CAMBRIDGE, Mass., Aug. 31 /PRNewswire-FirstCall/ -- Transkaryotic
Therapies, Inc. (Nasdaq: TKTX) announced that Applied Research Systems ARS
Holding N.V., a wholly-owned subsidiary of Serono International S.A.
("Serono"), today served TKT with an amended complaint that was filed in the
U.S. District Court of Massachusetts. In the suit Serono alleges that "by
making, using, selling and/or offering for sale the methods, cell lines,
and/or DNA constructs claimed therein," TKT infringes Serono's U.S. Patent No.
5,272,071 ("the '071 patent"), which purportedly covers certain methods of
gene activation. In the original complaint, Serono appealed a U.S. Patent and
Trademark Office ("PTO") decision that 34 of the claims of the '071 patent
are, in Serono's words, "unpatentable [sic:invalid]."
Serono and Cell Genesys were parties to an interference proceeding in the
PTO concerning the '071 patent declared in 1996; TKT was not a party to that
interference. In June of 2004, the Board of Patent Appeals and Interferences
of the PTO held that both Serono and Cell Genesys were entitled to certain
claims in their respective patent and patent application, and both Serono and
Cell Genesys appealed the decision on the interference.
The European counterpart to the '071 patent, EP No. 0 505 500 ("the '500
patent"), was revoked by the European Patent Office in January of 2002 on
grounds of invalidity due to insufficiency of disclosure. Although the
revocation of the patent was still on appeal, Serono prematurely sued TKT in
the Netherlands in January of 2003 and claimed that Replagal(TM) (agalsidase
alfa), TKT's enzyme replacement therapy for Fabry disease, infringed the '500
patent. Serono withdrew the suit in November of 2003 after the earlier
revocation of its patent was affirmed by a unanimous Technical Board of
Appeals.
"We believe Serono did not and could not enable claims to gene activation,
which is why the European Patent Office revoked the equivalent European
patent. Even if Serono's U.S. patent were to survive the pending appeal of
the interference proceeding, we believe that TKT has substantial defenses and
would expect to prevail on the merits as we did before the European Patent
Office," said Michael J. Astrue, President and Chief Executive Officer of TKT.
A copy of Serono's complaint is available on TKT's website within the
Legal News page of its News Bureau section at:
http://www.tktx.com/legal/index.htm.
About TKT
Transkaryotic Therapies, Inc. is a biopharmaceutical company primarily
focused on researching, developing and commercializing treatments for rare
diseases caused by protein deficiencies. Within this focus, the company
markets Replagal(TM), an enzyme replacement therapy for Fabry disease, and is
developing treatments for Hunter syndrome and Gaucher disease. In addition to
its focus on rare diseases, TKT intends to commercialize Dynepo(TM), its
Gene-Activated(R) erythropoietin product for anemia related to kidney disease,
in the European Union. TKT was founded in 1988 and is headquartered in
Cambridge, Massachusetts, with additional operations in Europe, Canada and
Latin America. Additional information about TKT is available on the
company's website at http://www.tktx.com.
This press release contains forward-looking statements, including
statements regarding a patent litigation with Serono involving gene activation
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 Company will be able to
successfully defend this patent lawsuit, whether the Company will be
prohibited from marketing its Gene-Activated products, whether the Company
will have to pay royalties on its Gene-Activated products when and if they
come to market, whether Serono's prosecution of claims in Europe similar to
the revoked '500 patent will ultimately be successful, and other factors set
forth under the caption "Certain Factors That May Affect Future Results" in
the company's Quarterly Report on Form 10-Q for the quarter ended June 30,
2004, which is on file with the Securities and Exchange Commission and are
incorporated herein by reference. While the Company may elect to update
forward-looking statements at some point in the future, the Company
specifically disclaims any obligation to do so, even if its expectations
change.
Gene-Activated(R) is a registered trademark and Replagal(TM) is a
trademark of Transkaryotic Therapies, Inc. Dynepo(TM) is a trademark of
Aventis.
For More Information Contact:
Justine E. Koenigsberg Daniella M. Lutz
Senior Director, Corporate Communications Manager
Corporate Communications
(617) 349-0271 (617) 349-0205
SOURCE Transkaryotic Therapies, Inc.
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CONTACT:
Justine E. Koenigsberg, Senior Director,
Corporate Communications, +1-617-349-0271, or Daniella M. Lutz,
Corporate Communications Manager, +1-617-349-0205, both of
Transkaryotic Therapies
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