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By Madhur Singh
CHANDIGARH, India--India's top court rejected an appeal April 1 by Swiss pharmaceutical company Novartis AG for grant of a patent for its cancer drug Glivec.
In a case widely watched around the world, the court ruled that the new form of the drug for which a patent was sought was not a significant improvement over an earlier version.
The Indian Supreme Court ruling will boost India's generics industry, but a Novartis statement said the ruling “discourages innovative drug discovery essential to advancing medical science for patients.”
At the culmination of its decades-long battle to win an Indian patent for Glivec, Novartis challenged Section 3(d) of the Indian Patents Act before India's Supreme Court. Earlier, in 2006, the Controller of Patents had rejected Novartis's patent application, a decision upheld by the Intellectual Property Appellate Board in 2009.
Section 3(d), which was included when India's patent laws were amended in 2005 to conform with the World Trade Organization's Trade Related Aspects of Intellectual Property Rights (TRIPS) Agreement, aims to prevent drug manufacturers from unfairly and indefinitely extending the duration of their patents by making small and trivial changes to existing formulations--a practice called “evergreening.”
They must prove that the new drug offers improved efficacy, but, crucially, does not provide a definition or a way of measuring efficacy, leaving ample room for disputes and litigation.
Novartis insisted that the beta crystal form of the molecule imatinib mesylate--the generic name for Glivec--for which it had applied for a patent, was a marked improvement over an earlier alpha crystal version in terms of its absorption in the body. It argued that since the beta crystal version was a result of years of research, it deserved patent protection.
Justices Aftab Alam and Ranjana Prakash Desai rejected Novartis's appeal on the ground that the beta crystalline form of imatinib mesylate did not improve the “therapeutic” efficacy of an earlier form of the drug. “[I]n the case of a medicine that claims to cure a disease, the test of efficacy can only be 'therapeutic efficacy,’” the court said. Significantly, it failed to define “efficacy,” leaving Section 3(d) open to further contention. “The court, however, refuses to rule on the exact scope of “therapeutic efficacy” and leaves it to be determined by future courts,” the court said.
The justices also found Novartis's application lacking in novelty and inventive step, Tahir Amin, co-founder and director of IP at the U.S.-based Initiative for Medicines, Access & Knowledge (I-MAK), told BNA April 1. “This is important as companies craft patent applications in a way to write follow up ones to get 3-5 years more exclusivity,” he said.
However, the court did not rule against incremental inventions per se: “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.”
The Supreme Court decision “makes it very clear that in order to obtain a patent for a new form of a known substance in India, the applicants must show in their patent specification, sufficient proof that the new form of a base compound of known substance is therapeutically more efficacious than the base compound or known substance,” the law firm Khaitan & Co. said in an April 1 statement. “Experimental data to establish that the new form has a therapeutic advantage will be essential in determining whether the new form will qualify for a patent in India vis-a-vis section 3(d) of the Act.”
Amin said the decision affirms the policy position of India regarding patents and development needs, and also its role as a provider of generics to other developing countries.
This ruling follows closely on the heels of another sensational patent-related decision-the Intellectual Property Appellate Board's March 4 decision upholding India's first compulsory license issued to generic drugmaker Natco to manufacture and sell a generic version of Bayer AG's cancer drug Nexavar (55 PTD, 3/21/13).
In a statement, Novartis said the decision shows Indian law offers only “limited” intellectual property protection. “The primary concern of this case was with India's growing non-recognition of intellectual property rights that sustain research and development for innovative medicines,” it said, adding, “This ruling is a setback for patients that will hinder medical progress for diseases without effective treatment options.”
Several multinational drug companies, including Switzerland's Roche, California-based Gilead Sciences, and Indiana-based Eli Lilly have been involved in disputes with India's patent office and generics makers. The battle between drugmakers' intellectual property rights and patients' access to affordable drugs intensified earlier this year, when the Indian health authorities announced that they had initiated the process of granting compulsory licenses for Roche's Herceptin and New York-based Bristol-Myers Squibb's leukemia drug Sprycel and breast cancer drug Ixempra.
Their worries were echoed by Pharmaceutical Research and Manufacturers of America President and CEO John Castellani in an April 1 statement. He said, “This decision marks yet another example of the deteriorating innovation environment in India. Innovation is critical in meeting unmet needs of patients and is particularly relevant in the context of changing healthcare systems. In order to solve the real health challenges of India's patients, it is critically important that India promote a policy environment that supports continued research and development of new medicines for the health of patients in India and worldwide. Protecting intellectual property is fundamental to the discovery of new medicines.”
Novartis can file a review petition within 90 days, but has not indicated if it will.
By Madhur Singh
Text of the opinion is available at http://op.bna.com/hl.nsf/r?Open=bbrk-96clsc.
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