POZEN Inc. (NASDAQ: POZN), a pharmaceutical company committed to transforming medicine that transforms lives, announced today that the U.S. District Court for the Eastern District of Texas has granted a preliminary injunction ordering Par Pharmaceutical Inc. (Par) not to make, use, sell, offer to sell, or import into the United States a generic version of sumatriptan/naproxen sodium that competes withTreximet® (sumatriptan and naproxen sodium) sold by GlaxoSmithKline in the United States under an exclusive license from the Company.
The order was entered in connection with the patent infringement lawsuit pending among the Company and Par, Alphapharm Pty Ltd. (Alphapharm), Teva Pharmaceuticals USA, Inc. (Teva), and Dr. Reddy's Laboratories, Inc. (DRL) relating to the submission to the U.S. Food and Drug Administration (FDA) of Abbreviated New Drug Applications (ANDAs) by the four generic companies and the generic companies' plans to market sumatriptan and naproxen sodium products pursuant to such ANDAs, which the Company contends infringe three of its patents covering Treximet. Teva was dismissed without prejudice from the consolidated litigation in April 2010. The case against the other three defendants was tried before Judge Leonard Davis in the Eastern District of Texas on October 12-15, 2010. A decision is pending in the case.
For purposes of evaluating POZEN's motion for a preliminary injunction, Judge Davis focused his analysis on two asserted claims of U.S. Patent No. 6,586,458, one of three patents challenged by the defendants in the case. Judge Davis concluded that the Company had shown "that it is likely to succeed against Par on the merits of its infringement claim of the '458 patent." The Court further concluded that POZEN "is likely to succeed against Defendants' invalidity claims" concerning the '458 patent and that it "does not find that Defendants' arguments raise a substantial question regarding the enforceability of the '458 patent."
The injunction will remain in effect until a final decision is issued in the pending patent litigation. The Company continues to believe that its patents covering Treximet are valid and enforceable, and that these beliefs will be upheld by the Court.
Source: POZEN Inc.
波曾公司(NASDAQ:POZN), 一家制药公司,致力于转变药变换的生活,今天宣布,美国地区法院对德克萨斯州东部地区已批准初步禁制令,下令帕药业公司(杆)不制造,使用,销售,许诺销售,进口或国家进入美国通用版本的舒马普坦/萘普生钠的竞争对手 Treximet ® (舒马普坦和萘普生钠)境内销售由葛兰素史克公司在美国根据一项独家授权,从本公司。
该命令是在连接输入与专利有关的侵权诉讼待本公司与Par灯Alphapharm私人有限公司(Alphapharm),Teva药厂美国公司(Teva公司)和雷迪博士实验室公司(迪士尼线)提交给美国食品和药物管理局(FDA)的简化新药申请(仿制药)由四个公司和通用公司的通用计划和萘普生钠市场舒马普坦按照这些仿制药产品,该公司声称侵犯其三专利涉及 Treximet 。 Teva公司被撤销不影响从2010年4月合并诉讼研究。 对案件的被告是尝试过其他三个法官伦纳德戴维斯在德克萨斯州东部地区在十月12-15日2010年。