TMI Blog2013 (4) TMI 348X X X X Extracts X X X X X X X X Extracts X X X X ..... beta crystalline form of Imatinib Mesylate, does not qualify the test of Section 3(d) of the Act but that is not to say that Section 3(d) bars patent protection for all incremental inventions of chemical and pharmaceutical substances. It will be a grave mistake to read this judgment to mean that section 3(d) was amended with the intent to undo the fundamental change brought in the patent regime by deletion of section 5 from the Parent Act. That is not said in this judgment. Section 2(1)(j) defines “invention” to mean, “a new product or …”, but the new product in chemicals and especially pharmaceuticals may not necessarily mean something altogether new or completely unfamiliar or strange or not existing before. It may mean something “different from a recent previous” or “one regarded as better than what went before” or “in addition to another or others of the same kind”. However, in case of chemicals and especially pharmaceuticals if the product for which patent protection is claimed is a new form of a known substance with known efficacy, then the subject product must pass, in addition to clauses (j) and (ja) of section 2(1), the test of enhanced efficacy as provided in section ..... X X X X Extracts X X X X X X X X Extracts X X X X ..... its patentability still be questioned and denied on the ground that section 3(d) puts it out of the category of invention ? On the answer to these questions depends whether the appellant is entitled to get the patent for the beta crystalline form of a chemical compound called Imatinib Mesylate which is a therapeutic drug for chronic myeloid leukemia and certain kinds of tumours and is marketed under the names Glivec or Gleevec . 4. These questions were debated at the bar intensely and at great length. The debate took place within a very broad framework. The Court was urged to strike a balance between the need to promote research and development in science and technology and to keep private monopoly (called an aberration under our Constitutional scheme) at the minimum. Arguments were made about India s obligation to faithfully comply with its commitments under international treaties and counter arguments were made to protect India s status as the pharmacy of the world . The Court was reminded of its duty to uphold the rights granted by the statute, and the Court was also reminded that an error of judgment by it will put life- saving drugs beyond the reach of the multitude o ..... X X X X Extracts X X X X X X X X Extracts X X X X ..... ediate stage, and thereafter, following further processes, reach the beta crystal form of Imatinib Mesylate. Following the second process, they would reach the beta crystal form of Imatinib Mesylate directly, skipping the intermediate stage in which Imatinib Mesylate first appears in amorphous form. In the third process, they would start with the alpha crystal form of Imatinib Mesylate and arrive at its beta crystal form. 7. It was stated in course of submissions, however, that for practical purposes, the best way to produce the beta form is by proceeding directly from the free base form to the beta form, as in examples 2 and 3 given below, by introducing a specified amount of the beta crystals at the step specified. The three processes are described by the appellant under the following three examples: EXAMPLE 1[4] Step 1 - 98.6 gms of Imatinib free base is added to 1.4 liters of ethanol. Step 2 - To the above, 19.2 gms of methanesulfonic acid is added drop wise for over 20 minutes. Step 3 - Solution obtained in Step 2 is heated under reflux (i.e. boiling). It is heated in a manner to preserve the solution from escaping as a gas, so the gas is captured, condensed and ob ..... X X X X Extracts X X X X X X X X Extracts X X X X ..... at 60 degrees Celsius with 55 (sic mg of) beta form of imatinib mesylate. Upon this, the product starts to crystallize. Step 3 - Thereafter, the crystals are dried at 50 megabars and at 100 degrees Celsius. This leads to crystallization of beta form of imatinib mesylate. Step 4 - The retention values (distance traveled by each chemical component in relation to the distance the solution front moves) obtained are as follows; Methylene chloride: ethyl acetate: Methanol: concentrated aqueous ammonium hydroxide solution = 6:10:30:2 (sic 60:10:30:2) Step 5 - To the above, High Pressure Chromatography is applied for 10.2 minutes. [Examples are also given for preparation of 100 mg tablets and 100 mg capsules of Imatinib Mesylate but there is no need to go into that at this stage.] 8. The appellant filed the application (Application No.1602/MAS/1998)[5] for grant of patent for Imatinib Mesylate in beta crystalline form at the Chennai Patent Office on July 17, 1998. In the application it claimed that the invented product, the beta crystal form of Imatinib Mesylate, has (i) more beneficial flow properties: (ii) better thermodynamic stability; and (iii) lower hygroscopicity than th ..... X X X X Extracts X X X X X X X X Extracts X X X X ..... tled to grant of patent, but for the moment we may note how the case has come to the present stage. 11. As noted above the patent application was made on July 17, 1998, giving July 18, 1997, the date on which the appellant had applied for grant of patent for the subject product in Switzerland, as the priority date . On July 18, 1997, Switzerland was not one of the Convention Countries as defined under section 2 (1)(d) read with section 133 of the Act and it was notified as a convention country as per section 133 of the Act on November 30, 1998. 12. In 1997, when the appellant filed its application for patent, the law in India with regard to product patent was in a transitional stage and the appellant s application lay dormant under an arrangement called the mailbox procedure . Before the application for patent was taken up for consideration, the appellant made an application (Application No. EMR/01/2002) on March 27, 2002, for grant of exclusive marketing rights (EMR) for the subject product under section 24A of the Act, which was at that time on the statute book and which now stands deleted. The Patent Office granted EMR to the appellant by order dated November 10, 2003. ..... X X X X Extracts X X X X X X X X Extracts X X X X ..... /1 to 5/2007/PT/CH. The other two writ petitions assailing section 3(d) of the Act were finally heard by a Division Bench of the High Court and dismissed by the judgment and order dated August 6, 2007. The appellant did not take that matter any further. 16. The appellant s appeals against the orders passed by the Assistant Controller were finally heard and dismissed by the IPAB by a long and detailed judgment dated June 26, 2009. 17. The IPAB reversed the findings of the Assistant Controller on the issues of anticipation and obviousness. It held that the appellant s invention satisfied the tests of novelty and non-obviousness, and further that in view of the amended section 133, the appellant was fully entitled to get July 18, 1997, the date on which the patent application was made in Switzerland, as the priority date for his application in India. The IPAB, however, held that the patentability of the subject product was hit by section 3(d) of the Act. Referring to section 3(d) the IPAB observed: Since India is having a requirement of higher standard of inventive step by introducing the amended section 3(d) of the Act, what is patentable in other countries will not be patenta ..... X X X X Extracts X X X X X X X X Extracts X X X X ..... Appellant 20. Though agreeing with the Assistant Controller that no product patent for the subject patent could be allowed in favour of the appellant, the IPAB held that the appellant could not be denied the process patent for preparation of Imatinib Mesylate in beta crystal form. The IPAB ordered accordingly. 21. Against the order of the IPAB the appellant came directly to this Court in a petition under Article 136 of the Constitution. When the matter was first taken up before this Bench, we first thought of dismissing the SLPs at the threshold as the appellant had an alternative remedy to challenge the judgment and order of the IPAB before the Madras High Court. However, Mr. Gopal Subramanium, the senior advocate appearing for the appellant, submitted that the SLPs were filed on August 11, 2009, and the Court issued notice to the respondents on September 11, 2009. Further, before coming to this Bench, the matter was listed before another Bench, where it was heard on merits on different dates from August 9, 2011 to September 6, 2011. Mr. Subramanium further submitted that relegating the appellant to the High Court might render the matter infructuous in as much as the period ..... X X X X Extracts X X X X X X X X Extracts X X X X ..... red grant of patent to substances intended for use, or capable of being used, as food or medicine or drug, or prepared or produced by chemical processes. The application was then put in the mailbox and was taken out for consideration when many changes had been made in the Patents Act, 1970, with effect from January 1, 2005, to make the patent law in the country compliant with the terms of an international agreement entered into by the Government of India. Following the international agreement, the Patents Act, 1970, was subjected to large scale changes in three stages; and finally, by the Patents (Amendment) Act, 2005, section 5 was altogether deleted from the Parent Act (Patents Act, 1970). Between January 1, 1995 and January 1, 2005, the Patents Act, 1970, underwent wide ranging changes, but if we are asked to identify the single most important change brought about in the law of patent in India as a result of the country s obligations under the international agreement, we would unhesitatingly say the deletion of section 5 from the Patents Act, which opened the doors to product patents in the country. It is, however, important to note that the removal of section 5 from the statu ..... X X X X Extracts X X X X X X X X Extracts X X X X ..... asis added) 28. Again in Reserve Bank of India v. Peerless General Finance and Investment Co. Ltd. and others[8] Justice Reddy said:- 33. Interpretation must depend on the text and the context. They are the bases of interpretation. One may well say if the text is the texture, context is what gives the colour. Neither can be ignored. Both are important. That interpretation is best which makes the textual interpretation match the contextual. A statute is best interpreted when we know why it was enacted. With this knowledge, the statute must be read, first as a whole and then section by section, clause by clause, phrase by phrase and word by word. If a statute is looked at, in the context of its enactment, with the glasses of the statute-maker, provided by such context, its scheme, the sections, clauses, phrases and words may take colour and appear different than when the statute is looked at without the glasses provided by the context. With these glasses we must look at the Act as a whole and discover what each section, each clause, each phrase and each word is meant and designed to say as to fit into the scheme of the entire Act. No part of a statute and no word of a statute ca ..... X X X X Extracts X X X X X X X X Extracts X X X X ..... ngicide, and a process for producing substance or any invention relating to surgical or curative devices. The committee s recommendation prompted the Government to introduce a bill (Bill no. 59 of 1953) in Parliament, but the bill was not pressed and it was allowed to lapse. 34. In 1957, another committee came to be appointed under the chairmanship of Justice N. Rajagopala Ayyangar to take a fresh look at the law of patent and to completely revamp and recast it to best sub-serve the (contemporary) needs of the country[10]. 35. Justice Ayyangar painstakingly collected valuable data (taking the figures for the years 1930 to 1939 from the Bakshi Tek Chand report) and, compiling them into a number of tables,[11] showed the share of Indians in the field of patents. He analyzed the figures in the tables and pointed out that during the period 1930-37, the grant of patents to Indians and foreigners was roughly in the ratio of 1:9. Even after Independence, though a number of institutions for post-graduate training were set up and several national laboratories were established to encourage a rapid growth of scientific education, the proportion of Indian and the foreign patents remained s ..... X X X X Extracts X X X X X X X X Extracts X X X X ..... observed that the provisions of the Patent law have to be designed, with special reference to the economic conditions of the country, the state of its scientific and technological advancement, its future needs and other relevant factors, and so as to minimize, if not to eliminate, the abuses to which a system of patent monopoly is capable of being put. Bearing in view the matters set above, he recommended retaining the patent system, but with a number of improvements. 39. One of the improvements suggested was to define, with precision, those inventions which should be patentable and equally clearly identify certain inventions, the grant of patents to which would retard research, or industrial progress, or be detrimental to the national health or well- being, and to make those inventions non-patentable. 40. Justice Ayyangar s report specially discussed (a) patents for chemical inventions; and (b) patents for inventions relating to food and medicine. 41. In regard to patents for chemical substances, he examined the history of the law in other countries and pointed out that Germany was the first to adopt the system of confining the patentability of inventions relating to chemic ..... X X X X Extracts X X X X X X X X Extracts X X X X ..... date as the Central Government may appoint, by notification in the official gazette. Section 2 contained the definition and interpretation clauses; it defined the terms invention and medicine in clauses (j) and (l) respectively as under[13]: Section 2(1)(j) invention means any new and useful i) art, process, method or manner of manufacture; ii) machine, apparatus or other article; iii) substance produced by manufacture, and includes any new and useful improvement of any of them, and an alleged invention. Section 2(1)(l) medicine or drug includes i) all medicines for internal or external use of human beings or animals, ii) all substances intended to be used for or in the diagnosis, treatment, mitigation or prevention of diseases in human beings or animals, iii) all substances intended to be used for or in the maintenance of public health, or the prevention or control of any epidemic disease among human beings or animals, iv) insecticides, germicides, fungicides, weedicides and all other substances intended to be used for the protection or preservation of plants; v) all chemical substances which are ordinarily used as intermediates in the preparation ..... X X X X Extracts X X X X X X X X Extracts X X X X ..... d inter- metallic compounds), no patent shall be granted in respect of claims for the substances themselves, but claims for the methods of processes of manufacture shall be patentable. 46. It is significant to note that section 5 in chapter II of the Act expressly excluded product patents for substances intended for use and capable of being used as food or as medicine or drug, and substances prepared or produced by chemical process, and made these substances non- patentable. Section 4 similarly prohibited grant of patent in respect of an invention relating to atomic energy. The Act thus clearly recognized and maintained the distinction between invention and patentability. 47. We have briefly examined some aspects of the legislative history of the patent law in India. We may now take a look at how the Patent and Designs Act, 1911, and the Patents Act, 1970, impacted the pharmaceutical industry and the availability of drugs in the country. 48. Sudip Chaudhuri in his book titled, The WTO and India s Pharmaceuticals Industry[14] describes the market shares of multi-national companies and Indian companies in India by means of a table as under: Market Shares of MNCs Indian Com ..... X X X X Extracts X X X X X X X X Extracts X X X X ..... t. Because of the patent regime under the 1911 Act and the unsupportive industrial policy, the indigenous sector lost its status in the 1950s and the 1960s. In contrast to 62 per cent of the market in the early 1950s, the market share of the indigenous sector declined to 32 per cent by 1970. In contrast, the market share of the MNCs increased from 38 per cent in 1952 to 68 per cent in 1970 (the table above). 51. However, according to Chaudhuri, the situation changed in the 1970s. Several official initiatives were taken in the 1970s, of which the most important one was the enactment of the Patents Act, 1970, which changed the environment in favour of the indigenous sector. 52. In regard to the Patents Act, 1970, Chaudhuri maintains that Patent reforms contributed directly to the transformation of the pharmaceutical industry. He points out that under the Patents Act, 1970, articles of food, medicines and drugs and chemical substances could be patented only for a new method or process of manufacture, not for the products as such (section 5 of the 1970 Act). Further, unlike in the previous patent regime, for each particular drug only one method or process the best known to the ..... X X X X Extracts X X X X X X X X Extracts X X X X ..... tory requirements, has emerged as India s largest export partner in pharmaceuticals. 58. Dealing with the growth of the Indian pharmaceutical industry after the change in the patent law, Chaudhuri writes: Because of the rapid growth and structural transformation in the last three decades or so, India now occupies an important position in the international pharmaceutical industry India has received worldwide recognition as a low cost producer of high quality bulk drugs and formulations. India produces about 350 bulk drugs ranging from simple pain killers to sophisticated antibiotics and complex cardiac products. Most of the bulk drugs are produced from basic stages, involving complex multi-stage synthesis, fermentation and extractions. For more than 25 bulk drugs, India accounts for more than 50 per cent of the international trade. India is a major force to reckon with in the western markets for such drugs as ibuprofen, sulphamethoxasole 59. Even as the country s pharmaceutical industry, helped by the basic changes made in the patent system by the Patent Act, 1970, was going from strength to strength, certain developments were taking place at the international level that w ..... X X X X Extracts X X X X X X X X Extracts X X X X ..... a notification as foreseen in those provisions to the Council for TRIPS. 2. Members may avail themselves of the exceptions permitted under paragraph 1 in relation to judicial and administrative procedures, including the designation of an address for service or the appointment of an agent within the jurisdiction of a Member, only where such exceptions are necessary to secure compliance with laws and regulations which are not inconsistent with the provisions of this Agreement and where such practices are not applied in a manner which would constitute a disguised restriction on trade. Article 7 Objectives The protection and enforcement of intellectual property rights should contribute to the promotion of technological innovation and to the transfer and dissemination of technology, to the mutual advantage of producers and users of technological knowledge and in a manner conducive to social and economic welfare, and to a balance of rights and obligations. Article 8 Principles 1. Members may, in formulating or amending their laws and regulations, adopt measures necessary to protect public health and nutrition, and to promote the public interest in sectors of vital importan ..... X X X X Extracts X X X X X X X X Extracts X X X X ..... here the subject matter of a patent is a process, to prevent third parties not having the owner's consent from the act of using the process, and from the acts of: using, offering for sale, selling, or importing for these purposes at least the product obtained directly by that process. 2. Patent owners shall also have the right to assign, or transfer by succession, the patent and to conclude licensing contracts. PART V Dispute Prevention and Settlement Article 63 Transparency 1. Laws and regulations, and final judicial decisions and administrative rulings of general application, made effective by a Member pertaining to the subject matter of this Agreement (the availability, scope, acquisition, enforcement and prevention of the abuse of intellectual property rights) shall be published, or where such publication is not practicable made publicly available, in a national language, in such a manner as to enable governments and right holders to become acquainted with them. Agreements concerning the subject matter of this Agreement which are in force between the government or a governmental agency of a Member and the government or a governmental agency of another Member shall a ..... X X X X Extracts X X X X X X X X Extracts X X X X ..... inisterial Conference to approve such recommendations or to extend the period in paragraph 2 shall be made only by consensus, and approved recommendations shall be effective for all Members without further formal acceptance process. Article 65 Transitional Arrangements 1. Subject to the provisions of paragraphs 2, 3 and 4, no Member shall be obliged to apply the provisions of this Agreement before the expiry of a general period of one year following the date of entry into force of the WTO Agreement. 2. A developing country Member is entitled to delay for a further period of four years the date of application, as defined in paragraph 1, of the provisions of this Agreement other than Articles 3, 4 and 5. 3. Any other Member which is in the process of transformation from a centrally-planned into a market, free-enterprise economy and which is undertaking structural reform of its intellectual property system and facing special problems in the preparation and implementation of intellectual property laws and regulations, may also benefit from a period of delay as foreseen in paragraph 2. 4. To the extent that a developing country Member is obliged by this Agreement to extend p ..... X X X X Extracts X X X X X X X X Extracts X X X X ..... product patent is granted or rejected in that Member, whichever period is shorter, provided that, subsequent to the entry into force of the WTO Agreement, a patent application has been filed and a patent granted for that product in another Member and marketing approval obtained in such other Member. 60. The Agreement (vide. Part V: Article 64) provides for a mechanism for resolution of disputes between the members of the WTO. In case of a dispute, a panel of specially appointed trade experts interprets the provisions of the Agreement and issues a report. The panel s decision may be subjected to appeal before the WTO Appellate Body. If a party to the decision fails to abide by a decision, the other party can impose trade sanctions on the member in breach, upon authorization by the Dispute Settlement Body. The dispute resolution mechanism in the TRIPS is strong and effective as was proved in the case of India herself. 61. Article 65 (sub-articles 1and 2) allowed India to delay the application of the provisions of the Agreement for a period of 5 years, that is, till January 1, 2000; sub-Article 4 allowed India to delay for a further period of five years, that is, till January 1, ..... X X X X Extracts X X X X X X X X Extracts X X X X ..... cal products pursuant to Article 70.8 of the TRIPS Agreement and of the legal authority for the grant of exclusive marketing rights for such products pursuant to Article 70.9 of the TRIPS Agreement. The WTO panel returned the finding that India had not complied with its obligations under Article 70.8 (a) and, in the alternative, paragraphs 1 and 2 of Article 63 and also 70.9 of the TRIPS Agreement. India took the matter in appeal. By a decision dated December 19, 1997, the Appellate Body affirmed the panel s findings that India had not complied with its obligations under Article 70.8(a) and Article 70.9 of the TRIPS Agreement, but set aside the panel s finding relating to the alternative claim by the United States under Article 63 of TRIPS Agreement. In conclusion, the Appellate Body recommended that the Dispute Settlement Body request India to bring its legal regime for patent protection of pharmaceutical and agricultural chemical products into conformity with India s obligations under Article 70.8 and 70.9 of the TRIPS Agreement . 63. In the proceedings arising from the complaint filed by the United States, the European Communities were added as the Third Party before the pane ..... X X X X Extracts X X X X X X X X Extracts X X X X ..... in the light of the object and purpose of the Agreement as expressed, in particular, in its objectives and principles. b. Each member has the right to grant compulsory licences and the freedom to determine the grounds upon which such licences are granted. c. Each member has the right to determine what constitutes a national emergency or other circumstances of extreme urgency, it being understood that public health crises, including those relating to HIV/AIDS, tuberculosis, malaria and other epidemics, can represent a national emergency or other circumstances of extreme urgency. d. The effect of the provisions in the TRIPS Agreement that are relevant to the exhaustion of intellectual property rights is to leave each member free to establish its own regime for such exhaustion without challenge, subject to the MFN and national treatment provisions of Articles 3 and 4. 6. We recognize that WTO members with insufficient or no manufacturing capacities in the pharmaceutical sector could face difficulties in making effective use of compulsory licensing under the TRIPS Agreement. We instruct the Council for TRIPS to find an expeditious solution to this problem and to report to the ..... X X X X Extracts X X X X X X X X Extracts X X X X ..... ective patent systems by regulating the grant of patents and to set up higher standards for patent protection for pharmaceutical and agricultural chemical products. The Union of India and all the Objectors maintained that the patent law in India, as it stands to-day after major changes were brought about in the Patents Act, 1970 in 2005, is fully TRIPS compliant. But they insisted that the Indian law must be judged and interpreted on its own terms, and not on the basis of standards of patentability prescribed in some countries of the western world. 66. We have referred to the TRIPS Agreement and certain developments arising from it not to comment upon the fairness or otherwise of the Agreement nor to examine the correctness and wisdom of the decision of the Government of India to subscribe to the Agreement. That is farthest from our mind. We have referred to the Agreement as being the main reason behind the basic changes brought about in the patent law of the country by legislative action. We have also referred to the Agreement as being the cause of a good deal of concern not only in this country but also (as we shall see presently) in other parts of the world; the concern being ..... X X X X Extracts X X X X X X X X Extracts X X X X ..... in the Patents Act, 1970 which came into force on the 20th April, 1972. The Act was last amended in March, 1999 to meet India s obligations under the Agreement on Trade Related Aspects of Intellectual Property Rights (TRIPS) which forms part of the Agreement establishing the World Trade Organisation (WTO). .. Development of technological capability in India, coupled with the need for integrating the intellectual property system with international practices and intellectual property regimes, requires that the Act be modified into a modern, harmonised and user-friendly legislation to adequately protect national and public interests while simultaneously meeting India s international obligations under the TRIPS Agreement which are to be fulfilled by 31st December, 1999. 2. xxx 3. While considering amendment to the Act, efforts have been made to make the law not only TRIPS complaint (sic) but also to provide therein necessary and adequate safeguards for protection of public interest, national security, bio-diversity, traditional knowledge, etc. Opportunity is also proposed to be availed of for harmonising the procedure for grant of patents in accordance with international practice ..... X X X X Extracts X X X X X X X X Extracts X X X X ..... n-working. Here, it may not be out of place to take note of section 83 which provided as under: Section 83: General principles applicable to working of patented inventions. Without prejudice to the other provisions contained in this Act, in exercising the powers conferred by this Chapter, regard shall be had to the following general considerations, namely: - a) that patents are granted to encourage inventions and to secure that the inventions are worked in India on a commercial scale and to the fullest extent that is reasonably practicable without undue delay; b) that they are not granted merely to enable patentees to enjoy a monopoly for the importation of the patented article; c) that the protection and enforcement of patent rights contribute to the promotion of technological innovation and to the transfer and dissemination of technology, to the mutual advantage of producers and users of technological knowledge and in a manner conducive to social and economic welfare, and to a balance of rights and obligations; d) that patents granted do not impede protection of public health and nutrition and should act as instrument to promote public interest specially in sectors of ..... X X X X Extracts X X X X X X X X Extracts X X X X ..... the Statement of Objects and reasons it is stated as under: Amendment Act 15 of 2005 Statement of Objects and Reasons. 5. The time-frame for this set of amendments was most crucial as any slippage in meeting the January 01, 2005 deadline had the potential of inviting retaliatory action under the WTO disputes mechanism. Having availed of the entire ten-year transition period provided under the TRIPS Agreement, India had no legal basis to defend its default on the deadline. The past record of delayed implementation would also not have helped the Indian case. This default would also have created a legal vacuum for the mailbox applications, as there would not be any mechanism to deal with them from January 01, 2005. This would have amounted to a specific default on the international commitment to examine and dispose of these cases, and might have again provided an opportunity to WTO member countries to raise a dispute against India in the WTO. There would also have been a legal vacuum in respect of fresh applications after January 01, 2005, as the law was salient on whether the mailbox provision would subsist or whether it would have ceased. Finally, there would have been a ..... X X X X Extracts X X X X X X X X Extracts X X X X ..... been actively monitoring the implications of trade agreements on public health. One key issue is the impact of the end of the transition period at 1 January 2005 allowed under the TRIPS Agreement, which delayed the application of product patents, on the local production and supply of generic antiretroviral agents. The WTO Ministerial Declaration on the TRIPS Agreement and Public Health adopted in Doha, 2001 affirmed that "the TRIPS Agreement can and should be interpreted and implemented in a manner supportive of WTO Members' right to protect public health and, in particular, to promote access to medicines for all." In line with this, recent resolutions of the World health Assembly have also urged that national legislation should be adapted in order to use to the full the flexibilities contained in the TRIPS Agreement (WHA 56.27, May 2003 and 57.14, May 2004). In accordance with its mandate, WHO will therefore seek to provide technical assistance and support to Member States to promote implementation of the TRIPS Agreement consistent with the public health objective of ensuring access to medicines. As India is the leader in the global supply of affordable antiretroviral drugs an ..... X X X X Extracts X X X X X X X X Extracts X X X X ..... umbersome and often unnecessary administrative burden on the importing country. Often, there will be no patent in the importing country and compulsory licenses are only required where a valid patent has been issued. Under the WTO Declaration on TRIPS and Public Health (the Doha Declaration) of November 2001, Least Developed Countries are not even required to issue patents in the pharmaceutical sector until 2016. In addition, the limitations under the Ordinance of the pre-grant opposition rule contained in the previous law removes an important opportunity for People Living with HIV and other members of civil society to participate in an open and transparent process. The implications of the current Ordinance are potentially devastating: the vast majority of countries hardest hit by AIDS do not have sufficient manufacturing capacity in the pharmaceutical sector and must rely upon imports from major producing countries such as India if they are to succeed in scaling up access to HIV treatment to the millions of their people in need. UNAIDS strongly supports the rights of governments to avail themselves of the flexibilities in TRIPS in promoting the widest possible access to afforda ..... X X X X Extracts X X X X X X X X Extracts X X X X ..... ficially extend the period of patent to keep competitors out and keep the prices of the patented product high. It was strongly argued that, while fulfilling its commitment under the TRIPS agreement, the Government must not bring in a patent regime where all the gains achieved by the Indian pharmaceutical industry are dissipated and large sections of Indians and people in other parts of the world are left at the mercy of giant multinational pharmaceutical companies. 80. One of the members from the Opposition benches said: Sir, even if this were a Bill, which affects only India, still it would be an extremely important one. But it is a Bill, which affects most parts of the world. We are supplying 50 per cent of the cheapest drugs in the world to places like Papua New Guinea, Laos, Kenya, Africa, etc. All these countries have complained to the WHO about this Bill. The two biggest international health organizations in the world, namely WHO, and Medicines Sans Frontiers have written to the Government saying that this is a very very serious matter. This has been the subject of editorials all over the world right from America onwards to every country from Bangladesh, Cambodia, China, ..... X X X X Extracts X X X X X X X X Extracts X X X X ..... situation was reversed. This 85 per cent of our country s medicinal requirement was met by our own products. That was a remarkable achievement. Not only that, we started exporting to countries which does not have the facility of infrastructure to produce their own medicines. We supplied medicine to meet their requirements. But will the Minister now assure that we will be able to meet our own requirements at a cheaper rate after adopting this product regime? Can it be assured that we would be able to meet the requirements of medicine of our people? Because, that was not our experience in the past. 82. It is interesting to note that in the Parliamentary debate, the names of the appellant company (Novartis) and the drug (Gleevec) being the subject matter of this case were repeatedly mentioned, and the excessively high price fixed for the drug after the grant of exclusive marketing rights to the appellant was expressly cited as the likely result of bringing in the product patent regime in pharmaceuticals. One of the members said: Sir, a company which obtains a patent by changing their chemicals, before the expiry of the patent, they will again apply for a patent and again get ..... X X X X Extracts X X X X X X X X Extracts X X X X ..... e amendments proposed by the minister, was passed by the Lok Sabha on March 22, 2005. Some of the very important amendments that were incorporated in the Bill related to section 2(1)(ja) and section 3(d), and the insertion of the provision for pre-grant opposition to grant of patent. After being passed by the Lok Sabha, the Bill was presented in the Rajya Sabha where it was passed on March 23, 2005. It received the assent of the President on April 4, 2005, and was published in the official gazette of April 5, 2005. 86. Thus, after deliberations that took place for just four days, the Patents Act, 1970, came in a completely new avatar. The haste with which the Government was constrained to rush the Bill through Parliament to make the law compatible with the TRIPS Agreement perhaps explains the somewhat unclear drafting of some very important provisions, which called for much greater clarity; the presence of some terms and expressions in the definition section[22] that are nowhere used in the Act; and a few loose ends that could have been properly tied up if more time and attention was given to the drafting. 87. We have seen in some detail the why and the how of the law. Let ..... X X X X Extracts X X X X X X X X Extracts X X X X ..... we have also seen earlier that the Patents Act, 1970, dealt with invention and patentability as two distinctly separate concepts. The duality of the two concepts is best illustrated by section 4 of the Act, which prohibits the grant of patent (either process or product) in respect of inventions relating to atomic energy falling within sub-section (1) of section 20 of the Atomic Energy Act, 1962 , and which has not undergone any change since inception. It is, therefore, fundamental that for grant of patent the subject must satisfy the twin tests of invention and patentability . Something may be an invention as the term is generally understood and yet it may not qualify as an invention for the purposes of the Act. Further, something may even qualify as an invention as defined under the Act and yet may be denied patent for other larger considerations as may be stipulated in the Act. Having, therefore, seen the meaning of invention , we may now advert to section 3 as it stands after the amendment of the Act in 2005. 92. Section 3 is in Chapter II of the Act, which initially contained sections 3, 4 and 5, but after the deletion of section 5 with effect from January 1, ..... X X X X Extracts X X X X X X X X Extracts X X X X ..... unless such known process results in a new product or employs at least one new reactant. Explanation. For the purposes of this clause, salts, esters, ethers, polymorphs, metabolites, pure form, particle size, isomers, mixtures of isomers, complexes, combinations and other derivatives of known substance shall be considered to be the same substance, unless they differ significantly in properties with regard to efficacy. 96. As may be seen, the amendment (i) adds the words the mere discovery of a new form of a known substance which does not result in the enhancement of the known efficacy of that substance or at the beginning of the provision; (ii) deletes the word mere before new use ; and (iii) adds an explanation at the end of the clause. 97. A perusal of the Parliamentary debate would further reveal that the whole debate centered on medicines and drugs. It would not be an exaggeration to say that eighty per cent of the debate was focused on medicines and drugs and the remaining twenty per cent on agricultural chemicals. In the entire debate, no substance of any other kind came under discussion. 98. The aforementioned amendment in section 3(d) is one of the most crucia ..... X X X X Extracts X X X X X X X X Extracts X X X X ..... of patents[28], and the multiple stages for opposition to the grant of patent[29]. 102. The submission may appear plausible if the scrutiny of the law is confined only to the Act as it stands today after undergoing the amendments in 2005. But examined in the larger perspective of the development of the law of patent over the past 100 years and especially keeping in mind the debates in the Parliament preceding the 2005 amendment, it would appear completely unacceptable. We find no force in this submission that section 3(d) is a provision ex majore cautela. To our mind, the submission completely misses the vital distinction between the concepts of invention and patentability a distinction that was at the heart of the Patents Act as it was framed in 1970, and which is reinforced by the 2005 amendment in section 3(d). 103. We are clearly of the view that the importance of the amendment made in section 3(d), that is, the addition of the opening words in the substantive provision and the insertion of explanation to the substantive provision, cannot be under-estimated. It is seen above that, in course of the Parliamentary debates, the amendment in section 3(d) was the only provision ..... X X X X Extracts X X X X X X X X Extracts X X X X ..... mermann patent. Further, even if example 21 was selected, the Zimmermann patent did not teach a person to select one particular salt. The Zimmermann patent did not teach a person how to prepare Mesylate salt of example 21. Hence, the coming into being of Imatinib Mesylate from Imatinib in free base was the result of an invention that involved technical advance as compared to the existing knowledge and brought into existence a new substance. 107. In the second invention, the appellant arrived at the beta crystal form of methanesulfonic acid addition salt of Imatinib. It was contended on behalf of the appellant that once the salt form of Imatinib was arrived at, the inventors had to further research to be able to ensure that that particular salt form of Imatinib is suitable for administration in a solid oral dosage form. This research further required defining the process parameters that brought into being the beta crystalline form of Imatinib Mesylate. It was argued on behalf of the appellant that there is certainly no mention of polymorphism or crystalline structure in the Zimmermann patent. The relevant crystalline form of the salt that was synthesized needed to be invented. The ..... X X X X Extracts X X X X X X X X Extracts X X X X ..... dentification thereof, hereinbefore and hereinafter any reference to the free compounds should be understood as including the corresponding salts, where appropriate and expedient. (emphasis added) 110. As regards the pharmacological properties of the compounds of formula I it was stated in the application: The compounds of formula I have valuable pharmacological properties and can be used, for example, as anti-tumoral drugs and as drags (sic drugs) against atherosclerosis. 111. The application also described the tests undertaken for determining the protein kinase C-inhibiting activities of compounds of formula I and their pharmaceutically acceptable salts as follows: To determine protein kinase C-inhibiting activity, protein kinase C from pig brain purified in accordance with the procedure described by T. Uchida and C. R. Filburn in J. Biol. Chem. 259, 12311-4 (1984) is used. The protein kinase C-inhibiting activity of the compounds of formula I is determined by the method of D. Fabbro et at., Arch. Biochem. Biophys. 239, 102-111 (1985). In that test the compounds of formula I inhibit protein kinase C at a concentration IC50 of as low as approximately from 0.1 to 10 ..... X X X X Extracts X X X X X X X X Extracts X X X X ..... ls of the immune system and cells of the central and peripheral nervous system. It was also said in the application: These compounds of formula I, which inhibit the tyrosine kinase activity of the receptor for the epidermal growth factor (EGF) are therefore useful, inter alia, for the treatment of benign or malignant tumours. They are able to effect tumour regression and to prevent metastasic spread and the growth of micrometastases. In particular, they can be used for treating epidermal hyperproliferation (psoriasis), for treating neoplasms of epithelial character, e.g. mastocarcinomas, and leucemias. In addition, the compounds of formula I are useful for treating diseases of the immune system and inflammations, subject to the involvement of protein kinases. These compounds of formula I can also be used for treating diseases of the central or peripheral nervous system, subject to the involvement of signal transmission by protein kinases. It was further stated in the application: Acid addition salts can be convened into the free compounds in customary manner, for example by treatment with a suitable basic agent. xxx The processes described above, including the proce ..... X X X X Extracts X X X X X X X X Extracts X X X X ..... (32.8 mmol) of 4-(4-methyl-piperazinomethyl)- benzoyl chloride; m.p. 211 -213 , Rf =0.33 (methylene chloride:methanol: 25% aqueous ammonia solution=95:5:1). Examples 35 to 37 were in respect of tablets in different doses. 113. In the claim at the end of the application under serial no. 23, it was stated as follows: The compound according to claim 1 of the formula I, said compound being N-{5-[4-(4-Methyl-piperazino-methyl)-benzoylamido]-2-methyl- phenyl}-4-(3-pyridyl)-2-pyrimidine-amine or a pharmaceutically acceptable salt thereof. (emphasis added) 114. The US Patent No. 5,521,184 (the Zimmermann patent) was granted on May 28, 1996. 115. Later, the appellant made the application for patent for beta crystalline form of Imatinib Mesylate (the subject of the present appeals) in the US on January 18, 2000. The US patent for beta crystalline form of Imatinib Mesylate was granted to the appellant about five and a half years later on May 17, 2005 following the order of the US Appellate Court dated November 23, 2003. It is, however, interesting to note that Gleevec, the drug was launched much earlier in the market, on the basis of the Zimmermann patent itself. 116. On Apr ..... X X X X Extracts X X X X X X X X Extracts X X X X ..... 3-[[4-(3-pyridinyl)-2- pyrimidinyl]amino]-phenyl]benzamide methanesulfonate 121. After the grant of drug approval for Gleevec, on July 3, 2001, the appellant made a Patent Term Extension Application for the Zimmermann patent (US Patent No. 5,521,184) under 35 USC 156(g)(1)(B), for extending the term of the patent for the time taken in the regulatory review for Gleevec. This application leaves no room for doubt that Imatinib Mesylate, marketed under the name Gleevec, was submitted for drug approval as covered by the Zimmermann patent. In column 4 of the application, it was stated that the sole active ingredient in Gleevec is Imatinib Mesylate. Further, it was stated that Imatinib, or any salt thereof, including Imatinib Mesylate, had not previously been approved for commercial marketing under the Federal Food, Drug and Cosmetic Act prior to the approval of NDA # 21- 235. In column 9 of the application, it was stated as under: (9) Statement Showing How the Claims of the Patent for Which Extension is Sought Cover the Approved Product: The operative claims in question are Claims 1-5, 10-13, and 21-23. Each of claims 1-5, 10-13 and 23 claim a compound or compounds which inclu ..... X X X X Extracts X X X X X X X X Extracts X X X X ..... ethod of treating warm-blooded animals suffering from a tumoral disease. On these facts, we disagree that the examiner has set forth adequate reasons or evidence to doubt the objective truth of statements in applicants specification that an effective amount of the -crystal form of imatinib mesylate may be administered to a patient as the manipulative step in a method for treating tumour disease in a patient. The rejection under 35 U.S.C. 112, first paragraph, is reversed. (emphasis added) 124. From the above passage from the judgment, it is evident that, according to the Board of Patent Appeals, the Zimmermann patent teaches any person skilled in the art how to use Imatinib, a compound of formula I, or a pharmaceutically acceptable salt thereof, in a pharmaceutical composition for treating tumours or in a method of treating warm-blooded animals suffering from a tumoral disease. However, the Board of Patent Appeals held that the teaching in the Zimmermann patent did not go beyond Imatinib Mesylate and did not extend to beta crystalline form of Imatinib Mesylate, which represented a manipulative step[36] in a method of treating tumor disease in a patient. 125. Further, N ..... X X X X Extracts X X X X X X X X Extracts X X X X ..... is now under consideration. The appellant is, therefore, fully bound by the finding and cannot be heard to take any contrary plea. 127. We have looked, so far, at the Zimmermann patent and the developments that have taken place on its basis. We now propose to take a look at certain publications. A journal called Cancer Research, in its issue of January 1996, published an article under the title Inhibition of the Abl Protein-Tyrosine Kinase in Vitro and in Vivo by a 2-Phenylaminopyrimidine Derivative . This article was authored by several people, including J rg Zimmermann. In this article there is a detailed discussion about the anti- tumoral properties of Imatinib and its methanesulfonate salt, i.e., Imatinib Mesylate. In the abstract at the beginning of the article, it is stated as under: ABSTRACT Oncogenic activation of Abl proteins due to structural modifications can occur as a result of viral transduction or chromosomal translocation. The tyrosine protein kinase activity of oncogenic Abl proteins is known to be essential for their transforming activity. Therefore, we have attempted to identify selective inhibitors of the Abl tyrosine protein kinase. Herein we describe an ..... X X X X Extracts X X X X X X X X Extracts X X X X ..... sing v sis- transformed BALB/c 3T3 cells revealed dose-dependent antitumor activity (Fig. 5B). Maximal T/C (X100%) values of 4% (AMuLV tumors) and 11% (v sis tumors) were obtained when CGP 57148B was administered at 50mg/kg body weight. In contrast, CGP 57148B showed no antitumor activity against tumors derived from NIH-527src cells when 50 mg/kg were administered p.o. once daily for 30 days (T/C, 102%). Using the same route of application, T/C values of 7 and 22% against AMuLV and v sis tumors, respectively, were obtained when 50 mg/kg CGP 57148B were given. It is further stated in the article: CGP 57148 selectively inhibited the in vitro activity of the v-Abl protein-tyrosine kinase and showed preferential inhibition of v-Abl autophosphorylation in cells. We have examined the specificity of CGP 57148 by analyzing its effects on signal transduction via different tyrosine kinase receptor-mediated pathways. Although the ligand-induced activation of the EGF, bFGF, insulin, and IGF-1 receptor tyrosine kinases were not affected by CGP 57148, the PDGF pathway was sensitive to inhibition by the compound. The antiproliferative activity of CGP 57148 against both v-abl- and v-sis- tra ..... X X X X Extracts X X X X X X X X Extracts X X X X ..... d. should not be construed to mean that Imatinib Mesylate was anticipated in the Zimmermann patent. Mr. Andhyarujina submitted that the Zimmermann patent did not disclose Imatinib Mesylate. The Zimmermann patent did not describe any working method for converting Imatinib to Imatinib Mesylate. It only stated that a salt may be formed by acid without disclosing any method, but simply calling the method to be per se . The Zimmermann patent mentioned multiple choices of compounds including Imatinib free base but not any salt of any compound, much less Imatinib Mesylate. Mr. Andhyarujina further submitted that it is well settled that the disclosure of an invention must be in a manner clear enough and complete enough for the invention to be performed by a person skilled in the art (Terrell on Law of Patents 16th edition, page no. 51, para 3.2/7). The learned counsel further submitted that there was a difference between that which is covered and that which is disclosed. Imatinib Mesylate is covered by the Zimmermann patent but not disclosed therein. He further submitted that, in any case, in patent law subsequent conduct of the patentee is irrelevant in construing the patent (Terrell on ..... X X X X Extracts X X X X X X X X Extracts X X X X ..... n of the clear teaching contained in the specification. The teaching of a patent lies in the disclosure/specification that supports the claim. The disclosure describes the invention. The claim defines through language the various ways the invention could be used, i.e., possible but not actualized products. This is the scope of protection granted under the patent. For the purpose of prior art, it is the disclosure in the specification supporting the claim and not the written description or the claims themselves, that must be assessed. The claim can never be the teaching. He further contended that it would be wrong to say that the appellant s claims for beta crystalline form of Imatinib Mesylate is a case of double or repeat patenting, that is, the same invention is being sought to be patented twice. The claim for patent for beta crystalline form of Imatinib Mesylate relates to a second and different invention. Though the invention in the first part (Imatinib) may be necessary to arrive at the invention in the second part, the final product does not come into existence without inventions. The principle is that if a product is covered, it means that it infringes a patent. Whether the ..... X X X X Extracts X X X X X X X X Extracts X X X X ..... providing better information to third parties; And, section 10(5) provides as under: (5) The claim or claims of a complete specification shall relate to a single invention, or to a group of inventions linked so as to form a single inventive concept, shall be clear and succinct and shall be fairly based on the matter disclosed in the specification. 141. The UK Patents Act, 1977, in sub-sections (2), (3), and (5) of section 14, provides as under: Making of an application 14. (2) Every application for a patent shall contain a) a request for the grant of a patent; b) a specification containing a description of the invention, a claim or claims and any drawing referred to in the description or any claim; and c) an abstract; but the foregoing provision shall not prevent an application being initiated by documents complying with section 15(1) below. (3) The specification of an application shall disclose the invention in a manner which is clear enough and complete enough for the invention to be performed by a person skilled in the art. (5) The claim or claims shall a) define the matter for which the applicant seeks protection; b) be clear and concise; c ..... X X X X Extracts X X X X X X X X Extracts X X X X ..... rage or the claim, and the disclosure or the teaching, have different parameters in a patent, and that the former may have an extended boundary within which disclosure or teaching may be confined to a narrower extent. In support of the submission, Mr. Andhyarujina relied upon a decision of the Court of Appeal in A.C. Edwards Ltd. v. Acme Signs Displays Ltd.[42] and another of the High Court of Justice Chancery Divisions Patent Court in Astellas Pharma Inc v. Comptroller-General of Patents[43]. 146. Mr. Gopal Subramanium strongly relied upon the decision of United States Court of Customs and Patent Appeals in In re Hogan[44] in support of his contention. 147. In Hogan, the Court of Customs and Patent Appeals held that a patent application that disclosed and enabled a method of making the crystalline form of polymer was entitled to a claim for the method of making a solid polymer, because the only known method for making a solid polymer at the time was the applicants method of making the crystalline form. 148. The Hogan decision was rendered in a jurisdiction that has the historical background of Blocking Patents. Further, Hogan that relates to the saga of acrimonious litiga ..... X X X X Extracts X X X X X X X X Extracts X X X X ..... ime of the patent application and therefore, that the patentee could not have been expected to claim the amorphous form at that time. The Court further took the view that the broad claim for a solid polymer would satisfy the enablement requirement under the state of the art, as that was known at the time of the filling of the patent application, because the amorphous form was not known at that time. The Court observed: Consideration of a later existing state of the art in testing for compliance with 112, first paragraph, would not only preclude the grant of broad claims, but would wreak havoc in other ways as well. The use of a subsequently-existing improvement to show lack of enablement in an earlier-filed application on the basic invention would preclude issuance of a patent to the inventor of the thing improved, and in the case of issued patents, would invalidate all claims (even some picture claims ) therein. Patents are and should be granted to later inventors upon unobvious improvements. Indeed, encouragement of improvements on prior inventions is a major contribution of the patent system and the vast majority of patents are issued on improvements. It is quite another t ..... X X X X Extracts X X X X X X X X Extracts X X X X ..... o decisions relied upon by Mr. Andhyarujina. Those two decisions also have no application to the facts of the present case, for the same reason as in case of Hogan. 156. However, before leaving Hogan and proceeding further, we would like to say that in this country the law of patent, after the introduction of product patent for all kinds of substances in the patent regime, is in its infancy. We certainly do not wish the law of patent in this country to develop on lines where there may be a vast gap between the coverage and the disclosure under the patent; where the scope of the patent is determined not on the intrinsic worth of the invention but by the artful drafting of its claims by skillful lawyers, and where patents are traded as a commodity not for production and marketing of the patented products but to search for someone who may be sued for infringement of the patent. 157. In light of the discussions made above, we firmly reject the appellant s case that Imatinib Mesylate is a new product and the outcome of an invention beyond the Zimmermann patent. We hold and find that Imatinib Mesylate is a known substance from the Zimmermann patent itself. Not only is Imatinib Mesyla ..... X X X X Extracts X X X X X X X X Extracts X X X X ..... d (f) of section 64(1) of the Act, which contain two of the grounds for revocation of patents, also use the expression publicly known . The expression publicly known may normally be construed more widely than known , and in that sense it is closer to the submission made by Mr. Subramanium. But even the expression publicly known received quite the opposite interpretation by this Court in Monsanto Company v. Coramandal Indag Products (P) Ltd.[49] In paragraph 6 of the judgment, Justice Chinnappa Reddy, speaking for the Court, held and observed as under: To satisfy the requirement of being publicly known as used in clauses (e) and (f) of Section 64(1), it is not necessary that it should be widely used to the knowledge of the consumer public. It is sufficient if it is known to the persons who are engaged in the pursuit of knowledge of the patented product or process either as men of science or men of commerce or consumers. The section of the public, who, as men of science or men of commerce, were interested in knowing about Herbicides which would destroy weeds but not rice, must have been aware of the discovery of Butachlor. There was no secret about the active agent Butachlo ..... X X X X Extracts X X X X X X X X Extracts X X X X ..... also possessed by Imatinib in free base. The relevant extract from the patent application is once again reproduced here: It goes without saying that all the indicated inhibitory and pharmacological effects are also found with the free base, 4-(4- methylpiperazin-1-ylmethyl)-N-[4-methyl-3-(4-pyridin-3-yl) pyrimidin-2- ylamino)phenyl] benzamide, or other cells thereof. The present invention relates especially to the -crystal form of the methanesulfonic acid addition salt of a compound of formula I in the treatment of one of the said diseases or in the preparation of a pharmacological agent for the treatment thereto. (emphasis added) 163. Now, when all the pharmacological properties of beta crystalline form of Imatinib Mesylate are equally possessed by Imatinib in free base form or its salt, where is the question of the subject product having any enhanced efficacy over the known substance of which it is a new form? 164. It may also be stated here that while going through the Zimmermann patent one cannot but feel that it relates to some very serious, important and valuable researches. The subject patent application, on the other hand, appears to be a loosely assembled, cut- ..... X X X X Extracts X X X X X X X X Extracts X X X X ..... paragraph 8 of the affidavit, explained that it was being filed to meet the conditions under section 3(d) of the Act. He stated that the proviso to section 3(d) was unique to India and there was no analogous provision in any other country of the world. The appellant was, therefore, never called upon to satisfy the tests laid down in section 3(d) of the Act to establish the patentability of the patent subject. He further stated that since no occasion to do so had arisen earlier, no study relating to the efficacy of the free base was carried out in the past. Upon coming to know the requirement of section 3(d), the deponent, asked by the appellant, immediately commenced such a study, ensuring that accuracy and universally accepted scientific and ethical guidelines were not sacrificed. 168. Manley, in paragraph 8 of his affidavit, stated: The physical properties of the Free Base and imatinib mesylate differ in that the Free Base is only very slightly soluble in water (0.001 g/100 ml) while imatinib mesylate is very soluble in water (beta crystalline form: 130 g/100 ml). Other physical characteristics of the subject compound are described at pages 2 3 of the specification. The at ..... X X X X Extracts X X X X X X X X Extracts X X X X ..... t was contended that the subject product, in terms of invention, is two stages removed from Imatinib in free base, and the substance immediately preceding the subject product is Imatinib Mesylate (non-crystalline). 171. That being the position, the appellant was obliged to show the enhanced efficacy of the beta crystalline form of Imatinib Mesylate over Imatinib Mesylate (non-crystalline). There is, however, no material in the subject application or in the supporting affidavits to make any comparison of efficacy, or even solubility, between the beta crystalline form of Imatinib Mesylate and Imatinib Mesylate (non-crystalline). 172. As regards the averments made in the two affidavits, for all one knows the higher solubility that is attributed to the beta crystalline form of Imatinib Mesylate may actually be a property of Imatinib Mesylate itself. One does not have to be an expert in chemistry to know that salts normally have much better solubility than compounds in free base form. If that be so, the additional properties that may be attributed to the beta crystalline form of Imatinib Mesylate would be limited to the following: i. More beneficial flow properties, ii. Better t ..... X X X X Extracts X X X X X X X X Extracts X X X X ..... ich the case is presented by Mr. Subramanium is an entirely new case made before this Court for the first time. Nevertheless, let us consider the case of the appellant as presented by Mr. Subramanium. 177. The portion added in section 3(d) by the 2005 amendment reads as under: The mere discovery of a new form of a known substance which does not result in the enhancement of the known efficacy of that substance [is not inventions within the meaning of the Act]. 178. The Explanation to section 3(d) also added by the 2005 amendment provides as under: Explanation. For the purposes of this clause, salts, esters, ethers, polymorphs, metabolites, pure form, particle size, isomers, mixtures of isomers, complexes, combinations and other derivatives of known substance shall be considered to be the same substance, unless they differ significantly in properties with regard to efficacy. 179. It may be seen that the word efficacy is used both in the text added to the substantive provision as also in the explanation added to the provision. 180. What is efficacy ? Efficacy means[50] the ability to produce a desired or intended result . Hence, the test of efficacy in the context of ..... X X X X Extracts X X X X X X X X Extracts X X X X ..... , we take note of two slightly diverging points of view urged before this Court. 183. Mr. Anand Grover, learned counsel appearing for one of the Objectors, Cancer Patients Aid Association, took a somewhat rigid position. The learned counsel submitted that in the pharmaceutical field, drug action is explained by pharmacokinetics (effect of the body on the drug) and pharmacodynamics (effect of the drug on the body). He further submitted that efficacy is a pharmacodynamic property, and contended that, in the field of pharmaceuticals, efficacy has a well-known meaning. Efficacy is the capacity of a drug to produce an effect. The IUPAC describes efficacy as the property that enables drugs to produce responses . It is that property of a drug which produces stimulus. When comparing the efficacy of two substances, efficacy describes the relative intensity with which agonists vary in the response they produce even when they occupy the same number of receptors . [IUPAC Glossary of Terms used in Medicinal Chemistry, 1998 in CPAA volume 9, at page 7]. In the words of Goodman and Gilman, the generation of response from the drug receptor complex is governed by a property described as ef ..... X X X X Extracts X X X X X X X X Extracts X X X X ..... above. 187. In whatever way therapeutic efficacy may be interpreted, this much is absolutely clear: that the physico-chemical properties of beta crystalline form of Imatinib Mesylate, namely (i) more beneficial flow properties, (ii) better thermodynamic stability, and (iii) lower hygroscopicity, may be otherwise beneficial but these properties cannot even be taken into account for the purpose of the test of section 3(d) of the Act, since these properties have nothing to do with therapeutic efficacy. 188. This leaves us to consider the issue of increased bioavailability. It is the case of the appellant that the beta crystalline form of Imatinib Mesylate has 30 per cent increased bioavailability as compared to Imatinib in free base form. If the submission of Mr. Grover is to be accepted, then bioavailability also falls outside the area of efficacy in case of a medicine. Leaving aside the submission of Mr. Grover on the issue, however, the question is, can a bald assertion in regard to increased bioavailability lead to an inference of enhanced therapeutic efficacy? Prof. Basheer quoted from a commentator[52] on the issue of bioavailability as under: It is not the intent of a bi ..... X X X X Extracts X X X X X X X X Extracts X X X X ..... 53]. However, in case of chemicals and especially pharmaceuticals if the product for which patent protection is claimed is a new form of a known substance with known efficacy, then the subject product must pass, in addition to clauses (j) and (ja) of section 2(1), the test of enhanced efficacy as provided in section 3(d) read with its explanation. 193. Coming back to the case of the appellant, there is yet another angle to the matter. It is seen above that in the US the drug Gleevec came to the market in 2001. It is beyond doubt that what was marketed then was Imatinib Mesylate and not the subject product, Imatinib Mesylate in beta crystal form. It is also seen above that even while the appellant s application for grant of patent lay in the mailbox awaiting amendments in the law of patent in India, the appellant was granted Exclusive Marketing Rights on November 10, 2003, following which Gleevec was marketed in India as well. On its package[54], the drug was described as Imatinib Mesylate Tablets 100 mg and it was further stated that each film coated tablet contains: 100 mg Imatinib (as Mesylate) . On the package there is no reference at all to Imatinib Mesylate in beta crys ..... X X X X Extracts X X X X X X X X Extracts X X X X ..... 8 199 869 1955 2,736 403 2,333 1937 1,246 202 1,044 1956 3,067 482 2,585 1938 1,243 220 1,023 1957 3,456 527 2,929 1939 1,060 238 822 1958 3,572 529 3,043 10,525 1,802 8,723 25,519 4,342 21,177 (17%) (17%) Table (2) Patents Granted From 1950-57- analysed according to the subject of the inventions. Year Food Indian No. Percentage Foreign No. Percentage Total 1950 22 16.5 111 83.5 133 1951 35 28.6 87 71.4 122 1952 18 18.9 77 81.1 95 1953 30 18.8 129 81.2 159 1954 31 8.3 341 91.7 372 1955 48 10.0 430 90.0 478 1956 30 7.0 402 93.0 432 1957 ..... X X X X Extracts X X X X X X X X Extracts X X X X ..... nti-tumoral drugs and as drags (sic drugs) against atherosclerosis. Page No. 60: The methane sulfonic acid addition salt of a compound of formula I, which is preferably used in the -crystal form possesses valuable pharmacological properties and may, for example, be used as an anti-tumour agent, as an agent to treat atherosclerosis. 2. Column 5: and anti-bacterial active ingredients.. Page No. 60: preventing the invasion of warm-blooded animal cells by certain bacteria, such as Porphyromonas gingivalis. 3. Column 4: The phosphorylation of proteins has long been known as an important step in the differentiation and proliferation of cells. The phosphorylation is catalysed by protein kinases which are divided into serine/threonine kinases and tyrosine kinases. The serine/threonine kinases include protein kinase C and the tyrosine kinases the PDGF (platelet-derived growth factor)-receptor tyrosine kinase. Page No. 60: The phosphorylation of proteins has long been known as an essential step in the differentiation and division of cells. Phosphorylation is catalysed by protein kinases subdivided into serine/threonine and tyrosine kin ..... X X X X Extracts X X X X X X X X Extracts X X X X ..... ound of formula I described in more detail hereinbefore, such as especially its -crystal form, inhibits PDGF-dependent acellular receptor phosphorylation. 6. Column 8: The compounds of this invention inhibit enzyme activity by 50% (IC50) typically in a concentration of 0.1 to 10 m. Page No. 61: the corresponding methanesulfonate salt inhibit the tyrosine kinase activity of the PDGF receptor at an IC50 (concentration at which activity is inhibited by 50% compared with the control) of about 120 nM and about 100 nM, respectively. 7 Column 7: Owing to the properties described, compounds of formula I can be used not only as tumour-inhibiting active ingredients but also as drugs against non-malignant proliferative diseases, e.g. atherosclerosis, thrombosis, psoriasis, sclerodermitis and fibrosis. They are also suitable for the further applications mentioned above for protein kinase C- modulators and can be used especially in the treatment of diseases that respond to the inhibition of PDGF-receptor kinase. Page No. 61: On the basis of the described properties, the methanesulfonic acid addition salt of a compound of formula I, such ..... X X X X Extracts X X X X X X X X Extracts X X X X ..... mour-inhibiting amount of a compound of formula I or of a pharmaceutically acceptable salt thereof. Page No.68: The invention relates also to a process for the treatment of warm-blooded animals suffering from said diseases, especially a tumour disease, . is administered to warm-blooded animals in need of such treatment. 12. Column 20: The invention relates further to the use of a compound of formula I or of a pharmaceutically acceptable salt thereof for inhibiting PDGF-receptor kinase or to the use of a compound of formula I wherein R4, and R8 are each hydrogen, or of a pharmaceutically acceptable salt thereof, for inhibiting protein kinase C in warm-blooded animals or for preparing pharmaceutical compositions for use in the therapeutic treatment of the human or animal body. Page No.68 : The invention relates moreover to the use of the -crystal form of the methanesulfonic acid addition salt of a compound of formula I for the inhibition of the above-mentioned tyrosine kinases, especially PDGF receptor kinase, v-abl kinase, and/or c-kit receptor kinase, or for the preparation of pharmaceutical compositions for use in treating the human or animal body. ..... X X X X Extracts X X X X X X X X Extracts X X X X ..... ining the active substance together with diluents, for example lactose, dextrose, sucrose, mannitol, sorbitol, cellulose and/or glycerin, and/or lubricants, for example silicic, talc, stearic acid, or salts thereof, typically magnesium or calcium stearate, and/or polyethylene glycol, are used for oral administration. Tablets may likewise contain binders, for example magnesium aluminium silicate, starches, typically corn, wheat or rice starch, gelatin, methylcellulose, sodium carboxymethylcellulose and/or polyvinylpyrrolidone, and, if so desired, disintegrants, for example starches, agar, alginic acid or a salt thereof, typically sodium alginate, and/or sweeteners. The pharmacologically active compounds of the present invention can also be used in the form of parenterally administrable compositions or in the form of infusion solutions. Such solutions are preferably isotonic aqueous solutions or suspensions, which, for example in the case of lyophilised compositions that comprise the active ingredient alone or together with a carder, for example mannitol, can be prepared before use. The pharmaceutical compositions may be sterilised and/or may comprise excipients, fo ..... X X X X Extracts X X X X X X X X Extracts X X X X ..... res are given in degrees Celsius ( C). APPENDIX III [pic] [1]4-(4-methylpiperazin-1 ylmethyl)-N-[4-methyl-3-(4-pyridin-3-yl)pyrimidin-2-ylamino)phenyl] benzamide. [2] Ibid [3] Ibid [4] Examples 1 to 3 stated below are reproduced from the written notes titled Novartis Document XIV: Examples in 1602/MAS/1998 (Subject Patent Specification), submitted by Mr. Subramanium, Senior Advocate appearing for the appellant in course of hearing on September 20, 2012. [5] The initial application that was filed was for Crystal modification of a N-phenyl-2-pyrimidineamine derivative, processes for its manufacture and its use . This application included both the alpha and beta crystalline forms. Later on during the course of prosecution of the patent application, the claims of the original application were restricted only to the beta form of Imatinib Mesylate and a separate divisional application no. 799/CHE/04 was filed for the alpha form in 2004. [6] The oppositions were made by M/s. Cancer Patients Aid Association (Respondent No. 4), NATCO Pharma Ltd. (Respondent No. 5), CIPLA Ltd. (Respondent No. 6), Ranbaxy Laboratories Ltd. (Respondent No. 7), Hetro Drugs Ltd. (Resp ..... X X X X Extracts X X X X X X X X Extracts X X X X ..... be granted in respect of claims for the substances themselves, but claims for the methods of processes of manufacture shall be patentable. [19] During this brief period, 125 applications for product patents were received and filed. [20] Excepting all chemical substances which are ordinarily used as intermediates in the preparation or manufacture of any of the medicines or substances referred to in sub-clauses (i) to (iv) of section 2 (1) (l) of the Parent Act. [21] Here it will be unfair not to state that in course of hearing of the case when the Court expressed its bewilderment over the price of the drug, it was strenuously stated on behalf of the appellant that they also ran a huge charitable programme under which the drug was supplied free to the needy persons. However, to the question by the Court why the appellant could not abolish the charitable programme and at the same time bring down the price of the drug so as the total revenue from the sale of the drug remains the same as it is with the abnormally high price and the charitable programme, no satisfactory answer was provided on behalf of the appellant. [22] Section 2(1)(l): New Invention , section 2(1)(ta) Pharm ..... X X X X Extracts X X X X X X X X Extracts X X X X ..... of the others hydrogen, lower alkyl that is unsubstituted orsubstituted by free or alkylated amino, piperazinyl, piperidinyl,pyrrolidinyl or by morpholinyl, or lower alkanoyl, trifluoromethyl, free,etherified or esterifed hydroxy, free, alkylated or acylated amino or freeor esterified carboxy, and to salts of such compounds having at least one salt-forminggroup. [33] 21 Code of Federal Regulations s 314.3: Drug substance means an active ingredient that is intended to furnish pharmacological activity or other direct effect in the diagnosis, cure, mitigation, treatment, or prevention of disease or to affect the structure or any function of the human body, but does not include intermediates use in the synthesis of such ingredient. [34] 21 Code of Federal Regulations s 314.3: Drug product means a finished dosage form, for example, tablet, capsule, or solution, that contains a drug substance, generally, but not necessarily, in association with one or more other ingredients. [35] Later on the appellant also got the drug approval vide letter dated April 18, 2003 in NDA # 21-588 granting approval to commercially market Gleevec (Imatinib Mesylate) Tablets, 100 mg and 400 mg. Needless ..... X X X X Extracts X X X X X X X X Extracts X X X X
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