Promega Reports: Court Rules Roche Taq Patent Obtained by Fraud / Remaining Taq and PCR Patents Worldwide May Fall

9.12.1999, 07:26

MADISON, Wis. (PROTEXT) - A Federal District Court ruled that"(a)ll claims of the '818 patent are... unenforceable," and in sodoing found that a key biotechnology patent owned by Hoffmann-LaRoche on Taq polymerase was obtained by fraud on the U.S.Patent and Trademark Office. The current global market for Taqsales alone is estimated to approach $200 million annually. In carefully worded and lengthy written findings, Judge VaughnWalker of the Northern District of California in San Franciscoconcluded that the patent was obtained by fraud. In eightseparate instances, the Court found that the patent holder hadintentionally withheld material information and distortedimportant facts in obtaining the patent. The patent at issue -- the '818 Taq patent -- involves anenzyme, Taq DNA polymerase, which is a critical component in suchimportant biotech processes as polymerase chain reaction (PCR)and gene sequencing. PCR is key to genetic identification andanalysis, and researchers use both processes extensivelyworldwide in pursuit of prevention of or cures for disease. The Court's decision renders this primary Taq patentunenforceable and sets the stage for a finding ofunenforceability for all related Taq and PCR patents. This is amajor blow to Hoffmann-LaRoche, putting in jeopardy its entireTaq and related PCR patent portfolio. It also undermines thecurrent PCR licensing strategy of both Roche and its licensingpartner, Perkin-Elmer, both of whom rely heavily on sales oflicensed Taq to obtain PCR royalties. The Court based its decision on extensive testimony anddocumentary evidence presented by Madison, Wisconsin-basedPromega Corporation during a four-week trial in February 1999.Hailing the decision as a victory for the scientific researchcommunity, Promega Chairman and CEO, William Linton, stated, "Thedecision is a significant victory, particularly for the researchcommunity. The Court has reaffirmed the importance of honesty andintegrity on the part of scientists and companies in the pursuitof patents. The decision also recognized the seminal discoveriesof Professor John Trela and his lab in 1974 and Dr. Kaledin in1980, who first published the isolation and purification of thiskey enzyme in the scientific literature." In addition to the financial impact of lost sales androyalties, Roche faces the prospect of monetary damages and othersanctions. The complete text of Judge Walker's order, along withextensive information on the case, may be obtained from Promega'sweb site: www.promega.com, "Patent News". ots Original TextService: Promega Internet: http://www.newsaktuell.de CONTACT:Diana Frank, Executive Assistant of Promega, 608-277-2513, ordfrank@promega.com Web site: http://www.promega.com

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