TMI Blog2009 (4) TMI 1009X X X X Extracts X X X X X X X X Extracts X X X X ..... , for which the plaintiff No. 2 claimed to hold a patent jointly with Pfizer Products Inc. The impugned judgment nevertheless put the defendant to terms including furnishing an undertaking to pay damages to the plaintiffs in the event of the suit being decreed, to maintain accounts of the sale of its product Erlocip, file in the court quarterly accounts along with the affidavit of one of its directors, and to file in the court annual statement of the sales of Erlocip duly authenticated by its chartered accountants on the basis of its records, including the sales tax and excise returns. 2. For convenience, the appellants are referred to as the plaintiffs and the respondent as the defendant. Case of the plaintiffs 3. In the plaint in the suit CS (OS) No. 89 of 2008 it is stated that plaintiff No. 2 OSI jointly owns a patent with Pfizer Products Inc. in respect of a small drug molecule medically termed as a Human Epidermal Growth Factor Type-1/Epidermal Growth Factor Receptor (HER/EGFR) inhibitor, popularly known as Erlotinib. It is claimed that the said drug marked a major breakthrough and innovation in the treatment of cancer. According to the plaintiffs the various tests ..... X X X X Extracts X X X X X X X X Extracts X X X X ..... have announced in the print and electronic media its plan to launch a generic version of Tarceva (Erlotinib) in India. One such news item appeared on 11th January, 2008 in an English daily Mint' having wide circulation in New Delhi, Mumbai and Bangalore. The plaintiffs state that from such news report they learnt for the first time of Cipla's plans to infringe and violate the plaintiffs' rights. According to the plaintiffs the drug Tarceva (Erlotinib) has been developed after a long sustained research and after incurring enormous expenditure inter alia on the tests which are mandatorily conducted for its efficacy and safety. It was alleged that the said innovation was duly protected under law and that no person except those legally authorized to exercise legal rights associated with the aforementioned patented drug could be allowed or permitted to simulate, re-create it in any manner or in any other name. It was alleged that the defendant had no right to opt to manufacture, sell or offer to sell any version of the drug Tarceva (Erlotinib) and that such action of the defendant, as announced by it, would be in blatant violation of the legal rights of the plaintiffs. 7 ..... X X X X Extracts X X X X X X X X Extracts X X X X ..... t it had applied for drug approval for the Erlotinib tablet in May 2007 and the approval was granted in October, 2007. As on December, 2007 it had received approval from the Government of Goa for manufacturing the said tablet in various pack sizes of 30,60,100,500 and 1000 tablets. The defendant had launched the product under the mark Erlocip and the said tablet was used for treatment of lung cancer. 11. It was pointed in the written statement that in terms of the second proviso to Section 11-A(7) of the Patents Act 1970, introduced by the Patents (Amendment) Act, 2005 (effective from 1st January, 2005), in case of patent applications filed under Section 5 (2) [which concerns a claim for patent of an invention for a substance itself intended for use, or capable of being used, as medicine or drug] the rights of a patentee accrue only from the date of the grant of the patent. It was also pointed out that although a certificate was issued to the plaintiffs by the Controller General of Patents bearing Patent No. 196774 dated 23rd February 2007, the pre-grant opposition was disposed of only on 4th July 2007. Therefore the patent could not have been granted with effect from 23rd Febru ..... X X X X Extracts X X X X X X X X Extracts X X X X ..... f. The plaintiff never chose to obtain exclusive marketing rights (EMRs) during the time that the law in India permitted it. 15. The written statement specifically pleaded public interest. It was pointed out that each tablet of the plaintiffs' drug Tarceva costs ₹ 4,800/- whereas each tablet the defendant's Erlocip costs ₹ 1,600/-. Thus, a one month dosage of Tarceva for a patient undergoing treatment for cancer would cost ₹ 1.4 lakh whereas the equivalent dosage of Erlocip would cost ₹ 46,000/-. It was pointed out that in the context of life saving drugs, it was in the public interest that the drug should be made available at cheap and affordable prices. 16. Along with the written statement, the defendant filed copies of the European Patent Publication No. 0566 226 A1 (hereinafter EP'226) which was an application of Astrazeneca Limited in the EU for grant of patent in respect of Gefitinib'. Among the other documents filed by the defendant was the decision dated 30th August, 2007 of the Controller of Patents in India rejecting the application by Astrazeneca UK Limited for grant of patent in respect of Gefitinib. In the said applicati ..... X X X X Extracts X X X X X X X X Extracts X X X X ..... n para 4 of the counter claim it was averred that the suit patent, i.e., Patent No. 196774 [corresponding to US Patent No. 5747498 - hereafter U.S.'498] had been obtained by the plaintiffs by suppression of material information. It was stated in para 4.2 as under: It is stated that the patentee knew very well that if it discloses the truth that the claimed product is in the form of a polymorph then the patent application would have been rejected at the outset because there is nothing to show that the product has enhanced therapeutic effect. Therefore by suppression of material facts the patentee has managed to obtain the impugned patent by by-passing the provisions of Section 3(d). 20. In para 5.2 of the counter claim the defendant pointed out as under: The present impugned patent fails to disclose that the compound of claim 1 of the impugned patent is actually a mixture of polymorphs, which is useless for pharmaceutical use. The patentee has intently and capriciously withheld material information that is important for practicing the alleged invention disclosed in the impugned patent. Therefore, the defendant states that the specification of the impugned patent does no ..... X X X X Extracts X X X X X X X X Extracts X X X X ..... y B polymorph of the hydrocholoride salt of N-(3-ethynylphenyl)-6, 7 bis(2-methoxyethoxy)-4-quinazolinamine. I further say that the X-ray powder diffraction of Tarceva clearly goes to show that it is not A polymorph or a mixture of A and B polymorph but is wholly B polymorph of the said compound. 22. It was stated in paras 12, 14 and 15 of the application as under: 12. The plaintiff in its various pleadings has claimed that the patented drug has been sold by it in India since April, 2006, meaning thereby the drug which is sold in India is the drug for which the patent has already been granted, i.e., Patent No. 196774. However, an analysis of the drug which is sold in India and the patent which is registered as also the patent which is pending in India reveals that the case of the plaintiff is completely false. The drug sold by the plaintiff in India appears to relate to the said pending patent applications and not the granted patent No. 196774.... 14. It is, thus, obvious that the plaintiff has come to this Hon'ble Court with a completely false and incorrect case. The plaintiff has deliberately failed to file the patent specification in the first place by claiming conf ..... X X X X Extracts X X X X X X X X Extracts X X X X ..... s in the injunction application I.A. No. 642/2008 were concluded before the learned Single Judge and orders reserved. Thus in the impugned judgment the learned Single Judge did not advert to I.A. No. 1272/2008 although a reference was made in the passing to the facts concerning polymorph-B. Summary of conclusions of the learned Single Judge 24. The summary of the conclusions arrived at by the learned Single Judge in the impugned judgment dated 19th March, 2008 are as under: (i) Section 3(d) of the Patents Act, 1970 was not merely clarificatory of the pre-existing law as contended by the plaintiffs. The Parliament consciously enacted a standard of known obviousness as a pre-condition of patentability; it also excluded the derivatives of known substances unless they differed significantly in properties with regard to efficacy. (ii) In patent infringement actions the court should not presume that a patent is valid especially if the defendant challenges it; the test to be applied in such event is to find out if the challenge by the defendant is genuine as opposed to a vexatious one and further that the defendant has an arguable case . (iii) In the instant case although ..... X X X X Extracts X X X X X X X X Extracts X X X X ..... was taken up for expeditious final hearing. Mr. Parag Tripathi and Dr. A.M. Singhvi, learned Senior Advocates appeared for the plaintiffs and Mr. Arun Jaitley, learned Senior Advocate and Ms. Pratibha Singh, learned Advocate appeared for the defendant. plaintiffs' subsequent application for grant of patent in respect of Polymorph B 27. In this appeal, one of the significant issues posed by the defendant, which has a bearing on whether the plaintiffs have made out a prima facie case for grant of injunction, is that the specification for the suit patent (i.e. patent No. 196774 corresponding to U.S.'498) showed that it was in respect of Erlotinib Hydrchloride Polymorphs A+B which was on their own showing an unstable form which could not be administered as such. It was contended that the case of the plaintiffs themselves was that it was Polymorph B which was the more stable form of the compound which could be administered in the tablet form. The x-ray diffraction pattern of the tablet Tarceva showed that it corresponded to Polymorph B for which the plaintiffs did not yet hold a patent. Their application for the grant of patent for Polymorph B was pending consideration. It ..... X X X X Extracts X X X X X X X X Extracts X X X X ..... rph B was subsumed in the compound which was a mixture of polymorphs A and B. As regards non-mention of the above facts before the learned Single Judge it is submitted that the application for Polymorph B was independent of the patent validly granted to the plaintiffs in respect of Polymorphs A and B. Inasmuch as even the defendant had in the written statement proceeded on the footing that the plaintiffs held a patent for Tarceva, and had therefore raised a challenge to the validity of the said patent, the Learned Single Judge was justified in not adverting to the contentions raised in the counter-claim and the I.A.1272 of 2008 while deciding the injunction application. It is further submitted that since the counter-claim and the I.A.1272 of 2008 were pending consideration before the learned Single Judge, this Court should not in deciding this appeal advert to the contentions raised therein. 30. Since this is an issue that did not arise for consideration before the learned Single Judge, and has been specifically raised in the appeal, this Court proposes to deal with it first. It must be noted at the outset that by the time the learned single Judge took up for consideration I.A. ..... X X X X Extracts X X X X X X X X Extracts X X X X ..... fectly possible and routinely done to patent incremental inventions e.g. Polymorph B of the main compound in addition to the main/dominating/umbrella compound , in India this is possible only subject to the conditions specified in Section 3 (d) of the Patents Act 1970. In other words Section 3 (d) read with its Explanation is, in the context of pharmaceutical products, an anti-evergreening provision. In the subsequent application for Polymorph B, the plaintiffs asserted that polymorph B is claimed to be thermodynamically more stable and it helps in providing improved oral dosage in solid form. Although the plaintiffs were quick to add that this did not mean that the umbrella compound and all possible polymorphs thereof whether singly or in mixtures were not useful and could not be used in solid oral dosage form , it does not answer a fundamental question that arises and which is this. Had the Controller of Patents while examining the plaintiffs' claim in respect of the compound which was a mixture of Polymorphs A and B been informed or was cognizant of the fact that there was another application pending in respect of Polymorph B in which the above statement was made by the p ..... X X X X Extracts X X X X X X X X Extracts X X X X ..... #39;221 which was granted to the plaintiffs for Polymorph B. The title begins with the words Stable Polymorph on N-(3-Ethnylphenyl)-6, 7-Bis (2 Methoxyethoxy)-4-Quinazolinamine Hydrochloride, Methods of Production, and Pharmaceutical Uses thereof. In the said document a reference is made to the earlier US Patent No. 5747498 issued on May 5, 1998 (which corresponds to Erlotinib Hydrocloride a combination of Polymorphs A B). A reference was made to the mesylate form of the compound which is easily deliverable according to parenteral methods of administration. By contrast, the hydrochloride compound was stated to be preferred with respect to solid administration such as with tablets and oral administration . The Summary' of the invention stated that the present invention relates to polymorphs, and methods for the selective production of polymorphs of N-(3-Ethnylphenyl)-6,7-Bis(2Methoxyethoxy)-4-Quinazolinamine Hydrochloride, particularly in the stable polymorph form . It was further disclosed in the said application as under: Stability of the hydrochloride compound is of concern for its use in the treatment of patients since variations will affect effective dosage level an ..... X X X X Extracts X X X X X X X X Extracts X X X X ..... d February 2007 to the plaintiffs, the facts concerning U.S.'498 and U.S.'221 were already known to the plaintiffs. The failure by the plaintiffs to bring the above facts to the notice of the Controller of Patents at the time of consideration of their application for patent for the compound of a combination of Polymorphs A and B was not consistent with the requirement of a full disclosure. The plaintiffs cannot be heard to say that after all the applications for grant of patent in respect of Polymorph B were pending before the Controller of Patents and he should have known that fact any way. It is perfectly possible that the Controller of Patents might not know, unless his attention is drawn to the fact, of other pending applications concerning the derivatives and forms of the product in question. It is also possible that the pre-grant opposed is not aware of them. Certainly the applicant would, as in this case, know how many more applications it has filed which are pending consideration. It would know what statements it made in the corresponding patents granted to it elsewhere. This would be relevant not only for the tests of novelty and obviousness but of efficacy as well ..... X X X X Extracts X X X X X X X X Extracts X X X X ..... n to comment on whether this flip flop is permissible or tenable, it is plain that the change in stand would admittedly have a direct impact on the question of patentability of either a compound of Polymorphs A and B or of Polymorph B free of Polymorph A. This made the full disclosure by the plaintiffs of all the facts pertaining not only to the umbrella' compound but the crystal or other forms of the product to the Controller of Patents imperative. It can be said with some certainty that such disclosure would have impacted the decision on the patentability of compound of Polymorphs A and B. When the defendant therefore questioned the validity of Patent No. 196774 on the above ground, it did raise a more than credible challenge. 39. The effect of non-disclosure of the above facts by the plaintiffs in their plaint in the suit will be considered next. Admittedly the plaintiffs did not disclose the above facts even while they asserted that Patent No. 196774 covered the product being marketed by them as Tarceva. The plaintiffs should have been candid and disclosed to the Court that they had filed separate applications for Polymorph B. They may have taken the plea, as they did r ..... X X X X Extracts X X X X X X X X Extracts X X X X ..... h B was the more stable form of Erlotinib Hydrochloride. For marketing it in the tablet form, it was Polymorph B, which would be relevant. The plaintiffs knew that a separate application for grant of patent for Polymorph B had been made and obtained in the USA. They knew that in the USA while being granted that patent (which although an exercise in evergreening is stated to be permissible there), it was claimed that the closest prior art U.S.'498 was for treatment of lung cancer in general not NSCLC in particular. The enhanced efficacy was sought to be thus justified. In short their case was that on its own strength Polymorph B of Erlotinib Hydrochloride deserved an exclusive patent on the ground of inventiveness and enhanced efficacy, non-obviousness and non-teaching by any prior Article Clearly the applications made by the plaintiff before the Controller of Patents for grant of patent in respect of Polymorph B was on the same lines. It is indeed in intriguing why the plaintiffs did not chose to be candid with this Court in making a full disclosure of all the above facts in its plaint. There can be no manner of doubt that had these facts fully disclosed in the plaint and the e ..... X X X X Extracts X X X X X X X X Extracts X X X X ..... ant had failed to provide comparative data compared to prior art U.S.'498 to show any enhancement in the therapeutic efficacy of the polymorph B. Even for the stability and bioavailability they claimed, no data was provided vis- -vis the prior art U.S.'498 compound. It was further held: A mere difference in physical property is a well known conventional variation of the same pure substance not showing an unobvious properties. Therefore, the changes alleged by the applicant is in the physical properties and not in the therapeutic efficacy. I therefore conclude that claim 1 and 2 are not patentable under Section 3 (d) of the Patent (Amendment) Act. Claim 6 of the plaintiffs in relation to composition comprising polymorph B form of Erlotinib was also struck down. The process claims of the plaintiffs in relation to Polymorph B have been set down for hearing. 45. It is sought to be contended by the plaintiffs that since their application for a patent in respect of the product Polymorph B form of Erlotinib stands rejected, the said order sets at rest the argument of the respondent regarding the Polymorph B application prejudicing and invalidating the present suit or the c ..... X X X X Extracts X X X X X X X X Extracts X X X X ..... the case has attained a different complexion. This Court finds that the plaintiffs ought to have been refused injunction for their failure to make out a prima facie case. 48. This Court nevertheless proposes to consider the points raised in the appeal independent of the finding on the issue of maintainability since extensive arguments have been addressed on this aspect. Principles that should govern while considering an application for grant of an injunction in a suit for infringement of a patent 49. The submission of the appellant is that once the plaintiff has been able to show that it has a prima facie case, injunction should automatically follow. Since the plaintiffs hold a valid patent in respect of Erlotinib Hydrochloride (polymorphs A B), which was not shown by the defendant to have been obtained by fraud, the plaintiff had made out a prima facie case of infringement and an injunction should automatically follow. It is submitted that that the patent granted to the plaintiffs in the instant case has undergone multiple level scrutiny and examination in terms of the procedures outlined under the Patents Act, 1970 as amended in 2005. The publication of the application u ..... X X X X Extracts X X X X X X X X Extracts X X X X ..... ant has not made a palpably unfounded claim . 51. It is contended on behalf of the defendant that under the Patents Act, 1970, as contrasted with the Trade Marks 1999, there is no presumption of validity of a patent. This is evident from reading of Section 13(4) as well as Sections 64 and 107 of the Act. It is possible to raise multiple challenges to validity of patent at various stages. It could be at the pre-grant and post-grant stages before the Controller of Patents. Thereafter before the Appellate Board or in a suit for infringement the defendant could question the validity of a patent on the grounds set out in Section 64. The patent in the instant case was, therefore, vulnerable to challenge notwithstanding it surviving the challenge at the pre-grant stage. The object behind this was to ensure that known inventions are not granted patents and that the patent is used for the public benefit. 52. The above submissions have been considered. It must be clarified that this Court has held already that the plaintiffs have failed to make out a prima facie case. The above submissions of the plaintiffs are therefore being dealt with assuming, as the learned Single Judge did, that ..... X X X X Extracts X X X X X X X X Extracts X X X X ..... td. v. Oswal Trading Co. Ltd . AIR2000Delhi23 ; Bilcare Ltd. v. Amartara Pvt. Ltd. 2007 (34) PTC 419(Del); Surendra Lal Mahendra v. Jain Glazers (1979) 11 SCC 511. In Beecham Group Ltd. v. Bristol Laboratories Pty Ltd. (1967) 118 CLR 618 and Australian Broadcasting Corporation v. O'Neill (2006) 229 ALR 457 it was held that the defendant alleging invalidity bears the onus of establishing that there is a serious question to be tried on that issue. In Hexal Australai Pty Ltd. v. Roche Therapeutics Inc. 66 IPR 325 it was held that where the validity of a patent is raised in interlocutory proceedings, the onus lies on the party asserting invalidity to show that want of validity is a triable question. In Abbot Laboratories v. Andrx Pharmaceuticals Inc. decision dated 22nd June 2006 of the U.S.Court of Appeals for the Federal Circuit 05-1433 the Court of Appeals followed its earlier ruling in Helifix Ltd. v. Blok-Lok Ltd. 208 F.3d 1339 where it was held (at 1359): In resisting a preliminary injunction, however, one need not make out a case of actual invalidity. Vulnerability is the issue at the preliminary injunction stage, while validity is the issue at trial. The showing ..... X X X X Extracts X X X X X X X X Extracts X X X X ..... the contentions of the plaintiffs on this issue and affirms the impugned judgment of the learned Single Judge. Defendant's challenge to the validity of the patent 56. The next question is whether the defendants have in fact been able to demonstrate that there exist serious triable issues concerning the validity of Patent No. 196774 granted to the plaintiffs. 57. The plaintiffs submit that apart from merely challenging the validity of the patent granted in their favour, the defendant had not produced any material to demonstrate that the compound for which the patent was granted was not a novel invention with proved enhanced efficacy over the closest prior Article Since the plaintiffs had demonstrated successfully before the Controller of Patents that their compound was an inventive step over the closest prior art, the burden lay on the defendant to show that the inventive step was obvious to a person having ordinary skill in the Article Contrary to the claim of the defendant, Erlotinib Hydrocholoride could not be anticipated with reference to the closest prior art EP'226. Methyl and ethynyl groups are different and the substitution of ethynyl with methyl in the the ..... X X X X Extracts X X X X X X X X Extracts X X X X ..... . The plaintiffs contest the argument that Erlotinib Hydrochloride is a derivative of a known substance EP'226. However, it appears that the closest prior art does teach the compound for which patent has been granted to the plaintiffs. Therefore, unless the enhanced efficacy as mandated by Section 3(d) was demonstrated, patent could not have been granted. The defendant has been able to show that order of the Controller of Patents was arguably deficient on this aspect. The defendant therefore must be taken to have raised a credible challenge to the validity of the patent. 61. Elaborate arguments have been addressed on whether Erlotinib Hydrochloride was only a modified form of Gefitinib. The order of the Patent Controller refers to EP 226 which was relied upon by the defendant to suggest that the molecule structure of the suit patent was similar to those disclosed in the aforementioned patent. In other words, it was contended by the defendant that the substitution of Methyl with Ethynyl would be obvious to a person skilled in the art when the closest prior art is taken to be Gefitinib which was claimed in EP 226. It is sought to be contended by the plaintiffs on the other ..... X X X X Extracts X X X X X X X X Extracts X X X X ..... otinib Hydrochloride was far better in enhanced efficacy than Gefitinib. It is therefore urged that a person of ordinary skill in the art would find no motivation at all to replace the methyl group at position 3 by an ethynyl group. It is further argued that even if a person of ordinary skill attempted to modify Example 51 of EP 226, the motivation would be to modify 6 or 7 positions not the third position. Even if such person was motivated to change the substitution in the third position the choice would be a halogen such a chlorine and fluorine and not ethynyl. 65. In the view of this Court, a bare perusal of the order of the Patent Controller would indicate that neither of the above arguments has been considered, and in any event not in the detailed manner in which they have been advanced before this Court. It is perfectly possible that the Controller had no occasion to consider such argument as it was not raised before him. That is perhaps the very purpose of the legislature permitting a challenge by a defendant to the validity of a patent in answer to an infringement suit, even if such defendant had not earlier raised an opposition either at pre-grant or the post-grant sta ..... X X X X Extracts X X X X X X X X Extracts X X X X ..... nt of the order of the Controller of Patents is, in the view of this Court, not without merit. The Controller failed to appreciate that the patent was claimed specifically on Example 20 and therefore stood on a footing different from that granted to the plaintiffs in other countries. The point about the credibility of the articles published in the journals being the product of researched sponsored by plaintiff No. 2 OSI was not even noticed by the Controller of Patents. The entire discussion on the aspect of enhanced efficacy in the order of the Controller is limited to a mention of these articles. Also, in the order dated 4th July 2007 of the Controller of Patents there is an incomplete sentence when there is a reference to the decided cases. The anomaly of the pre-grant opposition being disposed of only on 4th July 2007 whereas the patent certificate is of 23rd February 2007 remains unexplained. If it was indeed a pre-grant opposition that was being rejected, it is conceivable that the certificate would pre-date it. 69. Elaborate arguments were addressed on the question of balance of convenience on the ground that the judgment of the House of Lords in American Cyanamid require ..... X X X X Extracts X X X X X X X X Extracts X X X X ..... is the closest prior art and which is a known substance. A statement made by the applicant while prosecuting a patent application in any country would certainly be a relevant material to be considered. The decisions cited by learned Counsel are not relevant in this context as the law in this country is governed by the Patents Act 1970 which requires the applicant to make a full disclosure as noticed hereinbefore. 71. The discussion on this aspect is concluded by concurring with the learned Single Judge that, assuming that the plaintiffs held a patent for the product which was the subject matter of the suit for infringement, the defendant has raised a credible challenge to the validity of the patent by raising a serious triable and substantial question that renders it vulnerable to challenge. Public Interest 72. That brings us to the last submission of the plaintiffs which is that the learned Single Judge had applied principles not known to law in refusing injunction. The issues of public interest and pricing were not germane or relevant in the context of patent law. Public interest on the other hand required protecting a validly granted patent. The question of availability ..... X X X X Extracts X X X X X X X X Extracts X X X X ..... e Government to control the prices in the manner indicated, or a power under Section 47 of the Patents Act, 1970 to grant patents subject to conditions including use of the process by the government or even a pre-grant opposition akin to Section 25(1) of the Act. It is submitted that public interest in low cost general drugs has to be balanced by the public interest in protection of patent rights and that the need to encourage scientific research in discovering the drug outweighs the public interest in obtaining a low cost generic drug. Reliance is placed on the judgment of the District Court of the US in Eisai Co. v. Teva Pharamaceuticals dated 28.3.2008/Civ. No. 05-5727 (HAA) (ES); Payless Shoesource Inc. v. Reebok International Ltd. 998 F.2d 985 and Sanofi - Synthelabo v. Apotex 470 F.3d 1368 75. The defendant on the other hand counters this submission by submitting that pricing would indeed be a relevant considerations in determining whether the grant of an injunction would adversely affect the easy availability of a life saving drug. Reliance is placed on the decisions in Novartis AG v. Mehar Pharma 2005(3)BomCR191 ; Franz Xaver Huemer v. New Yash Engineers AIR1997Delhi ..... X X X X Extracts X X X X X X X X Extracts X X X X ..... fs in 1993 for patent in Canada shows that the plaintiffs have disclosed the compound as well as its salt. Beta crystals are clearly disclosed in the application. Therefore, in my opinion, apart from other challenges, this challenge can definitely be said to be serious insofar as the validity of EMR granted is concerned and if that be so, in terms of the law that appears to be settled referred to above, the EMR being of recent origin, the plaintiffs would not be entitled to the temporary injunction sought. It is further to be seen here that in the present case, it cannot be said that even if the plaintiffs ultimately succeed, the loss or injury that may be caused to the plaintiffs is not incapable of being compensated in terms of money. Indeed, in the plaint, the plaintiffs have worked out loss suffered by them and have in fact sought a monetary decree in relation thereto. In my opinion, the aspect of balance of convenience has also to be answered in favour of the defendants, especially because the drug in relation to which EMR is granted is a anti-cancer drug, is a life saving drug and the plaintiffs do not manufacture the drug in India but import it from foreign country. The defe ..... X X X X Extracts X X X X X X X X Extracts X X X X ..... nto account when considering the balance of convenience and whether in all the circumstances the discretion of the court should be exercised to grant an injunction. On the aspect of availability of a life saving drug it was held: Finally, therefore, I come to the interesting and, I think novel point as to whether this Court ought ever and, in particular, in this case to exercise its discretion to grant an injunction the effect of which will be, temporarily at any rate, to deprive members of the public of the benefit of a `life-saving drug which may be prescribed' for otherwise fatal heart diseases. In fairness to Mr. Aldous and the plaintiffs, I should say that it was made clear that if the proper conclusion was that this drug in question was unique they would not feel it right to contend that an injunction should be granted in such a case. It would, of course, be simple, subject to the practical difficulties of distribution, which could probably be got over, to make a limited injunction ensuring that patients already on the drug in question continued to be supplied with it. I do not think, however, that such a limitation can deal with the real point, which is whether membe ..... X X X X Extracts X X X X X X X X Extracts X X X X ..... oncur with the learned single Judge that in a country like India where question of general public access to life saving drugs assumes great significance, the adverse impact on such access which the grant of injunction in a case like the instant one is likely to have, would have to be accounted for. Erlocip is the Indian equivalent produced by the defendant in India as a generic drug manufacturer. It is priced at ₹ 1600 per tablet. Even if this does not make it inexpensive, the question of greater availability of such drug in the market assumes significance. 82. In the considered view of this Court, while it may be possible to distinguish the judgment of the US Supreme Court in E Bay as relating to a case of permanent and not temporary injunction, the traditional four factor test identified in the said judgment does assume relevance even at the stage of grant of an interim injunction. Given the nature of the drug, in the instant case, which admittedly is a life saving one, the fourth test identified in E Bay that the grant of an injunction should not result in the public interest being disserved would be relevant. 83. The judgments relied upon by the plaintiffs undersc ..... X X X X Extracts X X X X X X X X Extracts X X X X ..... d interim injunction in a suit for infringement of patent, it would be incumbent on the plaintiffs to make a full disclosure of the complete specification of the product whose patent is claimed to have been infringed. The plaintiffs will also have to disclose to Court the x-ray diffraction data of the product, particularly if it is a pharmaceutical drug. The plaintiffs have to make an unequivocal disclosure that the patent they hold covers the drug in question; whether there are any other pending applications seeking the grant of patent in respect of any derivatives or forms of the product for which they already hold a patent and the effect of such applications on the suit patent. (iv) The failure by the plaintiffs to disclose the complete specification of the product and the facts concerning the pending applications for Polymorph B led to the learned Single Judge not having the occasion to consider if in fact the suit patent covered Tarceva. Had these facts fully disclosed in the plaint and the entire specification of the patent held by the plaintiff together with X-ray diffraction data of Tarceva and Erlocip filed along with the plaint, it is possible that the plaintiff may ha ..... X X X X Extracts X X X X X X X X Extracts X X X X
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