Forest Laboratories and Lundbeck Enter Into Settlement Agreement With Alphapharm Related to Lexapro Patent Litigation
October 06 2005 - 9:01AM
PR Newswire (US)
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 Lexapro(R). 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.
http://www.newscom.com/cgi-bin/prnh/20001011/FORESTLOGO
http://photoarchive.ap.org/ DATASOURCE: Forest Laboratories, Inc.
CONTACT: Charles E. Triano, Vice President - Investor Relations of
Forest Laboratories, Inc., +1-212-224-6714, Web site:
http://www.frx.com/
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