Biotech Values

[DewDiligence]

Speaking of patent challenges…

[TKTX is the only biotech company I know that has an entire section of its website devoted just to legal news.]

http://biz.yahoo.com/prnews/040831/nytu113_1.html

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TKT to Defend Vigorously U.S. Patent Litigation Brought by Serono

Tuesday August 31, 8:07 pm ET

CAMBRIDGE, Mass., Aug. 31 /PRNewswire-FirstCall/ -- Transkaryotic Therapies, Inc. (Nasdaq: TKTX - News) 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The European counterpart to the '071 patent, EP No. 0 505 500 ("the '500 patent"), was revoked by the European Patent Office in January of 2002 on grounds of invalidity due to insufficiency of disclosure.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.
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