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
www.Allergan.com.
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.
CONTACTS:
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Allergan:
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Investors:
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Lisa
DeFrancesco
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(862)
261-7152
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Media:
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Mark
Marmur
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(862)
261-7558
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SOURCE Allergan plc