HERTFORDSHIRE, England and
PITTSBURGH, Oct. 26, 2017 /PRNewswire/ -- Mylan N.V. (NASDAQ,
TASE: MYL) today announced that the United Kingdom's High Court of Justice has
issued a decision in favor of Mylan and
its European partner Synthon, finding all claims of Teva's
patent EP (UK) 2 949 335 (EP 335)
relating to Copaxone® 40 mg/mL invalid based on obviousness.
This victory is yet another important
milestone for Mylan, and this U.K. court decision only further
increases Mylan's confidence in its ability to bring high
quality, lower-cost generic versions of Copaxone to the multiple sclerosis community and
patients around the world.
Over the course of the last eight years, Mylan has
successfully overcome Teva's four waves of U.S. patent litigation,
eight Citizen Petitions, injunction proceedings in India, more than 15 regulatory challenges, patent litigations
or commercial actions across Europe, and now the litigation in the U.K., in
addition to obtaining dismissal of Teva's suit against the FDA
seeking to delay approval of the 20 mg/mL
product. Today's positive ruling in the U.K. will further
help pave the way for Mylan's future launches of Glatiramer Acetate
Injection 40 mg/mL in certain European markets.
In addition, Mylan recently
learned of Teva's latest action with the filing of an
infringement action against Mylan's Irish subsidiary Mylan Teoranta
in the High Court of Ireland
alleging that Mylan's Glatiramer Acetate 40 mg/mL injection
infringes two European patents. In fact, one of those patents
is the same patent that was just invalidated today by the U.K. High
Court of Justice and the counterpart to a U.S. patent that was
previously held invalid by both the
United States District Court for the District of Delaware and the Patent Trial and Appeal
Board.
Mylan will support the multiple
sclerosis patient population through its continued commitment to
bring lower-cost generic versions of Copaxone around the world
regardless of any further attempts by Teva to deny such
access.
Glatiramer Acetate Injection 40 mg/mL in the U.S.
In
early October, Mylan received FDA approval and launched its
Glatiramer Acetate Injection 40 mg/mL for 3-times-a-week injection,
an AP-rated, substitutable generic version of Teva's Copaxone 40
mg/mL. According to the FDA approval letter, Mylan was one of the
first applicants to submit a substantially complete Abbreviated New
Drug Application for Glatiramer Acetate Injection, 40 mg/mL,
containing a Paragraph IV certification.
Glatiramer Acetate Injection 40 mg/mL in Europe
In Europe, Mylan is partnered with Synthon, the
developer and supplier of its European Glatiramer Acetate Injection
40 mg/mL product, and has exclusive distribution and supply rights
for the U.K. as well as
Germany, France, Spain, Portugal, Belgium, Italy, the
Netherlands, Republic of Ireland, Switzerland,
Greece, Denmark, Sweden, Norway, Finland, Cyprus and Malta.
On Oct. 5, Synthon received marketing
authorization approval in Europe
for its Glatiramer Acetate Injection 40 mg/mL product.
This press release includes statements that constitute
"forward-looking statements," including with regard to: the launch
of Mylan's Glatiramer Acetate Injection products; Mylan's
efforts to bring high quality, lower-cost generic versions of
Copaxone to market around the world; that today's positive
ruling in the U.K will further help pave the way for Mylan's future
launches of Glatiramer Acetate Injection 40 mg/mL in certain
European markets; that Mylan is supporting the multiple sclerosis
patient population through its continued commitment to bring its lower-cost generic versions of
Copaxone regardless of any further attempts by Teva to deny such
access. 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: changes in healthcare
and pharmaceutical laws and regulations in the U.S. and abroad;
actions and decisions of healthcare and pharmaceutical regulators;
determinations by health insurance companies regarding
coverage for Glatiramer Acetate Injection 20 mg/mL and 40 mg/mL;
any regulatory, legal, or other impediments to Mylan's ability to
bring Glatiramer Acetate Injection 20 mg/mL and 40 mg/mL to market,
including ongoing and unresolved allegations of patent infringement
around our launch of Glatiramer Acetate Injection 40 mg/mL; any
changes in or difficulties with Mylan's or its partners' inventory
of, and ability to manufacture and distribute, Glatiramer Acetate
Injection 20 mg/mL and 40 mg/mL to meet anticipated demand; the
potential impact of any change in patient access to or demand for
Glatiramer Acetate Injection 20 mg/mL and 40 mg/mL; the scope,
timing, and outcome of any ongoing legal proceedings, including but
not limited to government investigations, and the impact of any
such proceedings on Mylan's or its partners' business; the impact
of competition; strategies by competitors or other third parties to
delay or prevent product introductions, including Glatiramer
Acetate Injection 20 mg/mL and 40 mg/mL; changes in the economic
and financial conditions of the businesses of Mylan or its
partners; 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 any statements herein 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.
Copaxone® is a registered trademark of Teva Pharmaceutical
Industries Ltd.
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SOURCE Mylan N.V.