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Bayh-Dole Act

Stanford University v. Roche Molecular Systems, Inc. (09-1159)

Oral argument: Feb. 28, 2011

Appealed from: United States Court of Appeals for the Federal Circuit (Sept. 30, 2009)

BAYH-DOLE ACT, PATENT, PCR, POLYMERASE CHAIN REACTION, ROCHE, STANFORD UNIVERSITY, CETUS

In the late 1980s, Dr. Mark Holodniy, a Stanford University researcher, conducted part of his research at a private biotechnology company. The result of his work, which was partially funded by the government, was an improved method for testing the effectiveness of HIV treatments. Over the next few years, Roche Molecular Systems, the owner of the biotechnology company at which Dr. Holodniy conducted his research, incorporated his invention into its publicly sold HIV-testing kits. At roughly the same time, Stanford, Dr. Holodniy’s employer, began the process of patenting the invention under the University and Small Business Patent Procedure Act, commonly known as the Bayh-Dole Act. In 2005, Stanford sued Roche for patent infringement, arguing among other things that the Bayh-Dole Act gave Stanford the exclusive first right to acquire ownership of Holodniy’s invention. The district court ruled for Stanford, but the Federal Circuit reversed, holding that an assignment of ownership rights in an earlier confidentiality agreement between Holodniy and the biotechnology company trumped Stanford’s ownership rights. Now, the Supreme Court must decide whether the Bayh-Dole Act prevents individual inventors from assigning to third parties their ownership rights in federally funded inventions.

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