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Roche Taq Polymerase Patent Case Sent Back to Lower Court

NEW YORK, March 31 - The US Court of Appeals for the Federal Circuit sent a patent infringement lawsuit between Promega and Roche over the Taq DNA polymerase used in PCR and gene sequencing back to a lower court today.


While the circuit court's ruling does not end the dispute between the companies that began in 1992, Promega views it as a favorable ruling. In response to the decision, the company issued a statement saying, "We are pleased with the findings by the court of appeals. The case will now be remanded to the trial court for a determination of remedies and sanctions. Promega remains confident in the ultimate favorable outcome."


Roche had appealed a decision by the Federal District Court in December 1999 that ruled in favor of Promega and found the disputed patent, US 4,889,818, unenforceable. At the time, Judge Vaughn Walker of the Northern District of California in San Francisco concluded that the patent was obtained by fraud and that Roche had intentionally withheld material information and distorted important facts in obtaining the patent.


Today's ruling wraps up deliberations by the circuit court that began with an appeals hearing in May 2001.


The judges examined the district court's ruling, which found Roche guilty of "inequitable conduct" based on three categories: representations proving the effectiveness of a procedure described in the patent; representations concerning the "comparative fidelity and template dependence" of the Taq enzyme and the prior art enzymes; and representations regarding the difference in molecular weight between the claimed and prior art Taq enzymes.


Two out of three of the circuit court judges upheld the first two rulings by the district court, and reversed the third. The dissenting judge argued in favor of overturning all three findings by the district court.


"An important step in the judicial resolution of inequitable conduct claims is for the court to determine whether the material misrepresentations or omissions in question are sufficiently serious in light of the evidence of intent to deceive, under all the circumstances, to warrant the severe sanction of holding the patent unenforceable," wrote the circuit court judges. "In this case, the trial court did not expressly address this step in the inequitable conduct analysis."


The dispute between Roche and Promega began in 1992, when Roche filed a complaint against Promega alleging breach of contract and infringement of the Taq patent. Roche is seeking an injunction to prohibit Promega's sale of the Taq enzyme.


The companies are engaged in similar litigation in Europe and Australia. The Roche Taq patent is currently considered invalid in both regions, where appeals by Roche are currently pending.

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