Transcept (TSPT) Files Action Against Watson (WPI), Actavis Over '628 Patent
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On July 13, 2012 and July 17, 2012, Transcept Pharmaceuticals, Inc. (Nasdaq: TSPT) received Paragraph IV notice letters from Actavis Elizabeth LLC and Watson Laboratories, Inc. – Florida (NYSE: WPI), respectively, each advising Transcept that the respective party has filed an Abbreviated New Drug Application with the U.S. Food and Drug Administration for generic versions of the 1.75mg and 3.5mg strengths of Intermezzo (zolpidem tartrate) sublingual tablet C-IV. Each Paragraph IV notice letter alleges that Transcept’s U.S. Patent Nos. 7,658,945 and 7,682,628 are invalid, unenforceable and/or will not be infringed by the respective party’s manufacture, use or sale of the products for which such party’s ANDA was submitted.
On August 23, 2012, Transcept joined Purdue Pharmaceutical Products L.P., Transcept’s U.S. commercialization partner with respect to Intermezzo, and Purdue Pharma L.P. in filing an action against Actavis in the U.S. District Court for the District of New Jersey alleging infringement of the ’628 Patent and seeking injunctive and other relief against Actavis.
On August 27, 2012, Transcept joined Purdue Pharma and Purdue Pharma L.P. in filing an action against Watson, Watson Pharmaceuticals, Inc. and Watson Pharma, Inc. in the U.S. District Court for the District of New Jersey alleging infringement of the ’628 Patent and seeking injunctive and other relief against the defendants.
The commencement of the Actions automatically stays FDA approval of the respective ANDA until January 2015 or until an adverse court decision, if any, whichever may occur earlier. Under the Collaboration Agreement between Transcept and Purdue Pharma, Transcept is required to share 40% of the costs related to each of the Actions, up to an aggregate cap of $1.0 million per calendar year and $4.0 million over the term of the agreement.
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On August 23, 2012, Transcept joined Purdue Pharmaceutical Products L.P., Transcept’s U.S. commercialization partner with respect to Intermezzo, and Purdue Pharma L.P. in filing an action against Actavis in the U.S. District Court for the District of New Jersey alleging infringement of the ’628 Patent and seeking injunctive and other relief against Actavis.
On August 27, 2012, Transcept joined Purdue Pharma and Purdue Pharma L.P. in filing an action against Watson, Watson Pharmaceuticals, Inc. and Watson Pharma, Inc. in the U.S. District Court for the District of New Jersey alleging infringement of the ’628 Patent and seeking injunctive and other relief against the defendants.
The commencement of the Actions automatically stays FDA approval of the respective ANDA until January 2015 or until an adverse court decision, if any, whichever may occur earlier. Under the Collaboration Agreement between Transcept and Purdue Pharma, Transcept is required to share 40% of the costs related to each of the Actions, up to an aggregate cap of $1.0 million per calendar year and $4.0 million over the term of the agreement.
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