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Two of the six initial ANDA filers have withdrawn their ANDAs and a third has dropped its challenge against the Gralise Orange Book listed patents.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.
Depomed, Inc. is a specialty pharmaceutical company that commercializes products for pain and neurology related disorders. Gralise® (gabapentin) is a once-daily treatment approved for the management of postherpetic neuralgia. Zipsor® (diclofenac potassium) Liquid Filled Capsules is a non-steroidal anti-inflammatory drug indicated for relief of mild to moderate acute pain in adults. CAMBIA® (diclofenac potassium for oral solution) is a non-steroidal anti-inflammatory drug indicated for acute treatment of migraine attacks with or without aura in adults (18 years of age or older). Lazanda® (fentanyl) Nasal Spray is an intranasal fentanyl drug used to manage breakthrough pain in adults (18 years of age or older) who are already routinely taking other opioid pain medicines around-the-clock for cancer pain. Gralise and various partner product candidates are formulated with Depomed's proven, proprietary Acuform® drug delivery technology. Additional information about Depomed may be found at www.depomed.com.
"Safe Harbor" Statement under the Private Securities Litigation Reform Act of 1995. The statements that are not historical facts contained in this release are forward-looking statements that involve risks and uncertainties including, but not limited to, those related to the intellectual property associated with Gralise, uncertainties relating to enforcement of intellectual property rights in the life science industry and other risks detailed in the company's Securities and Exchange Commission filings, including the company's Annual Report on Form 10-K for the year ended December 31, 2012 and most recent Quarterly Report on Form 10-Q. The inclusion of forward-looking statements should not be regarded as a representation that any of the company's plans or objectives will be achieved. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof. The company undertakes no obligation to publicly release the result of any revisions to these forward-looking statements that may be made to reflect events or circumstances after the date hereof or to reflect the occurrence of unanticipated events.
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