The Supreme Court of India Monday denied a patent request by Swiss drug giant Novartis AG (NVS) for an updated version of its cancer drug Glivec or imatinib mesylate. The Court has ruled that the drug used for the treatment of chronic myeloid leukaemia and other forms of cancer did not satisfy "the test of novelty or inventiveness" required by Indian law.
Novartis said the Court's decision discourages future innovation in India. Since 2006, the company has been trying to get the patent in India, one of the fastest growing pharmaceutical market. According to reports, the latest verdict would be helpful for cheaper generic versions of life-saving drugs in developing countries. Usually patents covers exclusive sales for 20 years.
The Indian authorities find the new version only slightly different from the old drug. The company has been claiming that the updated version of Glivec was easier to absorb and it has never been granted an original patent in India.
Ranjit Shahani, vice chairman and managing director, Novartis India Ltd., stated, "We strongly believe that original innovation should be recognized in patents to encourage investment in medical innovation especially for unmet medical needs...This ruling is a setback for patients that will hinder medical progress for diseases without effective treatment options."
Novartis stated that Glivec is a life-saving medicine for certain forms of cancer, patented in nearly 40 countries including China, Russia, and Taiwan. It had filed a Special Leave Petition with the Indian Supreme Court in 2009 challenging the denial of Glivec beta crystal form patent on two grounds, based on Sections 3(d) and 3(b) of the Indian patent law.
Patents are currently allowed in India only for new drugs or for an updated version of a drug that displays enhanced therapeutic efficiency and the price of the drug is also a matter of concern as a patent is likely to threaten access to cheap generic versions in poorer countries.
However, Novartis said, more than 9 out of 10 patients, currently taking Glivec in India will continue to receive drug free of charge through Novartis Oncology Access programs.
According to the firm, it provides Glivec free of charge to 95 percent of patients prescribed the drug in India, through its full donation programs. This currently comes to more than 16,000 patients. Further, the remaining 5 percent of patients are either reimbursed, insured, or participate in a very generous co-pay program, it said.
In 2012, the Group achieved net sales of $56.7 billion, while research and development totaled about $9.3 billion.
by RTT Staff Writer
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