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Gilead sues Teva over patent for HIV drug

Biopharmaceutical company Gilead Sciences has filed a lawsuit in the US against Teva for infringement of its patents for Truvada

Biopharmaceutical company Gilead Sciences has filed a lawsuit in the US against Teva for infringement of its patents for Truvada, an antiretroviral agent for the treatment of HIV-1 in adults.

Teva has submitted an Abbreviated New Drug Application (ANDA) to the US Food and Drug Administration (FDA) requesting approval to manufacture and market a generic version of Truvada. Gilead has filed a lawsuit against the Israeli company as it claims it has two valid patents covering emtricitabine, a component of Truvada.

By filing a lawsuit, Gilead has temporarily put a stop to Teva's ANDA. The FDA is unable to approve the request for 30 months or until a court rules in favour of Teva.

Ten patents, all of which would need to be expired or invalidated before a generic version of the drug could be marketed, currently protect Truvada.

In November, PMLiVE reported that Cephalon and Eurand had filed a similar lawsuit against generic manufacturers Mylan and Barr relating to the muscle relaxant, Amrix.

As generic competition increases, we expect to see more manufacturers turning to the courts in a bid to defend their intellectual property.
 

15th December 2008

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