No-Go on Hepatitis Drug Patent in India: More Developing-Country Bad News for Big Pharma
In a move that will upset drug makers, the Intellectual Property Appellate Board in India late last week revoked the patent on the Pegasys hepatitis C treatment marketed by Roche, which will make it possible for generic drug makers to introduce lower-cost copycat versions. The board ruled that the drug is not a new invention after hearing an appeal filed by Sankalp Rehabilitation Trust, a patient advocacy group, against the validity of the patent.
Interestingly, Pegasys was the first medicine to have been granted a patent in India after the Indian Patents Act was amended in 2005 to honor product patents. The decision is likely to intensify the battle between global drug makers, patient advocates and the government over the delicate balance between intellectual property rights and affordable access to life-saving medicines. This is the second blow to big pharma this year over the issue, however.
Across the industry – think Pfizer (PFE), GlaxoSmithKline (GSK), Novartis (NVS), Merck (MRK) and Sanofi (SNY) – big drug makers are trying to expand sales in developing countries, as expiring patents on existing blockbuster drugs and a failure to develop enough new drugs makes revenue growth tough to come by.
Several months ago, India’s Patent Office for the first time granted a generic drugmaker a compulsory license to make a copycat version of a patented medicine. The license was awarded to Natco, which can now make a generic of a Bayer kidney and liver cancer medication called Nexavar, although only for domestic distribution. Bayer subsequently lost an appeal (see Pharma news); Natco must pay a royalty, by the way.
Meanwhile, the Supreme Court in India is reviewing whether the government had the right to deny a patent to Novartis for Gleevec, which is marketed as Glivec in India. Novartis wants a patent based on a new form of its drug, which would offer a 20-year extension. An earlier government ruling denied this after deciding the new form did not meet a standard for enhanced efficacy (see Pharma news and Pharma news).
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Ed Silverman is the editor of Pharmalot and a contributor to YCharts, which includes the just-released YCharts Pro Platinum for professional investors.