On Nov 08, 2016, Indian patent office by its decision on pre-grant opposition rejected Pfizer’s patent application for Xtandi (Enzalutamide) molecule. The pre-grant oppositions were filed by such known stakeholders as Indian Pharmaceutical Alliance, BDR Pharmaceuticals Limited and Fresenius Kabi Oncology Ltd.
The application (IN 9668/DELNP/2007) was rejected on two principal grounds: lack of inventive step and Section 3(d) & 3(e). Other grounds such as Novelty, Sufficiency and Section 8 were acknowledged by patent office and thus rejected the arguments of opponents based on these grounds.
The patent office held that the claimed invention lacks inventive step over US patent US 4511981 and US 6518257 , along with D1 (J Med Chem. 2004 Jul15;47(15), 3765-16), a non-patented article.
The refusal to grant a patent paves the way for the entry of drug’s generic version at a fraction of the price – at least 60-70% cheaper. At present, Japan’s Astellas Pharma sells the drug in India at Rs 3.35 lakh for a pack of 112 capsules for a month’s dose.
Ms Archana Shankar represented on behalf of Applicant and Mr Vishal Sudan & Ms Rajeshwari Hariharan represented on behalf of Fresenius Kabi & BDR pharma respectively.
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