Efavirenz (600 mg) + Emtricitabine (200 mg) + Tenofovir Disoproxil Fumarate (300 mg) (Atripla):Innovator Files Second Patent Infringement Lawsuit

Refer to our earlier news on Atripla Here , wherein, we reported Para IV filing by Teva pharma on Efavirenz (600 mg) + Emtricitabine (200 mg) + Tenofovir Disoproxil Fumarate (300) mg (Atripla). After receipt of Para IV notice letter, innovator Gilead Sciences announced (in a press release Here ) that it has filed a lawsuit in U.S. District Court in New York against Teva Pharma for infringement of following Orange Book listed patents for Atripla [(Efavirenz (600 mg) + Emtricitabine (200 mg) + Tenofovir Disoproxil Fumarate (300) mg]:
US6642245 (Expiry: May 4, 2021): which covers a method for treating HIV infection in humans comprising administering an effective amount of (-)-.beta.-L-2-hydroxymethyl-5-(5-fluorocytosin-1-yl)-1,3-oxathiolane, or its physiologically acceptable salt, optionally in a pharmaceutically acceptable carrier.
US6703396 (Expiry: Sep 9, 2021): which covers a (-)-enantiomer of cis-4-amino-5-fluoro-1-(2-hydroxymethyl-1,3-oxathiolane-5-yl)-(1H)-pyrimid in-2-one that is at least 95% free of the corresponding (+)-enantiomer

Teva has challenged above patents by sending Para IV letter to innovator, wherein , Teva alleged that patents on Emtricitabine are invalid, unenforceable and/or will not be infringed by Teva's manufacture, use or sale of the product described in its ANDA submission:
Earlier, Teva challenged the validity of ‘245 and ‘396 Emtricitabine patents with an ANDA filing for Truvada® (Emtricitabine and Tenofovir disoproxil fumarate)The antiviral combination is currently sold in the United States through a joint venture between Bristol-Myers Squibb (BMS) and Gilead.