HERTFORDSHIRE, England, and
PITTSBURGH, Oct. 16, 2017 /PRNewswire/ -- Mylan N.V.
(NASDAQ, TASE: MYL) today announced that the United States District
Court for the Eastern District of Texas has issued a 135-page decision finding
all asserted claims of the patents relating to Restasis® invalid
based on obviousness. The Court, recognizing that Allergan's patent
protection for Restasis ended in 2014, concluded that "Allergan is
not entitled to renewed patent rights for Restasis in the form of a
second wave of patent protection." The invalidated patents are
United States Patent Numbers 8,629,111; 8,648,048; 8,685,930 and
9,248,191. Mylan received a covenant not to sue on the remaining
two Orange Book patents, U.S. Patent Numbers 8,633,162 and
8,642,556, shortly before the trial began.
The Court's decision also will be binding against the Saint
Regis Mohawk Tribe, which the Court added to the lawsuit. In
ultimately allowing the Tribe to join the lawsuit, the Court
expressed its concerns that "sovereign immunity should not be
treated as a monetizable commodity that can be purchased by private
entities as part of a scheme to evade their legal responsibilities.
It is not an inexhaustible asset that can be sold to any party that
might find it convenient to purchase immunity from suit. Because
that is in essence is [sic] what the agreement between Allergan and
the Tribe does, the Court has serious reservations about whether
the contract between Allergan and the Tribe should be recognized as
valid, rather than being held void as being contrary to public
policy."
Mylan CEO Heather Bresch
commented, "We couldn't be more pleased with today's federal court
ruling invalidating the Restasis patents. For decades, our
investments and perseverance continue to pay off as we have led the
charge in challenging the unnecessary roadblocks often put up by
brand pharmaceutical companies, whether it's through the regulatory
pathway or around its intellectual property, which often delay
access to affordable generic medicines to patients.
Bresch continued, "We look forward to continuing to work with
the FDA to expeditiously bring our more affordable, generic
Restasis product to patients."
The admitted purpose of the Allergan/Saint Regis Mohawk Tribe
transaction was to employ Native American sovereign immunity to
cut-off pending IPR proceedings before the Patent Trial and Appeal
Board (PTAB) and to prevent the PTAB from canceling Allergan's
invalid patents. The Court's decision emphasized the
duplicitousness of Allergan's changing course with respect to the
Patent Office, explaining that the company "invoked the benefits of
the patent system" but now seeks "the right to continue to enjoy
the considerable benefits of the U.S. patent system without
accepting the limits that Congress has placed on those
benefits."
Forward-Looking Statements
This press release includes
statements that constitute "forward-looking statements," including
with regard to the status of litigation and that Mylan has been
working with FDA for years to gain approval for generic Restasis
and is proud that Mylan's investment and perseverance will
contribute to bringing this product to patients. These
statements are made pursuant to the safe harbor provisions of the
Private Securities Litigation Reform Act of 1995. Because
such statements inherently involve risks and uncertainties, actual
future results may differ materially from those expressed or
implied by such forward-looking statements. Factors that
could cause or contribute to such differences include, but are not
limited to: any changes in or difficulties with Mylan's or its
partners' ability to develop, manufacture, and commercialize
products; any regulatory, legal, or other impediments to Mylan's or
its partners' ability to bring products to market, including
generic Restasis; Mylan's and its partners' ability to protect
intellectual property and preserve intellectual property rights;
the effect of any changes in Mylan's or its partners' customer and
supplier relationships and customer purchasing patterns; other
changes in third-party relationships; the impact of competition;
changes in the economic and financial conditions of the businesses
of Mylan or its partners; the scope, timing, and outcome of any
ongoing legal proceedings, including any appeal of the Court's
decision invalidating the Restasis patents, and the impact of any
such proceedings on Mylan's or its partners' business; actions and
decisions of healthcare and pharmaceutical regulators, and changes
in healthcare and pharmaceutical laws and regulations,
in the United States and abroad; risks associated with
international operations; other uncertainties and matters beyond
the control of management; and the other risks detailed in Mylan's
filings with the Securities and Exchange Commission. Mylan
undertakes no obligation to update these statements for revisions
or changes after the date of this release.
About Mylan
Mylan is a global pharmaceutical company
committed to setting new standards in healthcare. Working together
around the world to provide 7 billion people access to high quality
medicine, we innovate to satisfy unmet needs; make reliability and
service excellence a habit; do what's right, not what's easy; and
impact the future through passionate global leadership. We offer a
growing portfolio of more than 7,500 marketed products around the
world, including antiretroviral therapies on which approximately
50% of people being treated for HIV/AIDS in the developing world
depend. We market our products in more than 165 countries and
territories. We are one of the world's largest producers of active
pharmaceutical ingredients. Every member of our more than
35,000-strong workforce is dedicated to creating better health for
a better world, one person at a time. Learn more at Mylan.com.
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SOURCE Mylan N.V.