Delhi HC sets aside order on Gilead’s Sovaldi patent

New Delhi: In a setback to generic drug makers, the Delhi high court on Friday set aside an order of the Deputy Controller of Patents and Designs rejecting a patent to US drug maker Gilead Pharmasset Llc for the hepatitis C drug Sovaldi.

The medicine costs $1,000 a pill and cures hepatitis C in 90% of cases when given for a 12-week course. India’s patent office had questioned the therapeutic efficacy under which the patent was claimed by Gilead and rejected its application using the controversial Section 3(d) of the Patents Act, which prevents evergreening of patents and provides that no new form of an existing substance shall be patented unless the new form is much more effective than the old one.

The Indian patent office, while rejecting the patent application, had maintained that minor changes in the molecule did not improve its efficacy. With the patent set aside, domestic generic drug manufacturers could make the same drug for as low as $1 a pill. “It was expected that the appeal would succeed because the process of reasoning in the controller’s order was really shoddy, without commenting on the merits of the conclusion,” said Shamnad Basheer, former professor at National University of Juridical Sciences, Kolkata, and founder of intellectual property blog SpicyIP.

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