DUBLIN, Dec. 22, 2017 /PRNewswire/ -- Allergan plc (NYSE : AGN ), a leading global pharmaceutical company, today announced that the United States Court of Appeals for the Federal Circuit affirmed the United States District Court for the Eastern District of Texas' earlier decision that that each of three Allergan patents (U.S. Patent Nos. 7,030,149, 7,320,976 and 8,748,425) that are listed in the Orange Book for COMBIGAN® is valid. The Federal Circuit also affirmed the district court's finding that Sandoz' proposed generic version of COMBIGAN® does not infringe the '149 and '976 patents, and reversed the district court's decision that Sandoz' proposed generic product infringes the '425 patent.
Allergan expects to file petitions for rehearing and/or rehearing en banc of the appeals court decision within 30 days. Allergan does not believe the federal district court's injunction preventing final approval and launch of the Sandoz product will be lifted prior to a decision on Allergan's petitions.
In addition, Allergan and Sandoz are parties to a lawsuit in the United States District Court for the District of New Jersey in which Allergan asserts that Sandoz' proposed generic product infringes an additional patent listed in the Orange Book for COMBIGAN® (U.S Patent No. 9,770,453) that expires in April 2022. As a result Allergan believes that today's appeals court ruling will not result in the market formation for a generic COMBIGAN® product.
About Allergan plc
Allergan plc (NYSE : AGN ), headquartered in Dublin, Ireland, is a bold, global pharmaceutical company and a leader in a new industry model – Growth Pharma. Allergan is focused on developing, manufacturing and commercializing branded pharmaceutical, device, biologic, surgical and regenerative medicine products for patients around the world.
Allergan markets a portfolio of leading brands and best-in-class products for the central nervous system, eye care, medical aesthetics and dermatology, gastroenterology, women's health, urology and anti-infective therapeutic categories.
Allergan is an industry leader in Open Science, a model of research and development, which defines our approach to identifying and developing game-changing ideas and innovation for better patient care. With this approach, Allergan has built one of the broadest development pipelines in the pharmaceutical industry with 55+ mid-to-late stage pipeline programs currently in development.
Allergan's success is powered by our more than 18,000 global colleagues' commitment to being Bold for Life. Together, we build bridges, power ideas, act fast and drive results for our customers and patients around the world by always doing what is right.
With commercial operations in approximately 100 countries, Allergan is committed to working with physicians, healthcare providers and patients to deliver innovative and meaningful treatments that help people around the world live longer, healthier lives every day.
For more information, visit Allergan's website at www.Allergan.com.
Statements contained in this press release that refer to future events or other non-historical facts are forward-looking statements that reflect Allergan's current perspective on existing trends and information as of the date of this release. Actual results may differ materially from Allergan's current expectations depending upon a number of factors affecting Allergan's business. These factors include, among others, the difficulty of predicting the timing or outcome of FDA approvals or actions, if any; the impact of competitive products and pricing; market acceptance of and continued demand for Allergan's products; difficulties or delays in manufacturing; and other risks and uncertainties detailed in Allergan's periodic public filings with the Securities and Exchange Commission, including but not limited to Allergan's Annual Report on Form 10-K for the year ended December 31, 2016 and Allergan's Quarterly Report on Form 10-Q for the period ended September 30, 2017. Except as expressly required by law, Allergan disclaims any intent or obligation to update these forward-looking statements
SOURCE Allergan plc