An application made by Novartis to patent an updated version of Glivec (imatinib) has been rejected by the Supreme Court of India, in a verdict seen as setting a precedent in Indian drug patent cases.
The case has been running since 2006, when the Patent Controller in Chennai rejected a patent application made by Novartis in 1998. In a 112-page document explaining the most recent decision against the appeal, the Supreme Court of India ruled that the product failed to meet the invention and patentability requirements set by Indian patent law.
“The Court was urged to strike a balance between the need to promote R&D in science and technology and to keep private monopoly (called an ‘aberration’ under our Constitutional scheme) at the minimum,” wrote the judges, according to The Pharma Times. “Arguments were made about India’s obligation to faithfully comply with its commitments under international treaties and counter arguments were made to protect India’s status as ‘the pharmacy of the world.’ The Court was reminded of its duty to uphold the rights granted by the statute, and the Court was also reminded that an error of judgement by it will put life-saving drugs beyond the reach of the multitude of ailing humanity, not only in this country but in many developing and under-developed countries, dependent on generic drugs from India.”
Medecins Sans Frontiers (MSF) International president Dr Unni Kaunakara hailed the decision as a relief for patients and doctors, and was quoted in The Pharma Times to say that “the Supreme Court’s decision now makes patents on the medicines that we desperately need less likely. This marks the strongest possible signal to Novartis and other multinational pharmaceutical companies that they should stop seeking to attack the Indian patent law.”
Novartis, however, point out that they had never been granted an original patent for Glivec in India, despite the drug obtaining a patent in nearly 40 countries. Ranjit Shahani, Vice Chairman and Managing Director, Novartis India Limited, said that the company strongly believes "original innovation should be recognized in patents to encourage investment in medical innovation especially for unmet medical needs.” The company expressed that its primary concern was India's "growing non-recognition of intellectual property rights that sustain research and development for innovative medicines," adding that they provide Glivec free of charge to 95% of patients, and the remaining 5% are “either reimbursed, insured or participate in a very generous co-pay programme.”
According to Reuters, the main beneficiaries of the ruling will be India's Cipla Ltd and Natco Pharma Ltd, who sell the generic version of Glivec in the country at around one-tenth of the price.
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