Allergan Comments On PTAB Decision Regarding Mylan's Petitions For Inter Partes Review (IPR) Of RESTASIS Patents

Published: Dec 08, 2016

DUBLIN, Dec. 8, 2016 /PRNewswire/ -- Allergan plc (NYSE:AGN), a leading global pharmaceutical company, today announced the U.S. Patent & Trademark Office's Patent Trial and Appeal Board (PTAB) granted Mylan Pharmaceutical Inc.'s Petitions to institute Inter Partes Reviews (IPRs) of U.S. Patent Nos. 8,629,111 (the "'111 patent"), 8,633,162 (the "'162 patent"), 8,642,556 (the "'556 patent"), 8,648,048 (the "'048 patent"), 8,685,930 (the "'930 patent"), and 9,248,191 (the "'191 patent").  Each of these patents are listed in FDA's Orange Book in connection with RESTASIS® (Cyclosporine Ophthalmic Emulsion) 0.05% and will expire on August 27, 2024. The PTAB's decision on the IPRs is expected in the fourth quarter of 2017. 

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Allergan is dissapointed in the PTAB's decision to institute IPR proceedings regarding the patents that protect RESTASIS®.  Allergan is currently reviewing the grounds for the decision to institute, and will continue to vigorously defend the patents in the IPR proceeding and pursue all legal options available to protect its products and intellectual property rights for this product.

Allergan's portfolio of intellectual property includes six patents listed in the Orange Book covering RESTASIS®. Allergan's Hatch-Waxman litigations involving these patents against Mylan and other generic defendants remain pending in the United States District Court for the Eastern District of Texas.

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 pharmaceuticals, devices and biologic 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, the Company's R&D model, which defines our approach to identifying and developing game-changing ideas and innovation for better patient care.  This approach has led to Allergan building one of the broadest development pipelines in the pharmaceutical industry with 70+ mid-to-late stage pipeline programs in development.

Our Company's success is powered by our more than 16,000 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

Forward-Looking Statement

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 of existing trends and information as of the date of this release. Except as expressly required by law, Allergan disclaims any intent or obligation to update these forward-looking statements. 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, 2015 and Quarterly Report on Form 10-Q for the quarter ended September 30, 2016 (certain of such periodic public filings having been filed under the "Actavis plc" name). Except as expressly required by law, Allergan disclaims any intent or obligation to update these forward-looking statements.




Lisa DeFrancesco      

(862) 261-7152


Mark Marmur

(862) 261-7558


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SOURCE Allergan plc

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