HERTFORDSHIRE, England and
PITTSBURGH, Aug. 25, 2015 /PRNewswire/ -- Mylan N.V.
(Nasdaq: MYL) today announced that the U.S. Patent and Trademark
Office (PTO) has instituted inter partes review (IPR)
proceedings against two Copaxone® 40 mg/mL patents, U.S. Patent
Nos. 8,232,250 and 8,399,413, owned by Yeda Research &
Development Co., Ltd. and licensed to Teva Pharmaceuticals
Industries Ltd. The patents relate to methods for the
treatment of multiple sclerosis through the administration of at
least three 40 mg subcutaneous injections of glatiramer acetate
over a period of seven days with at least one day between each
injection. Mylan also has filed another petition for inter
partes review of a related patent (U.S. Patent No. 8,969,302),
which the PTO is expected to act upon shortly.
Mylan CEO Heather Bresch
commented, "We believe that the patents at question are invalid and
are pleased that, in instituting an inter partes review on
all claims, the PTO has determined that there is a reasonable
likelihood of prevailing on the invalidity assertion. We believe
our generic version of Copaxone 40mg/mL represents an exciting
first-to-file opportunity for Mylan."
In August 2014, the U.S. Food and
Drug Administration accepted Mylan's abbreviated new drug
application (ANDA) filing for a three times per week Glatiramer
Acetate Injection 40 mg/mL, the generic version of Copaxone 40
mg/mL Mylan believes it is one of the first companies to have filed
a substantially complete ANDA containing a Paragraph IV
certification for this product 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 $2.6 billion for the 12 months ending
June 30, 2015, 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. 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 around 1,400 generic pharmaceuticals and several brand
medications. In addition, we offer a wide range of antiretroviral
therapies, upon which nearly 50% of HIV/AIDS patients in developing
countries depend. We also operate one of the largest active
pharmaceutical ingredient manufacturers and currently market
products in about 145 countries and territories. Our workforce of
approximately 30,000 people 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.