NOVARTIS AG v. UNION OF INDIA & OTHERS

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[AFTAB ALAM, J.]

63Copy pinpoint63. In the proceedings arising from the complaint filed by A ; the United States, the European Communities were added as the Third Party before the panel and as the Third Participant before the Appellate Body. Nonetheless, the European Communities and their members filed a similar but separate complaint against India (WT/DS79/R, dated August 24, 1998). B ...( The WTO panel, accepting the complainant's request, extended the findings in the earlier dispute (WT/DS50), as modified by -' "f the Appellate Body, to the complaint filed by the European Communities and their member States as well. This matter did not go to the WTO Appellate Body. c

64Copy pinpoint64. The TRIPS Agreement also provides for a built-in mechanism for review through the biennial Ministerial Conference (vide Article 71). The Ministerial Conference is the highest decision-making body of the WTO and it can make decisions on all matters under any of the WTO agreements, D ,.,., including the TRIPS Agreement. The fourth WTO Ministerial 4 Conference in Doha on November 14, 2001, adopted the Doha Declaration on the TRIPS and Public Health. The Doha Declaration is as follows: --\ E "1. We recognize the gravity of the public health problems afflicting many developing and least-developed countries, especially those resulting from HIV/AIDS, tuberculosis, malaria and other epidemics. -4

2. We stress the need for the WTO Agreement on Trade- F •' Related Aspects of Intellectual Property Rights (TRIPS Agreement) to be part of the wider national and international action to address these problems.

3. We recognize that intellectual property protection is G important for the development of new medicines. We also recognize the concerns about its effects on prices.

4. We agree that the TRIPS Agreement does not and should not prevent members from taking measures to H

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A protect public health. Accordingly, while reiterating our commitment to the TRIPS Agreement, we affirm that the 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 B access to medicines for all.

In this connection, we reaffirm the right of WTO members to use, to the full, the provisions in the TRIPS Agreement, which provide flexibility for this purpose.

C 5. Accordingly and in the light of paragraph 4 above, while maintaining our commitments in the TRIPS Agreement, we recognize that these flexibilities includ~:

a. In applying the customary rules of interpretation of public international law, each provision of the TRIPS Agreement shall be read 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. G 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 H treatment provisions of Articles 3 and 4.

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[AFTAB ALAM, J.]

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 General Council before the end of 2002.

7. We reaffirm the commitment of developed-country members to provide incentives to their enterprises and institutions to promote and encourage technology transfer to least-developed country members pursuant to Article 66.2. We also agree that the least-developed country members will not be obliged, with respect to pharmaceutical products, to implement or apply Sections 5 and 7 of Part II of the TRIPS Agreement or to enforce rights provided for under these Sections until 1 January D 2016, without prejudice to the right of least-developed country members to seek other extensions of the transition periods as provided for in Article 66.1 of the TRIPS Agreement. We instruct the Council for TRIPS to take the necessary action to give effect to this pursuant to Article E 66.1 of the TRIPS Agreement."

65Copy pinpoint65. In the course of the hearing, we were told that the Doha ~ Declaration effectively reflected and addressed the deep disquiet of the developing and the least-developed countries F regarding their obligation under TRIPS to grant patent protection for pharmaceutical and agricultural chemical products and the likelihood of its. highly adverse consequence on public- health. Dr. Dhawan, appearing for Cipla (one of the Objectors), was particularly severe in his criticism of the TRIPS Agreement G and called it a "predatory and coercive" agreement. The other qounsel, though, appearing for the different Objectors, were more muted in their criticism of the TRIPS Agreement. Mr. '\.uhad, the learned Additional Solicitor General appearing for the Union of India, and Mr. Grover, Senior Advocate, appearing H on behalf of the M/s. Cancer Patients Aid Association (one of

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A the Objectors), especially adapted their submissions, taking the TRIPS Agreement as a fact that cannot be simplywished away However, all the counsel representing the Union of India anc the different Objectors unanimously took the stand that the TRIPS Agreement has sufficient flexibility (vide Articles 7, 8 anc B 27), which was further reaffirmed by the Doha Declaration (in paragraphs 4 to 6), to enable the member States to control the patent rights in a manner as to avoid any adverse impact on public-health. It was contended on behalf of the Union of India and the Objectors that the TRIPS Agreement coupled with the c Doha Declaration leaves it open to the member States to adjust their respective 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 D 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 E world.

66Copy pinpoint66. 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 ~ F 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 that patent protection to pharmaceutical and agricultural chemical products might have the effect of putting life-saving medicines beyond the reach of a very large section of people. In the following lines we shall see how the Indian legislature addressed this concern and, while

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[AFTAB ALAM, J.] harmonizing the patent law in the country with the provisions of A the TRIPS Agreement, strove to balance its obligations under the international treaty and its commitment to protect and promote public health considerations, not only of its own people but in many other parts of the world (particularly in the Developing Countries and the Least Developed Countries). B

67Copy pinpoint67. We have seen above that, simultaneously with the TRIPS coming into force, the Government of India had brought an Ordinance to comply with the provisions of Article 70 (8) and (9), but the Ordinance lapsed without being replaced by any enactment. Complaints were then filed on which pronouncements were made againstlndia. On the complaint filed by the USA, the decision of the Appellate Body was rendered on December 19, 1997; and on the complaint filed by the European Communities, the report of the Panel came on August 24, 1998. Thus faced with the threat of trade sanctions, Parliament paSSE;ld the Patents (Amendment) Act 1999 (Act No. 17 of 1999) on March 26, 1999, which amended the provisions .of the Patents Act 1970 retrospectively, with effect from January 1, 1995, the date when the TRIPS Agreement came into force. By the Amendment Act of 1999, E section 5 of the Parent Act was amended to provide for making "a claim for patent of an invention for a substance itself intended for use or capable of being used, as medicine or drug"20 . The Amendment Act further incorporated in the Parent Act, Chapter IVA, which contained provisions for grant F of exclusive marketing rights in respect of pharmaceutical substances for which a claim for patent was made under section 5 of the Act. The Amendment Act of 1999 thus complied with Article 70(8) and (9) ofJhe TRIPS Agreement.

68Copy pinpoint68. Three years later the Patents (Amendment) Act, 2002 G

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) (I) of the Parent Act. H

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A (Act No. 38 of 2002) came to be enacted on June 25, 2002. It .\ brought large scale amendments in the Patents Act, 1970. The Statement of Objects and Reasons for the Amendment Act of .., 2002 is stated as under:

"Amendment Act 38 of 2002 - Statement of Objects and B Reasons.-· The law relating to patents is contained 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 c (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 F 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 G patents in accordance with international practices and to make the system more user friendly.

4. Some of the salient features of the Bill are as under:-

(a) to define the term "invention" in consonance with H

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[AFTAB ALAM, J.] )- A international practices and consistent with TRI PS Agreement;

(b) to modify section 3 of the present Act to include exclusions permitted by TRIPS Agreement and also subject-matters like discovery of any living or non-living B substances occurring in nature in the list of exclusions which in general do not constitute patentable invention;

(c) to align rights of patentee as per article 28 of the TRIPS Agreement; c (d) to (k) xxx;

(I) to amend several provisions of the Act with a view to simplifying and rationalising the procedures aimed at benefiting users. D ,., (emphasis added)

69Copy pinpoint69. The Amendment Act of 2002 greatly expanded the definition clause in section 2 of the Parent Act by including a number of new expressions and terms and redefining some E earlier terms.

.. 70. "Invention" was defined in the Parent Act as under:

"Section 2(1)(j) "Invention" means any new and useful- F

(i) art, process, method or manner of manufacture;

(ii) machine, apparatus or other article;

(iii) substance produced by manufacture, G

and includes any new and useful improvement of any of them, and an alleged invention."

71Copy pinpoint71. "Invention" was re-defined by the Amendment Act of 2002 as under: H

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A "Section 2(1 )(j) "invention" means a new product or process involving an inventive step and capable of industrial application." "

72Copy pinpoint72. The expressions "capable of industrial application" and "inventive step" were separately defined in clauses (ac) and ua) 8 respectively which are as under:

"Section 2(1 )(ac) "capable of industrial application", in relation to an invention, means that the invention is capable of being made or used in an industry. c Section 2(1 )(ja) "inventive step" means a feature that makes the invention not obvious to a person skilled in the art."

73Copy pinpoint73. Section 3 of the Parent Act, which provided for exclusions from patentability, was recast. In section 5 of the --<! Parent Act, an Explanation was added after sub-section (2). Chapter XVI was substituted with the Chapter Heading "Working of Patents, Compulsory Licenses and Revocation". Section 83 in this Chapter laid down the general principles applicable to working of patented inventions; section 84 provided for compulsory licenses; and section 85 for revocation of patents for non-working. Here, it may not be out of place to take note of section 83 which provided as under: ~

F "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: - G .... ~

(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;

H {b) that they are not granted merely to enable

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[AFTAB ALAM, J.] ,)- 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; -f

(d) that patents granted do not impede protection of c public health and nutrition and should act as instrument to promote public interest specially in sectors of vital importance for socio- economic and technological development of India; D (e) that patents granted do not in any way prohibit Central Government in taking measures to protect public health;

(f) that the patent right is not abused by the patentee or person deriving title or interest on patent from the E patentee, and the patentee or a person deriving title or interest on patent from the patentee does not resort to practices which unreasonably restrain trade or adversely affect the international transfer of technology; and F

(g) that patents are granted to make the benefit of the patented invention available at reasonably affordable prices to the public." ~ 74. The many amendments to and enlargement of the G Parent Act by the Amendment Act of 2002 laid most of the ground-work, but India was yet to take the one final step to make its patent law compliant with the mandate of TRIPS. And ") that was to amend the Act to allow for grant of product patents for pharmaceutical and agricultural chemical substances. Steps H

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A were taken to finally amend the Patents Act, 1970, but the draft Bill lapsed in February 2004. Further efforts were made but the legislature was unable to bring an enactment to make that final amendment in the Act by December 2004; thus, the Government of India had no option but to amend the law through B an Ordinance. Therefore, in order not to default on its obligations under the TRIPS Agreement, the Government brought the Patents (Amendment) Ordinance, 2004 (Ordinance No. 7 of 2004) with effect from January 1, 2005. By this Ordinance, section 5 of the Patents Act, 1970, which barred ~ C the grant of patent for substances intended for use or capable of being used as food or as medicine or drugs or substances prepared or produced by chemical processes was done away with, opening the doors for grant of patents to, amongst others, pharmaceutical products.

75Copy pinpoint75. But the troubles were far from over, because the Ordinance was to lapse on March 31, 2005. Hence, it was imperative for Parliament to pass an enactment, replacing the Ordinance before it lapsed on March 31, 2005. The pressure of time under which Parliament was obliged to deal with the E matter and pass the Act, replacing Ordinance No. 7 of 2004 and amending the Patents Act, 1970, is best stated in the Statement of Objects and Reasons for the Patents (Amendment) Act, 2005 (Act 15 of 2005). In paragraph 5 of the Statement of Objects and reasons it is stated as under: F "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 I-

G 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 H implementation would also not have helped the Indian

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[AFTAB ALAM, J.) case. This default would also have created a legal vacuum A 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 B 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, c there would have been an erosion of India's credibility in the international field. In the circumstances it was considered necessary to bring in the required amendments in time and as Parliament was not in session, the President promulgated the Patents (Amendment) D Ordinance, 2005 (Ord. 7 of 2004) on the 26th December, 2004."

76Copy pinpoint76. Parliament had an absolutely unenviable task on its hands. It was required to forge, within a very limited time, an Act that would be TRIPS compliant without, in any way, compromising on public health considerations. It is seen above that the TRIPS Agreement had aroused grave concerns about its impact on public health. India had learnt from experience the inverse relationship between product patents and the indigenous pharmaceutical industry, and its effects on the availability of essential drugs at affordable prices. It is also seen above that after the patent system in India barred the grant of patents for pharmaceutical and chemical substances, the pharmaceutical industry in the country scaled great heights and became the major supplier of drugs at cheap prices to a G number of developing and under developed countries. Hence, the reintroduction of product patents in the Indian patent system through the TRIPS Agreement became a cause of alarm not only in this country but also for some international agencies. Our attention was invited to a letter of the HIV/AIDS Director of the H

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A WHO, dated December 17, 2004, to the Minister of Health and Family Welfare, Government of India. The letter deserves to be noted in full. "17 December 2004 Dr. A Ramadoss B Minister of Health and Family Welfare Government of India I f\jirman Bhawan, Maulana Azad Road ' New Delhi-110 001 India ... c Dear Dr. Ramadoss,

We would like to bring to your attention that several of our Member States have expressed. their concern that in the future, generic antiretroviral drugs from D India may no longer be available to them. AmQng other places, these concerns were expressed by the -t delegations of Ghana, Lesotho, Malawi, and Namibia at our recent Procurement & Supply Management (PSM) Workshop in Nairobi, Kenya (2-9 December, E 2004), and by Bangladesh, Cambodia, China, Indonesia, Korea, Laos, Thailand, Papua New Guinea, and Vietnam at the Asian Regional Workshop on the WTO/TRIPS Agreement and Access to Medicines held in Kuala Lumpur, Malaysia (28-30 November 2004). ~ F As you are aware, WHO has 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 G production and supply of generic antiretroviral agents. A

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. H implemented in a manner supportive of WTO Members'

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[AFTAB ALAM, J.] ,;. · right to protect public health and, in particular, topromote · A 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). B In accordance with its mandate, WHO will therefore seek to provide technical assistance and support to Member States to promote implementation of the TRIPS -1 Agreement consistent with the public health objective of ensuring access to medicines. c As India is the leader in the global supply of affordable antiretroviral drugs and other essential medicines, we hope that the Indian government will take the necessary steps to continue to account for the needs of the poorest nations that urgently need D access to antiretrovirals, without adopting unnecessary restrictions that are not required under the TRIPS Agreement and that would impede access to medicines. E We thank'you for your attention to this issue and send our best regards .

. . Sincerely, Dr. Jim Yong Kim ·Director · F Department of HIV/AIDS" (emphasis added)

• 77. We were also shown another letter dated February 23, 2005, from the Director of Advocacy, Communication and G

Leadership for UNAIDS, to the Minister of Commerce and Industry, Governrnent of India, This letter is also useful as reflecting the concern of the international community over the impending change jn the patent system in India. This letter is H

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A as under: "Honourable Minister Mr Kamal Nath I- I

Ministry of Commerce and Industry Udyog Bahavan B New Delhi 110001 India 23 February 2005

Reference: ACUAD/lp c Excellency,

I have the honour to refer to India's leadership in promoting access to and supplying affordable essential generic HIV medicines to those most in need in developing countries, D which has long been recognized and applauded by the international community. India can rightly take pride in the fact that it has significantly supported the response to the global AIDS emergency through helping to ensure AIDS medicines are more affordable and accessible. E Affordable HIV medications from India have so far saved thousands of lives yet more than 8,000 people around the world continue to die every day because they have no access to treatment. Despite concerted efforts across the F world, only about one in ten people in urgent need of HIV antiretroviral treatment in low- and middle-income countries has access to existing medicines.

Current legislative proposals intended to take the 1970 Indian Patents Act beyond the commitments agreed in the G World Trade Organization's Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS) threaten to undermine India's leadership in providing affordable medicines. For example, the requirement that countries wishing to import from India under the WTO 30 August H

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[AFTAB ALAM, J.] 2003 Decision must issue a compulsory license in every A case goes far beyond the WTO Decision. This requirement in the Indian Ordinance places a cumbersome 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 B 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 c 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. o 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 affordable medicines and technologies.

Therefore, we would respectfully urge you to consider all appropriate legal means to protect and scale up access to essential affordable medicines. The Doha Declaration, G in which India played an important role, makes clear that the interests of public health and equitable access to medicines for all should be primary concerns in the application of the TRIPS Agreement and related trade and intellectual property rules. H

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A UNAIDS has learnt that a Global Day of Action is planned for 26 February 2005 against th.e Indian. Patent Ordinance. Civil society, organizations of people living with HIV and AIDS and the media will be watching closely. This day presents an opportunity for India to send out a strong B message in support of both research innovation and access to affordable HIV-related pharmaceuticals and other essential medicines, while fully complying with the applicable multilateral trade and intellectual property agreements. c Please accept, Excellency, the assurance of my highest consideration. Achmat Dangor Director D Advocacy, Communication and Leadership cc: Dr Prasada Rao, UNAIDS Regional Director, Regional , Support Team, Bangkok ·Permanent Mission of India to the United Nations and other International Organizations in Geneva"

78Copy pinpoint78. It was thus under the twin pressure of time and anxiety to safeguard the public health objectives that Parliament was called upon to deliberate over the amendments required to be made in the patent law to make it fully compliant with the TRIPS Agreement.

79Copy pinpoint79. On December 18, 2004, the Bill to further amend th_e Patents Act, 1970, which was materially the same as Ordinance No. 7 of 2004, was introduced in Parliament. The Bill evoked a highly insightful and informed debate on the subject. To anyone going through the debate on the Bill, Parliament would appear keenly alive to national interests, human-rights considerations and the role of India as the producer and supplier of drugs to different parts of the world where impoverished humanity is critically in need of those drugs at cheap and affordable prices. Cutting across party lines, member after member from the Opposition benches highlighted

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[AFTAB ALAM, J.] . ). the grave risk in creating private monopolies in an area like . A pharmaceuticals, the abuses to which product patents in pharmaceutical products were vulnerable, and the ploys used by big companies to artificially 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 B 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 c companies.

80Copy pinpoint80. One of the members from the Opposition benches said:

"Sir, even if this were a Bill, which affects only India, D 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. E

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, Indonesia, Nairobi, Korea, Laos, Thailand, Vietnam, etc. All of them have complained about our Bill. It is a Bill that affects so many parts of the world. Do you not think that we should have a slightly more serious discussion on it, rather than attempting to pass it through?"

. The same member speaking at a later stage in the debate said: ,, H

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A "India has benefited from the low cost generic indwstry to dominate 30 per cent of the low cost drugs in the world ....

Secondly, it (the bill) is vague about the evergreening effect in which companies extend their patent rights by switching from capsules to tablets, for instance. This 8 extends monopolies. Parliament must make sure that it protects the rights of India to make these generic drugs. We should remove the provision that allows this evergreening .... What should and what should not be patentable has also been left open to c interpretation. Earlier, the new use for a substance could not be patented. Now this has been qualified to allow it by putting "mere new use" instead of "new use".

xxx D Sir, I am going to limit my speech to six points only. This is what we need:

1. We need to limit the scope of patentability to only new chemical entities. E

2. No patents for new usage and dosage of known drugs.

3. Retain pre-grant opposition in its original form. )..

F 4. Simple procedures with a time limit for grant of compulsory licences.

5. Immunity for generic drugs which are already available in the market. G

6. Introduction of ceiling on royalty to pharmaceutical companies"

81Copy pinpoint81. Another member, also from one of the parties in the Opposition, had this to say: H

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[AFTAB ALAM, J.] ). "Sir, a lot of things have been said for and against the Bill. A Certain basic positions have to be re.-stated even now. That is, in India, we had legislation in 1891 on the Patents and Designs. That was product regime, under which it had been told that in India, in relation to medicines, at that time, 85 per cent of our medicinal requirements was met by B import of medicines from abroad. In those days, probably, the transnational corporations were not as big as they are today. But even then, with the product regime that was there upto 1911, the situation in this country was such that we had to depend upon imports for the 85 per cent of our c medicinal requirements.

After 1970, when India adopted a new Patents legislation, where. we had adopted a process regime, the situation was reversed. This 85 per cent of our country's medicinal requirement was met by our own products. That was a D 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 E 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. ... " F

82Copy pinpoint82. 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 G 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 a patent. So, in this way, H

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A they will continue to get a patent for the same medicine. For example, the drug called 'Glevic' (sic Gleevec/Glivec), is used for the treatment of Leukaemia. It is patented by Novartis. This was originally patented in 1993. The cost of the drug for the treatment of this disease comes to about B Rs.1,20,000 per month 21 in India. At the same time, the generic versions are available in the country which cost only Rs.8,000 to Rs.10,000."

83Copy pinpoint83. As the deliberations were going on in Parliament, C negotiations were also held between the ruling party and some of the opposition parties, in course of which certain amendments were suggested in the Bill. And in order to allay the apprehensions and fears voiced by the Opposition, one of the members from the Government said:

D "Madam, I am concluding. I would only like to refer to the amendment which is being incorporated in Clause 3 which talks of the known inventions, the products which are not considered to be inventions and therefore cannot be covered by the patent and patents cannot be sought for them. A good amendment is being introduced to that effect in Clause 3 of the Bill which says:

"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 of (sic or) the mere discovery of any new property or new use for a known substance or of the mere use of a known process, machine

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 titne 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.

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[AFTAB ALAM, J.] or apparatus unless such known process results in a new product or employs at least one new reactant."

The explanation to that should completely allay the fears of our friends on the other side. I hope they would accept that."

84Copy pinpoint84. Speaking at the conclusion of the debate, the minister who had sponsored the Bill also referred to the amendment proposed in section 3(d). He said:

.... "There are so many provisions here. In regard to evergreening, I just want to read out section 3(d) which says c . that a mere discovery of a new property or a new use for a known substance or the mere use of known process .in a new product - these are exceptions, these will not be granted :any patent - and substances obtained. by a mere ad-mixture resulting only in aggregation of properties of the D components thereof or, processes of producing such substances will not be given patents ... "

85Copy pinpoint85. Finally, after three days of debate (March 18, 21 and 22) the Bill, along with the amendments proposed by the minister, was passed by the Lok Sabha on March 22, 2005. E 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 -'1. to grant of patent. After being passed by the Lok Sabha, the Bill was presented in the Rajya Sabha where it was passed F 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 G j. 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 H

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A 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.

87Copy pinpoint87. We have seen in some detail the "why" and the "how" 8 of the law. Let us now examine what the law is in light of its "why" and "how". In order to understand the meaning of "invention" under the Patents Act, 1970, as it stands today after its amendment by the amending Act of 2005, we must refer to clauses (ac), 0) and (ja) of section 2(1) of the Act: 23

"Section 2. Definitions and interpretation. - (1) In this Act, unless the context otherwise requires,-

(ac) "capable of industrial application", in relation to an invention, means that the invention is capable of being made or used in an industry;

0) "invention" means a new product or process involving an inventive step and capable of industrial application;

E (ja) "inventive step" means a feature of an invention that involves technical advance as compared to the existing knowledge or having economic significance or both and that makes the invention not obvious to a person skilled in the art;"

88Copy pinpoint88. Section 2(1)(j) requires a product to satisfy three conditions to qualify as an invention.

(i) It must be "new", that is to say it must not have been

22. Section 2(1 )(I): "New Invention", section 2(1 )(ta) "Pharmaceutical substance·.

23. Clauses (I) and (ta) of section 2(1) are also on the issue of "invention· but as noted above those provisions, though defined in section 2 are not used anywhere else in the Act and, therefore, we do not take those provisions in consideration for construing the meaning of "invention". H

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[AFTAB ALAM, J.] anticipated; A

(ii) Its coming into being must involve an "inventive step"; and

(iii) It must be "capable of industrial application", that is to say it must be capable of being made or used in an industry [section 2(1 )(ac)].

89Copy pinpoint89. "Inventive step" is separately defined in section 20a) to mean a feature of an invention that involves technical advance as compared to the existing knowledge, or having economic significance or both and that makes the invention not obvious to a person skilled in the art. To paraphrase, the invention that creates the product must have a feature that involves technical24 advance as compared to the existing knowledge or having economic significance or both and this o feature should be such as to make the invention not obvious to a person skilled in the art.

90Copy pinpoint90. On a combined reading of causes 0), (ac) and Oa) of section 2(1), in order to qualify as "invention", a product must, therefore, satisfy the following tests: E

(i) It must be "new";

---\ (ii) It must be "capable of being made or used in an industry" F (iii) It must come into being as a result of an invention which has a feature that:

(a) entails technical advance over existing knowledge; G Or

(b) has an economic significance

24. "Adjective: 1. of or relating to a particular subject, art, or craft or its techniques. 2. of, involving, or concerned with applied or industrial sciences" : The New Oxford Dictionary of English, Edition 1998. H

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A And ~

(c) makes the invention not obvious to a person skilled in the art.

91Copy pinpoint91. We have seen the meaning of "invention"; 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 E "invention", we may now advert to section 3 as it stands after the amendment of the Act in 2005.

92Copy pinpoint92. 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, 2005, Chapter II has only two sections: sections 3 and 4. The Chapter has the Heading "Inventions Not Patentable" and section 3 has the marginal heading "What are not inventions." As suggested by the Chapter heading and the marginal heading of section 3, and as may be seen simply by going through section 3, it puts at one place provisions of two different kinds: one that declares that certain things shall not be deemed to be "inventions" [for instance clauses (d) & (e)]; and the other that provides that, though resulting from invention, something may yet not be granted patent for other considerations [for instance clause (b)]. H

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[AFTAB ALAM, J.]

93Copy pinpoint93. For the purpose of these appeals, however, we need only to focus on clause (d) of section 3.

94Copy pinpoint94. We have seen earlier that, in course of the debate in Parliament, an amendment (by way of addition) in clause (d) of section 3 was proposed by the Government in order to allay the fears of the members from the Opposition concerning the introduction of product patents for pharmaceuticals and agricultural chemicals, and it was on the Government's -""( assurance that the proposed amendment in section 3(d) (besides some other change$ in the Act) would take care of the apprehensions about the abuse of product patent in c medicines and agricultural chemical substances that the Bill was passed by Parliament. We once again examine here what was the amendment introduced in section 3(d) by the amending Act of 2005. Immediately before its amendment in 2005, section 3(d) was, in the Patents (Amendment) Ordinance, 2004 D r- (Ordinance No. 7 of 2004), as under:-

"~ection 3. What are not inventiOns.- The following are not inventions within the meaning of this Act,- E (d) the mere discovery of any new property or mere new use for a known substance or of the mere use of a known - process, machine or apparatus unless such known "I process results in a new product or employs at least one new reactant." F

95Copy pinpoint95. After the amendment with effect from Jan 1, 2005, section 3(d) stands as under: -

"Section 3. What are not inventions.- The following are not inventions within the meaning of this Act,- G (d) 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 the mere discovery of any new property or new use for a known H

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A substance or of the mere use of a known process, machine \... or apparatus unless such known process results in a new product or employs at least one new reactant.

Exp/anation.-For the purposes of this clause, salts, esters, ethers, polymorphs, metabolites, pure form, B 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." c

96Copy pinpoint96. 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 D word "mere" before "new use"; and (iii) adds an explanation at the end of the clause. ~

97Copy pinpoint97. A perusal of the Parliamentary debate would further reveal that the whole debate centered on medicines and drugs. E 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.

98Copy pinpoint98. The aforementioned amendment in section 3(d) is one F of the most crucial amendments that saw the Bill through Parliament and, as noted, the amendment is primarily in respect of medicines and drugs and, to some extent, agricultural chemical substances.

99Copy pinpoint99. In regard to section 3(d) both Mr. Andhyarujina and Mr. Subramanium, learned counsel appearing for the appellant, strenuously argued that section 3(d) is not meant to be an exception to clauses (j) and (ja) of section 2(1) of the Act. Both the learned counsel insisted that section 3(d) has no application

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[AFTAB ALAM, J.]

to the case of the subject product. The subject product, having A satisfied the tests of invention as provided in clauses 0) and Oa) of section 2(1), cannot be denied patent for allegedly failing to satisfy the tests under section 3(d). Mr. Andhyarujina submitted that section 3(d) is a provision put in ex abundanti cautela non nocet2 5 to remove all doubts. B

100Copy pinpoint100. Mr. Subramanium submitted that section 3(d) is ex majore caute/a 26 • The learned counsel· submitted that the primary purpose of section 3(d), as is evidenced from the legislative history, is to prevent "evergreening" and yet to encourage incremental inventions. "Evergreening" is a term used to label practices that have developed in certain jurisdictions wherein a trifling change is made to an existing product, and claimed as a new invention. The coverage/ protection afforded by the alleged new invention is then used to e'Xtend the patentee's exclusive rights over the product, preventing competition. Mr. Subramanium submitted that, by definition, a trifling change, or in the words of the section "a mere discovery of a new form of a kn.own substance", can never ordinarily meet the threshold of novelty and inventive step under clauses 0) and Oa) of section 2(1). An invention cannot be characterized by the word "mere". The Word "invention" is distinct from the word "discovery". He, therefore, submitted that section 3(d) operates only as ex majore cautela, ensuring that i mere discoveries can never, by an effort at interpretation of clauses 0) and Oa) of section 2(1), be considered inventions. F

101Copy pinpoint101. In regard to the concerns about public health issues and the flexibility of the TRIPS Agreement coupled with the Doha Declaration, allowing the scope to address the issues of , public health, Mr. Subramanium submitted that those concerns G 1.

are ad~ressed in·the Act, in provisions relating to compulsory

25. Abundant caution does no harm.

26. Out of abundant caution. H

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A licensing 27 , revocation of patents 28 , and the multiple stages for .1..._ • opposition to the grant of patent29 .

102Copy pinpoint102. 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 8 larger perspective of the development of the law of patent over the past 100 years and especially keeping in mind the d~ates in the Parliament preceding the 2005 amendment, -it would appear completely unacceptable. We find no force in this C 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}. D

103Copy pinpoint103. 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- E estimated. It is seen above that, in course of the Parliamentary debates, the amendment in section 3(d) was the only provision cited by the Government to allay the fears of the Opposition members concerning the abuses to which a product patent in medicines may be vulnerable. We have, therefore, no doubt that the amendment/addition made in section 3(d) is meant especially to deal with chemical substances, and more particularly pharmaceutical products. The ar:nenaed portion of section 3(d) clearly sets up a second tier of qualifying standards for chemical substances/pharniel{;eutical products in order to leave the door open for true and genuine inventions

27. See Chapter XVI: "Working of Patents, Compulsory Licences and Revocation" in the Patents Act, 1970.

28. See sections 63, 64, and 65 of the Patents Act, 1970.

H 29. See section 25 of the Patents Act, 1970.-

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[AFTAB ALAM, J.]

..> but, at the same time, to check any attempt at repetitive patenting or extension of the patent term on spurious grounds.

104Copy pinpoint104. We have so far seen section 3(d) as representing "patentability", a concept distinct and separate from "invention". But if clause (d) is isolated from the rest of section 3, and the legislative history behind the incorporation of Chapter II in the Patents act, 1970, is disregarded, then it is possible to see section 3(d) as an extension of the definition of "invention" and --\ to link section 3(d) with clauses U) and Ua) of section 2(1 ). In that case, on reading claw~es U) and Ua) of section 2(1) with section 3(d) it would appear that the Act sets different c standards for qualifying as "inventions" things belonging to different classes, and for medicines and drugs and other chemical substances, the Act sets the invention threshold further higher, by virtue of the amendments made in section 3(d) in the year 2005. D ~

105Copy pinpoint105. Admittedly, the genesis of this patent application lies in one of the derivatives of N-phenyl-2- pyrimidine-amine in free base called lmatinib30 , vide example 21 of the Zimmermann patent. According to the appellant, beginning with lmatinib, the subject product, i.e., lmatinib Mesylate in beta crystalline form, was brought to being by not one but two inventions.

106Copy pinpoint106. The first invention lies in selecting example 21 out of ~ the 37 examples given in the Zimmermann patent and then choosing methanesulfonic acid to produce the methanesulfonic acid addition salt of the free base lmatinib, called lmatinib Mesylate. It was emphasized by both Mr. Gopal Subramanium and Mr. Andhyarujina, Senior Advocates appearing for the appellant, that the Zimmermann patent did not teach or suggest _A to a person skilled in the art to select example 21 in preference to other compounds of which examples were given in the Zimmermann patent. Further, even if example 21 was selected,

30. 4-(4-methylpiperazin-1-ylmethyl)-N-[4-methyl-3-(4-pyridin-3-yl)pyrimidin-2- ylamino)phenyl] benzamide. H

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A 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 lmatinib Mesylate from lmatinib in free base was the result of an invention that involved technical advance as 9 compared to the existing knowledge and brought into existence a new substance.

107Copy pinpoint107. In the second invention, the appellant arrived at the beta crystal form of methanesulfonic acid addition salt of · C lmatinib. It was contended on behalf of the appellant that once the salt form of lmatinib was arrived at, the inventors had to further research to be able to ensure that that particular salt form of lmatinib 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 lmatinib Mesylate. It was argued on behalf of the appellant that there is certainly no mention of polymorphism or i crystalline structure in the Zimmermann patent. The relevant crystalline form of the salt that was synthesized needed to be invented. There was no way of predicting that the beta crystalline form of lmatinib Mesylate would possess the characteristics that would make it orally administrable to humans without going through the inventive steps. It was further argued that the Zimmermann patent only described, at most, how to prepare lmatinib free base, and that this free base would have anti-tumour properties with respect to the BCR ABL kinase. Thus, arriving at the beta-crystalline form· of lmatinib Mesylate for a viable treatment of Chronic Myeloid Leukemia required further invention - not one but two, starting from lmatinib in free base form, as stated above. G

108Copy pinpoint108. The subject product admittedly emerges from the Zimmermann patent. Hence, in order to test the correctness of the claim made on behalf of the appellant, that the subject product is brought into being through inventive research, we need to examine in some detail the Zimmermann patent and H certain developments that took place on that basis

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[AFTAB ALAM, J.]

109Copy pinpoint109. An application for grant of patent for the Zimmermann A invention (Pyrimidine Derivatives and Processes for the Preparation thereof) was filed ih the United States of America on April 2, 1993, by Ciba Geigy31 (US Patent' Application No. 08/042,322). This application was abandoned and another continuation-in-part application was then filed on April 28, 1994 B (US Patent Application No. 5,521,184): The Zimmermann invention 32 related to N-pheriyl-2-pyrimidine~amine derivatives

31, In 1996, CIBA Geigy merged with Sandoz to form Novartis, the present appellant. · C

32. The invention relates to N-phenyl-2-pyrimidine-amine derivatives, to processes for the preparation thereof, to medicaments comprising those compounds, and to the use thereof in the. preparation of pharmaceutical · compositions for the therapeutic treatment of warm-blooded animals. · The invention relates to N-phenyl-2-pyrimidine-amine derivatives of formula 1 0

~ wherein R1 i~ 4-pyrazinyl, 1-m~thyl-1 H-~yrrolyl, amino- or amino-lower alkyl- subst1tuted phenyl wherein the ammo group in each case is free, alkylated or acylated, 1H-indolyl ~r 1H-imidazolyl bonded at a five-membered ring car.ban atom, or unsubstituted or lower alkyl"Substituted pyridyl bonded at F a nng carbon atom and unsubstituted or substituted at the nitrogen atom by oxygen, R2 and R3 are. each independenily of the other hydrogen or lower alkyl; one ~r two of the radicals R4, R5, R6, R7 and RB are each nitro, fluoro- subst1tuted lower alkoxy or a radical of formula II G -N(R9)-C(=X)-(Y)n-R 10 wherein R9 is ·hydrogen or lower alkyl, X is o~o •. thio, imino, N-lower alkyl-imino, hydroximino or 0-lower alkyl- hydrox1m1no, H

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A (called, "formula I" in the patent application), and the compounds thereof, the process for their preparation, and to their tr ·apeutic uses. In the patent application, it was expressly stated that the compounds of formula I included their respective salts: B "Salt-forming groups in a compound of formula I are groups or radicals having basic or acidic properties. Compounds having at least one basic group or at least one basic radical, for example a free amino group, a pyrazinyl radical or a pyridyl radical, may form acid addition salts, for c example with inorganic acids, such as hydrochloric ·acid, sulfuric acid or a phosphoric acid, or with suitable organic carboxylic or sulfonic acids ... " - Further:· D "Owing to the close relationship between the novel . compounds in free form and in the form of their salts, including those salts that can be used as intermediates, for example in the purification of the novel compounds or for the identification thereof, herein before and hereinafter E any reference to the free compounds should be understood as including the corresponding salts, where appropriate and expedient."

(emphasis added) F

Y is oxygen or the group NH, n is O or 1 and R10 is an aliphatic radical having at least 5 carbon atoms, or an aromatic, aromatic-aliphatic, cycloaliphatic, cycloaliphatic-aliphatic, heterocyclic or heterocyclic-aliphatic radical, and the remaining radicals R4, R5, R6, R7 and RS are each independently of the others hydrogen, lower alkyl that is unsubstituted or substituted 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 free or esterified carboxy, and to salts of such compounds having at least one salt-forming group.

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[AFTAB ALAM, J.]

110Copy pinpoint110. As regards the pharmacological properties of the A 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 8 atherosclerosis."

111Copy pinpoint111. 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: C

"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 0 kinase C-inhibiting activity of the compounds of formula I t 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 E 10 µmol/liter, especially approximately from 0.05 to 5 µmol/liter. On the other hand, the compounds of formula I inhibit other enzymes, for example protein kinase A, phosphorylase protein kinase- and certain types of tyrosine protein kinase, for example the tyrosine protein kinase of EGF (epidermal growth factor) receptors, only at a far higher concentration, for example 100 times higher. That is an indication of the selectivity of the compounds of formula I. With a view to reducing undesired side effects, it is important for the protein kinase C-inhibitors to be as . A.. selective as possible, i.e. inter alia to have as little effect as possible on other enzymes, especially when the effect of the activity of those other enzymes has no equivalent or synergistic effect on the disease to be treated.

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A As might already be expected on the basis of the inhibiting action on protein kinase C described above, the compounds of formula I wherein R4 and RB are hydrogen, and their pharmaceutically acceptable salts, have anti- proliferative properties which can be demonstrated directly B in the following, different test. In that test the inhibiting action of compounds of formula I on the growth of human T24 bladder carcinoma cells is determined ... "

It was also stated:

C "The tumour-inhibiting activity of the compounds of formula I can also be demonstrated in- vivo.

The tumour-inhibiting activity is determined using female Balb/c nude mice in which human T24 bladder carcinoma 0 has been trarisplanted ... "

The application further claimed:

"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.

Some of the compounds of formula I, e.g. N-[3-(1, 1,2,2- tetrafluoroethoxy)phenyl]-4-(3-indolyl)-2-pyrimidine-amine, furthermore. inhibit the tyrosine kinase activity of the receptor for the epidermal growth factor (EGF). This JI!... receptor-specific enzyme activity is a key factor in the signal transmission in a host of mammalian cells, including human cells, especially epithelial cells, cells of the immune system and cells of the central ancf peripheral nervous system."

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[AFTAB ALAM, J.] It was also said in the application: A

''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 8 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 C compounds of formula I are useful for treating diseases of the immune system and inflammations, subject to the involvement of prot_ein kinases. These compounds of 'I 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." · D

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. )()()(

The processes described above, including the processes for removing protecting groups and the additional process steps, are, unless otherwise indicated, carried out in a manner known per se, for example in the presence or absence of preferably inert solvents and diluents, if necessary in the presence of condensation agents or catalysts ... " · ·· G

It was also affirmed in the application:

"The invention relates also to a method of treating warm- blooded animals suffering from a tumoral disease, which comprises administering to warm-blooded animals H -

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A requiring such treatment an effective, tumour- inhibiting amount of a compound of formula I or ofa pharmaceutically acceptable salt thereof... Effective doses, for example daily doses of approximately from 1 to 1000 mg, especially from 50 to 500 mg, are B administered to a warm-blooded animal of approximately 70 kg body weight according to species, age, individual condition, mode of administration and the individual syndrome.

The invention relates also to pharmaceutical compositions c comprising an effective amount, especially an amount effective in the prevention or therapy of one of the above- mentioned diseases, of the active ingredient together ... with pharmaceutically acceptable car~iers that are suitable for topical, enteral, for example oral or rectal, or parenteral administration, and may be inorganic or organic, solid or liquid. For oral administration there are used especially tablets or gelatin capsules comprising the active ingredient together with diluents, for example lactose, dextrose, sucrose, mannitol, sorbitol, cellulose and/or glycerol ... Tablets may also comprise binders, for example magnesium aluminium silicate, starches, such as corn, wheat or rice starch, gelatin, methylcellulose, sodium carboxymethylcellulose and/or polyvinylpyrrolidone, and, if ·F desired, disintegrators, for example starches, agar, alginic acid or a salt thereof, such as sodium alginate, and/or effervescent mixtures, or adsorbents, dyes, flavourings and sweeteners."

112Copy pinpoint112. The application gave examples to illustrate the invention, making it clear at the same time that those illustrations did not limit the invention in any way. Example 21, which admittedly relates to lmatinib, the "e-duct" for the subject product, is as under:

H "EXAMPLE 21

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[AFTAB ALAM, J.] Analogously to Example 20, N-{5-[4-(4-methyl- A piperazinomethyl)-benzoylamido]-2-methylphenyl}-4-(3- pyridyl)-2-pyrimidine-amine is prepared from 10.68 g (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)." B

Examples 35 to 37 were in respect of tablets in different doses.

113Copy pinpoint113. In the claim at the end of the application under serial no. 23, it was stated as follows: c "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." D -.,.., (emphasis added)

114Copy pinpoint114. The US Patent No. 5,521,184 (the Zimmermann patent) was granted on May 28, 1996. E

115Copy pinpoint115. Later, the appellant made the application for patent for beta crystalline form of lmatinib Mesylate (the subject of the present appeals) in the US on January 18, 2000. The US patent -y for beta crystalline form of lmatinib Mesylate was granted to the appellant about five and a half years later on May 17, 2005 F 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. - ,.....

116Copy pinpoint116. On April 9, 1998, the appellant filed the lnvestigational G New Drug Application (IND # 55,666) for Gleevec and on February 27, 2001, the original New Drug Application (NOA# 21-335) before the Food and Drug Administration (FDA), USA, for lmatinib Mesylate, formerly STl571, CGP57148B (capsules) for the treatment of patients with Chronic Myeloid Leukemia. H

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A The application contained results of extensive preclinical, J..... _ technical and clinical research, and it stated as under:

"The clinical studies discussed in this NOA include one multiple dose tolerability/dose-finding study (phase I) and three large open, uncontrolled efficacy and safety studies B (phase II), as an accelerated development to allow early registration in CML patients. A total of 1234 patients with CML and other Ph+ leukemias have been enrolled in these trials. The results of the Glivec studies are discussed in the perspective of the current state of knowledge in the c treatment of CML as described with a comprehensive review of the literature for each target population (Appendix 4-6 of the Integrated Summary of Efficacy)."

117Copy pinpoint117. In the patent information furnished in connection with D the NOA as required under (US Code) 21 C.F.R. § 314.53, the active ingredient of the drug was stated as lmatinib Mesylate. The Drug Substance 33 (active ingredient), Drug Product3 4 (composition/formulation) and method of use were declared to be covered by US Patent No. 5,521, 184 (i.e. the Zimmermann E patent). It was further declared that the United States Patent No. 5,521, 184 covered the composition, formulation, and/or method of use of lmatinib Mesylate (STl571).

118Copy pinpoint118. In the chemistry review(s) of the NOA# 21-335 (drug approval for capsules) made on March 27, 2001, there was again a reference to US Patent # 5,521, 184 (expiration date - 5/28/2013).

33. 21 Code of Fec;leral Regulations s 314.3: Drug substance means an active ingredient that is intended to furnish pharmacological aciivity 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.

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[AFTAB ALAM, J.] ~ J 119. The FDA approval for the drug Gleevec (lmatinib A Mesylate) 50 mg and 100 mg capsules was granted vide Letter dated May 10, 2001 35 • Following this, the drug was commercially launched in the market long before the grant of patent for beta crystalline form of lmatinib Mesylate. B

120Copy pinpoint120. In the package insert of Gleevec TM (lmatinib Mesylate capsules) the description of the drug was stated as follows:

"GLEEVEC™ capsules contain imatinib mesylate equivalent to 100 mg of imatinib free base. lmatinib mesylate is designed chemically as 4-[(4-Methyl-1- C piperazi nyl )methyl]-N-[ 4-methyl-3-[[4-(3-pyrid i nyl)-2- pyrimidinyl]amino ]-phenyl]benzamide methanesulfonate ... "

121Copy pinpoint121. After the grant ofdrug approval for Gleevec, on July 3, 2001, the appellant made a Patent Term Extension D Application for the Zimmermann patent (US Patent No. 5,521, 184) under 35 USC§ 156(g)(1 )(8), for extending the term of the patent for the time taken in the regulatory review for Gleevec. This application leaves no room for doubt thatlmatinib 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 lmatinibMesylate. Further, it was stated that lmatinib, or any salt thereof, including lmatinib Mesylate, had not previously been approved for commercial marketing under the Federal Food, Drug and Cosmetic Act prior to the approval of NOA# 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 G Product:

35. Later on the appellant also got the drug approval vide letter dated April 18, 2003 in NOA# 21-588 granting approval to commercially market Gleevec (lmatinib Mesylate) Tablets, 100 mg and 400 mg. Needless to say that in regard to the tablet as well the reference is to the Zimmermann patent. H

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~. A 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 include the approved product, imatinib mesylate. Claim 21 claims a composition containing a compound or compounds which include the B approved product, imatinib mesylate. Claim 22 claims a method of treating tumors in warm-blooded animal_s with a compound or compounds which include the approved product, imatinib mesylate."

122Copy pinpoint122. The application was accepted and the term of the patent, which was due to expire on May 28, 2013, was extended for the period of 586 days.

123Copy pinpoint123. It is noted above that the appellant had made an application no. 09/463,097 in the USA for grant of patent for D beta crystalline form of lmatinib Mesylate. The application was rejected by the examiner and, against the examiner's decision, the appellant preferred an appeal (that is, appeal no. 2003- 0919) before the Board of Patent Appeals and Interferences. The Board of Patent Appeals, by its judgment and order dated E November 23, 2003, allowed the appellant's appeal and reversed the examiner's decision, rejecting claims 1 through 8, 10, and 13 through 16. Dealing with the examiner's rejection of appellant's claim 14 under 35 USC § 112, the Board of Patent Appeals referred to claims 21 and 22 of the F Zimmermann patent. With reference to those claims in the Zimmermann patent, the Board of Patent Appeals observed and held as under:

"Under the provisions 35 U.S.C. § 282, a patent shall be presumed valid; and each claim of a patent shall be presumed valid independently of the validity of other claims.

Accordingly, claims 21 and 22 of the U.S. Patent No.5,521, 184 (the Zimmermann patent), shall be presumed valid. We may presume, therefore, that claims 21 and 22 are based on an enabling ,

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[AFTAB ALAM, J.] disclosure; and that the specification of the A Zimmermann patent teaches any person skilled in the art how to use 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 s suffering from a tumoral disease. In claim 23, Zimmermann recites imatinib, a specific compound within the scope Qf formula I, or a phatn:iaceutically acceptable salt thereof. In Jight of 35: U.S.C. § 282, therefore, we may presume thatthe specification of c the Zimmermann patent teaches any person skilled in the art how to use imatinib, or a pharmaceutically acceptable salt thereof, in a pharmace_utical composition for treating tumours or in a method of treating warm-blooded animals suffering from a 0 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 b-crystal form of imatinib mesylate may be administered to a patient as the manipulative step in a method for treating tumour E disease in a patient. ·

The rejection under 35 U.S.C. § 112, first paragraph, is reversed." F ·(emphasis added)

124Copy pinpoint124. 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 lmatinib, a compound of formula I, or a pharmaceutically G 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 lmatinib Mesylate and did not extend H

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A to beta crystalline form of lmatinib Mesylate, which represented a manipulative step 36 in a method of treating tumor disease in a patient.

. 125. Further, NATCO Pharma Ltd., one of the Objectors to the grant of patent to the appellant in this country, had 8 marketed a drug called VEENAT 100 (capsules) in the UK. A legal notice on behalf of the appellant was given to NATCO Pharma Ltd. on February 13, 2004. The notice stated that the appellant was the proprietor of European patent EP-A- 0 564 409 (the Zimmermann patent) and that this patent claimed, C among other things, the compound lmatinib and acid addition salts of that compound such as the Mesylate salt. In the notice it was pointed out that NATCO Pharma Ltd. was selling, in the UK market, VEENAT 100 capsules, the active pharmaceutical ingredient of which was lmatinib Mesylate as claimed in the D Zimmermann patent. The importation, sale and offer to sell VEENAT 100 capsules in the UK market infringed the Zimmermann patent and NATCO Pharma Ltd. was therefore warned to immediately cease the importation, sale and promotion of VEE NAT 100 capsules and other E pharmaceutically substances containing "lmatinib". The matter was finally settled out of court, we are toid, at considerable expense to NATCO Pharma Ltd. which of course had to stop marketing its drug VEENAT 100 capsules in the UK.

126Copy pinpoint126. From the above discussion it would be clear that the drug Gleevec directly emanates from the Zimmermann patent and comes to the market for commercial sale. Since the grant of the Zimmermann patent, the appellant has maintained that Gleevec (that is, lmatinib Mesylate) is part of the Zimmermann G patent. It obtained drug approval for Gleevec on that basis. It ~I claimed extension of the term of the Zimmermann patent for the period of regulatory review for Gleevec, and it successfully

36. Not an "inventive step"! A "manipulative step" may or may not be an "inventive H step", which is the requirement under Indian law.

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[AFTAB ALAM, J.] stopped NATCO Pharma Ltd. from marketing its drug in the A UK on the basis of the Zimmermann patent. Not only the appellant but the US Board of Patent Appeals, in its judgment granting patent for beta crystalline form of lmatinib Mesylate, proceeded on the basis that though the beta crystal form might not have been covered by the Zimmermann patent, the B Zimmermann patent had the teaching for the making of lmatinib Mesylate from lmatinib, and for its use in a pharmacological compositions for treating tumours or in a method of treating warm-blooded animals suffering from a tumoral disease. This finding was recorded by the US Board of Patent Appeals, in c the case of the appellant itself, on the very same issue that is now under consideration.· The appellant is, therefore, fully bound by the finding and cannot be heard to take any contrary plea.

127Copy pinpoint127. We have looked, so far, at the Zimmermann patent and the developments that have taken place on its basis. We D 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 E by several people, including Jurg Zimmermann. In this article there is a detailed discussion about the anti-tumoral properties of lmatinib and its methanesulfonate salt, i.e., lmatinib Mesylate. In the abstract at the beginning of the article, it is stated as under: F

"ABSTRACT

Oncogenic activation of Abl proteins due to structural modifications can occur as a result of viral transduction or A-- chromosomal translocation. The tyrosine protein kinase G 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 inhibitor (CGP H

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A 57148 37 ) of the Abl and platelet-derived growth factor (PDGF) receptor protein-tyrosine kinases from the 2- phenylaminopyrimidine class, which is highly active in vitro and in vivo. Submicromolar concentrations of the compound inhibited both v-Abl and PDGF receptor B autophosphorylation and PDGF-induced c-fos mRNA expression selectively in intact cells .... Furthermore, anchorage-independent growth of v-abl- and v-sis- transformed BALB/c 3T3 cells was inhibited potently by CGP 57148. When tested in vivo, CGP 57148 showed c antitumor activity at tolerated doses against tumorigenic v-abl- and v-sis- transformed BALB/c 3T3 cells. In contrast, CGP 57148 had no antitumor activity when tested using src-transformed BALB/c 3T3 cells. These findings suggest that CGP 57148 may have therapeutic potential for the treatment of diseases that involve abnormal cellular D proliferation induced by Abl protein-tyrosine kinase deregulation or PDGF receptor activation." y (emphasis added)

128Copy pinpoint128. Under the heading "MATERIALS AND METHODS", it is stated as under:

"Materials. CGP 57148 and its methane sulfonate salt (CGP 571488 38 ) were synthesized by CIBA Pharmaceuticals Division, as will be described elsewhere. F For in vitro and cellular assays, a stock concentration of 10 mM CGP 57148 was prepared in Me2SO and stored at - 20°C. No significant difference in results could be seen between the two forms of CGP 57148. The form used in in vitro experiments is indicated in the text and legends. G All in vivo experiments were performed using CGP 571488 .... "

129Copy pinpoint129. The article goes on to discuss the in vivo

37. lmatinib.

H 38. lmatinib Mesvlate.

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[AFTA8 ALAM, J.] ~· experiments and the in vitro selectivity of CGP 57148 for A inhibition of protein kinases: Identification of CGP 57148 as an ' inhibitor of v-Abl kinase. The article also discussed the in vivo anti-tumour activity of CGP 571488 and it states as follows:

"In Vivo Antitumor Activity. 8 The maximally tolerated dose for a single p.o. or i.p. administration of CGP 571488 in 8AL8/c mice was >500 mg/kg. 8AL8/c AMuLV and 8AL8/c 3T3 v-sis cells, which were sensitive in the colony-forming assay, were used to test CGP 571488 for antitumor activity in female 8AL8/c c nude mice. Once daily i.p. applications of 50, 12.5, or 3.13 mg/kg CGP 571488 given for 30 consecutive days resulted in a strong antitumor effect against AMuLV- transformed 8AL8/c 3T3 tumors (Fig. 5A). Similarly, anti- tumor experiments using v-sis- transformed 8AL8/c 3T3 D cells revealed dose-dependent antitumor activity (Fig. 58). Maximal TIC (X100%) values of 4% (AMuLV tumors) and 11 % (v-sis tumors) were obtained when CGP 571488 was administered at 50mg/kg body weight. In contrast, CGP 571488 showed no antitumor activity against tumors E derived from NIH-527src cells when 50 mg/kg were administered p.o. once daily for 30 days (TIC, 102%). Using the same route of application, TIC values of 7 and ·--f 22% against AMuLV and v-sis tumors; respectively, were obtained when 50 mg/kg CGP 571488 were given." F 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 G examined the specificity of CGP 571.48 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 H.

p. 248 Copy page pinpoint

A PDGF pathway was sensitive to inhibition by the J.~

, compound. The antiproliferative activity of CGP 57148 ~ against both v-ab/- and v-sis- transformed BALB/c 3T3 : support the selectivity profile of CGP 57148 further."

The article concludes by observing as follows: B "The reported findings with CGP 57148 suggest that it may be a development candidate for use in the treatment of Philadelphia chromosome-positive leukemias. Additional potential applications for CGP 57148 may include c proliferative diseases that involve abnormal PDGF receptor activation."

130Copy pinpoint130. Another article was published in Nature Medicine magazine of the year 1996 under the title "Effects of a selective D inhibitor of the Abl tyrosine kinase on the growth of Bcr-Abl positive cells". This article, too, was authored by several people, including JOrg Zimmermann. In this article also, there is a discussion about lmatinib as a compound designed to inhibit Abl protein tyrosine kinase.

131Copy pinpoint131. In the face of the materials referred to above, we are completely unable to see how lmatinib Mesylate can be said to be a new product, having come into being through an "invention" that has a feature that involves technical advance over the existing knowledge and that would make the invention r- F not obvious to a person skilled in the art. lmatinib Mesylate is all there in the Zimmermann patent. It is a known substance from the Zimmermann patent.

132Copy pinpoint132. That lmatinib Mesylate is fully part of the Zimmermann patent is also borne out from another circumstance. It may be G noted that after the Zimmermann patent, the appellant applied for, and in several cases obtained, patent in the US not only for the beta and alpha crystalline forms of lmatinib Mesylate, but also for lmatinib in a number of different forms. The appellant,· however, never asked for any patent for lmatinib H

p. 249 Copy page pinpoint

[AFTAB ALAM, J.]

' .~~ Mesylate in non-crystalline form, for the simple reason that it had always maintained that lmatinib Mesylate is fully a part of the Zimmermann patent and does not call for any separate patent.

133Copy pinpoint133. We thus find no force in the submission that the development of lmatinib Mesylate from lmatinib is outside the Zimmermann patent and constitutes an invention as understood in the law of patent in India.

134Copy pinpoint134. Mr. Andhyarujina and Mr. Gopal Subramanium, learned Senior Advocates appearing for the appellant, c strenuously argued that the patent information furnished by the appellant before the US FDA, or its Patent Term Extension Application, or the legal notice given at its behest to NATCO Pharma Ltd. should not be construed to mean that lmatinib

.,. Mesylate was anticipated in the Zimmermann patent. Mr. Andhyarujina submitted that the Zimmermann patent did not disclose lmatinib Mesylate. The Zimmermann patent did not D

describe any working method for converting lmatinib to lmatinib . 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 lmatinib free base but not any salt of any compound, much less lmatinib 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. lmatinib Mesylate is covered by the Zimmermann A-- G 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 Law of Patent 16th edition, page no. 192 citing G/averbe/ vs. British (1993) RPC 80). Referring to the two articles in Cancer Research and H

p. 250 Copy page pinpoint

A Net ire Medicine, Mr. Andhyarujina submitted that though in the ~~. firsL article there was a reference to lmatinib Mesylate, there was no teaching as to how it is to be prepared. In the Nature Medicine article there was no reference to lmatinib Mesylate but only to lmatinib. B

135Copy pinpoint135. Mr. Gopal Subramanium submitted that the Zimmermann patent is a patent for "Pyrimidine Derivatives and Processes for the Preparation thereof'. The patent is related to a genus of compounds, and each of the compounds within the genus shares a common chemical structure (Markush c structure) and common properties with respect to the inhibition of certain tyrosine kinases (there being a total of 518 kinases in existence). Mr. Subramanium further submitted that the appellantin its application before the US Food and Drug Administration Authority had made a reasonable assertion that D the Zimmermann patent covers the product that was made out of the beta crystalline form of lmatinib Mesylate, i.e., Gleevec30 • T Further, on the basis of the US FDA approval, .the appellant obtained an extension of the period of protection under the Zimmermann patent with respect to Gleevec. E

136Copy pinpoint136. Mr. Subramanium further submitted that the scope of coverage is distinct from the scope of disclosure in a patent. lmatinib Mesylate could be said to be not new and known from the Zimmermann patent only in case there was a complete )'- F disclosure of the method of its preparation in the Zimmermann patent. The learned counsel strongly contended that coverage ., under a patent of the Markush kind cannot lead to any ' presumption of disclosure, m~e,h less any enabling disclosure of all the compounds within the genus. The learned counsel further contended that coverage that is granted in respect of a G patent is not always coextensive with what is disclosed in that

39. There is. a factual error in the submission in as much as in the Drug Approval application before the US FDA the drug Gleevec is represented as lmatinib Mesylate. Before the US FDA there is no refer~c;e to Ute beta H crystalline form of lmatinib Mesylate.

p. 251 Copy page pinpoint

[AFTAB ALAM, J.]

_J patent. In certain circumstances, where it is a pioneering A invention (as in the case of the Zimmermann invention), the patent may be entitled to larger coverage than what is specifically disclosed in it. The learned counsel argued that coverage cannot be used to presume an enabling disclosure of the beta crystalline form of lmatinib Mesylate in the B Zimmermann patent. Disclosure in a specification can never be presumed, and that is a question 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 c 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 y further contended that it would be wrong to say that the appellant's claims for beta crystalline form of lmatinib 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 lmatinib Mesylate relates to a second and different invention. Though the invention in the first part (lmatinib) 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 patent infringed disclosed every aspect of the product in its specification is a separate inquiry.

137Copy pinpoint137. Mr. Subramanium maintained thatthe boundary of the .j, Zimmermann patent was extended up to lmatinib Mesylate but the enablement or disclosure made therein ended at lmatinib. He submitted that it was possible for Zimmermann himself, or for anyone else, to invent lmatinib Mesylate starting from lmatinib. The inventor of lmatinib Mesyfate, be it Zimmermann or anyone else, would also be entitled to get patent for lmatinib H

p. 252 Copy page pinpoint

A Mesylate, but in case the inventor was anyone other than Zimmermann, he would require Zimmermann's permission for marketing lmati1nib Mesylate, since lmatinib had the protection of the Zimmermann patent4°.

138Copy pinpoint138. The submissions of Mr. Andhyarujina and Mr. 8 Subramanium are based on making a distinction between the coverage or claim in a patent and the disclosure made therein. The submissions on behalf of the appellant can be summed up by saying that the boundary laid out by the claim for coverage is permissible to be much wider than the disclosure/ enablementlteaching in a patent.

139Copy pinpoint139. The dichotomy that is sought to be drawn between coverage or claim on the one hand and disclosure or enablement or teaching in a patent on the other hand, seems to strike at the very root of the rationale of the law of patent. Under the scheme of patent, a monopoly is granted to a private - y individual in exchange of the invention being made public so that, at the end of the patent term, the invention may belong to the people at large who may be benefited by it. To say that the coverage in a patent might go much beyond the disclosure thus seem to negate the fundamental rule underlying the grant of patents.

140Copy pinpoint140. In India, section 10(4) of the Patents Act, 1970 mandates: F "Section 10. Contents of specifications.- (4) Every Complete specification shall -

(a) fully and particularly describe the invention and its G operation or use and the method by which it is to be performed;

{b) disclose the best method of performing the

H 40. Blocking Patents!

p. 253 Copy page pinpoint

[AFTAB ALAM, J.] .. ......). invention which is known to the applicant and for A which he is entitled to claim protection; and

(c) end with a claim or claims defining the scope of the invention for which protection is claimed;

(d) be accompanied by an abstract to provide 8 technical information on the invention:

Provided that - )I. (i) the Controller may amend the abstract for c 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 D "Y 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."

141Copy pinpoint141. The UK Patents Act, 1977, in sub-s.ections (2), (3), E and (5) of section 14, provides as under:

"Making of an application

14. - (2) Every application for a patent shall contain - F (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 G

(c) an abstract;

but the foregoing provision shall not prevent an application being initiated by documents complying with section 15(1) below. H

p. 254 Copy page pinpoint

\__ - A (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 - B (a) define the matter for which the applicant seeks protection: ¥ (b) be clear and concise; c (c) be supported by the description; and

(d) relate to one invention or to a group of inventions which are so linked as to form a single inventive concept." D

142Copy pinpoint142. Further, section 112(a) of the Title 35 of US Code y provides as under:

"35 U.S;C. § 112441 E (a) IN GENERAL.-' The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, >-- F to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention."

143Copy pinpoint143. Terrell on the Law of Patents (Seventeenth Edition, G 2011) in Chapter 9: "Construction of the Specification and ~- .

41. Recall that it is on the basis of this provision that the U.S. Board of Patent Appeals had held in the case regarding the appellant's claim for patent for beta crystalline form of lmatinib Mesylate that "in light of 35. U.S.C. § 282, therefore, we may presume that the specification of the Zimmermann patent teaches any person skilled in the art how to use lmatinib, or a H pharmaceutically acceptable salt thereof, ... ".

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[AFTAB ALAM, J.] Claims", under the heading "Principles equally applicable to A : ---+ infringement and validity" states:

"9.05 - Section 125(1) defines an "invention" as (unless the context otherwise requires) that specified in a claim of the specification, and both validity (see sections 1 to 4 and 8 72 of the Act) and infringement (see section 60) are to be tested by reference to the "invention". It is, of course, a fundamental principle that the construction of a claim is the same whether validity or infringement is to be considered; no patentee is entitled to the luxury of an "elastic" C claim which has a narrow meaning in the former case but a wide meaning in the latter. Under English procedure, infringement and validity are normally litigated at the same time and therefore the court is astute to avoid such a result. ... " D (emphasis added)

144Copy pinpoint144. Chisum on Patents: A Treatise on the Law of Patentabi/ity, Validity, and Infringement (Vol. 3, June 2007) in Chapter: "Adequate Disclosure" notes:. E "§ 7.03 - The Enablement Requirement

Since 1790, the patent laws have required that the inventor set forth in a patent specification sufficient information to enable a person skilled in the relevant art to make and use F ., the invention .

The "invention" that must be enabled is that defined by the particular claim or claims. of the patent or patent application. This is consistent with the general principle of G • ;f-- patent law that the claim defines the invention for purposes of both patentability and infringement."

145Copy pinpoint145. Nevertheless, both Mr. Andhyarujina and Mr. Subramanium strenuously argued that the coverage or the claim, and the disclosure or the teaching, have different H

p. 256 Copy page pinpoint

A 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.G. Edwards Ltd. v. Acme Signs & Displays Ltd. 42 and B another of the High CouAtof Justice Chancery Divisions Patent Court in Astellas Pharma Inc v. Comptroller-General of Patents. 43

146Copy pinpoint146. Mr. Gopal Subramanium strongly relied upon the decision of United States Court of Customs and Patent Appeals x C in In re Hogan 44 in support of his contention.

147Copy pinpoint147. 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.

148Copy pinpoint148. 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 litigation over the claim of priority of invention for crystalline polypropylene among five competing companies was a rather unusual decision even in the US. ·

149Copy pinpoint149. In Hogan, 45 the Court of Custom and Patent Appeals had before it an appeal from the decision of the Board of Appeals, affirming the rejections by the Patent and Trademark

42. [1992] R.P.C. 131

G 43. [2009] EWHC 1916 (Pat)

45. The following discussion on the Hogan decision is partially based on the · article "Allocating Patent Rights Between Earlier and Later Inventions" by Charles W Adams, Professor of Law at the University of Tulsa College of Law, published in the Saint Louis University Law Journal (Vol. 54-55, 2009, H pp 56-112).