The Indian Patent Office (Mumbai, India) has rejected a patent application from Pfizer (NY, USA) relating to its rheumatoid arthritis drug tofacitinib, on the grounds that the new patent did not improve the efficacy of the drug, which is currently approved in the country.
Pfizer was seeking approval of a patent that covers a critical chemical formulation of tofazitinib’s active compound. The Indian Patent Office asserted in its denial that the company had not established that the compound to be patented was therapeutically more effective than the active compound.
An assistant controller at the patent office, Bharat N.S, wrote in a statement: "The invention disclosed and claimed in the instant application ... is not considered as an invention under the provisions of the Act.”
India’s healthcare market is booming, but global drug-makers have faced difficulty of securing certain drug patents in the Indian courts. Companies, including Pfizer, Bayer and Roche have all struggled to retain exclusivity on their drugs in recent years, and have claimed that the Indian patent system is deliberately designed to favor local drug industry by making it legal to produce generic versions of blockbuster therapeutics.
India has asserted that its drug patents policy is designed to ensure that medicines are affordable, as less than 15% of Indians have health insurance. This decision follows India’s rejection of Pfizer’s original patent application for tofacitinib in 2011, which was reconsidered after Pfizer appealed to the Intellectual Property Appellate Board (Chennai, India).
The Indian patent system is designed to favor generic drugs, a system which has saved India and other developing nations millions of dollars. For example, an Indian company, Cipla (Mumbai, India) produces a generic triple-combination therapy for HIV/Aids for <$200 per person per year, a price available across the developing world. The same therapy, for the same duration, costs $10,000 per patient in industrialized nations .
India is rapidly industrializing and has a growing middle class suffering from chronic diseases previously considered diseases of the West. It is likely that this trend will continue, and other developing countries will follow suit. It remains to be seen if the stance India has taken against pharmaceutical patenting will do what the Indian government intended and provide desperately needed benefits to the country’s sick.