Courts Cast Clouds Over PCR Pricing

The polymerase chain reaction (PCR)--a technique invented by Kary Mullis in 1983, published in 1986,1 and the subject of the Nobel Prize in chemistry in 1993--can well be described as one of the most important technical advances of modern molecular biology. How much researchers have to pay to use the technology, however, is now largely in the hands of US and European courts that are deciding who controls patents on a critical enzyme that, in simplistic terms, amounts to the P in PCR. Basel, Swi

Written byAileen Constans

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Basel, Switzerland-based F. Hoffmann-La Roche and Pleasanton, Calif.-based Roche Molecular Systems Inc. (Roche), along with Applied Biosystems in Foster City, Calif., own the patents that cover the use of Taq polymerase in PCR, as well as the technique itself and related instrumentation. But recent legal decisions in the United States and Europe concerning the patentability of one form of this important enzyme may affect the way it is sold, possibly driving down the price of an enzyme that currently generates, according to Roche, approximately $100 million annually in worldwide sales.

At issue is the potential for patents held by Roche on recombinant Taq and on PCR technology in general to fall in the wake of decisions affecting the validity of the patent held on the native enzyme (the polymerase purified directly from the thermophilic bacteria, Thermus aquaticus). Legal opinions on the implications of the decisions are mixed. Although other patents ...

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