Momenta Pharmaceuticals Announces Supreme Court Decision to Remand Generic Copaxone(R) Case Back to CAFC
January 21 2015 - 8:30AM
Momenta Pharmaceuticals, Inc. (Nasdaq:MNTA) today announced that
the United States Supreme Court has vacated the 2013 decision of
the Court of Appeals for the Federal Circuit ("CAFC") which found
several of the Copaxone (20 mg injection) patents, including the
one patent expiring September 1, 2015, invalid for being
indefinite. The Supreme Court has overturned the long standing
practice whereby the CAFC reviewed a District Court's claim
interpretation "de novo," without deference to the District Court's
claim interpretation, and ruled that the CAFC must instead give
deference to the district court's findings of fact on issues of
claim interpretation. The Supreme Court did not rule on the
validity or invalidity of the patents per se, but has sent the case
back to the CAFC to be reheard under the new deference
standard.
"We continue to believe that the patents should be held invalid
under the Supreme Court's new standard for claim construction and
we plan to aggressively pursue our case on remand," said Craig
Wheeler, President and Chief Executive Officer of Momenta. "We
expect that the CAFC could rehear the case and issue a new decision
within a year. We remain optimistic that the ANDA for M356, our
generic Copaxone, could be approved by the FDA in the near term,
providing patients with a more affordable generic alternative for
the treatment of multiple sclerosis."
The case involved patents asserted by Teva against Momenta for
patent infringement associated with the submission of an
Abbreviated New Drug Application (ANDA) to the U.S. Food and Drug
Administration (FDA) for generic Copaxone by Momenta's commercial
partner for the product, Sandoz Inc. The case is Teva
Pharmaceuticals v. Sandoz and Momenta and Mylan et al., case
numbers 2012-1567, -1568, -1569, -1570. The asserted patents
included eight listed in the FDA Orange Book and one non-Orange
Book patent.
About M356, a generic version of Copaxone (glatiramer
acetate injection) M356 (glatiramer acetate injection) is
a generic version of Copaxone, a synthetic polypeptide medicine,
developed in collaboration with Sandoz and currently under review
by FDA. Copaxone is prescribed for patients with
relapsing-remitting multiple sclerosis, a chronic disease of the
central nervous system characterized by inflammation and
neurodegeneration. Copaxone is one of the leading products marketed
for treating multiple sclerosis.
About Momenta Momenta Pharmaceuticals is a
biotechnology company specializing in the detailed structural and
functional analysis of complex drugs and is headquartered in
Cambridge, MA. Momenta is applying its technology to the
development of generic versions of complex drugs, biosimilar and
potentially interchangeable biologics, and to the discovery and
development of novel therapeutics for oncology and autoimmune
indications.
To receive additional information about Momenta, please visit
the website at www.momentapharma.com, which does not form a part of
this press release. The company's logo, trademarks, and service
marks are the property of Momenta Pharmaceuticals, Inc. All other
trade names, trademarks, or service marks are property of their
respective owners.
Forward-Looking Statements Statements in this
press release regarding management's future expectations, beliefs,
intentions, goals, strategies, plans or prospects, including
statements relating to its beliefs and intentions related to the
outcome of litigation with Teva Pharmaceuticals and our ability to
achieve approval of our generic Copaxone (M536) product, are
forward-looking statements within the meaning of the Private
Securities Litigation Reform Act of 1995. Forward-looking
statements can be identified by terminology such as "anticipate,"
"believe," "could," "could increase the likelihood," "hope,"
"target," "project," "goals," "potential," "predict," "might,"
"estimate," "expect," "intend," "is planned," "may," "should,"
"will," "will enable," "would be expected," "look forward," "may
provide," "would" or similar terms, variations of such terms or the
negative of those terms. Such forward-looking statements
involve known and unknown risks, uncertainties and other factors
referred to in the Company's Quarterly Report on Form 10-Q for the
quarter ended September 30, 2014 filed with
the Securities and Exchange Commission under the section
"Risk Factors," as well as other documents that may be filed by
Momenta from time to time with the Securities and Exchange
Commission. As a result of such risks, uncertainties and
factors, the Company's actual results may differ materially from
any future results, performance or achievements discussed in or
implied by the forward-looking statements contained
herein. Momenta is providing the information in this press
release as of this date and assumes no obligations to update the
information included in this press release or revise any
forward-looking statements, whether as a result of new information,
future events or otherwise.
Copaxone® is a registered trademark of Teva Pharmaceuticals
CONTACT: Investor Relations:
Sarah Carmody
Momenta Pharmaceuticals
1-617-395-5189
IR@momentapharma.com
Media Relations:
Karen Sharma
MacDougall Biomedical Communications
1-781-235-3060
Momenta@macbiocom.com
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