Federal Court Rejects Challenge to Roche's Portfolio of PCR-Related Patents

A California U.S. District Court has refused to find Roche Diagnostics' portfolio of patents to its Nobel Prize-winning DNA replication technology unenforceable, rejecting challenger Promega Corporation's attack on the foundational patents covering revolutionary "PCR" or the "polymerase chain reaction" process, which is used by a vast majority of medical and law enforcement officials.

"We are pleased the Court has rejected Promega's argument and refused to find the PCR process patents, the foundation of Roche's revolutionary replication technology, to be unenforceable," said Heino von Prondzynski, head of the Diagnostics Division and member of the Roche Executive Committee. "The validity of these patents has already been thoroughly tested and proven in both European and U.S. tribunals."

Roche intends to press its remaining claims challenging Promega's illegal conduct, including the infringement of Roche's PCR process patents.

"We intend to hold Promega accountable for this irresponsible misuse of Roche's intellectual property," said von Prondzynski.

Roche plans to appeal the Court's determination that its patent on the enzyme used by some practitioners to perform PCR, called "Taq," is unenforceable due to a finding of inequitable conduct. Taq is only one of many enzymes that can be used effectively in the PCR/DNA replication process. The Federal Circuit Court of Appeals had previously vacated the lower court's earlier finding of unenforceability, which it called an "extreme remedy."

"We are hopeful that the appellate court will once again overturn the lower court's finding on the enforceability of the Taq patent," said Lanny Davis, outside counsel to Roche. "No misrepresentations were made about the molecular weight of Taq, its distinguishing feature over the prior art. We believe that, after balancing the equities, the appellate court will affirm the Taq patent's enforceability."

PCR is a Nobel-prize winning nucleic acid amplification technology that allows minute amounts of genetic material to be amplified into billions of copies in just a few hours, facilitating, e.g., detection of the DNA or RNA of pathogenic organisms even before antibodies to these organisms are formed. It has enabled many significant advances in the Human Genome project, DNA fingerprinting and in the diagnosis and monitoring of diseases such as AIDS and hepatitis.

About Roche and Roche Diagnostics
Headquartered in Basel, Switzerland, Roche is one of the world's leading innovation-driven healthcare groups. Its core businesses are pharmaceuticals and diagnostics. Roche is number one in the global diagnostics market, the leading supplier of pharmaceuticals for cancer, and a leader in virology and transplantation. As a supplier of products and services for the prevention, diagnosis and treatment of disease, the Group contributes on a broad range of fronts to improving people's health and quality of life. Roche employs roughly 65,000 people in 150 countries. The Group has alliances and research and development agreements with numerous partners, including majority ownership interests in Genentech and Chugai. Roche's Diagnostics Division, the world leader in in-vitro diagnostics with a uniquely broad product portfolio, supplies a wide array of innovative testing products and services to researchers, physicians, patients, hospitals and laboratories worldwide. For further information, please visit our websites www.roche.com and www.roche-diagnostics.com.