphasis Supplied) 57. Amendment of application and specification before Controller (1) Subject to the provisions of Section 59, the Controller may, upon application made under this Section in the prescribed manner by an applicant for a patent or by a patentee, allow the application for the patent or the complete specification l[or any document relating thereto] to be amended subject to such conditions, if any, as the Controller thinks fit: PROVIDED that the Controller shall not pass any order allowing or refusing an application to amend an application for a patent or a specification l[or any document relating thereto] under this Section while any suit before a court for the infringement ..... X X X X Extracts X X X X X X X X Extracts X X X X ..... ification or any other documents related thereto is allowed by the Controller or by the Appellate Board or the High Court, as the case may be,- (a) the amendment shall for all purposes be deemed to form part of the specification along with other documents related thereto; (b) the fact that the specification or any other documents related thereto has been amended shall be published as expeditiously as possible; and (c) the right of the applicant or patentee to make amendment shall not be called in question except on the ground of fraud.] (3) In construing the specification as amended, reference may be made to the specification as originally accepted. 175. There are Patent rules 2003 (as amended in the year 2006) wherein there is a procedure prescribed for amendment or to carry out the amendment in the specification which reads as under:- 81. Amendment of application, specification or any document relating thereto - (1) An application under Section 57 for the amendment of an application for a patent or a complete specification or any document related thereto shall be made in the Form 13. (2) If the application for amendment under sub-rule (1) relates to an applic ..... X X X X Extracts X X X X X X X X Extracts X X X X ..... 3) indicates that the amendments which are filed under Section 57 relates to voluntary amendments and not the amendments which are consequent upon the directions of the Controller as the same remains unaffected as per sub Section 6 of Section 57 of the Act. 177. Uptil this stage, there is no confusion. However, the debate begins when one sees Rule 81(3) (a) read with Section 57 (3) which provides that the application for amendment made after the grant shall be published and reads it with Section 13(3) alongside which says that when the complete specification is amended before the grant of patent, the amended application shall be examined and investigated in the like manner. 178. Now the question arises as to whether the expression examined and investigated as original specification would include the stage of publication or not in order to come to the finding as to whether publication of the amendment is possible pre-grant in the absence of express provision regarding such publication of amendment. 179. For the purposes of the same, one has to consider Section 57(3) and rule 81(3) deeply as both the provisions are inserted by virtue of amendments made and carried out in t ..... X X X X Extracts X X X X X X X X Extracts X X X X ..... n which is conferred upon the controller to issue further directions which will remain unaffected. This has been done by insertion of Section 57(6) wherein the controller in any case may give such directions in spite of what has been contained in Section 57. d) The legislative intent of this nature is self-evident from the fact that the amendment of 2005 conferred the right of post grant opposition to the third party in addition to pre grant opposition and thereafter the patent is also vulnerable to challenge in civil court or in IPAB in the form of revocation proceedings and therefore there are ample opportunities conferred upon the third party opponent with the additional right to object post grant which was earlier absent prior to the amendment. e) Therefore, the legislative intent which is emerging from the collective reading of the Sections as seen above is that the process for grant of patent has been simplified with less obstructions and opposition right has been classified into two parts so that there should be less obstruction or hurdles at the pre grant stage and the patent should proceed smoothly towards the grant and in the event amendments are carried out after a ..... X X X X Extracts X X X X X X X X Extracts X X X X ..... application for a patent in the prescribed manner. [under sub-Section (1) or sub-Section (3) of Section 11B, the application and specification and other documents related thereto shall be referred at the earliest by the Controller] to an examiner for making a report to him in respect of the following matters, namely,- (a) whether the application and the specification and other documents relating thereto are in accordance with the requirements of this Act and of any rules made thereunder; (b) whether there is any lawful ground of objection to the grant of the patent under this Act in pursuance of the application; (c) the result of investigations made under Section 13; and (d) any other matter which may be prescribed. (2) The examiner to whom the application and the specification and other documents relating thereto] are referred under sub-Section (1) shall ordinarily make the report to the Controller within [such period as may be prescribed]. 13. Search for anticipation by previous publication and by prior claim (1) The examiner to whom an application for a patent is referred under Section 12 shall make investigation for the purpose of ascertaining whether the ..... X X X X Extracts X X X X X X X X Extracts X X X X ..... scheme of the examination and investigation of the patent applications can be discerned: 1. Section 12 provides that upon receipt of the request for examination, the controller shall forward the said request for the purposes of examination to the examiner, who shall in turn send his report to the controller within the prescribed time. The said report shall contain the matters provided under Section 12 (1) (a) to (d). This is clear from reading of Section 12 (1) and Section 12 (2). 2. The said examiner so appointed under Section 12 shall thereafter proceed to make the examination and investigation as per the Section 13 and make the investigations in relations to the matters of anticipation and prior claim as contained in the Section 13. This is clear from the collective reading of Section 12 and 13 (1) and (2). 3. The patent application and the specification so amended shall be examined and investigated in the like manner as that of the original specification. The said Section 11 (3) provides that the criterion for the evaluating the amended specification for the purposes of examination and investigation under Section 12 and 13 would be in the like manner. The said wording ..... X X X X Extracts X X X X X X X X Extracts X X X X ..... from the date of filing of the application or from the date of priority of the first mentioned application or within six months from the date of filing of the further application, whichever is later;] (v) The period for making request for examination under Section 11B, of the applications filed before the 1st day of January, 2005 shall be 1[the period specified under Section 11B before the commencement of the Patents (Amdt.) Act, 2005 or] the period specified under these rules, whichever expires later. (2)2[(i) The period within which the Controller shall refer the application and specification and other documents to the examiner in respect of the applications where the request for examination has been received shall ordinarily be one month from the date of its publication or one month from the date of the request for examination whichever is later: PROVIDED that such reference shall be made in order in which the request is filed under sub-rule (1).] (ii) The period within which the examiner shall make the report under sub-sec. (2) of sec. 12, shall ordinarily be one month but not exceeding three months from the date of reference of the application to him by the Contro ..... X X X X Extracts X X X X X X X X Extracts X X X X ..... ssue the examination report at every stage of the objections. However, it is altogether different matter, that the patent office as a matter of the practice issues the examination reports at the subsequent stages also. This is necessary to indicate as to how far under the law and rules framed thereunder, it can be insisted that the authority has to perform the act in a particular manner when no such reference exists either in law and rules made thereunder and even no consequences are prescribed for. 5. There is reference to the words first examination report when it comes to the examination of the application, however the legislature as well as the framers of the rules use separate words called gist of objections when it comes to the process of investigation under Section 13. This is equally essential to indicate the separate requirements prescribed under the law. This can also mean in practice, which I think is logical that if the examination report has been issued and replied by the applicant, the gist of objections which are residual may follow for further investigation. The same can be cured either by reply or by personal hearing or by both depending upon the satisfactio ..... X X X X Extracts X X X X X X X X Extracts X X X X ..... ich is for the satisfaction of the examiner so as to the report to the controller as to whether the said invention submitted in the application satisfies the matters mentioned under Section 12. The same is clear from the Section 13 (4) which expressly provide that the matters of the examination and investigation do not in any way warrant the validity of the patent and no liability can be ascribed to the central government or the officers in relation to the examination or investigation or proceeding thereof. In other words, the said Section is itself making it clear that the said examination and investigation is a matter of the satisfaction of the examiner and does not guarantee the validity of the patent. 8. The said satisfaction is that of the examiner and therefore it is with in the power of the examiner to choose the manner in which he feels fit to get himself completely satisfied that the application is in order for grant. Of course, the said satisfaction cannot be purely subjective and arbitrary but has to be based on reasonable and justifiable grounds. However, in order to aid the functioning of the authority seized of the complex issues like patent, each and every step ta ..... X X X X Extracts X X X X X X X X Extracts X X X X ..... ending the following: A perusal of the entire Patent office record prior to the grant reveals as follows: The Patent had a total of 27 claims - Not clear whether they were 24 claims first and then 3 claims were added; It was these 27 claims that were examined by the Patent office; [FER 22.2.06] Response dated 2.6.06 - dealt with only these 27 claims. Only claims 19 to 23 were deleted- Response mentions that corresponding US'498 has been granted. By this time even US'221 and US'613 are granted but this is not mentioned; FER dated 12.7.06 - specific objection raised that Claims 1 to 12 and 20 are not allowable under 3(d) and 2(1)(j) as the efficacy over the known compounds not established. Thus the patent office was conscious that efficacy over compounds of EP'226 have to be established. The Patent office refers to EP'226 as the known parent compound. Response dated 27.10.2006 - Claims are NOT narrowed down as argued by the Applicant. The claims on file are in fact REPLACED with two new claims. Even page 53 which is page on which Claims are typed was replaced. The Applicant understood which is the known parent compound and referred to G ..... X X X X Extracts X X X X X X X X Extracts X X X X ..... .2006. I think firstly, it is essential in order to adjudge the scope of examination and investigation as to what were the objections raised by the examiner, the same objections are reproduced hereinafter: 1) Subject matter of claims does not constitute an invention under Section 2 (1) (j) as it lacks novelty and inventive step in view of citation nos. JP 7138238, JP 6073023 and JP 6336481 2) Claims 19 to 24 falls within the scope of sub clause of Section 3 (i) 3) Claims 1 to 27 are not clear in respect of the expressions as indicated therein. 4) Claims 1 to 27 are not clearly worded. 5) Title is inconsistent with description and claims 6) Power of attorney should be filed 7) Pages of the specification should be renumbered 8) Extraneous matter of the specification should be deleted. 9) Abstract should be filed with a title and concise summary of the invention within 150 words in accordance with rule 13 (7)(a) of the Patent Rules 2003. 10) Details regarding applications for patents which may be outside India from time to time for the same or substantially the same invention should be furnished within three months from the dates of the filing of the said ..... X X X X Extracts X X X X X X X X Extracts X X X X ..... ame dated 27.10.2006 merely replaced 2 new claims and no where satisfied the objection. It is also stated that the applicant could not have relied upon the clinical trials which were carried out on Polymorph B form. The two new publications filed before the patent office related to the new compound. I have gone through the record of the examination reports of the 22.2.2006, response thereto on 1.06.2006, thereafter the objections raised on 12th July 2006 and response thereto on 27th October 2006. I think the applicant has attempted to answer the aspect of efficacy by annexing the two publications relating to clinical trials in their response on 27.10.2006. it is equally seen that the applicant has responded to the objection of Section 3(d) and 2 (1) (j) of the Act by dedicating the paragraph relating to the same. Thereafter, the applicant demanded a hearing in the matter. I find the said response whatsoever credibility it holds is sufficient for the purposes of satisfaction of the examiner till the time the examiner himself does not raise the objection to the same. I think defendant is missing the point which is that this Court has to test the examination and investigatio ..... X X X X Extracts X X X X X X X X Extracts X X X X ..... es containing set pattern. The said practice cannot be said to be unusual or abnormal to ascribe any malice or arbitrary behavior. The defendant is further raising this challenge by asserting that the claims were amended during the last few days between October 2007 to January 2007, the examiner got satisfied within that time and the objections which were serious enough which went un replied still got cured by the examiner and in turn the said case became the perfect case for grant of the patent and therefore there is an infirmity. I think one has to pause here for a moment and then has to see process of examination and investigation step by step rather than to come immediately to anxious conclusion that the said examination is bad. No doubt that there was a gist of objections raised by the examiner of the patent dated 9.1.2007. But it would be factually wrong to state that no steps were taken in furtherance to the said letter. The noting mad of the examiner contained in the order sheets where under there is an order dated 22.2.2007 clearly records that the agents have re-filed the documents on 14.2.2007 in response to the letter dated 9.1.07. The said document is placed on re ..... X X X X Extracts X X X X X X X X Extracts X X X X ..... eafter the attempt to satisfy the same by the applicant. Consequently, no infirmity can be found on the said count either. So far as the republication of the amended claims are concerned, I have already discussed the same that the republication of the amendments during the pre grant stage is not the legislative intent as the patent act has been amended considerably in this respect, thus, no republication is warranted. Even no issue was framed and no evidence was led by the defendant. 188. Here, I think, at this stage, it is time to examine the submission made by the defendant that the examiner of the patent ought to have passed a speaking order as to how the objections stood removed when there were objections prior to the personal hearing. I find that the said submission though seems to be attractive but the same cannot be acceded to. This is due to the reason that the said order of personal hearing has to be read in the context along side with the previous process of examination and investigation carried out by the patent office and responses thereto given by the applicant herein. The overall collective reading of the same would be determinative of the fact that whether th ..... X X X X Extracts X X X X X X X X Extracts X X X X ..... be sequential, just and reasonable. 190. I also do not agree with the defendant's submission that the patent specification does not explain the working of the invention in respect of formulation, dosages etc or the same does not compare with the prior art. All this would cover under the separate ground for revocation of the patent which is misdescription, but the same cannot be used to say that the examination and investigation is bad in process. 191. I find the submission of the defendant meritless that there is no correlation between the originally granted claims with that of the final ones. It is seen that the answer to the same clearly finds mention that in the order of the patent controller dated 4.7.2007 while disposing of the opposition preferred by Natco Pharmaceuticals where under the Controller observed that the claims as finally granted were covered by the scope of Claims 1, 10 and 19 as originally filed. I think that on this basis again, the examination and investigation process cannot be said to be bad as the patent office including the controller was well aware of the fact as to what it was proceeding to do at that time by granting the patent. 192. I have ..... X X X X Extracts X X X X X X X X Extracts X X X X ..... ection 64 (1) (m) is made out. 2. The defendant has failed to discharge the onus of the proof on facts that there were concealments made in relation to the prosecution besides the above before the patent office or there is an improper examination done by the patent office. Therefore, the examination and investigation process cannot be called into question by the defendant in view of the discussion done above. 3. The amended claims stands examined as the same were consequential to the process of the examination and investigation and thereafter the gist of the objections was issued on 9.1.2007 and replied on 14.2.2007 coupled with the personal hearing on the same, therefore the examination and investigation process cannot be said to be bad in so far as it relates to amended claims. Likewise, the said amendments were not in law entitled to be published in view of the avowed legislative intent emerging from the amendments carried out in the year 2005. 4. The challenge on the ground of ownership title and other concealments have not been established by the defendant by not discharging the onus casted upon it. No issue was framed. No evidence was led by the defendant. In view ..... X X X X Extracts X X X X X X X X Extracts X X X X ..... laintiffs state that both the compounds are different in their Polymorphic forms, therefore the defendant is stating so. In effect, the defendant supports the said position that the combination of Polymorphs A and B as contained in IN'774 is distinct from Polymorphic version B which is contained in US'221. 198. In the light of the said stand taken by the defendant, I find that the discretion tilts in favour of the plaintiffs and against the defendant as no useful purpose will be served by revocation of the mark on the sole ground of revocation when the defendant is stating otherwise before this Court. 199. It is equally well-settled that the party cannot be allowed to approbate or reprobate at the same time so as to take one position, when the matter is going to his advantage and another when it is operating to his detriment and more so, when there is a same matter either at the same level or the appellate stage. 200. In the case of Kok Hoong vs. Leong Cheong Kweng Mines Ltd ., reported in 1964 Appeal Cases 993, the Privy Council held that a litigant may be shown to have acted positively in the face of the Court, making an election and procuring from it an order ..... X X X X Extracts X X X X X X X X Extracts X X X X ..... ay, 1998. 206. The plaintiffs in the paragraph 11 of the plaint have stated that the defendant had been proposing to launch the generic version of the drug namely Tarceva (Erlotinib) which they had learnt from the Newspaper articles published on 11. 1.2008 in the English Daily titled as Mint and this led the plaintiffs to file the present suit on the basis of IN'774. In the plaint, the plaintiffs contends that they own a patent no. 196774 dated 23.2.2007 in respect of a compound namely [6,7-bis (2-methoxyethoxy) quinazolin-4-y1]-(3-ethynylphenyl) amine hydrochloride. It is contended that the plaintiff's drug is administered in the form of tablet. The tablet formulation of Erlotinib is sold by the plaintiffs under the trade mark and the name TARCEVA. It is also stated in the plaint that the drug as well as the process of its manufacture is patented under the provisions of the Patents Act, 1970 and this entitled to the protection. 207. The plaintiffs have claimed the following relief on the said basis in the prayer clause: a) Pass a decree of permanent injunction restraining the defendant, its directors, officers, servants, agents, and all others acting for and on it ..... X X X X Extracts X X X X X X X X Extracts X X X X ..... pleaded facts of the parties. 212. The plaintiffs have thereafter filed the evidence by way of affidavit of Mr. Shiv Prasad Laud (PW1) who is a constituted attorney of the plaintiffs. He has deposed about the aspect of the infringement on the basis what has been stated in the packaging of the defendant namely Erlotinib Hydrochloride and also some declaration made before the authorities as to what had been contained in the medicine is ERLOTINIB HYDROCHLORIDE. It is noteworthy to mention that no clinical tests have been placed on record either by attorney of the plaintiffs or by the expert of the plaintiffs which would show and analyzes as to what are the exact constituents of the plaintiffs drug Tarceva and the defendant's drug ERLOCIP more specifically the question whether the same corresponds with the Indian Patent in the entirety or whether the same are the Polymorphic version B of the suit patent compound. Rather, the plaintiffs attorney has deposed everything on the basis of what has been shown in the physical form of literature of the drug of the defendant which only demonstrates that it contains Erlotinib Hydrochloride. There are other evidence of Mr. Thatcher PW 3 and ..... X X X X Extracts X X X X X X X X Extracts X X X X ..... intiffs on the aspect as to when such x-ray reports were taken, where are the originals of the said x-ray diffractions, about the correctness of the trends and no suggestions were put to Ms. Shashikala that the reports submitted by her are not correct or false. It is also not put to her that the reports are false as the plaintiffs are manufacturing the medicine or drug which actually corresponds to suit patent IN'774. Further, it is also not suggested to her that the reports are prepared only as a replica to trends contained in US patent 221 by looking at the diffractions stated therein and actually no such trends ever emerged. The only thing which was put to her was that Indian Patent _774 is broad enough to cover any Polymorphic form prepared by anybody. Besides the same, nothing was to put to her to bring out a positive case that the plaintiff's patent corresponds to the drug manufactured by them in the market. 215. In the absence of the said suggestions, it can be said that the defendant has at least shown on record that the plaintiffs' product which is being manufactured and sold as Tarceva is Polymorphic B version of the compound. It is also clear from the plai ..... X X X X Extracts X X X X X X X X Extracts X X X X ..... hether all are the same in the nature, characteristics, properties in all respects with the parent compound. It is also not established by the plaintiffs' deposition that the chemical structure of the plaintiff's compound may not change when the same is converted into from admixture of Polymorph A B to Polymorph B. I think all these questions if at all answered in the form of the evidence would have simplified the plaintiff's case so as to establish that the direct case of infringement rather than to say simply that if at all Polymorph B exists in Defendant's tablet, the same is an infringement of the Plaintiffs Indian Patent '774 as it is covered within its ambit. 219. Nevertheless, let me now consider and evaluate what the parties have to say about the case of infringement of the patent at this juncture. The plaintiffs contend that the claim defines the scope of the invention and therefore the court while determining the infringement of the patent has to compare what has been contained in the claim of the invention vis- -vis the constituents of the product of the defendant. The plaintiffs state that in the instant case IN 196774 (IN'774 or the _s ..... X X X X Extracts X X X X X X X X Extracts X X X X ..... mine infringement is a 2 step process: i. First, the claim needs to be interpreted; ii. Second, the impugned product has to be compared with the claim. As per Section 48, it is erroneous to compare the impugned product of the Defendant with the Plaintiff's product. Therefore in the present suit, the infringement should be judged as whether the Defendant's product, i.e., ERLOCIP, falls under the scope of the Claim 1 of IN'774. The plaintiffs have cited several authorities wherein the rules of interpretation of the claims in patent are laid down by the courts from time to time. The said authorities relating to several propositions can be discussed in the following manner: i. Interpretation of a patent is a question of law and not fact. (Markman v. Westview, 517 US 370 at p. 384). ii. Claims have to be interpreted as on the date of priority of the patent application. (Philips v. AWH, 415 F. 3d 1303 at p. 1313) iii. If the words in the claims are clear and unambiguous then no aid of any other document to interpret is admissible. (Philips v. AWH, 415 F. 3d 1303 at p. 1314; F.H. B. Corporation v. Unichem , AIR 1969 Bom 255 at para 8) iv. If the wo ..... X X X X Extracts X X X X X X X X Extracts X X X X ..... CIP (Ex. P1,) clearly shows that the Defendant manufactures, offers for sale, and sells Erlotinib Hydrochloride tablets. c. Further, the package insert of the Defendant's product ERLOCIP (Ex. P2) clearly shows the composition of the tablets manufactured by the Defendant have the Active Pharmaceutical Ingredient (API), Erlotinib Hydrochloride. d. The license received by the Defendant from the Central Drug Standard Control Organisation on October 19, 2007 (Ex. PW1/D2,) was for manufacture of Erlotinib Hydrochloride (DW 1, Q 220,). e. The approval received by the Defendant from the Department of Food and Drug Administration, Government of Goa in December, 2007 was for manufacture of Erlotinib Hydrochloride tablets. f. It is further submitted that the Written Statement in the present suit contains an express admission by the Defendant that it manufactures and markets a generic version of Erlotinib Hydrochloride. Importantly, the Written Statement does not have any denial of infringement of Claim 1 of the suit patent. It is therefore humbly submitted that the Plaintiffs in the present case have discharged the onus of proving infringement of Claim 1 in view of ..... X X X X Extracts X X X X X X X X Extracts X X X X ..... Part I(B) of the Court Record). k. It is further submitted the Defendant has not placed on record any X Ray Diffraction data to show that it is manufacturing Erlotinib Hydrochloride in Polymorph B form or that the same differs from Erlotinib Hydrochloride as claimed in Claim 1 of the suit patent IN'774. l. Therefore the Defendant's averments in oral arguments that the product manufactured by them is the Erlotinib Hydrochloride in Polymorph B form and therefore, the product does not infringe claimed compound Erlotinib Hydrochloride of suit patent IN'774 is false and contrary to their own admissions. m. In the absence of any such pleading or evidence, it is submitted that the Defendant has not rebutted or explained away its admissions that it has the license and governmental approvals to manufacture _Erlotinib Hydrochloride' and not any Polymorphic form, and that it does so under the brand ERLOCIP. The plaintiffs submitted that without prejudice whatever alleged difference exists between the combination of Polymorph A and B and Polymorph B, the defendant could not have arrived at Polymorph B form of the molecule which is stated by the defendant without cro ..... X X X X Extracts X X X X X X X X Extracts X X X X ..... f molecules which is designated as a particular Polymorphic form of a compound. s. Importantly, there has been no evidence or process stated by Defendant to show that Erlotinib Hydrochloride in Polymorph B form can be made without using claimed Erlotinib Hydrochloride. (paragraph 35 of the Evidence Affidavit of DW3) t. It is submitted that it is Defendant's own argument that one person's finished product can be another's raw material. More specifically, this implies that Erlotinib Hydrochloride tablets (the finished product allegedly being Erlotinib Hydrochloride in Polymorph B form) has to be made from Erlotinib Hydrochloride bulk (i.e. the Active Pharmaceutical Ingredient which is undisputedly the same Erlotinib Hydrochloride as claimed in Claim 1 of the suit patent IN'774). u. Importantly, even the application for the Erlotinib Hydrochloride in Polymorph B form in the US, US 6900221 (US'221) states that Erlotinib Hydrochloride in Polymorph B form results from re-crystallization of Erlotinib Hydrochloride using different solvents and temperature condition. This has been admitted by DW3 in (Q.82, DW3), during the course of cross examination. v. Simp ..... X X X X Extracts X X X X X X X X Extracts X X X X ..... as been expounded in several leading commentaries including Philip W. Grubb's, PATENTS FOR CHEMICALS, PHARMACEUTICALS AND BIOTECHNOLOGY (at p.4, 1999 edition) stating that, Exclusionary Right.... In a very common situation where A has a patent for the basic invention and B later obtains a patent for an improvement to this invention, then B is not free to use his invention without the permission of A, and A cannot use the improved version without coming to terms with B. v. This passage has been cited with approval in the case of Hindustan Unilever Limited v. Lalit Wadhwa, 2007 (35) PTC 377 at paragraphs 14 and 16. a. Therefore, it is well-known as well as statutorily recognized that more than one patent can cover a single product. vi. Thus, assuming that Erlotinib Hydrochloride in Polymorph B form or any other Polymorphic form had been granted a separate patent, then such patent could not be worked without the approval and/or license of the patentees to the suit patent IN'774. vii. This situation is also evident upon a reading of the US Judgment, OSI Pharmaceuticals LLC Ors. v. Mylan Pharmaceuticals from the District Court of Delaware in favour of Plaintiff ..... X X X X Extracts X X X X X X X X Extracts X X X X ..... loride compound as claimed in Claim 1 of the suit patent, IN '774. Therefore, once Erlotinib Hydrochloride in Polymorph B form is deemed to be the same pure substance as Erlotinib Hydrochloride under Section 3(d), it is not permissible to treat Erlotinib Hydrochloride in Polymorph B form as a different substance for the purpose of Section 48 or any other provisions of the Act. The Supreme Court in various cases while applying the principle of 'deeming fiction' has held that if the statute requires a person to treat an imaginary state of affairs as real, then one must, unless prohibited from doing so, also imagine as real the consequences and incidents which, if the putative state of the affairs had in fact, existed must have inevitably flowed from. After one imagines this specified state of the affairs, then one cannot cause or permit one's imagination to boggle when it comes to the inevitable corollaries of that state of affairs. c. Therefore after the rejection of the application for Erlotinib Hydrochloride in Polymorph B form, the separate invention of Erlotinib Hydrochloride in Polymorph B form has been deemed by legal fiction to be a part of the known substa ..... X X X X Extracts X X X X X X X X Extracts X X X X ..... USA and patent applications in India clear admissions have been made that the suit patent is related to Polymorph A+B but the second patent US'221 and corresponding applications in India relates to Polymorph B form of Erlotinib Hydrochloride. The date of application of Polymorph B in USA under US'221 was 9th November, 2000 which was granted on 31st may, 2005 and in India the plaintiffs' application for Polymorph B was IN-507/DEL filed on 14th May, 2002. The defendant argued that the Plaintiffs had to explain these admissions which have not been done throughout arguments till conclusion of their arguments. No evidence was led nor was an attempt was made to argue why these admissions cannot be relied upon. The only argument of the Plaintiffs is that the inventors are different of the suit patent and Polymorph B patent or that the subsequent patent cannot be looked into. It is absurd to argue and is not based on any legal proposition that that in a counterclaim, admissions of the plaintiffs cannot be looked into. All these patents being US'221, US'613 and applications IN/497/DEL, IN/507/DEL belong to the same family. For the Plaintiffs to ask the Court not to ..... X X X X Extracts X X X X X X X X Extracts X X X X ..... oduct is a commercially saleable product. This is clear from the following decisions: i. Delhi Cloth and General Mills Co Ltd vs. RR Gupta, Commercial Tax Offcier, Jaipur (1976) 3 SCC 443 ii. UOI Ors vs. Tata Iron and Steel Co (1975) 1 SCC 78 iii. South Bihar Sugar Mills Ltd vs. UOI Anr (1968) 3 SCR 21 iv. Bhor Industries Ltd Bombay vs. Collector of Central Excise Bombay (1989) 1 SCC 602 Therefore, there is a fallacy in the argument of the plaintiffs that the product in question is irrelevant. If the composition of the said product does not match with the claims, then the same cannot be covered within the ambit of the patent. The defendant argued that by relying on the IN'774 after the rejection of IN 507 relating to Polymorph B, the plaintiffs are indulging into the act of double patenting which is impermissible. It has been argued that the concept of umbrella patent is alien to patent law. It is clear that double patenting is not permissible. The plaintiffs have not chosen to respond to this. It is obvious that there cannot be two patents for the same product. If Polymorph B is an independent invention, it cannot be covered under the suit patent ..... X X X X Extracts X X X X X X X X Extracts X X X X ..... st as to whether the impugned product is infringing the patented subject matter especially when there is a patent claim on the subject and there is a product which may not strictly covered within the patent claim but contains something else as well in form of variant or reactants. 228. As per the plaintiffs, the test is that the Court has to see what has been claimed in the patented invention and the product in question and if the product which is claimed is subsumed within the product which is stated to be infringing, the infringement is established. As per the plaintiffs, the Court has to look only claims and product and if there is exists ambiguity, then the resort must be taken to the specification and nothing else. 229. In effect, the plaintiffs state that the Court has to interpret the claim or specification strictly and compare it with the product which is impugned in order to find out infringement. I find the said tests appears to be correct so far as it relates to simplicitor infringement cases where the impugned product is straightaway subsumed in the claimed portion of the invention without anything else in the said product. However, the question remains whether th ..... X X X X Extracts X X X X X X X X Extracts X X X X ..... where the resort was taken to such construction of the patent claim in order to enlarge the scope of the patent, which was never the intent or the purpose of the said invention, the Courts also came across the cases where the properties and characteristics of the product significantly varied from what has been claimed in the patented invention. Those were the cases where the alleged infringing product contained some additional variant or the part in addition to the product or process under patent, the Courts in such a case answered the said question by laying down that much shall dependent upon the role of the said variant in the said product. The cases in which the role of the said variant is inconsequential in nature and does not change the nature and characteristics of the article, then in those cases, the product in question is an infringement of the patent, in all other cases, where there is a role of such variant which may alter the characteristics and quality of the said product or process, there is no infringement of the patent. However, what is a role of such variant in each case is essentially a question of the fact and same shall depend upon case to case basis. 233. ..... X X X X Extracts X X X X X X X X Extracts X X X X ..... e asked is thus in summary, whether the strict compliance with the particular piece of the claim language would be understood to be an essential requirement of this invention. The necessary understanding is that of those skilled in the art (though ultimately, as explained below, the final determination of the true construction is a matter for the Court, once properly instructed, and not witnesses. Lord Diplock then proceeded to lay down the exception to the said principle or true question by discussing as to in which cases the said question framed above will not arise. As per him, the said question of strict construction of the claim and generally understanding of the persons skilled in the art would not arise in cases where the variant which is included in the invention would have material impact or effect on the working of the invention. This is in a way exception to the rule of construction laid down by Lord Diplock which is in applicable where there exists a role of the variant which may have effect on the working of the invention. Lord Diplock propounded this approach by observing in the following manner: The question, of course does not arise where the variant would in ..... X X X X Extracts X X X X X X X X Extracts X X X X ..... ) There is thereafter an exception to exception which is laid down by Lord Diplock so as to determine in which cases where variant is present, the said rule of purposive construction can still be applicable. Those are the cases where it is proved on record that from the reading of the patented claim the patentee could not have intended to exclude the minor variants which to the knowledge of him as well as readers of the patent could have no material effect in the way in which the invention worked. The said exception can be sub-categorized into the following fact finding enquiry:- i) That one has to show by an evidence as to what is missing in the patented claim and the product in question is a minor variant; ii) That there could not have been intention of the patentee to exclude such minor variant from the ambit of invention; iii) That the said minor variant could have no material effect on the way in which the invention worked. 235. The presence of these facts collectively on record coupled with the positive evidence to the said effect would be determinative of the fact that the invention and the patented claim would subsume even the product which contains some minor v ..... X X X X Extracts X X X X X X X X Extracts X X X X ..... al on 18.5.2009, although it is another matter in that the case how the said approach was used depends upon the facts of that case) 239. To take the discussion further, the rule of purposive construction laid down by Lord Diplock does not rest here and the Courts have taken this test further in order to analyze the infringement claims in the future patent claims by applying conveniently either the rule or the exception or the exception to exception depending upon the facts and circumstances of the case as to in which case there are major variants added in the product or claim and in which case there are minor variants added to the patented claim. 240. Justice Laddie of Patent Court in UK applied the Catnic approach in the cases relating to chemical compounds in the case of Merck and Co. Inc. Vs Generic UK Limited, reported as 2004 RPC page 31. The said case gains its relevance as Justice Laddie laid down further test as to what the patented claim should contain in order to arrive at the finding as to whether the role of variants is sufficiently explained or not and further whether only the patented claim or specification is relevant for the purposes of construction or whether ..... X X X X Extracts X X X X X X X X Extracts X X X X ..... t which make no material difference to the way it works. For example, the invention may relate to a mechanical device in which two parts are connected together. A new method of connection might not be covered by the exact words of the claim, but the notional reader would be reasonably confident that the patentee may choose a form of language which emphasizes which features of an invention are important and which are not. For example it is common to find claims which start with general description followed by characterized in followed by a list of features. The addressee would appreciate that the latter features are particularly important but the features before the words characterized in are less so. If there is a variant to the latter which obviously does not affect the way in which the invention works, the notional reader may be reasonable confident that the inventor wanted to cover this variant as well. In these types of cases, the monopoly is likely to extend to the new variant. (Emphasis Supplied) 43. In my judgment, the same principles underpin the Protocol. The aim is always to determine objectively from the words used particularly, but not necessarily exclusivel ..... X X X X Extracts X X X X X X X X Extracts X X X X ..... s patented claim. Justice Laddie thereafter compared /tested the said chemical compound on the basis of improver questions which are exception to the rule laid down in Catnic in the following words:- 55. The first Improver question does not create a factual dispute which needs to be resolved in order to determine whether an embodiment outside the contextual scope of the claim is within the monopoly created by the patent. It is only question (3) which determines construction. In most cases the answer to the first question will not be in dispute. If the variant does not work in the same way as the invention it cannot be within the scope of the patent. The patentee could not have intended otherwise. Thus a negative answer to this question will inevitably lead to the third and crucial question being answered in a way which excludes the variant from protection. But what if it is unclear to those skilled in the art whether the warrant works in the same way as the invention, either because the way the invention works is not clear or the way the variant works is not clear, or both? In such a case it is impossible for it to be apparent to the reader that the limitations in the claim wer ..... X X X X Extracts X X X X X X X X Extracts X X X X ..... the Catnic approach was adopted. (Emphasis Supplied) 243. In view of the above stated observations of Court in Merck (supra) it is clear that the said Catnic approach is good law and can also be applied to the cases relating to chemical compounds. Even in the case of Merck Co.(supra) Justice Laddie proceeded to apply the said test and came to the conclusion that there was no infringement in the said case as the role of variants outweighed the patented claim. This has been observed by learned Justice Laddie in the following words in para 67 by applying the Catnic approach and coming to the conclusion that further experimentation with the reactants was never contemplated within the ambit of patented claim. In the words of Justice Laddie:- 67. As Hoffmann J. said in relation to Improver question (1) whether use of a product or process outside the acontextual scope of a claim has a material effect on the way the invention works depends on the level of generality at which one describes the way the invention works. If in this case, the inventions consists simply of running a process for making alendronate in which the reaction is maintained in a fluid and homogeneous state, ..... X X X X Extracts X X X X X X X X Extracts X X X X ..... be achieved. 79. In my view it is not proved that the notional skilled reader would have even thought of substituting another sulphonic acid for MSA. The hesitation of Dr. Cunningham represented more closely the approach of such a reader. Furthermore, it is not proved that any skilled worker would have considered it obvious that replacement of MSA by another sulphonic acid would be so effective that it would achieve the same, or substantially the same, level of purity and yield promised by the patent. He would not have been confident that such substitution would produce such a yield and purity that the production of alendronate could be achieved in a one-pot process as promised by the patentee, rather than with a separate extraction and purification step (as in the CIPLA process) Improver question 2 is answered in the negative. 245. The afore quoted observations of Justice Laddie make it apparent that the test of obviousness to revoke a patent is distinct from the test of obviousness to a person to whom the specification is made available to arrive at the product containing variant is concerned. Both do not coincide and if the Court believes that they coincide then the Court ..... X X X X Extracts X X X X X X X X Extracts X X X X ..... intiffs are doing so and time and again maintaining that the Polymorphic version is subsumed in the underlying patent which is IN'774 and all other reasons discussed above. The stand what the defendant is taking is that the defendant is making what the plaintiffs are making which is the Polymorphic B version of the compound which was never intended to be included in the patent and does not even corresponds with the patent claim. To which, the plaintiffs' response is two-fold, first is that the defendant is making Erlotinib Hydrochloride which is under suit patent and the said position is thus disputed, second is that in any case whatsoever is the case, due to manifold reasons and admissions discussed and enumerated above, the defendant's Polymorphic version B if any shall still fall within the ambit of the suit patent. I shall now discuss both the said positions of the plaintiffs after applying the test of comparison in the present case. It is the case of the plaintiffs that the plaintiffs are concerned with the claim 1 of the Compound namely Erlotinib Hydrochloride. It is seen that the onus is on the plaintiffs to show that the said product of the defendant correspo ..... X X X X Extracts X X X X X X X X Extracts X X X X ..... ld have been done by deposing on the following facts: The fact as to what is exactly claimed in the patent claim as a compound. The fact as to what is the actually the Polymorphic version B of the said compound Erlotinib Hydrochloride The fact as to how many reactants or variants with which the Erlotinib Hydrochloride as a compound is reacted with in order to arrive at the Polymorphic version B of the same. The fact whether the properties and the characteristics of the said compound changes or varies after the said variants or reactants are reacted with or not. The plaintiffs in order to show that there is an infringement should have deposed to the effect that the said properties and characteristics are not changed pursuant to the reaction. The fact that whether the change if any to the property or characteristic is based on the role of the reactant in the said process of crystallization or otherwise due to the presence of the main compound itself. The fact that the conversion of the Polymorphic version B from the main compound which is combination A and B is not based on the major reactants and the result of minor reactants or variants, the role of wh ..... X X X X Extracts X X X X X X X X Extracts X X X X ..... basis of some existing facts by picking and choosing the versions of the parties from here and there in the collateral litigations. I think the same by itself is not sufficient discharge of the onus which is independently casted upon the plaintiffs to show that the invention of the plaintiffs under IN'774 subsumes the product in question of the defendant. Therefore, the plaintiffs have followed this indirect route by relying on some stands taken in the case of the defendant from time to time and not by directly adducing any positive evidence to dislodge the defendant position that the drug in question is made on the basis of Polymorphic version B of the compound. The other reasons stated below would further unveil as what compelled the plaintiffs by taking such stand and not adducing the direct positive evidence towards the establishment of the facts essential and material to determine the infringement. The plaintiffs have not followed the approach 2 as the plaintiffs do not want to adduce an evidence to the effect that the role of the reactants or the variants attached to the said compound is minimal which though may somewhere include their Polymorphic version B in the su ..... X X X X Extracts X X X X X X X X Extracts X X X X ..... compound. PW3 discusses about the role of the said compound in preventing human cancer. The said witness deposes that the Erlotinib is sold in tablet form. It is stated that European Medicines Agency and other references no references to the Polymorphic forms. The said witness however does not depose positively as to what is clinically and medically correct position as to whether the drug Tarceva is a Polymorphic version B of the compound in the suit patent or not. The said PW3 nowhere relies upon any x-ray diffraction reports relating to the said deposition which could have clarified this aspect. Thereafter PW3 immediately proceeds to discuss clinical trials, the success of the medicine by deposing that Erlotinib is the only compound recommended for treatment of the cancer and that Erlotinib and Astrazeneca's Gefitinib are different. There is no whisper in the entire evidence relating to what exactly is the plaintiff's product and the defendant products and the approaches discussed above are completely missing. The said PW3 was cross examined in great detail where in some questions were asked relating to US'221 and about the existence of unstable version Erlotinib Hyd ..... X X X X Extracts X X X X X X X X Extracts X X X X ..... by making legal arguments and arguments on some alleged admission), if so, then what is the role of the reactants with which the claimed compound is reacted in order to arrive at the Polymorphic version and whether the properties and characteristic of the Polymorphic version corresponds with that of the suit patent. Consequently, the plaintiffs have not been able to discharge such onus of proof upon the plaintiffs in relation to establishment of such facts which would aid towards establishment of the infringement of the patent. 256. The answer to all these questions can be found if one reads the document DW1/6 which is the US221, placed on record by the defendant. The said patent was applied in the year 2002 which provides that the US 498 which corresponds with IN'774 relates Erlotinib Hydrochloride in the form of combination of Polymorphs A and B. However, it has been seen that by adopting the steps of chlorination, further steps stated in the said patent in requisite temperature, the Polymorphic version B of the said compound can be arrived at. Some of the excerpts from the said specification documents are worth noting and the same reads as under: The present invention ..... X X X X Extracts X X X X X X X X Extracts X X X X ..... Polymorphic forms which have been designated A, B and C of increasing stability with different x-ray powder patterns....... (note there are other paragraphs which compare such x-ray diffractions which are not reproduced for the sake of brevity.) 257. From the reading of the afore noted paragraphs of the specification of US'221, the following facts can be deduced: The said compound namely N-(3-ethynylphenyl)-6-7-bis (2-methoxyethxy)-4-Quinazolinamine exists in different Polymorphic versions and what contained in US'498 which corresponds to IN'774 is a combination of the Polymorphic A and B version of the said compound. The stability of the compound varies with the existence in the different Polymorphic forms and the most stable is the one in form B which forms subject matter of US'221 and the same is rejected in India in the form of IN'507. The Polymorphic B version is preferred in tablet form over the combination form due to its reduced stability. Stability has been a matter of concerns for the patients. There are several steps involved in reactions of the said compound in order to arrive at the pure Polymorphic form B Not merel ..... X X X X Extracts X X X X X X X X Extracts X X X X ..... of reactants have been rejected in India on the ground of Section 3(d) and obviousness and thus there was in fact no role of the reactants in the Polymorphic version and the said inference is incorrect. I think there is inherent defect in such an argument due to the reason that the mere rejection of the Indian Patent on the ground of new form of the old compound does not automatically minimize the role of the reactant as inconsequential on basis of which the compound was worked upon. There may arise a case where the reactant role is still substantial in nature but they are mere workshop results and not innovative one which may exclude Polymorph from the suit patent and at the same time leads to rejection of new patent on the ground of being obviousness or lack of novelty. 261. In this context, I find my respectful agreement with to the test laid down by Justice Laddie (supra) in Merck which is that the obviousness in the context of the patentability cannot be equated with the obviousness in relation to person who is given a specification to arrive at the product containing variant is concerned. If in the later case, the said person has to do the further experimentation, then th ..... X X X X Extracts X X X X X X X X Extracts X X X X ..... nner infringing the legal rights in the drug Tarceva. In para-11 of the plaint, it is specifically stated that the plaintiffs are manufacturing the drug under the process of patented product. The said statement apparently untrue as it is evident as per material available on record that they are marketing the product under new version of Polymorph B for which the plaintiffs have registration in India. 264. The plaintiffs' argument that the defendant's witness is able to identify the formula of the erlotinib hydrochloride and thus the infringement should be inferred on the basis of admission is equally incorrect because the plaintiffs have knowingly sought to restrain the defendant from infringing the legal rights in the product Tarceva. The prayer as to infringement of Patent IN'774 is not mentioned in the prayer clause. After the discussion done under this head, it has been found that no such legal rights subsist in the product Tarceva which is a Polymorphic version B which was never intended to be included in the claim of the suit patent on the purposive construction of the claim. These attending circumstances clearly establish that on the date of filing the suit, t ..... X X X X Extracts X X X X X X X X Extracts X X X X ..... onstituents of the plaintiffs' drug and whether the same corresponds with the suit patent which is clearly missing in the instant case. Therefore, the said alleged admissions are inconsequential for the purposes of discharge of the plaintiffs' onus of the proof. 267. Further, the admissions which the plaintiffs are setting up are not the ones which are clear and unambiguous. There are chains of the facts which are to be established in order to show an infringement. Mere identification of the chemical structure of the compound by the witness and reading along side with the fact that earlier in the written statement there was no reference of Polymorphic B version made by the defendant and to say that would lead to clear admission on the part of the defendant that what the defendant is actually making is the drug under the suit patent will not actually establish infringement. This more so, when the defendant is disputing such position till date in the arguments as well as there is a reference of the Polymorphic versions in the counter claim. In these circumstances, the admissions which the plaintiffs are setting up are not clear and unambiguous to draw such inference. This ..... X X X X Extracts X X X X X X X X Extracts X X X X ..... resent case, the plaintiffs have not adduced any positive evidence to show the role of the major or minor reactant. On the contrary, the US'221 patent specification reveals that there are number of the steps involved in arriving at the Polymorphic version B. therefore, the argument of the plaintiffs that the compound patent will take care of the Polymorphic version in absence of the positive evidence is rejected. 269. The contention of the learned Senior counsel appearing on behalf of the plaintiffs that the Polymorphic form loses its significance when the said medicine is consumed and therefore what is left over is the suit compound, therefore the Court should infer the infringement. Again, the said submission does not addresses the key questions which are that why there is no positive evidence defining clearly that the role of the reactants stated in US'221 is inconsequential in nature, the question that the tablet containing the Polymorphic version of the compounds contains reactants?, if so what is the role of the said reactants?, Whether the role of the reactants also leads to change in the working of the invention? The said answers are not coming forward rather it ..... X X X X Extracts X X X X X X X X Extracts X X X X ..... e the scope of the patented compound as it was never intended by the plaintiffs to be included at the first place. Therefore, the said principle propounded by the plaintiffs does not aid the case of the plaintiffs for the purposes of discharging the onus of the proof as to infringement. 272. The reliance on the judgment of the US District Court in the case of, OSI Pharmaceuticals LLC Ors. v. Mylan Pharmaceuticals will also not assist the case of the plaintiffs. This is due to the reason that in the present case after examining material evidence on record, I have found that the plaintiffs have not been able to discharge the onus as to establishing the infringement. The said judgment was rendered where the defendant admitted the aspect of infringement of the patent and also in the context of the law where both the patents US 498 and US'221 are valid and here in India the facts and circumstances are different. Moreover, the suit was also filed on the basis of two registered Patent Nos.US-221 and US-613 of Poly-B. The defendant challenged only validity. In India, admittedly the plaintiffs' application for Poly-B has been rejected. Thus, the said judgment is clearly disting ..... X X X X Extracts X X X X X X X X Extracts X X X X ..... thereto, it cannot be said that the provisions use the words deeming or deemed to be , rather the provisions states that the Polymorphic versions shall be considered to be same substance unless they differ significantly in properties with regard to efficacy. The said wordings used are considered and not deemed to be considered . It is well settled principle of law that the Courts cannot under the premise of interpretation can read into the words in the provisions of the statute when they are not specifically legislated. The Court also cannot enlarge or limit the scope of the provisions by reading into something which is not present in the wordings of the Section. Applying the same principle of law to the present case, when the legislature used the word considered unless the Polymorphic version differs in the efficacy, then the same shall be only considered unless the contrary is proved. But that does not mean that it shall be deemed to be for all practical purposes the same product or substance. Therefore, there is only a limited scope of consideration which is enacted in the form of explanation till the time the efficacy differences are shown and not the blanket fictio ..... X X X X Extracts X X X X X X X X Extracts X X X X ..... product in question is subsumed within the claims of the patent. The said onus has to be discharged by the plaintiffs independently by showing the positive evidence. There is no merit in the submission of the plaintiffs that the plaintiffs failure to discharge onus to the contrary to show efficacy and ultimately a different substance before the controller may lead to automatically the discharge of onus to prove that the Polymorphic version B is the same substance as that of the claimed in the patent. I think both the onus is different and distinct lied upon on the plaintiffs at different occasions. The failure to discharge the one cannot be equated to successful discharge of other when both are inconsistent to each other. There may arise a circumstance that the product in question may not be so novel or obvious to the person or may not have industrial use or may be based on same substance (but not identical) and hence not separately patentable being not novel and at the same time, the said product also does not fall within the ambit of the previous patent too. Thus, in order to dislodge the said circumstance or eventuality, the plaintiffs have to establish independently that ..... X X X X Extracts X X X X X X X X Extracts X X X X ..... protected from light during patient administration. (Q. 155-156, PW3) e. Further as borne out from the Investigators Brochure (PW1/X2), Erlotinib Hydrochloride was successfully administered in the tablet form in trials conducted in 1997 i.e. two years prior to the invention of Polymorph B form of Erlotinib. 276. I think the reliance of the plaintiffs on the defendant's cross examination to this effect is a step towards the correct approach. But, it should have first come from the plaintiffs end as to for what role then the reactants played in order to arrive at the Polymorphic version B. How the same can be termed as inconsequential when the same affects the change in the property or form of the compound by making it solid, re-crystallized and pure, how the said reactants do not affect the working of the product materially when as per the plaintiffs own declaration before US patent office in US'221, the said reactions as steps make the compound the stable in form. If the answers of these questions would have been emanated from the plaintiffs in the form of depositions so as to establish that the Polymorphic version was intended by the inventor to be included in suit p ..... X X X X Extracts X X X X X X X X Extracts X X X X ..... ent No. US'498 is a mixture of Polymorph A B. Therefore, the plaintiffs had knowledge that the hydrochloride compound in the suit patent was in the form of mixture of Polymorph A B way-back in the year 2000 when the said application US'221 was made for registration. However, the said fact was not revealed by the plaintiffs either in the suit proceedings or in the pending application in the suit patent till the date of grant of suit patent i.e. July, 2007. It is not denied by the plaintiffs that the compound under the suit patent is not preferred form for making tablets. The B-Polymorph form as admitted in US'221 is more stable and also suitable for making tablets. Significantly, in plaint the plaintiffs chose not to provide the XRD graphs and data of the product 'Tarceva' although in the said US Patent No. 6900221 the plaintiffs have provided XRD data of both A B Polymorph forms and which were readily available to them at the time of the filing of the suit. The defendant in its evidence has been able to prove that Tarceva tablets which are sold in India are wholly B Polymorph of the hydrochloride salt of N-(3-ethynylphenyl)-6, 7-bis (2-methoxyethoxy)-4-quinaz ..... X X X X Extracts X X X X X X X X Extracts X X X X ..... ffs' counsel and no attempt has also been made to dislodge the same. 279. The plaintiffs have admittedly no registration of Polymorph B version. In fact, the plaintiffs filed the application for registration of the same under No. IN'507/DEL. The same was opposed by the defendant. The said application was rejected on the ground that it does not qualify the requirement of Section 3(d) of the Patents Act, 1970. In India, Section 3(d) of the Act does not qualify variant of a basic drug Molecule unless such version shows an enhanced therapeutic efficacy. Though the said application was corresponded with the US'226 application patent of which was granted by US Patents Office who has accepted the claim of the plaintiffs for the same enhanced therapeutic efficacy, the detail of which is already referred in paras-257 258 of my order. After rejection of the said application by the Controller of Patents in India, his order was not challenged by the plaintiffs in higher Court. It is pertinent to mention here that the condition similar to Section 3(d) in Indian Patents Act is not the law in US. No suit for infringement of patent is maintainable unless the patent is registere ..... X X X X Extracts X X X X X X X X Extracts X X X X ..... also made by the learned counsel for the defendant that any injunction passed on such patent will not effect the business of the defendant, as it is marketing its products in Polymorph B version. According to the defendant, the plaintiffs have intentionally made the prayer in the plaint to restrain the defendant from infringing the Tarceva product of the plaintiff as on the date of filing of the suit the plaintiffs was aware that the Tarceva is marketed under Polymorph B version. 283. This Court is conscious about the fact that a monopoly of the patent is a reward of the inventor and there must be presumption of validity of the patent but at the same time, law mandates that the Court must look at the whole case, the strength of the case of the patentee and the strength of the defence raised in the matter. 284. In these circumstances, in the absence of the discharge of onus of proof by the plaintiffs which was independently lied upon them, the plaintiffs have not been able to establish the infringement of the IN'774 on balance of the probabilities. Therefore, the said issue is answered against the plaintiffs and in favour of defendant. 285. To sum up the findings arriv ..... X X X X Extracts X X X X X X X X Extracts X X X X ..... e dosages and form like tablet one also changes than the earlier one. The factum of the rejection of the separate patent IN'507 filed in India which was the attempt of the plaintiff's to seek the separate protection to the Polymorphic version B. this is again indicative of the fact that the plaintiffs as a patentee never intended to include the said Polymorphic version B in the suit patent but always intended to treat the same as a separate invention. The plaintiffs' rejection of the patent in IN'507 is due to the reason of failure of the plaintiffs to satisfy the controller as to efficacy part under the explanation appended to Section 3(d) and the said order has attained finality. The plaintiffs' inability to show the positive evidence to establish as to how the statements made in US'221 are not relevant especially when the role of the reactants and workings are clearly defined therein. The plaintiffs could have done so by their own defining the role of the reactants and their effect on the working by leading contrary evidence. The plaintiffs not following the direct approach of establishing the infringement by clinically examining the produc ..... X X X X Extracts X X X X X X X X Extracts X X X X ..... issue no. 4. The said issue no. 4 reads as under : Whether defendant/counter-claimant proves that the plaintiffs' subsequent US Patent 6900221, is to the effect that the compound of claim No. 1 of the suit patent is a mixture of two Polymorph A and B Compound and need to be separated to perform and get the claimed compound for acceptable efficacy; and its effect on the plaintiffs' patent? OPD. 289. The afore noted issue can be classified into two parts: Whether the defendant has proved that the plaintiffs' subsequent US patent 6900221 is to the effect that the compound of claim no. 1 of the suit patent is a mixture of the two Polymorph A and B Compound Whether the defendant has proved that there is need of separation to perform and the get the compound of acceptable efficacy and its effect on the plaintiffs' patent. 290. I will now answer the said issue collectively as both are interlinked to each other and classified only for the purposes of understanding. 291. The onus to prove this issued was on the defendant. 292. Once I have held that the plaintiffs themselves are not able to explain the role of the existing two patents in US'498 an ..... X X X X Extracts X X X X X X X X Extracts X X X X ..... and where there is a product containing variants, the tests laid down in Catnic (supra) are applicable. Secondly, learned counsel stated that the evidence of the defendant is inaccurate and improper to establish the present issue. I tend to somehow agree with the learned counsel for the plaintiffs that the evidence is not too strong to establish to the certainty about the same but it's not too weak either especially in the light of the facts of the present case. I find that the case in hand is peculiar to its own facts wherein the plaintiffs are not able to explain and show that the suit patent includes the Polymorphic version B of the compound. Once, the plaintiffs themselves are not able to show the same, I think the evidence of this kind may work towards the discharge of the onus of the proof lied on the defendant. Learned counsel for the plaintiffs argued that no external aid of construction can be used to draw an inference against the plaintiff. I have already answered this submission under the infringement head wherein I have stated that overall facts and the facts correlating the invention with that of the product containing variants are relevant and material f ..... X X X X Extracts X X X X X X X X Extracts X X X X ..... for the plaintiffs argued that the subsequent statements made by the plaintiffs cannot be construed as admissions to limit the claim of the suit patent. I have already answered this submission that all the attending facts are relevant to draw an inference. This Court is not coming to finding on the basis of the admission but drawing an inference after evaluating the evidence of the parties and looking into the facts preceding and posterior to the filing of the patents in India and US as to what can be the possible interpretation of the suit patent as contained in claim 1. Learned counsel for the plaintiffs argued that there are admissions made by the defendant in the opposition proceedings by reading the pleadings of the plaintiffs in opposition proceedings. I would say that the same are not admissions as the defendant while contesting the opposition has merely stated that the IN 507 may not be allowed as the same lacks efficacy and in a way same substance to that of the Erlotinib Hydrochloride. However, that by itself does not mean that the defendant could not show before this Court that the US'221 relates to Polymorphic version B and IN'774 relates only the main com ..... X X X X Extracts X X X X X X X X Extracts X X X X ..... ication of US'221 indeed shows that there are certain steps which are to be taken in the form of further reactions to the compound claimed in suit patent in order to arrive at the Polymorphic version. The factual dispute, which the plaintiffs are canvassing now either should have been shown by adducing an evidence, which is relevant here as well as in the infringement action as what role these reactions, steps played in the working of the invention. The reactions or variants are shown in the specification playing a significant role which changes the form of the compound from one to another as well as also changes the advantages by making it more stable as stated therein. Therefore, these trivial aspects may not lead to any change in the case and the same are irrelevant. Learned counsel for the plaintiffs has placed reliance of the order of the Controller in the opposition to IN'507 as well as some statement made by the defendant where it is contended that there is no thereaupatic efficacy increase between the suit compound and the Polymorphic version B. It is correct that there are inconsistent stands are taken by the defendant but the same are to be evaluated in the l ..... X X X X Extracts X X X X X X X X Extracts X X X X ..... and against the plaintiffs. Re: Objections relating to marking of documents 299. Both the parties have raised certain objection with regard to marking of documents. There are certain documents which are not referred in the pleadings and the same are marked in the affidavits of the witnesses. I have seen the documents during the course of the proceedings which are mainly patent specifications, orders of the controller and the documents filed with the list of the documents filed by the parties. The said documents are, more or less, of the public documents in nature which are relating to litigation, which has happened between the parties and relied upon by the Controllers and Patent offices as well. Therefore, in case, there are pleadings pertaining to the contents of the documents, I am inclined to deal with the said documents which are in the nature of public/Government documents considering the exposition of the law that the objections as to exhibit numbers does not necessarily mean that the Court will not apply its judicial mind which document to be looked into and which not. (See the judgment passed in the case of Sudhir Engineering Company vs. Nitco Roadways Ltd , 1995 ( ..... X X X X Extracts X X X X X X X X Extracts X X X X
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