CAMBRIDGE, Mass., Oct. 9 /PRNewswire-FirstCall/ -- Transkaryotic
Therapies, Inc. (Nasdaq: TKTX) today announced that the United States Court of
Appeals for the Federal Circuit has issued a decision in favor of TKT in
patent litigation brought by Genzyme Corporation and Mount Sinai School of
Medicine relating to Replagal(TM) (agalsidase alfa). The Court of Appeals
upheld the District Court of Delaware's claim interpretation of a key term in
favor of TKT and upheld its decision that U.S. Patent No. 5,356,804 was not
infringed by TKT.
"We are extremely pleased with this ruling because we have always believed
Replagal and the process to produce it clearly do not infringe this patent,"
said Michael J. Astrue, President and Chief Executive Officer of TKT. "Since
further legal review is unlikely, time and resources allocated for this
litigation should now be devoted to expanding the market for Replagal and
advancing our product pipeline."
Yesterday, TKT and Genzyme signed a global legal settlement involving an
exchange of non-suits between the companies. As part of this exchange,
Genzyme agreed to withdraw from this suit. However, Mt. Sinai could petition
the Federal Circuit for a hearing en banc.
Background on Litigation
In July 2000, Genzyme and Mt. Sinai filed a patent infringement action
against the TKT in the United States District Court of Delaware alleging that
activities relating to Replagal infringe U.S. Patent No. 5,356,804. In
January 2002, the United States District Court of Delaware dismissed the
patent litigation, granting TKT's motion for summary judgment of non-
infringement and denying the motion for summary judgment of infringement filed
by Genzyme and Mt. Sinai. Genzyme and Mt. Sinai appealed the District
Court's decision to the U.S. Court of Appeals for the Federal Circuit in March
2002.
About TKT
TKT is a biopharmaceutical company developing therapeutics for the
treatment of rare genetic diseases caused by protein deficiencies. The company
currently markets one product, Replagal(TM) (agalsidase alfa) for the
treatment of Fabry disease in the European Union and certain other countries.
TKT is headquartered in Cambridge, Massachusetts and has a majority-owned
subsidiary in Sweden, TKT Europe-5S AB, which is responsible for European
sales and marketing activities of Replagal. Additional information on TKT is
available on the company's website at http://www.tktx.com.
This press release contains forward-looking statements, including
statements regarding the results of a patent litigation with Genzyme and Mt.
Sinai involving Replagal and the potential for future litigation with Mt.
Sinai under this patent and statements containing the words "believes,"
"anticipates," "plans," "expects," "will" and similar expressions. These
forward-looking statements are based on the Company's opinion and expectations
as of the date of this release and are subject to risks and uncertainties that
could cause actual results to differ materially from the results indicated by
such forward-looking statements. Important factors that could cause results
to differ include, but are not limited to: whether the Federal Circuit will
hear an appeal en banc; whether the Supreme Court would agree to an appeal;
whether the Company will be forced to remove Replagal from the market or pay
royalties related to the sale of Replagal; and other factors set forth under
the caption "Certain Factors That Affect Future Results" in the Company's
Quarterly Report on Form 10-Q for the quarter ended June 30, 2003 which is on
file with the Securities and Exchange Commission and are incorporated herein
by reference. The Company does not undertake any obligation to update any
forward-looking statements.
Replagal(TM) is a trademark of Transkaryotic Therapies, Inc.
CONTACT:
Justine E. Koenigsberg
Director, Corporate Communications
(617) 349-0271
SOURCE Transkaryotic Therapies, Inc.
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http://www.tktx.com
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CONTACT:
Justine E. Koenigsberg, Director, Corporate
Communications of Transkaryotic Therapies, Inc., +1-617-349-0271
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