Indian Patent Office rebuffed a prostate cancer drug patent to Xtandi

The Indian Patent Office in one of its recent decisions dated November 8, 2016, repudiated a patent to Xtandi (Enzalutamide), an expensive drug for prostate cancer, on the strapping grounds of pre-grant opposition, lodged by cluster of renowned companies, namely, Mumbai-based BDR Pharma, drug company Fresenius Kabi and Indian Pharmaceutical Alliance.

Xtandi the wonder drug for prostate cancer was evolved at the University of California (UCLA), Los Angeles, by the innovation of NIH and Department of Defense grants, which was later licensed to Medivation a biopharma company that eventually made a deal with Japanese Astellas Pharma, which sold the drug in India at USD 5000/EUR 4600 for a pack of 112 capsules for a month’s dose. The drug, nearly sum up to $3 billion in worldwide sales, and was taken over by Pfizer Inc as part of a deal, when Medivation was acquired by Pfizer Inc .

The Application towards the Xtandi drug was duly filed with Delhi Patent Office on December 13, 2007 and was opposed by Fresenius Kabi on December 12, 2012 and by BDR pharma on July 24, 2013 on the following grounds of the Indian Patents Act:

1. Section 25(1)(e) - Lack of Inventive Step

2. Section 25(1)(f) - Not inventive (u/s 3(d) and u/s 3(e))

3. Section 25(1)(g) - Lack of Clarity and sufficiency

The opponents put forth that the subject matter is not patentable under Section 3(d), as it was new form of a known substances and lacks inventiveness.

Therefore, since, the invention lacked inventive step and did not incur any improvement in efficacy, as per Section 3(d) of the Indian Patents Act, the Assistant Controller of Patents & Designs, Mr. Umesh Chandra Pandey, rejected the invention under Section 25(1).

This landmark principle decision of Patent Office shall play a significant role in reduction of costs of the drug. The complete order issued by the IPO can be read here