RegSmart

Cubist Files Patent Infringement Lawsuit Against Teva

Posted in Patent Challenge by regsmart on March 24, 2009

Cubist Pharmaceuticals, Inc. confirmed today that it has filed a patent infringement lawsuit against Teva Parenteral Medicines, Inc. (TPM), Teva Pharmaceuticals USA, Inc. and Teva Pharmaceutical Industries Ltd. The complaint, which was filed in the U.S. District Court for the District of Delaware, alleges infringement of US Patent Nos. 6,468,967 and 6,852,689, which expire on September 24, 2019, and US Patent No. RE39,071, which expires on June 15, 2016.

Cubist filed the lawsuit in response to an Abbreviated New Drug Application (ANDA) filed by TPM seeking U.S. Food and Drug Administration (FDA) approval to market a generic version of daptomycin prior to the expiration of Cubist’s patent rights. Daptomycin is marketed in the U.S. and internationally under the brand name CUBICIN® (daptomycin for injection) as therapy for serious skin and bloodstream infections caused by certain Gram-positive bacteria.

Under current U.S. law, the filing of the lawsuit automatically prevents the FDA from approving the ANDA for 30 months from Cubist’s receipt of TPM’s Paragraph IV notification letter in February 2009 unless the court (1) enters judgment in favor of TPM in less than 30 months, or (2) finds that a party has failed to cooperate reasonably to expedite the lawsuit.

Additional information can be found at Cubist’s web site at www.cubist.com.

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