U.S. Court of Appeals Denied Momenta Pharmaceuticals Petition for Rehearing En
Banc in "Safe-Harbor" Case
Company Plans to File Petition for Rehearing to Supreme Court
CAMBRIDGE, Mass., Nov. 20, 2012 (GLOBE NEWSWIRE) -- Momenta Pharmaceuticals,
Inc. (Nasdaq:MNTA), a biotechnology company specializing in the
characterization and engineering of complex drugs, today announced that the
United States Court of Appeals for the Federal Circuit (CAFC) denied its
request for a rehearing en banc to reconsider its three-judge panel opinion in
the case of Momenta Pharmaceuticals vs. Amphastar Pharmaceuticals, Inc., which
held that Amphastar's use of Momenta's patented method for processing
enoxaparin sodium injection was protected by the "safe harbor" from patent
infringement under 35 U.S.C. sec. 271(e)(1).
The request for all active judges of the court to reconsider a panel decision,
known as rehearing en banc, is only granted upon a majority vote.
"We will continue to pursue our appellate options and we plan to file a
petition for certiorari, asking the Supreme Court to review this case," said
Craig Wheeler, President and Chief Executive Officer of Momenta."We strongly
believe that the CAFC panel decision in this case finds no support in the
statutory text of the safe harbor provision of the patent law, or in Supreme
Court precedent, and a final decision upholding this case could have
wide-ranging, negative effects on drug development."
About "Safe Harbor" provision
Enacted as part of the Hatch-Waxman Act of 1984, the 'safe harbor" provision
of the patent statute provides that it is not an act of patent infringement to
use a patented invention "solely for uses reasonably related to the
development and submission of information under a Federal law which regulates
the manufacture, use, or sale of drugs."
About Momenta Pharmaceuticals, Inc. vs. Amphastar patent infringement case
Momenta sued Amphastar for infringement of Momenta's U.S. Patent No.
7,575,866, which claims methods for processing enoxaparin (the generic name
for the active ingredient in Lovenox®).The patented methods assure that
enoxaparin, a highly complex drug product, is reproducibly manufactured.
In October, 2011, the U.S. District Court for the District of Massachusetts
granted Momenta a preliminary injunction, enjoining Amphastar from selling any
of its enoxaparin product. According to the District Court, Amphastar's
activity was not protected from infringement by the "safe harbor" provision
because the alleged infringing activity involved use of Momenta's patented
methods "on each commercial batch of enoxaparin that will be sold after FDA
Amphastar appealed the grant of the preliminary injunction to the CAFC, and
the CAFC stayed the preliminary injunction in January, 2012 without issuing a
written opinion.In August 2012, The CAFC issued its written opinion. The
opinion held that Amphastar's use of the patented methods was protected from
infringement under the safe harbor, and remanded the case to the District
Court for further proceedings consistent with this conclusion. The District
Court proceedings are currently stayed pending resolution of the en banc
Momenta Pharmaceuticals is a biotechnology company specializing in the
detailed structural analysis of complex mixture drugs and is headquartered in
Cambridge, MA. Momenta is applying its technology to the development of
generic versions of complex drug products, as well as to the discovery and
development of novel drugs.
To receive additional information about Momenta, please visit the website at
www.momentapharma.com, which does not form a part of this press release.
Our 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.
Special Note Regarding 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 litigation with
Amphastar and Watson,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, 2012 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.
CONTACT: Lora Pike
Senior Director, Investor Relations
and Corporate Communications
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