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High Court to Hear Stanford v. Roche Patent Case Next Week

NEW YORK (GenomeWeb News) – The US Supreme Court on Monday, Feb. 28, will hear an infringement case between Stanford University and Roche Molecular Systems related to PCR patents for detecting HIV load and for monitoring effectiveness of treatments.

In the 2005 lawsuit, which Stanford said could have "a significant impact on research universities across the country," the university claimed that Roche has been infringing three patents and that it filed the suit only after years of attempting to get the company to license the IP.

The school claims that one of its AIDS researchers, Professor Mark Holodniy, developed the patented process with federal funding and that while collaborating with a company called Cetus, which was developing PCR technology and later sold those assets to Roche, he gave away the rights to the patents resulting from the collaboration.

Holodniy's collaboration with Cetus' work led to the development of PCR-based test kits that incorporate the technology covered by the three disputed patents — US Patent Nos. 5,968,730; 6,503,705; and 7,129,041.

Stanford, which filed for the patents after Cetus was acquired by Roche, argues that because the technology was developed with federal funding it owns the patents under the 1980 Bayh-Dole Act.

Former US Senator Birch Bayh, who co-sponsored the legislation, has maintained that inventors may obtain patent rights only if the university waives its rights and the governmental funding agency gives its approval, according to Stanford.

The US District Court for the Northern District of California ruled in 2008 that the patents were invalid, but did not agree that Roche owned them, and both parties appealed.

In 2009, the US Court of Appeals for the Federal Circuit took Roche's side, ruling that it owned rights to all three patents because Holodniy only promised to assign the rights to Stanford at an undetermined date, giving precedent to his agreement with Cetus.

Stanford has appealed that ruling with the Supreme Court on the argument that the Bayh-Dole law supersedes an individual's rights to grant ownership to an invention.

As GenomeWeb Daily News reported when the high court accepted the case, the Obama Administration has taken the side of the university, arguing in a brief that the appeals court decision held "that an individual inventor may contract around the Bayh-Dole Act's framework for allocating ownership of federally funded inventions."

"The court of appeals' decision — which holds that Holodniy's assignment to Cetus limited the patent rights that Stanford could assert under the Bayh-Dole Act — turns the Act's framework on its head," the administration stated in the brief.

The Association of American Universities, the National Venture Capital Association, and the American Association for the Advancement of Science, have filed briefs supporting Stanford's case.

Bayh-Dole "has been immensely successful, but that success is cast in serious doubt by the court of appeals' decision, under which it is virtually impossible for universities to ensure clear title to their inventions," the AAU-led amicus brief stated.

That brief cited federally-funded university-derived IP and inventions such as Google and Internet Explorer as examples of how Bayh-Dole has spurred innovation and has led to highly successful industries.

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