Idenix Pharmaceuticals, Inc. a biopharmaceutical company focused on the discovery and development of drugs for human viral diseases, has filed two lawsuits against Gilead Sciences, Inc.

A patent is not a perfect protection against imitation. It merely grants the patent holder the right to sue infringers once they have been identied, which implies that the patent holder must supervise the market and react in case of infringement. The reality is that when an innovator applies for a patent, there is some probability that one or several rms active in the market will try to impede him from monopolizing a portion of this market.

In the pharmaceutical industry, interest in the availability of prescription drugs and the role of patents has grown considerably. In fact, the industry has been described as patent-intensive. Organizations within this sector frequently obtain patent protection and enforce patent rights and reportedly place a higher comparative value on patents than competitors in other markets.

The Patent Act of 1952 allows inventors to obtain patents on processes, machines and compositions of matter that are useful, new and nonobvious. Granted patents confer the right to exclude others from making, using, selling, offering to sell, or importing into the United States the patented invention. However, The Drug Price Competition and Patent Term Restoration Act of 1984 – known as the “Hatch-Waxman Act” – made significant changes to the patent laws in order to encourage innovation in the pharmaceutical industry while facilitating the fast introduction of low-cost generic drugs.

In one recent patent infringement instance, Idenix Pharmaceuticals, Inc. a biopharmaceutical company focused on the discovery and development of drugs for human viral diseases, filed two lawsuits against Gilead Sciences, Inc. – a patent infringement lawsuit in the U.S. District Court in Boston and a patent infringement and interference lawsuit in the U.S. District Court in Wilmington, Del.

According to the Massachusetts lawsuit, Gilead infringes on two U.S. patents for treating the hepatitis C virus using 2'-methyl nucleosides co-owned by Idenix. Idenix is seeking a declaration that Gilead's distribution, importation, use, sale or offer to sell drugs containing sofosbuvir, a 2'-methyl nucleoside compound, infringes on Idenix's patents.

“Idenix has invested significant resources in nucleoside drug discovery and in building an intellectual property portfolio that aids in the discovery and development of drugs for the treatment of the hepatitis C virus and other viral diseases,” said Maria Stahl, senior vice president and general counsel at Idenix, in a statement.

The lawsuit says Gilead infringes a separate U.S. patent co-owned by Idenix that covers methods of treating the hepatitis C virus using 2'-methyl-2'-fluoro nucleosides. Therefore, Idenix is seeking a declaration that Gilead's distribution, importation, use, sale or offer to sell drugs containing sofosbuvir infringes the Idenix '600 patent.

Additionally, the Delaware lawsuit asserts a claim for interfering patents between the Idenix '600 patent and a U.S. patent owned by a Gilead subsidiary, Gilead Pharmasset LLC. Idenix is seeking to have the Gilead '322 patent declared invalid.

“While we have attempted to resolve this matter with Gilead without resorting to infringement litigation, we intend to diligently and vigorously protect our patent rights for the benefit of our company and our shareholders and prevent infringing use by others. Idenix remains confident in its patent portfolio and has several patent families that provide the Company coverage for 2'-methyl nucleoside compounds and 2'- methyl, 2'- fluoro nucleoside compounds specifically,” Stahl continued.

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