HERTFORDSHIRE, England and
PITTSBURGH, Sept. 15, 2020 /PRNewswire/ -- Mylan N.V.
(NASDAQ: MYL) today announced that the Technical Board of Appeal of
the European Patent Office (EPO) has held that Yeda Research and
Development Company, Ltd.'s European Patent no. 2 949 335 related
to Teva's Copaxone® 40 mg/mL three times weekly product
is invalid and revoked across Europe.
With the EPO's decision, Mylan has once again overcome Teva's
attempts to restrict MS patients' access to safe and affordable
alternatives. Over the course of the last eleven years,
Mylan has successfully defeated Teva's four waves of U.S. patent
litigation, eight Citizen Petitions, injunction proceedings in
India, and more than 15
regulatory challenges, patent litigations or commercial actions
across Europe. The EPO's positive
ruling will allow Mylan to immediately return to the market and
accelerate commercialization in other markets across Europe.
Mylan CEO Heather Bresch commented: "There are many
ways in which we demonstrate our commitment to expand access to
medicine, including by leveraging our legal expertise to overcome
barriers on behalf of the patients we serve. The decision by the
EPO marks a significant step forward for Mylan in several ongoing
legal actions around Europe
related to this important product, and further increases our
confidence in our ability to continue to expand access to a
lower-cost, high quality, therapeutically equivalent version of
Copaxone to the multiple sclerosis community across even more
markets in Europe and beyond."
Indicated for the treatment of patients with relapsing forms of
multiple sclerosis (MS), a chronic inflammatory disease of the
central nervous system, Mylan's lower-cost therapeutically
equivalent version of Copaxone® will benefit thousands of MS
patients across Europe who are
living with this very difficult condition and in need of a more
affordable treatment option. Mylan's product is currently marketed
under a number of brand names in European markets including Brabio,
Clift, Copemyl, Copemyltri and Glatiramyl.
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
portfolio of more than 7,500 marketed products around the world,
including antiretroviral therapies on which more than 40% of people
being treated for HIV/AIDS globally 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 approximately 35,000-strong workforce is
dedicated to creating better health for a better world, one person
at a time. Learn more at Mylan.com. We routinely post information
that may be important to investors on our website at
investor.mylan.com.
Forward-Looking Statements
This press release includes
statements that constitute "forward-looking statements," including
with regard to the outcome of litigation; the decision further
clears legal pathway to expand access for patients living with
multiple sclerosis in markets across Europe; the EPO's positive ruling will allow
Mylan to immediately return to the market and accelerate
commercialization in other markets across Europe; and the decision by the EPO marks a
significant step forward for Mylan in several ongoing legal actions
around Europe related to this
important product, and further increases our confidence in our
ability to continue to expand access to a lower-cost, high quality,
therapeutically equivalent version of Copaxone to the multiple
sclerosis community across even more markets in Europe and beyond. Because forward-looking
statements inherently involve risks and uncertainties, actual
future results may differ materially from those expressed or
implied by such statements. Factors that could cause or contribute
to such differences include, but are not limited to the potential
widespread and highly uncertain impact of public health outbreaks,
epidemics and pandemics, such as the COVID-19 pandemic; any changes
in, interruptions to, or difficulties with Mylan's or its partners'
ability to develop, manufacture, and commercialize products; 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 and the impact of any such proceedings on
Mylan's or its partners' business; any regulatory, legal, or other
impediments to Mylan's or its partners' ability to bring products
to market; actions and decisions of healthcare and pharmaceutical
regulators, and changes in healthcare and pharmaceutical laws and
regulations, in the United States
and abroad; Mylan's and its partners' ability to protect
intellectual property and preserve intellectual property rights;
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.
View original content to download
multimedia:http://www.prnewswire.com/news-releases/mylan-and-development-partner-synthon-win-significant-european-patent-office-ruling-related-to-copaxone-40mgml-301130691.html
SOURCE Mylan N.V.