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 that it is not a new drug and lacked inventions.
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 the patent office 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 stop 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 an annual sales of around $285 million.
In its order last month, the Delhi patent office's assistant controller of patents & designs N R Meera refused to grant patent for Hepsera.
Gilead has reportedly said it will contest the rejection of its patent application for its other drug, Tamiflu.
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