Gilead Sciences will appeal a recent decision by India's patent office to reject a patent application for the hepatitis C therapy Sovaldi (sofosbuvir). Gregg Alton, the company's executive vice president of corporate and medical affairs, said "Gilead strongly defends its intellectual property," adding that along with an appeal it is "exploring additional procedural options."
According to Gilead, the "rejection relates to the patent application covering the metabolites of sofosbuvir," while "the main patent applications covering sofosbuvir are still pending before the Indian Patent Office." In its ruling, the patent office determined that "minor changes in the molecule" did not improve its efficacy. The decision followed challenges by Natco Pharma and the Initiative for Medicines, Access & Knowledge, which argued that Sovaldi is not inventive enough compared with a previous formulation.
Alton remarked "we are pleased that the patent office found in favour of the novelty and inventiveness of our claims, but believe their Section 3(d) decision to be improper." Under Section 3(d) of India's patent act, patent protection is not allowed on drugs that are seen as being an amended version of a known compound, unless it shows greater therapeutic efficacy.
The patent office's ruling potentially paves the way for companies to sell generic versions of the drug in India. Gilead previously entered agreements with seven drugmakers permitting them to manufacture and distribute Sovaldi in 91 developing countries. Gilead indicated that it would introduce the treatment in India at a price of $900 for a full course, which represents about 1 percent of the cost in the US.
"These proceedings do not impact our commitment to enabling access to our hepatitis C medicines in India and other developing countries, and our generic licensing programme with our Indian partners continues as normal," Gilead noted.
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