Gilead’s Hepatitis patent plea rejected

NEW DELHI: The Delhi Patent Office has rejected American company Gilead Sciences��� plea to patent its Hepatitis B drug adefovir dipivoxil sold under the brand name Hepsera. India���s largest drugmaker Ranbaxy had filed a pre-grant opposition against Gilead���s patent application saying it is not a new drug and lacked invention.

This is Gilead���s second drug to be rejected by the Delhi Patent office in the last two months. Last month, the same patent office turned down the company���s patent application for its popular antiflu drug Tamiflu as it found merit in Cipla���s opposition that the drug lacked invention to be given a patent under Indian patent laws.

Hepsera is also used by HIV patients infected with Hepatitis B. As per Gilead���s website, Hepsera is used to treat chronic infection with hepatitis B virus (HBV) in adults. It stops Hepatitis B virus (HBV) from multiplying by blocking HBV DNA polymerase, an enzyme that is necessary for the replication of the virus in the body.

A patent grant to Gilead for Hepsera would have prevented any other generic company from making a low-cost version of
the drug without the consent of the patent-holder for the next two decades. The drug has annual sales of around $285 million.

In its order last month, the Delhi patent office���s assistant controller of patents and designs NR Meera refused to grant patent for Hepsera.

Mumbai-based patent consultancy firm IP Feathers��� Varun Chhonkar, who reviewed the decision, said the patent office found Gilead���s application lacking invention and that it failed to provide comparative data with respect to known substance to prove improvement-enhanced thereupatic efficacy.

Gilead has reportedly said it will contest the rejection of its patent application for its other drug, Tamiflu. The rejection came as a timely booster for generic drugmakers ahead of the global Swine flu outbreak. Cipla and other generic companies can now legally manufacture and sell their generic drug in India and other countries where Roche does not hold patent.

Swiss company Roche has the marketing licence for the drug in India and as per Gilead���s website it has earned around $33 million globally for the quarter ended March 31, 2009, as royalties for Tamiflu from Roche.