HERTFORDSHIRE, England and
PITTSBURGH, Sept. 1, 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 U.S. Patent
No. 8,969,302, which is owned by Yeda Research & Development
Co., Ltd. and licensed to Teva Pharmaceuticals Industries Ltd.,
unpatentable. This is the third patent related to Copaxone®
40 mg/mL to be found unpatentable in the last week.
On Aug. 24, the PTO's Patent Trial
and Appeal Board (PTAB) found Teva's first two patents, U.S. Patent
Nos. are 8,232,250 and 8,399,413, unpatentable in Mylan's IPR
challenge of these patents.
Mylan CEO Heather Bresch
commented, "Through significant investment in research and
development and by challenging these invalid patents, we are
working to bring a more affordable generic alternative of Copaxone®
to market. Challenging patents is just one of the ways that Mylan
helps to ensure patient access to medicines. In the last few years
alone, Mylan's patent challenges have allowed earlier access to
generic competition for brand products equating to nearly
$20 billion in annual brand sales
product and reducing more than 60 years of patent life that
otherwise could have blocked generics from entering the
market."
On Aug. 15, the PTAB found Mylan's
petition 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 and the earlier favorable
rulings in Mylan's IPRs against the '250 and '413 patents strongly
undermines the '776 patent as well. As such, Mylan will proceed
with pursuing all avenues to challenge the '776 patent.
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.
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SOURCE Mylan N.V.