HERTFORDSHIRE, England and
PITTSBURGH, Jan. 30, 2017 /PRNewswire/ -- Mylan N.V. (NASDAQ,
TASE: MYL), today announced the United States District Court for
the District of Delaware issued a
decision finding all asserted claims of four Orange Book-listed
patents relating to Copaxone® 40 mg/mL invalid based on
obviousness.
The invalidated patents are United States Patent Numbers
8,232,250; 8,399,413; 8,969,302; and 9,155,776, which are owned by
Yeda Research & Development Co., Ltd. and licensed to Teva
Pharmaceuticals Industries, Ltd.
On Dec. 2, 2016, the U.S. Patent
and Trademark Office's U.S. Patent Trial and Appeal Board (PTAB)
reaffirmed a prior decision that three of these patents ('250, '413
and '302) are unpatentable in its inter partes review (IPR)
proceedings initiated by Mylan. Mylan also challenged the '776
patent in an IPR proceeding. The PTAB is expected to issue its
institution ruling on the '776 patent IPR by May 16, 2017.
Mylan CEO Heather Bresch
commented, "Today's ruling by the U.S. District Court is yet
another positive step in our effort to bring to market a more
affordable generic version of Copaxone® 40 mg/mL. We will continue
to challenge the validity of patents as a way to expedite the
availability of generic drugs and help deliver access and savings
to patients and the overall healthcare system."
Mylan believes it is one of the first companies to have filed a
substantially complete abbreviated new drug application containing
a Paragraph IV certification for a three times per week Glatiramer
Acetate Injection 40 mg/mL
Copaxone 40 mg/mL had U.S. sales of approximately $3.3 billion for the 12 months ending
Nov. 30, 2016, according to IMS
Health.
This press release includes statements that constitute
"forward-looking statements," including that Mylan will continue to
challenge the validity of patents as a way to expedite the
availability of generic drugs and help deliver access and savings
to patients and the overall healthcare system; that the PTAB is
expected to issue its institution ruling on the '776 patent IPR by
May 16, 2017; and that Mylan believes
it is one of the first companies to have filed a substantially
complete abbreviated new drug application containing a Paragraph IV
certification for a three times per week Glatiramer Acetate
Injection 40 mg/mL. 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: the use of legal, regulatory and
legislative strategies by competitors or other third parties to
delay or prevent our introduction of new products; actions taken by
regulatory and governmental agencies with respect to our or our
competitors' current or future products; success of clinical trials
and our ability to execute on new product opportunities; other
risks inherent in legal and regulatory processes, uncertainties and
matters beyond the control of management; and the other risks
detailed in the company's filings with the Securities and Exchange
Commission. The company undertakes no obligation to update these
statements for revisions or changes after the date of this
release.
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 2,700 generic and branded pharmaceuticals,
including antiretroviral therapies on which approximately 50% of
people being treated for HIV/AIDS worldwide depend. We market our
products in more than 165 countries and territories. Our global
R&D and manufacturing platform includes more than 50
facilities, and 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.
To view the original version on PR Newswire,
visit:http://www.prnewswire.com/news-releases/mylan-wins-us-district-court-ruling-related-to-copaxone-40-mgml-patents-300399092.html
SOURCE Mylan N.V.