Federal Court of Appeals to decide on claims for United States in fraud case against Hoffmann-La Roche.

Fourth Circuit Court of Appeals will decide the right of the United States to recover losses on payments made to Hoffmann-La Roche (Nutley, NJ) and its partner Applera Corporation on a key patent in molecular biology. A preliminary communication from the United States District Court in Virginia indicates that the case will be dismissed and Promega Corporation (Madison, WI) announced it will appeal that determination. This allows the appellate court to resolve the issue of whether lies told to the United States Government in procuring the patent on Taq DNA Polymerase can be addressed under the False Claims Act.

The claim filed in Virginia seeks recovery of what could be hundreds of millions of dollars in wrongful payments for Taq DNA Polymerase by the Government to Hoffmann-La Roche and Applera. This action arose out of other litigation in which the Roche Taq patent was ruled unenforceable. The Federal Court for the Northern District of California ruled in 1999 and reaffirmed this past May that the patent for Taq could not be enforced against anyone because it had been obtained with a series of false material statements that were intentionally made to the United States Patent and Trademark Office, which even included the fabrication of experimental data. Promega damage claims on its own behalf remain pending in California.

"As the Federal Court in California held, people lied to the United States Patent and Trademark Office in obtaining the Taq patent," stated Randall Dimond, Promega Vice President and Chief Technical Officer. "As many in the scientific community recognize, Roche's aggressive enforcement of this patent caused hundreds of millions to be paid to Roche through government grants and other government programs, and we believe the people who paid those monies, including the government, should be paid back. We believe the False Claims Act is one important way to ensure integrity in the patent process. Wrongfully obtained patents prevent free and open competition and thus lead, as they did here, to grossly excessive pricing caused by the payment of royalties and license fees on a patent that never should have been allowed. Open competition guarantees that precious federal dollars are not needlessly squandered."

The Virginia action is based on the False Claims Act, a federal statute allowing recovery of funds improperly paid by the Government. While the case was brought by Promega on behalf of the United States, the United States Department of Justice had, as well, previously filed a Statement of Interest in the Virginia case in support of Promega. At the insistence of Hoffmann-La Roche, the media and public have been barred from seeing the substance of the latest False Claims Act allegations.

Promega is a leader in providing innovative solutions and technical support to the life sciences industry. The company's 1,200 products enable scientists worldwide to advance their knowledge in genomics, proteomics, cellular analysis, molecular diagnostics and human identification. Founded in 1978, the company is headquartered in Madison, WI, USA with branches in 10 countries and 54 global distributors. Annual sales exceed $165 million.

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