Patent Trials and Appeal Board (PTAB) Upholds Four AMPYRA® Patents
March 09 2017 - 2:43PM
Business Wire
Acorda Therapeutics, Inc. (Nasdaq: ACOR ) today
announced that the United States Patent and Trademark Office
(USPTO) Patent Trials and Appeal Board (PTAB) upheld all four
patents challenged via the inter partes review (IPR) process. U.S.
Patent Nos. 8,663,685 (the ‘685 patent), 8,440,703 (the ‘703
patent), 8,354,437 (the ‘437 patent) and 8,007,826 (the ‘826
patent) apply to AMPYRA® (dalfampridine) Extended Release Tablets,
10 mg. These patents are set to expire in 2025, 2025, 2026 and
2027, respectively.
“The court decision reflects the merits of the case we presented
and the validity and strength of our intellectual property for
AMPYRA,” said Ron Cohen, M.D., Acorda's President and CEO. “Medical
innovation depends on the recognition of valid intellectual
property claims. Our in-house legal team and external counsel
presented a compelling case, and will continue to defend the
validity of our intellectual property rights for AMPYRA.”
Acorda was advised by Gerald Flattmann, Naveen Modi, Thomas
Phalen, Michael Stamiello, Daniel Zeilberger, and Lucas Kressel of
Paul Hastings LLP.
These patents, as well as U.S. Patent No. 5,540,938 that also
pertains to AMPYRA, have also been challenged in the U.S. District
Court for the District of Delaware. The Court has completed the
trial of the case, but not yet issued its decision.
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, migraine and multiple sclerosis. Acorda markets three
FDA-approved therapies, including AMPYRA® (dalfampridine) Extended
Release Tablets, 10 mg.
For more information, please visit the Company’s website at:
www.acorda.com.
Forward-Looking Statement
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 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
(dalfampridine) Extended Release Tablets, 10 mg 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 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,
any other products under development, or the products that we will
acquire when 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 regulatory agencies.
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 press 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 press release.
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version on businesswire.com: http://www.businesswire.com/news/home/20170309006322/en/
Acorda TherapeuticsJeff Macdonald,
914-326-5232jmacdonald@acorda.com
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