San Francisco

A company that sells an enzyme used in the polymerase chain reaction (PCR) is suing the corporation that holds a patent on it, alleging that researchers who use the enzyme almost every day are being overcharged.

Promega of Madison, Wisconsin, has filed a lawsuit against the Swiss pharmaceutical giant Hoffmann-La Roche, which holds a patent on the Taq enzyme. In the suit, which was filed on 13 November at a federal district court in Virginia, Promega alleges that government-funded researchers, who use the enzyme in PCR to amplify genetic material, are paying Roche too much.

Promega is claiming $1 billion under a law that allows you to file a suit against anyone you think is swindling the US federal government. If successful, the company stands to collect up to 30% of any award. Roche says that the allegations are “without merit”.

The case is being pursued under the 1863 False Claims Act, which protects the government against fraud by allowing citizens to sue on the government's behalf. A 1986 amendment allowed the litigant to claim treble damages and raised the maximum amount that the litigant may pocket from 25% to 30% of the total. Since then, the number of suits under the act has soared, and the US Treasury has recovered more than $10 billion.

“It certainly is an innovative tactic,” says Greg Aharonian, a technology patent consultant based in San Francisco. Of half-a-dozen intellectual-property lawyers contacted by Nature, none had heard of the act being invoked in a patent dispute.

Roche and Promega have been wrangling over Taq since 1992, when Roche sued Promega for violating its patent on the enzyme, which is isolated from the bacterium Thermus aquaticus that lives in hot springs. Roche obtained the patent in 1991 from Cetus, a now-defunct biotechnology company in Emeryville, California. Promega responded to the suit by claiming that the patent had been fraudulently obtained and should be invalidated.

In 1999, the US district court in San Francisco finally agreed with Promega. In his decision, Judge Vaughn Walker ruled that the original patent application from Cetus contained eight instances of misrepresentation that were intended to deceive the patent office, rendering the Taq patent unenforceable.

Roche quickly appealed. In March 2003, the US Court of Appeals for the Federal Circuit in Washington DC, overruled Walker on six of the eight cases. The appeals court then sent the case back to Walker to decide whether the remaining two instances were sufficient to justify voiding the patent. A decision is expected early next year.

One reason that the whistleblower act hardly ever comes up in patent cases is that the government rarely spends a lot of money on patented products, Aharonian says. But over the years, government agencies have spent a small fortune on Taq, including royalty payments to Roche.

Promega reached the sum of $1 billion by claiming triple damages, as allowed by the law, plus a $10,000 charge for each time a Taq purchase generated royalties for Roche. “This looks like a chance to go for big bucks,” says Jerry Selinger, a Dallas patent lawyer and board member of the American Intellectual Property Law Association.

But Selinger and others don't give the suit much chance of success. For one thing, the Department of Justice, after reviewing the lawsuit's claims, declined to participate in prosecuting it. And although the future of Roche's Taq patent is uncertain in the United States, the European Patent Office issued a final ruling upholding it on 30 October.