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Depomed Announces Favorable Markman Ruling In GRALISEA® Patent Litigation

Stocks in this article: DEPO

NEWARK, Calif., Jan. 29, 2014 /PRNewswire/ -- Depomed, Inc. (NASDAQ: DEPO) announced today a favorable "Markman" claim construction ruling by Judge Joel A. Pisano of the United States District Court for the District of New Jersey in Depomed's ongoing patent infringement case against filers of three Abbreviated New Drug Applications (ANDAs) seeking to market generic versions of Depomed's GRALISE ® (gabapentin) product prior to the expiration of Depomed's patents listed for Gralise in the FDA's Orange Book.

In a Markman ruling, the court determines the meaning of disputed patent terms at issue in patent litigation.  Judge Pisano's ruling construed 24 terms in the patents asserted by Depomed in the litigation.  As to 23 of the disputed patent terms, the ruling either principally adopted Depomed's proposed claim construction or the plain and ordinary meaning of the term.  The defendants' proposed construction was adopted as to one patent term that appears in one of the asserted patents.

"We are pleased with the Court's ruling and remain confident that our Gralise intellectual property will provide significant commercial exclusivity for the product," said James A. Schoeneck, Depomed's President and Chief Executive Officer.

The Gralise ANDA Litigation

Between March 2012 and May 2012, Depomed filed patent infringement suits in the United States District Court for the District of New Jersey against six filers of ANDAs seeking FDA approval to market generic versions of GRALISE 300 mg and 600 mg tablets prior to the expiration of Depomed's nine patents listed in the Orange Book for Gralise.  Five of the patents, which relate to Gralise and other proprietary formulations of gabapentin, expire between October 2022 and February 2024.  The other four patents, which relate to Gralise and other products formulated with Depomed's Acuform drug delivery technology, expire between 2016 and 2021. 

Two of the six initial ANDA filers have withdrawn their ANDAs and a third has dropped its challenge against the Gralise Orange Book listed patents.  A trial date for the consolidated litigation has not yet been set.  

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