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This article was originally published in The Gray Sheet

Executive Summary

ROCHE/PERKIN-ELMER TAQ POLYMERASE LICENSING DEAL WITH BOEHRINGER MANNHEIM will provide a second supplier for the thermostable enzyme for use in the polymerase chain reaction (PCR) DNA amplification process. Under the licensing deal, announced by the three firms in a joint July 20 release, Boehringer Mannheim receives "worldwide rights to manufacture and sell Taq DNA polymerase and other thermostable enzymes and products in the research market for use in" PCR. The most widely used enzyme in PCR, Taq polymerase currently is marketed for use in the amplification process only by Perkin-Elmer; the firm is Roche Molecular Systems' exclusive distributor for PCR products other than in vitro diagnostics. The agreement provides that both Roche and Perkin-Elmer will receive royalty payments from Boehringer Mannheim's sales of PCR products. The non-exclusive licensing deal is "valid for the life of...Roche's PCR patents"; the company's basic PCR patents expire in 2004, while its Taq polymerase patents expire in 2006 and 2009. In addition to selling Taq polymerase, Boehringer Mannheim is free to develop and market its own alternative enzymes and reagent kits for use in PCR. The pact also give Boehringer Mannheim "the option for a variety of other applications including research, identification, animal diagnostics and food testing," the release states. Commenting on the agreement, Roche Molecular Systems President Kathy Ordonez said that Roche and Perkin-Elmer "agree that this license will increase the accessibility and variety of PCR products used by researchers...Boehringer Mannheim has established ongoing relationships with these researchers and is a major supplier of biochemical products. Together we can better serve all of the customers in this growing market." Boehringer Mannheim U.S. Products Division President Dennert Ware added that the company's "expertise in the manufacture and sale of molecular biology enzymes places us in a strong market position to take advantage of this licensing agreement." Roche and Perkin-Elmer's monopoly to date in the Taq polymerase PCR market currently is being challenged in court by Promega, a Madison, Wisconsin-based firm that licensed certain rights to Taq polymerase in 1990 from Cetus, which sold the PCR business to Roche in December 1991 ("The Gray Sheet" Dec. 16, 1991, I&W-2). Roche filed suit against Promega in October 1992, maintaining that the company had breached terms of the licensing deal: according to Roche, the agreement only allows Promega to make and sell Taq polymerase for "applications other than nucleic-acid amplification technologies, including PCR" ("The Gray Sheet" Nov. 2, 1992, p. 11). Promega announced in April that it filed a countersuit challenging the validity of Roche's Taq polymerase patent.

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