TKTX Transkaryotic Therapies (MM)

TKT to Defend Vigorously U.S. Patent Litigation Brought by Serono 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 The European counterpart to the '071 patent, EP No. 0 505 500 ("the '500 patent"), was revoked by the European Patent Office in January of 2002 on grounds of invalidity due to insufficiency of disclosure.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 http://www.newscom.com/cgi-bin/prnh/19990913/TKTLOGO http://photoarchive.ap.org/ DATASOURCE: Transkaryotic Therapies, Inc. 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 Web site: http://www.tktx.com/ Company News On-Call: http://www.prnewswire.com/comp/120657.html

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