Science, Volume 292, Number 5523, Issue of 8 Jun 2001, p. 1815.
Robert F. ServiceA key biotechnology patent belonging to Swiss pharmaceutical giant Hoffmann-La Roche ran aground on the legal shoals of a third continent last week. On 30 May the European Patent Office (EPO) revoked Roche's patent on native Taq polymerase, a crucial element of the polymerase chain reaction (PCR), the ubiquitous technique used to amplify snippets of DNA. Roche officials say they will appeal the ruling. But this is a costly setback, because the company is already fighting to overturn related decisions in both the United States and Australia.
The ruling marked another in a string of victories for a group of small biotech companies that have challenged Roche's Taq patents in recent years. The companies, led by biological reagent supplier Promega of Madison, Wisconsin, have argued among other things that labs in the United States and Russia isolated the native Taq (n-Taq) enzyme before scientists at Cetus Corp., which transferred the patent to Roche in 1992. The Munich-based EPO agreed, ruling that the patent EP-0-258-017 B1 was invalid. "This decision reaffirms once again what Promega and many others in the research community have long believed: that the Taq patents should never have been issued," says Promega CEO William Liton.
The decision means that Promega can continue to sell n-Taq without paying royalties to Roche. Roche officials argue that this has little effect on the bottom line, because n-Taq makes up only 10% of the Taq they sell; the other 90% is recombinant forms of Taq (r-Taq), which are widely used in automated gene-sequencing machines and are covered by separate patents. But Promega's general counsel Brenda Furlow contends that the legal damage to Roche is broader, because some of the provisions of the patent struck down by the EPO applied to r-Taq, and Roche's separate r-Taq patent is currently being challenged in Europe. "We think the recombinant [Taq] claims will fall," says Furlow.
Genetics researchers are hoping that Roche's patent troubles will bring down prices. Although gene sequencers predominantly use r-Taq, n-Taq remains widely used in a host of other genetic studies, such as genotyping, a procedure used to sort out how genes are inherited in families. These studies typically require Taq or another polymerase enzyme to amplify specific DNA strands. "This is done very well with native Taq," says Maynard Olson, who heads a genome sequencing center at the University of Washington, Seattle. But cost remains a big issue.
Taq currently costs about 50 cents for the amplification step used in a single round of genotyping, says Olson: "There would be a lot more genotyping done if it only cost a penny for the Taq." Olson adds that he is hopeful that if Roche does wind up losing its hold on the Taq patents, this will encourage other companies to enter the market and bring down the cost. "That would be very welcome for us," agrees James Weber, a geneticist whose lab conducts approximately 6 million genotypes a year at the Marshfield Medical Research Foundation in Wisconsin. Weber says that about 8% of his research budget currently goes to paying for Taq. "If we could reduce the cost of Taq, we could produce more genotypes per year. No doubt."
Category: 2. Patent Law, 19. General Patent and Biotechnology Information