ARDSLEY, N.Y.--(BUSINESS WIRE)--
Acorda Therapeutics, Inc. (NASDAQ:ACOR) today announced that the United
States Court of Appeals for the Federal Circuit has upheld a lower court
ruling that Acorda’s Abbreviated New Drug Application (ANDA) litigation
against Mylan N.V. (NASDAQ: MYL) can continue in the District Court of
Delaware. Mylan had appealed to the Federal Circuit after losing its
motion to the Delaware District Court to have the patent litigation
proceed in West Virginia. As a result of this decision, all of the ANDA
litigation related to AMPYRA ® (dalfampridine) Tablets, 10 mg
patents will continue to proceed in the District Court of Delaware.
“We’re pleased that the Federal Circuit agreed that our litigation
against Mylan should stay in Delaware,” said Jane Wasman, President,
International and General Counsel of Acorda. “This decision allows us to
direct our resources to a trial in one jurisdiction, and potentially
eliminates conflicting rulings in different courts. It also may set an
important precedent for future patent litigation cases that will allow
patent holders to focus on defending patents in a single court.”
Mylan has 30 days to request a rehearing of the case to an en banc panel
of the Federal Circuit where the Court can reconsider its ruling. Mylan
could also seek an appeal to the Supreme Court.
Acorda has filed patent infringement suits against several parties,
including Mylan, related to AMPYRA. Acorda holds five Orange Book listed
patents that extend through 2027. A trial for this patent litigation is
scheduled to begin in the District Court of Delaware in September 2016.
Acorda was represented by Gibson Dunn LLP and Kaye Scholer LLP in the
Federal Court of Appeals case.
About Acorda Therapeutics
Founded in 1995, Acorda Therapeutics is a biotechnology company focused
on developing therapies that restore function and improve the lives of
people with neurological disorders.
Acorda has an industry leading pipeline of novel neurological therapies
addressing a range of disorders, including Parkinson’s disease,
epilepsy, post-stroke walking deficits, migraine, and multiple
sclerosis. Acorda markets three FDA-approved therapies, including AMPYRA® (dalfampridine)
Extended Release Tablets, 10 mg.
For more information, please visit www.acorda.com.
This press release includes forward-looking statements. All statements,
other than statements of historical facts, regarding management's
expectations, beliefs, goals, plans or prospects should be considered
forward-looking. These statements are subject to risks and uncertainties
that could cause actual results to differ materially, including: the
ability to complete the Biotie transaction on a timely basis or at all;
the ability to realize the benefits anticipated from the Biotie and
Civitas transactions, among other reasons because acquired development
programs are generally subject to all the risks inherent in the drug
development process and our knowledge of the risks specifically relevant
to acquired programs generally improves over time; the ability to
successfully integrate Biotie’s operations and Civitas’ operations,
respectively, into our operations; we may need to raise additional funds
to finance our expanded operations and may not be able to do so on
acceptable terms; our ability to successfully market and sell Ampyra in
the U.S.; third party payers (including governmental agencies) may not
reimburse for the use of Ampyra or our other products at acceptable
rates or at all and may impose restrictive prior authorization
requirements that limit or block prescriptions; the risk of unfavorable
results from future studies of Ampyra or from our other research and
development programs, including CVT-301, Plumiaz, or any other acquired
or in-licensed programs; we may not be able to complete development of,
obtain regulatory approval for, or successfully market CVT-301, Plumiaz,
any other products under development, or the products that we would
acquire if we complete the Biotie transaction; the occurrence of adverse
safety events with our products; delays in obtaining or failure to
obtain and maintain regulatory approval of or to successfully market
Fampyra outside of the U.S. and our dependence on our collaborator
Biogen in connection therewith; competition; failure to protect our
intellectual property, to defend against the intellectual property
claims of others or to obtain third party intellectual property licenses
needed for the commercialization of our products; and failure to comply
with regulatory requirements could result in adverse action by
These and other risks are described in greater detail in our filings
with the Securities and Exchange Commission. We may not actually achieve
the goals or plans described in our forward-looking statements, and
investors should not place undue reliance on these statements.
Forward-looking statements made in this release are made only as of the
date hereof, and we disclaim any intent or obligation to update any
forward-looking statements as a result of developments occurring after
the date of this release.
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Source: Acorda Therapeutics, Inc.