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THE POLYMERASE CHAIN REACTION (PCR) U.S. Patent No. 4,683,195; 4,683,202; 4,889,818; 4,965,188 Issued:Four key patents: two in July 1987 to Kary Mullis; one in December 1989 to David Gelfand and others; one in October 1990 to Kary Mullis Assigned tInitially to Cetus Corp.; now held by Hoffman La-Roche Prosecuted by:In-house at Cetus Corp. Litigated by:San Francisco’s Orrick Herrington & Sutcliffe; Barbara Caulfield and Denise Alter, lead partners. Newark’s Crummy, Del Deo, Dolan, Griffinger & Vecchione; John Ridley, lead partner. New York’s Pennie & Edmonds; Todd Wagner and Scott Familant, lead partners. Think of the polymerase chain reaction as a Xerox machine for DNA. The process enables scientists to take a minute amount of genetic material and multiply it exponentially — increasing the sample millions of times over in just a few hours. It is the crucial process in fields like forensic research, where the material that scientists have at hand to work with — a strand of hair from a crime scene, for example — is, by itself, often insufficient for testing. “Before PCR, you were flat out of luck if you didn’t have enough DNA,” says Lisa Haile, an attorney at Gray Cary Ware & Freidenrich. “That’s why it’s only recently that you’ve seen [genetic testing] in court.” PCR’s uses go far beyond DNA fingerprinting. The process has revolutionized drug research and medical diagnostics by enabling researchers to find faulty genes and identify viruses. It has also allowed scientists to map the human genome and ushered in the technology behind cloning. PCR patents have also ushered in some lengthy litigation. The validity of Mullis’ first two patents were challenged by E.I. du Pont de Nemours and Co. in 1990. The company contended that the PCR process was made obvious by the earlier work of H. Gobind Khorana, a professor at the Massachusetts Institute of Technology and a Nobel laureate. But in February 1991, a federal jury upheld the patents, finding that Khorana’s work did not anticipate the PCR technology. The bigger legal stir was caused by the 1989 patent, which covers the key Taq polymerase enzyme used to carry out PCR. Hoffman-La Roche, which had acquired the PCR patents in 1992 from Cetus Corp., sued Promega Corp. later that year for what it claimed was a breach of a licensing agreement. Promega countersued, questioning the validity of the Taq patent. In 1999 a San Francisco federal court found that Cetus had committed fraud by intentionally omitting material information from its patent application, and invalidated the patent. Hoffman-La Roche appealed to the U.S. Court of Appeals for the Federal Circuit, which held a hearing in May 2001, but has yet to make a ruling. Alan Cohen is a free-lance writer based in New York City. His e-mail is [email protected].

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