Stanford has filed a petition to the Supreme Court seeking to appeal a Federal Circuit Court decision in favor of biotech company Roche Molecular Systems. The decision, made last September, denies the University full ownership on several patents on work by Stanford School of Medicine researchers.

The court’s opinion hinged on its interpretation of the Bayh-Dole Act, an intellectual property law passed in 1980 to regulate the assignment of patents that result from federally funded research. It was designed to accelerate the “technology transfer” from lab to market by predefining the owner of new patents—usually a university—and thereby keeping taxpayer-funded technologies benefiting the public by making them easier to license.

But with the court’s decision, the lawsuit has grown beyond just Roche and Stanford. ‪Stanford’s petition argues that a university that receives federal funding has the legal right to patents even if the inventor assigns his or her patent claim to a third party. But the court’s decision makes universities’ claims to full patent ownership uncertain—which could make ambiguous the cases where patents from research receiving public funding could be claimed by an institution.

The Massachusetts Institute of Technology (M.I.T.), the Wisconsin Alumni Research Foundation and institutions represented by groups including The American Council on Education (ACE) and the Association of American Universities (AAU) have filed amicus curiae briefs supporting Stanford’s petition.

In its brief, the AAU argued the Appeals Court’s decision threatens the success of the Bayh-Dole Act “by casting in doubt the rights of universities and the federal government alike to inventions arising” from federally-funded research and “allowing rights in federally funded patents to be disposed of in obscure private contracts between researchers and third parties rather than according to Congress’s dictates.”

Case History

According to case files, as a Stanford post-doc in 1989, Mark Holodniy collaborated with researchers at Cetus Corporation, a Berkeley biotechnology firm acquired by Roche in 1991. As part of his work, Holodniy, now a professor of medicine, used a DNA amplification technology invented at Cetus called polymerase chain reactions, or PCR. At the time, he was also required to sign a confidentiality agreement stating, in part, that he waived patent rights to Cetus for future work that related to Cetus business or resulted from knowledge gained there.

The use of PCR led to a method invented at Stanford that measures HIV levels in the blood. The technology is being used today in HIV test kits developed and sold by Roche.

Holodniy did not respond to a request for comment.

The Appeals Court ruling holds that the patent was assigned to Holodniy before the University took ownership and that, because of the agreement Holodniy made with Cetus while he was employed there, Stanford and Roche hold dual ownership of the patents.

Stanford contends that Roche’s claim on the HIV technology is clearly invalid and that the Bayh-Dole act indicated the patents’ assignment to the University, as opposed to Holodniy as an individual or to Roche.

Roche did not immediately return requests for comment.

“If you’re building a house, you need a hammer to build a house,” said Patrick Dunkley, senior counsel for Stanford, referring to the role of PCR in the HIV detection method. “It’s a tool that’s used.”

Stanford has been locked in the legal fight with Roche since 2005, when it first sued Roche for patent infringement.

As reported by M.I.T.’s student newspaper The Tech, Roche is set to file an opposition brief on May 26.