[Ip-health] Patent denied (for Xtandi), price of prostate cancer drug may go down
shailly.gupta at geneva.msf.org
Thu Nov 10 00:30:17 PST 2016
Patent denied, price of prostate cancer drug may go down
The blockbuster drug which nets nearly $3 billion in worldwide sales, was acquired in August by Pfizer Inc as part of a deal when it bought Medivation, a biotech company.
New Delhi: The Indian Patent Office has denied a patent to Xtandi (Enzalutamide), a steeply-priced wonder drug used in prostate cancer, on the pre-grant opposition filed by a clutch of entities, including Mumbai-based BDR Pharma, drug company Fresenius Kabi and Indian Pharmaceutical Alliance. 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.
The blockbuster drug which nets nearly $3 billion in worldwide sales, was acquired in August by Pfizer Inc as part of a deal when it bought Medivation, a biotech company. Medivation and Astellas jointly market Xtandi, with the latter selling the drug outside the US.
The patent was opposed on grounds of "lack of inventive step, lack of novelty, and lack of clarity and sufficiency", according to the order, a copy of which was accessed by TOI . The drug was discovered by University of California, and patent application made in 2007 in the Delhi Patent Office, while it was opposed by Fresenius Kabi in 2012, and by BDR Pharma in 2013.
BDR Pharma had earlier launched an affordable version of prostate cancer drug, Abiraterone, marketed by Johnson & Johnson at Rs 1.25 lakh for 120 tablets for a month's dose. BDR was the first generic to make an entry at around Rs 30,000 per pack for a month's dose. Umesh Pandey, assistant controller Patents & Designs, said in the order "in view of above instant application is hereby refused as the claimed invention is lacking inventive step under section 2(1) (ja) and also not patentable under section 3(d) and 3(e)".
The opponents had argued that the compound is not patentable under Section 3(d) of the Patents Act, 1970 as amended by the Patents (Amendment) Act, 2005 as it is a new form of known substances. "The drug showed no enhanced efficacy over the compound known in prior published document of which it is a derivative," legal experts say.
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