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POZEN, AstraZeneca file lawsuit against Dr. Reddy's for patent infringement relating to VIMOVO


POZEN Inc. (NASDAQ: POZN), a pharmaceutical company committed to transforming medicine that transforms lives, today announced that it and AstraZeneca filed a lawsuit against Dr. Reddy's Laboratories (Dr. Reddy's) in the United States District Court for the District of New Jersey, for infringement of U.S. Patent No. 6,926,907 relating to VIMOVO™ (naproxen / esomeprazole magnesium) delayed-release tablets. In a Notice Letter sent to AstraZeneca and POZEN in March 2011 (Notice Letter), Dr. Reddy's informed AstraZeneca and POZEN that it submitted an Abbreviated New Drug Application (ANDA) seeking U.S. Food and Drug Administration (FDA) approval to market a generic version of VIMOVO prior to expiration of U.S. Patent No. 6,926,907, which is one of seven patents listed in the FDA's Orange Book for VIMOVO. The patent expires in 2023. Under the terms of its agreement with POZEN, AstraZeneca has exercised its first right to defend the patent at issue and will take the leading role in prosecuting the infringement suit against Dr. Reddy's.

The filing of this patent infringement lawsuit by AstraZeneca and POZEN within forty-five days of receipt of Dr. Reddy's Notice Letter will result in the FDA automatically instituting a stay, or bar, of final approval of Dr. Reddy's ANDA for up to 30 months or until a final court decision is entered in the infringement suit in favor of Dr. Reddy's, whichever occurs first. VIMOVO currently has regulatory exclusivity through April 30, 2013.

POZEN and AstraZeneca have full confidence in and will vigorously defend and enforce its intellectual property protecting VIMOVO.

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,它和阿斯利康提起雷迪博士实验室的诉讼在美国联邦地区法院对新泽西地区,(雷迪博士)对侵犯美国专利号6926907有关商品名Vimovo™(萘普生/埃索美拉唑镁)缓释片。在通知信发出2011年3月(注意字母),雷迪博士的知情阿斯利康和波曾到阿斯利康及Pozen,它提交了一份简化新药申请(ANDA)寻求美国食品和药物管理局(FDA)批准向市场推出了仿制药的商品名Vimovo之前,美国专利号6926907,这是在FDA的黄皮书为商品名Vimovo上市七项专利一到期。这项专利在2023年到期。根据其与波曾协议的条款,阿斯利康公司已行使其权利,捍卫首次颁发专利,并率先在起诉对雷迪博士侵权诉讼的主导作用。

这种由阿斯利康公司专利侵权和波曾在四十五个雷迪博士的信日内通知诉讼申请,将导致美国FDA实行自动中止,或酒吧的雷迪博士ANDA的最终批准,长达30个月或直到最后进入法庭的决定是在侵权诉讼赞成雷迪博士,以先到为准。商品名Vimovo目前已通过二〇一三年四月三十日监管排他性。

波曾和阿斯利康公司有充分的信心,并会积极维护和执行知识产权保护的商品名Vimovo。

源波曾公司


 
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