India’s patent office took two significant decisions of cancelling patents issued to two leading International pharmaceutical companies namely Pfizer and Roche during the last 30 days. The Delhi Patent Office revoked the patent granted in 2007 to US Pfizer for sunitinib (Sutent), a drug used to treat a type of kidney cancer on October 5. The ground for the revocation of the patent was lack of inventive step for the drug as claimed by the company. The drug costs roughly Rs1.96 lakh for a 45-day treatment, or Rs 4,357 per 25 mg capsule. The revocation follows a post-grant opposition filed by Mumbai-based generic drug maker Cipla against Pfizer’s patent on the drug. Now, on November 2, Intellectual Property Appellate Board (IPAB) revoked another patent granted to Roche for pegylated interferon alfa-2a (Pegasys), a medicine used to treat hepatitis C on a petition filed by a patients’ group. The IPAB held that Roche did not provide any evidence, in specification or even otherwise, to prove that Pegasys has any enhanced efficacy over the original molecule. The patent granted to Roche in 2006 was the first product patent for a medicine in India under the newly adopted product patent regime for medicines in 2005. By obtaining the patent for Pegasys, Roche enjoyed a monopoly to market drug in the country. The patients with chronic hepatitis C, needing a six-month course of treatment have to thus purchase it at a cost of approximately Rs.4,36,000.
These two patent cancellations and the grant of the first compulsory license for the manufacture of cancer drug Nexavar of Bayer to Hyderabad based Natco in last March by the Patent Controller is a major victory against unfair drug pricing of patented drugs in India by the multinationals. These actions by the Indian Patent Office should be seen more as a relief to thousands of patients suffering from cancer and other killer diseases in the country rather than an incentive to the Indian generic companies. The fact that IPAB recognized public interest in setting aside the undeserving patents is highly laudable and need to be adopted by the patent offices of other developing countries. Along with these pro active decisions, country’s patent office also needs to urgently scrutinize all patent applications for medicines to avoid grant of patents to undeserving cases. MNCs have been claiming patent rights for products which were not actually new molecules since 2005. These companies have been filing applications for patenting different forms of the same drugs, like salt, polymorphs, analogues, crystalline and combinations with other drugs. With such bogus filings, they managed to corner a broader spectrum of protection for commercially significant forms of the same compound. It is high time this unfair trade practice is put to an end by the India's patent controller throughout the country.