Agreement With Alphapharm Related to Lexapro Patent Litigation
NEW YORK, Oct. 6 /PRNewswire-FirstCall/ -- Forest Laboratories, Inc.
(NYSE: FRX) and its wholly-owned subsidiary, Forest Laboratories Holdings
Limited, announced today that it and its licensing partner H. Lundbeck A/S
have entered into a settlement agreement with defendant Alphapharm Pty Ltd., a
subsidiary of Merck KGaA of Germany, regarding its pending patent infringement
dispute regarding U.S. Patent Re. No. 34,712, (the '712 patent), which was
licensed to Forest by H. Lundbeck A/S on an exclusive basis in the United
States and relates to Forest's Lexapro(R) (escitalopram oxalate) product. The
Settlement Agreement with Alphapharm does not settle the pending patent
litigation by Forest and Lundbeck against Ivax Pharmaceuticals, Inc. jointly
with Cipla Ltd, ("IVAX") and does not affect the status of Ivax as an ongoing
defendant in the pending litigation. A trial in that litigation is currently
scheduled for December 2005.
(Logo: http://www.newscom.com/cgi-bin/prnh/20001011/FORESTLOGO )
Pursuant to the terms of the settlement agreement with Alphapharm, and
subject to review of the settlement terms by the Federal Trade Commission:
1. Alphapharm will acknowledge that the '712 Patent is valid,
enforceable and infringed by Alphapharm's proposed product and
will agree to modify its ANDA filing accordingly, and will agree that
it will neither assert the invalidity nor the non-infringement of the
'712 Patent with respect to any generic equivalent (tablet, capsule or
other version) to Lexapro(R) in any proceeding or forum.
2. Forest and Lundbeck will agree to appoint Alphapharm as the exclusive
distributor of generic versions of Lexapro(R), which may be launched
under the scenarios outlined below. The distributorship arrangement
will have a term of five (5) years subject to Alphapharm's right to
renew for successive one-year periods.
(a) In the event that Forest and Lundbeck are successful in their
infringement action against IVAX regarding the '712 patent, the
distribution arrangement with Alphapharm will only commence two
weeks prior to the expiration of the '712 patent.
(b) In the event Forest and Lundbeck are unsuccessful in their
infringement action against IVAX regarding the '712 patent, and
such determination that the '712 Patent is invalid or
unenforceable is affirmed by the appellate court, or a third party
launches at risk, the distribution arrangement with Alphapharm
would commence upon the introduction of the generic version of
Under either scenario Forest will receive from Alphapharm a portion of the
profit from such generic sales in consideration of the license.
Forest and Lundbeck will agree to reimburse certain of Alphapharm's legal
costs in connection with the patent litigation.
Howard Solomon, Chairman and Chief Executive Officer of Forest, stated:
"We are pleased to have concluded this settlement with Alphapharm. We
continue to have confidence in the validity of our Lexapro patent and the
terms of the settlement with Alphapharm are clearly consistent with that view
of our patent's validity. We therefore expect that the litigation which
continues with IVAX and is scheduled to be tried in December this year will
uphold the patent's validity."
Except for the historical information contained herein, this release
contains "forward-looking statements" within the meaning of the Private
Securities Reform Act of 1995. These statements are subject to risks and
uncertainties that affect our business, including risk factors listed from
time to time in the Company's SEC reports, including the Company's Annual
Report on Form 10-K for the fiscal year ended March 31, 2005 and quarterly
report filed on Form 10-Q for the period ended June 30, 2005. Actual results
may differ materially from those projected.
SOURCE Forest Laboratories, Inc.
Charles E. Triano, Vice President - Investor Relations of Forest Laboratories,
Inc., +1-212-224-6714, Charles.Triano@frx.com
-0- Oct/06/2005 12:00 GMT
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