Wednesday, December 12, 2007

Pfizer Patented First Antiretroviral Compound in India

Mumbai Patent Office lately granted an Indian Patent No. 204132 (the ‘132 patent) to Pfizer for newly approved antiretroviral drug Selzentry, a second-line treatment for HIV, often prescribed to patients who develop resistance to first-line drug therapies. The ‘132 patent is issued against the mail-box Application No. 885/BOM/1999 filed December 02, 1999 under section 5(2) of the Patents Act, 1970 claiming earliest priority from Great Britain applications dated October 23, 1998. Selzentry, worldwide marketed as Maraviroc is the first antiretroviral drug compound to be awarded patent protection in India, which obviously will cause a concern among the generic pharmaceutical companies in India and also the Non-profit Government Organizations advocating affordable drugs for poor patients. Not only Pfizer will be able to keep generic competitors out of the market, but also fueled its market share value on the Bombay Stock Exchange, which clearly indicates the building confidence of Indian market for patent portfolio. Earlier this year in August, the US Food and Drug Administration approved Selzentry oral tablet prescription for the treatment of patients infected with CCR5-TROPIC HIV-1 through an accelerated regulatory approval process, and subsequently listed two US patents with the Orange Book. US Patent No. 6,586,430 is the US equivalent of the ‘132 patent. Although patent is granted in India, Pfizer still need to overcome the post-grant opposition period under section 25(2) of the Patents Act, 1970 which will be valid till one year from the date of grant of patent to have the real taste of Indian market exclusivity. However, there were no pre-grant oppositions for Pfizer’s patent application because Indian generic industry did not find any (financial) market potential for this newly approved drug (which still need to achieve market acceptability and monetary success), which in fact a clear indication that Indian Generic companies are more concern about the profit margins rather than patients’ well-being in India or other least-developed countries, and even so the NGOs who keep targeting patent applications which cover drugs already achieved market success. Despite Selzentry is a critical drug therapy, NGOs and Indian Generics completely failed to spot Pfizer’s patent application for pre-grant opposition because they keep focusing around blockbuster and profitable drug products, which again raises a crucial question who come first profit or patient? Fishy …

1 comment:

  1. Dear Varun
    It is much appriciated to bring the notice of this application to public and also it is more relevant to show how much Indian generic are concerned to Patient .