US Supreme Court Rules in Favor of Roche in University Patent-Rights Case - Pharmaceutical Technology

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US Supreme Court Rules in Favor of Roche in University Patent-Rights Case

ePT--the Electronic Newsletter of Pharmaceutical Technology

The US Supreme Court, in a decision concerning the patent rights of research universities, ruled in favor of Roche in a patent-dispute case between the pharmaceutical company and Stanford University. In a 7–2 vote, the Court upheld a lower court’s decision that Stanford did not have a claim to patents for technology to detect HIV blood levels using polymerase chain reaction (PCR) technology.

The issues surrounding the patent-dispute case date back to 1988, when a California-based research company, Cetus, began to collaborate with scientists at Stanford University’s Department of Infectious Diseases to test the efficacy of new AIDS drugs. Mark Holodniy, a research fellow at Stanford at the time, was assigned to Cetus to conduct research and developed a PCR-based procedure for measuring the amount of HIV in a patient’s blood. Upon returning to Stanford, he and other Stanford employees tested the procedure, and Stanford secured three patents relating to the measurement process. Roche later acquired Cetus’s PCR-related assets, and after conducting clinical trials on the HIV quantification method developed at Cetus, commercialized the procedure. In his capacity at Stanford, Holodniy had signed an agreement assigning his interests to the university for inventions that resulted from his employment there and also had signed an agreement with Cetus, as part of gaining access for his research at Cetus, that assigned his interests to Cetus.

The crux of the case centered on whether Holodniy had the right to assign his interest to Cetus or whether the rights belonged to Stanford under the University and Small Business Patent Procedures Act of 1980 (i.e., Bayh-Dole Act), which established a framework for determining ownership interest in federally funded research. Stanford first sued Roche in 2005, and in 2009, a federal appeals court ruled that Stanford did not have grounds for patent infringement. The US Supreme Court ruling this week affirmed the lower court’s decision.

Chief Justice John Roberts, who delivered the opinion of the court stated: “The Bayh-Dole Act does not automatically vest title to federally funded inventions in federal contractors or authorize contractors to unilaterally take title to such inventions.”

In commenting on the ruling, Stanford University issued a statement, saying that it “respectfully disagrees” with the court’s ruling. “We are disappointed with the ruling by the Supreme Court in this case, but will move forward to protect the interests of all parties in inventions created with federal funding, including the interests of the federal government and companies that license technology from Stanford,” said Stanford General Counsel Debra Zumwalt in the statement.

In its statement, Stanford also raised concerns over the potential implications of the ruling on federally funded research. “For example, the federal government could lose its many rights in the inventions, could lose the assurance that the royalties that would have gone to the university are used to further scientific research and education, and could lose the requirement that exclusive licensees will manufacture any products substantially in the United States.”


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