Gilead to appeal Indian Patent Office rejection of Sovaldi patent application

US biotech major Gilead Sciences (Nasdaq: GILD) is to appeal a recent decision by India’s Patent Office (The Pharma Letter January 15) to reject a patent application for the hepatitis C therapy Sovaldi (sofosbuvir).

The company says that the rejection relates to the patent application covering the metabolites of sofosbuvir while the main patent applications on sofosbuvir are still pending before the Indian Patent Office. Natco Pharma and the Initiative for Medicines, Access and Knowledge contested that Sovaldi is not inventive enough compared with a previous formulation. Gregg Alton, executive vice president of corporate and medical affairs at Gilead, said: "Gilead strongly defends its intellectual property... [and is] exploring additional procedural options. 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"

The 3(d) decision relates to a section of the patent act where patent protection is not permitted on drugs that are an amended version of a known compound, unless it shows greater therapeutic efficacy.