The Trouble with Taq

Photodisc Both sides claim partial victory in the latest phase of a long-running patent fight over a widely used DNA-replicating enzyme. The case presents fascinating legal issues, but the ultimate question is, what does it have to do with the price of Thermus aquaticus DNA polymerase, known as Taq?1 On March 31, the US Court of Appeals for the Federal Circuit Court overturned a lower court ruling that effectively invalidated Roche's patent on Taq for PCR.2 By a 2-to-1 vote, the appellate court upheld some of US District Judge Vaughn R. Walker's findings, but asked him to take another look at the December 1999 decision, which says that scientists cheated to land the patent, rendering it worthless against Promega. Lawyers say they do not know which way Walker will move when he does reconsider the case, and it may take years for the lawsuit that began in 1992 to conclude. But at least one vendor that dropped out of the game early in the litigation is selling Taq again. "When Cetus [a Roche predecessor on the patent] received a patent, they upped the price so much that we didn't feel justified selling it to the scientific community for that price, so we didn't take a license from them," says Donald Comb, president of New England Biolabs, a Beverly, Mass.-based firm. PRICING THE COMPETITION Royalty charges ran 16¢ (US) a unit, Comb says. New England BioLabs returned to the market once the litigation appeared. His company is now selling Taq for 10¢ a unit. Other vendors list prices of 10¢ to 16¢ per unit. A spokesman for Applied Biosystems in Foster City, Calif., a major conduit of Roche-licensed Taq to the academic research community, declined to discuss specific prices. "It depends on the customer. It depends on the licensing program," says Lori Murray, manager of communications for Applied Biosystems. Ultimately, lab budgets could feel the impact of a decision in the case, which is headed back to a northern California court. A win for Roche is expected to drive Taq prices up across the board. Promega and other purveyors of Taq for PCR who are not now paying Roche royalties can expect to be hit hard by the Swiss giant if it prevails, on a theory that these companies induced academics and other researchers to violate the patent. At one point in the litigation, Roche produced a list of scientists it says had infringed its patent by using Taq from unlicensed suppliers, which aroused consternation in the community. Roche prepared the list of alleged infringers only to show in court that Promega had allegedly induced others to infringe the patent, says Melinda Griffith, general counsel of Roche Molecular Systems, the California subsidiary that handles most of Roche's PCR business. "Promega put the list on their Web site and said Roche is going to charge these people with infringement," the Roche attorney says. "We didn't do that and had not planned to do that." Roche has not announced plans to assess back royalties against individual researchers. "I'm not saying we won't," Griffith cautions. Promega, on the other hand, could be looking at triple damages for alleged willful infringement, should Roche prevail, she says. If Promega prevails, it would likely continue distributing Taq. "We are pleased with the decision," says Brenda Furlow, counsel for Promega. "Technically, the patent is back in force, but I don't really think it changes anything." A victorious Roche may not give chase to the scientists who use Taq that hasn't been licensed for PCR. Nevertheless, researchers would likely see price hikes from unlicensed suppliers who are under the gun for back payments. John Marchalonis, chairman of microbiology and immunology at the University of Arizona, says a precipitous price jump would be disastrous. "We use PCR for everything," he adds. Douglas E. Berg, a genetics researcher at Washington University School of Medicine in St. Louis, points out that the unprecedented increases in federal research funding have ended, prompting lab belt-tightening. "A doubling of Taq costs would impact significantly on our budget," he writes in an E-mail. Even though the University of Washington, Seattle, gets a bulk discount, Taq accounts for 10% to 15% of the biology department's supply budget, says Toby Bradshaw, a professor in the department. Promega and Roche both say they expect to prevail. Judge Walker is scheduled to hold more hearings on the case this summer before he decides whether findings of unfairness in obtaining the patent justify stripping Roche of its rights to collect license fees. Peg Brickley (pegbrickley@hotmail.com) is a freelance writer in Philadelphia. References 1. D.H. Gelfand et al., "Purified thermostable enzyme," US Patent No. 4,889,818, issued Dec. 26, 1989. (Roche also accuses Promega of infringing two foundational PCR process patents, U.S. Patent Nos. 4,683,195 and 4,683,202.) 2. Hoffman-La Roche, Inc., and Roche Molecular Systems, Inc., v. Promega Corp., U.S. Court of Appeals for the Federal Circuit, 00-1372, decided March 31, 2003. function sendData() { document.frm.pathName.value = location.pathname; result = false if (document.frm.score[0].checked) result = true; if (document.frm.score[1].checked) result = true; if (document.frm.score[2].checked) result = true; if (document.frm.score[3].checked) result = true; if (document.frm.score[4].checked) result = true; if (!result) alert("Please select") return result; } .myradio{background-color : #94bee5} Please indicate on a 1 - 5 scale how strongly you would recommend this article to your colleagues? Not recommended 1 2 3 4 5 Highly recommended Please register your vote

The Trouble with Taq

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