HERTFORDSHIRE, England and
PITTSBURGH, Aug. 24, 2016 /PRNewswire/ -- Mylan N.V.
(NASDAQ, TASE: MYL) today announced that the U.S. Patent and
Trademark Office (PTO) has ruled in favor of Mylan in its inter
partes review (IPR) proceeding and found all claims of two
related Copaxone® 40 mg/mL patents to be unpatentable. The U.S.
Patent Nos. are 8,232,250 and 8,399,413, which are owned by Yeda
Research & Development Co., Ltd. and licensed to Teva
Pharmaceuticals Industries Ltd. A decision by the PTAB on Mylan's
third petition seeking inter partes review of U.S. Patent
No. 8,696,302 is expected on or before September 1, 2016.
On Aug. 15, the PTO's Patent Trial
and Appeal Board (PTAB) found Mylan's application against a fourth
Copaxone 40 mg/mL patent, U.S. Patent No. 9,155,776, ineligible for
post-grant review for procedural reasons. However, Mylan believes
that today's favorable ruling in the IPR against the '302 patent
strongly undermines the '776 patent as well. As such, Mylan will
proceed with pursuing all avenues to challenge the '776 patent.
Mylan CEO Heather Bresch
commented, "We believe the Board's decision is comprehensive,
well-reasoned, and highly persuasive in detailing the bases for the
invalidity of Teva's 40 mg patents, and we look forward to further
demonstrating the invalidity of the patents covering Copaxone 40
mg/mL."
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, and expects to be eligible for 180 days
of marketing exclusivity in the U.S. upon final FDA approval.
Copaxone 40 mg/mL had U.S. sales of approximately $3.3 billion for the 12 months ending
June 30, 2016, according to IMS
Health.
This press release includes statements that constitute
"forward-looking statements," including with regard to Mylan's
belief that it is one of the first companies to have filed a
substantially complete ANDA containing a Paragraph IV certification
for Glatiramer Acetate Injection 40 mg/mL and that it expects to be
eligible for 180 days of marketing exclusivity in the U.S. upon
final FDA approval[; our expectation that the decision on the
Copaxone® 40 mg/mL patent, U.S. Patent No. 8,969,302, will be made
on or before Sept. 1, 2016; our
belief that today's favorable ruling in the IPR against the '302
patent strongly undermines the '776 patent and that Mylan will
proceed with challenging the '776 patent in in the District Court
and is evaluating a potential IPR challenge; and our belief that
the Board's decision is highly persuasive and relevant evidence of
the invalidity of Teva's 40 mg patents and that we look forward to
further demonstrating the invalidity of these patents in the
District Court. 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 in the developing world 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
40,000-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.