Omeros today, in response to investor questions, announced that it plans to file a patent infringement lawsuit against Par Pharmaceutical and its subsidiary, Par Sterile Products, LLC, in response to the abbreviated new drug application (ANDA) filed by Par seeking FDA approval to market a generic version of Omeros' commercial drug Omidria (phenylephrine and ketorolac injection) 1%/0.3%, according to a company news release.
Omidria is approved by the FDA for use during cataract surgery or intraocular lens replacement to maintain pupil size by preventing intraoperative miosis (pupil constriction) and to reduce postoperative ocular pain. As reported in the company's quarterly report on Form 10-Q filed with the Securities and Exchange Commission on August 10, 2015, Omeros received a notice from Par on July 27, 2015, which addresses the ANDA and Par's request to market a generic version of Omidria pursuant to Paragraph IV of the Hatch-Waxman Act following expiration of the drug's new product exclusivity and, if applicable, the subsequent pediatric exclusivity, but prior to the expiration of three patents published in the FDA's Approved Drug Products with Therapeutic Equivalence Evaluations, or Orange Book, which have terms extending to as late as 2033, according to Omeros. Approximately 3.8 million cataract and lens replacement procedures are projected in the United States in 2015.
Omeros currently owns 34 issued patents worldwide related to Omidria. The patents that are listed in the Orange Book were granted by multiple examiners in multiple art groups based on review of prior art from multiple searches. Omeros is highly confident in its patent estate protecting Omidria.
Omeros has reviewed Par's Paragraph IV assertions and plans to file a patent infringement suit against Par within 45 days of Omeros' receipt of Par's notice. In this regard, Omeros has engaged a prominent Hatch-Waxman litigation team at Covington & Burling LLP. Filing of the planned lawsuit will trigger what is generally a 30-month stay of FDA action on Par's ANDA. Issued US patents are presumed to be valid, and only clear and convincing evidence presented in federal court can establish invalidity. Independent of its patents, Omidria has also received 36-month market exclusivity through the New Product Exclusivity provided by the Federal Food, Drug, and Cosmetic Act as well as an additional 6 months of market exclusivity available upon successful completion of the company's pediatric clinical plan according to the Written Request from FDA.
"Generic manufacturers challenging branded drug products is 'business as usual' in the pharmaceutical industry and, based on its track record this is not an uncommon activity for Par," Gregory A. Demopulos, MD, chairman and chief executive officer of Omeros, said in the news release. "This action confirms our belief in the market potential of Omidria. We are confident in the strength of our product's broad patent estate. We have engaged one of the premier biotech patent litigation teams in the country to pursue aggressively our case against Par, so I do not anticipate this effort becoming a distraction for Omeros. We remain focused on continuing to build on our successful launch of Omidria and on increasing the product's market uptake."