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Patricia Van Arnum was executive editor of Pharmaceutical Technology.
Ruling has implications for intellectual property protection for innovator drugs in India.
The Indian Supreme Court ruled against Novartis in the company’s appeal to be granted a patent for the company’s anticancer drug, Glivec/Gleevec (imatinib mesylate) in India. The ruling, which was issued on Apr. 1, 2013, has broader implications for intellectual property protection and the role of innovator drugs in the Indian market.
Terms of the case
In a statement on the ruling, Novartis said that it had never been granted an original patent for Glivec in India. Novartis filed a Special Leave Petition with the Indian Supreme Court in 2009 challenging the denial of the Glivec beta-crystal form patent on two grounds based on Sections 3(d) and 3(b) of the Indian patent law. In addition to seeking a patent for Glivec, the company filed the case to help clarify these unique aspects of the patent law.
"Novartis has never been granted an original patent for Glivec in India,” said Ranjit Shahani, vice-chairman and managing director, Novartis India Limited, in the company’s statement. “We strongly believe that original innovation should be recognized in patents to encourage investment in medical innovation especially for unmet medical needs. We brought this case because we strongly believe patents safeguard innovation and encourage medical progress, particularly for unmet medical needs. This ruling is a setback for patients that will hinder medical progress for diseases without effective treatment options."
At issue in the case was whether Glivec was considered an innovative product and, therefore, afforded protection under Indian patent law. Novartis had argued that the beta-crystal form of imatinib mesylate was novel and that it should be given patent protection under India law. India, which is part of the World Trade Organization, had amended its patent law in 2005 to assert that pharmaceutical companies had to prove enhanced clinical efficacy of their drugs over already patented compounds. In its ruling against Novartis, the Indian Supreme Court cited a 1996 patent (US Patent No. 5,521,184), which included several derivatives of N-phenyl-2-pyrimidine-amine, including imatinib, in a free-base form (1). Novartis asserted that it had first developed the methanesulfonic acid addition salt, imatinib mesylate, and later the beta-crystalline form of the salt, which had improved properties, such as flow, thermodynamic stability, and lower hygroscopicity compared with the alpha-crystal form. The India Supreme Court, however, ruled that the beta-crystalline form of imatinib failed to meet the tests of “invention” and “patentability” under Indian law.
“PhRMA is very disappointed with the Indian Supreme Court’s decision to deny a patent on Glivec,” said Pharmaceutical Research and Manufacturers of America (PhRMA) President and CEO John Castellani, in an Apr. 1, 2013 statement. “This decision marks yet another example of the deteriorating innovation environment in India....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. The research-based pharmaceutical industry is committed to working closely with the Indian Government and other stakeholders to find appropriate solutions to this challenge.”
The Novartis ruling follows other high-profile cases regarding intellectual-property protection in India. In March 2012, Natco Pharma was granted a compulsory license for sorafenib tosylate, the active ingredient in Bayer’s Nexavar, a drug to treat liver and kidney cancer. The compulsory license enables Natco to sell the drug at a price not exceeding Rs. 8880 ($163) for a pack of 120 tablets (one month’s therapy) compared with the Rs. 284,428 ($5225) as the cost of Nexavar sold by Bayer. The license is valid until the expiry of the patent in 2021. The order is subject to certain conditions such as maintaining account of sales, and payment of royalty at 6% of the net sales on a quarterly basis . The order also makes it obligatory for Natco to supply the drug freeof cost to at least 600 needy and deserving patients per year.
The Natco ruling was significant as it was the the first time the Indian controller general of patents, designs, and trademarks granted a compulsory license to a generic-drug maker (2) and it has since opened the door for other such applications. In March 2013, BDR Pharmaceuticals applied to the Indian patent office for a compulsory license to sell a generic version of Bristol-Myers Squibb’ anticancer drug Sprycel (dasatinib) after unsuccessfully seeking a voluntary licence from Bristol-Myers (3).
In another ruling, in November 2012, the Intellectual Property Appellate Board in revoked the patent of Roche’s hepatitis C drug Pegasys (peginterferon alfa-2A). Roche had received a patent for Pegasys in India in 2006, which was subsequently challenged by the Indian generic-drug maker Wockhardt and a nongovernmental organization, Sankalp Rehabilitation Trust, on the grounds that that drug was not novel and did now demonstrate inventiveness (4). In its decision to set aside Roche's patent, the appellate board supported the company's claims that its work on Pegasys was novel but asserted that the technology involved in the invention was "obvious" and could be replicated easily (4). Also, in October 2012, Pfizer had its patent for its anticancer drug Sutent (sunitinib malate) revoked (5).