A Medical Device Daily

Innogenetics (Gent, Belgium) reported that the U.S. District Court for the Western District of Wisconsin earlier this week entered a permanent injunction against Abbott Laboratories (Abbott Park, Illinois), enjoining Abbott from further sales or use of products that infringe on Innogenetics’ patented Hepatitis C Virus (HCV) genotyping technology. The court’s injunction also prohibits Abbott from exporting components of the infringing products to foreign countries.

However, the judge overturned a jury’s unanimous finding that Abbott’s infringement had been willful.

Innogenetics said it is currently evaluating the total case and its legal options including an appeal on willfulness.

In September 2006, a jury found that Abbott had willfully infringed Innogenetics’ U.S. patent No. 5,846,704 (the ‘704 patent) covering a method of genotyping HCV, and awarded Innogenetics $7 million in damages.

This week’s ruling came at the close of a hearing to determine the potential public impact of a permanent injunction against Abbott. Innogenetics said that at the hearing the court repeated its finding that Innogenetics suffered irreparable harm from Abbott’s infringement, that Innogenetics has the capacity to serve the needs of the Hepatitis C diagnostic market and that Innogenetics had taken “all reasonable steps to comply with the FDA’s Good Manufacturing Procedures.”

“Small, forward-looking companies must be able to protect their innovations from misappropriation by larger more powerful competitors,” said Frank Morich, CEO of Innogenetics. “I hope that Abbott has learned through this process that other people’s intellectual property can not be ignored in the pursuit of profit.”

In September 2005, Innogenetics sued Abbott alleging infringement of the ‘704 patent covering a method of genotyping the Hepatitis C Virus. The court found the patent was infringed by Abbott. On Sept. 1, 2006, a jury ruled that Innogenetics’ ‘704 patent was valid. On Sept. 8, 2006, that jury found Abbott’s actions willful and directed Abbott to pay Innogenetics $7 million in damages related to the infringement.

On Jan. 4, the judge dismissed Abbott’s requests for a new trial, affirmed the jury’s finding that Abbott infringed the patent, that the patent was valid in all respects and approved the award of $7 million (Medical Device Daily, Jan. 5, 2007).

Innogeneticshas parallel businesses in the areas of specialty diagnostics and therapeutic vaccines.

In other legalities:

• Cepheid (Sunnyvale, California) and Idaho Technology (Salt Lake City) reported that they have entered into a settlement and cross-license agreement to resolve a dispute related intellectual property covering rapid polymerase chain reaction (PCR) methods and instrumentation, the use of SYBR Green I in PCR reactions, and certain methods of analysis of real-time PCR data.

Cepheid said that under the agreement it has made a one-time payment to Idaho of $3.35 million.

The agreement resolves all claims asserted in the U.S. District Court for the District of Utah. Idaho Technology and its licensor, University of Utah Research Foundation (also Salt Lake City), initiated the lawsuit in 2005, claiming infringement on three of their patents.

As a result of the settlement and cross-license agreement, the action will be dismissed, and each of the parties have paid-up licenses under certain of the other’s patents to continue to make and sell their respective lines of products.

Cepheid is a molecular diagnostics company that manufactures systems for genetic analysis in the clinical, industrial and biothreat markets.

Idaho Technology bills itself as “the birthplace” of rapid DNA analysis, including real-time DNA amplification and mutation analysis. Its biothreat detection system, the Joint Biological Agent Identification and Diagnostic System, is used by the military for force protection from biothreat agents.