India has reportedly rejected US drug-maker Pfizer’s new patent application for rheumatoid arthritis drug, tofacitinib, for the second time.
In an order dated 3 September, India Patent Office assistant controller of patents and designs Bharat NS was quoted by media sources as saying: "After having considered the submissions of the applicant, it is hereby ordered that the invention disclosed and claimed in the application is not considered as an invention under the provisions of the act.
"I do not admit that the claimed compound has enhanced efficacy over the base compound and hence not patentable under Section 3(d) of Patents Act. I therefore, hereby refuse this application."
Pfizer spokesperson was quoted by PTI as saying that the US drug-maker is currently reviewing its options for further action, stating ‘the company’s base patent for tofacitinib remains valid in the country’.
The decision is considered a major issue among global drug manufacturers seeking to expand in India’s fast-growing healthcare market.
In recent years, global firms such as Pfizer, Bayer and Roche had to struggle to retain exclusivity on drugs in India.
In India, less than 15% of the population has health insurance, and so the drug patents policy is designed to ensure medicines remain affordable.
In 2011, India’s patent office had rejected Pfizer’s application for the same drug. After an appeal by Pfizer, the Intellectual Property Appellate Board (IPAB) ordered the office to reconsider the decision.