The Indian Supreme Court’s Novartis Decision – A View from India

• By: Dr. Uday Shetty, founder and Executive Director of Drug Regulations
• Date: April 19, 2013
• Source: http://www.drugregulations.org/2013/04/the-gleevec-chicanery.html

A lot has been written about Novartis not getting the patent for Gleevec in India: how this would affect investments in India by pharma companies, how it would stifle innovation and discovery of new treatments, how this ultimately is not in the interest of patients, how India does not honour patents and how the patent law implementation is weak in India. Patient groups, NGOs and generic manufacturers all over the world have welcomed the decision, especially in the developing world which depends significantly on India for the supply of lifesaving generics.

The judgement of the Supreme Court is very detailed and dwells upon many aspects of the Indian Patent law, how it was enacted and amended, the apprehension of the Parliament of India to amend the “Patent Act 1970” in 2005 and to introduce product patents. It also highlights one very important aspect of the litigation and exposes the chicanery of Novartis to obtain a patent for Imatinib Mesylate when the patent laws in India did not permit this.

Below is a little background to understand this:

Jürg Zimmermann invented a number of derivatives of N-phenyl-2- pyrimidineamine, one of which was CGP 571481 in free base form (later given the International Nonproprietary Name ‘Imatinib’ by the World Health Organisation). The N-phenyl-2-pyrimidine-amine derivatives, including Imatinib, and its derivatives were submitted for patent in the US. The application was made on April 28, 1994 and patent was granted on May 28, 1996 under US Patent No. 5,521,184 and European patent under Patent No. EP-A-0 564 409. ( Novartis in their appeal contented that this patent does not contain patent for “Imatinib Mesylate” but the Supreme Court ruled otherwise).

Novartis in India filed a patent application (Application No.1602/MAS/1998) for grant of patent for Imatinib Mesylate in beta crystalline form at the Chennai Patent Office on July 17, 1998 giving July 18,1997, the date on which the Novartis had applied for grant of patent for Imatinib Mesylate in beta crystalline form in Switzerland, as the “priority date”.

At this time India was following Patents Act 1970 which did not grant product patents but only granted process patents. However, following the Uruguay round of multilateral negotiations under the General Agreement on Tariffs and Trade (GATT), the Agreement on Trade-Related Aspects of Intellectual Property Rights (The TRIPS) was arrived at and it came into force on January I, 1995. All members of the World Trade Organisation (WTO) were bound by the obligations under the TRIPS Agreement. Based on this agreement India was required to introduce “Product Patents” from 2005 for products for which patents were filed after 1995. As the patent for Imatinib Mesylate was filled in the year 1994 in the US, it was not eligible for a patent in India.

In order to circumvent this, Novartis filed a patent for the beta crystal form of Imatinib Mesylate, claiming that the new invented product was not patented in the original patent of 1994 in the US. They further claimed that the original US patent was only for Imatinib and did not include even Imatinib Mesylate and therefore the Imatinib Mesylate beta crystal can be patented in India. The patent application claimed that Imatinib Mesylate beta Crystal has (i) more beneficial flow properties: (ii) better thermodynamic stability; and (iii) lower hygroscopicity. It further claimed that these properties make the invented product “new” (and superior!) as it “stores better and is easier to process”; has “better processability”; and has a “further advantage for processing and storing”.

Novartis also contended that the original molecule in the 1994 patent was only amorphous Imatinib and could not be given to humans to treat Chronic Myeloid Leukemia and required further invention whereas the patent application of Novartis clearly stated that Imatinib and its salts including Mesylate could treat various types of tumors.

Novartis contented that only Imatinib Mesylate Beta crystal form can treat Chronic Myeloid Leukemia in humans whereas an IND # 55,666 was filed in US on April 9, 1998 and original NDA# 21-335 on February 27, 2001 for Imatinib Mesylate capsules. The FDA approval for the drug Gleevec (Imatinib Mesylate) 50 mg and 100 mg capsules was granted vide Letter dated May 10, 2001. Following this, the drug was commercially launched in the market long before the grant of patent for beta crystalline form of Imatinib Mesylate.

After the application was made and before it was taken up for consideration, a number of amendments were introduced in the Indian Patents Act, 1970, which brought about fundamental changes in the patent law of India. When Novartis filed its application for patent, the law in India with regard to product patent was in a transitional stage and the application of Novartis lay dormant under an arrangement called “the mailbox procedure”. Before the application for patent was taken up for consideration, Novartis made an application (Application No. EMR/01/2002) on March 27, 2002, for grant of exclusive marketing rights (EMR) under section 24A of the Act, which was at that time on the statute book and which now stands deleted. The Patent Office granted EMR to Novartis by order dated November 10, 2003.

Novartis marketed the product under this marketing exclusivity in India at an unaffordable price of Rs. 120,000 for a month’s treatment. What is now intriguing to note is that on its package, the drug was described as “Imatinib Mesylate Tablets 100 mg” and it was further stated that “each film coated tablet contains: 100 mg Imatinib (as Mesylate)”. The Supreme Court in its judgement remarks that “On the package there is no reference at all to Imatinib Mesylate in beta crystalline form. What appears, therefore, is that what was sold as Gleevec was Imatinib Mesylate and not the subject product, the beta crystalline form of Imatinib Mesylate.” Further the Supreme Court in its judgement remarks that “Coming back to the case of the appellant, there is yet another angle to the matter. It is seen above that in the US the drug Gleevec came to the market in 2001. It is beyond doubt that what was marketed then was Imatinib Mesylate and not the subject product, Imatinib Mesylate in beta crystal form”

And finally in paragraph 194 of the judgement the Supreme Court makes a scathing remark “... the case of the appellant appears in rather poor light and the claim for patent for beta crystalline form of Imatinib Mesylate would only appear as an attempt to obtain patent for Imatinib Mesylate, which would otherwise not be permissible in this country”.

The Supreme Court further in its judgement further remarks that “We have held that the subject product, the beta crystalline form of Imatinib Mesylate, does not qualify the test of Section 3(d) of the Act but that is not to say that Section 3(d) bars patent protection for all incremental inventions of chemical and pharmaceutical substances.”

Western media who have been widely criticizing the judgement should read the judgement in detail to understand the Indian viewpoint and the Indian Patent Law before making wild allegations. The Indian law has a different benchmark for incremental innovations. Apart from the requirement of Novelty and Non obviousness, the section 3 (d) of the Indian act requires that the Incremental Invention should also demonstrate enhanced therapeutic efficacy. Since India is having a requirement of higher standard of inventive step under section 3(d) of the Act, what is patentable in other countries will not be patentable in India. The object of section 3(d) of the Act is nothing but a requirement of higher standard of inventive step in the law particularly for the drug/pharmaceutical substances.

In many western media it is said that multinational companies like Novartis and others may not do research in India. This statement really does not make any sense as to begin with none on the MNCs did any research in India. Let alone research, most of the MNCs do not have even a factory to manufacture their products – most of the MNCs get their products manufactured at contractors.

MNCs will continue to invest in India and that will not be for research but to tap the vast Indian market and would pay several multiples of sales to buy local businesses as was the case when Daiichi Sankyo Group bought Ranbaxy or when Abbott bought the Pharmaceutical business of Piramal’s. MNC's will also pour money in India to acquire manufacturing assets for global generic supply as seen from the recent purchase of Stride Arcolab’s Agilia division (Injectable unit) by Mylan.

MNCs never did research in India and will not do so in future for different reasons not connected with this patent decision but more related to lack of suitable regulatory system, lack of persons skilled for discovery research, difficulty in doing first in human trials and related issues.

This decision will make the MNC’s change their strategy for India with respect to pricing and the way they market their products. We will see more collaborations with local companies to market the new drugs on the lines of the deals entered by Roche and Merck with local companies.

The decision of the Indian Supreme Court is not only a landmark but an appropriate response to the tactics adopted by Novartis which could be termed nothing but a “chi•can•er•y”.

Original source: www.drugregulations.org/2013/04/the-gleevec-chicanery.html

Author Bio:

Uday Shetty is the founder and Executive Director of Drug Regulations a non-profit organization since March 2012 and also an Independent Pharmaceutical Consultant currently involved on co-founding a Contract Research Organization. Previously, Dr. Shetty was the Managing Director at Stabicon Life Sciences. He is a pharmaceutical professional meeting business deliverables consistently for past 25 years. Dr. Shetty demonstrated strengths in developing and building organizations to deliver superior business results. He supervised the manufacturing of formulations, contract research & development, and General Management functions like Finance, Purchase, Imports, engineering, EHS and Project Management. Dr. Shetty has set up, nurtured and grew number of organizations to deliver superior business results in the field of Contract Research and Manufacturing. His specialties includes high level of business acumen including ability to build technical organizations based on analysis and understanding of the Pharmaceutical Industry in the Asia Pacific region. Dr. Shetty has demonstrated achievements in the area of Contract Research and Manufacturing & Developing organizations. Visit his blog http://www.drugregulations.org/ for more insight on pharmaceutical regulatory compliance.

Disclaimer: The views expressed in this article are the author's own and do not necessarily reflect ComplianceOnline’s editorial policy.