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Stanford Loses HIV Patent Case with Roche at Supreme Court

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By Cynthia Hsu, Esq. on June 06, 2011 2:19 PM

The Roche Supreme Court decision (in Stanford v. Roche) has come down in favor of Roche, 7-2, granting Roche and Stanford equal rights in the patent over a HIV testing technology.

The court decision centered around the Bayh-Dole Act, which governs who owns the right to inventions and discoveries made by employees under federal research funds.

The issue in the case was about the creation and discovery of a method for testing HIV treatment. Mark Holodniy, the employee at the center of the suit, originally worked for Cetus Corp. doing research, according to the opinion.

Cetus Corp. was in the process of developing a way to test for HIV using polymerase chain reaction technology, or PCR. Cetus and Stanford University began to collaborate with each other, and in 1988, Holodniy signed with Stanford to be a research fellow at the school. Part of the contract stated that he would be signing away his "right, title and interest" in inventions resulting from his work at Stanford, according to the opinion.

Later, Roche acquired Cetus' PCR techniques, and after a testing period, Roche commercialized the product. Stanford filed suit, contending that they had superior rights over the HIV testing kits.

Stanford's argument was that the Bayh-Dole Act made it so that Stanford's right over the PCR methods superseded any of Cetus' (and in turn, Roche's) claim on the technology. The Bayh-Dole Act only applies to technology and inventions made with federal funding, and the PCR research was partly funded by federal grants to Stanford, according to the opinion.

The Supreme Court found that the Bayh-Dole act does not automatically vest title to federally funded inventions to the inventor's employer, the federal contractor. Under Section 202(a) of the Bayh-Dole Act, the contractor may "elect to retain title," which the Court found to mean that it could only retain title to inventions that it already has possession over. So, only when an invention belongs to the contractor (or employer) will the Bayh-Dole Act really come into play.

Under Stanford's reading of the Bayh-Dole Act, any invention that was conceived even before employment would have been belonged to the university, so long as it was further refined under the university's employment - and so long as even one cent of federal funding went towards its development. The Court specifically rejected this notion in its finding.

The Roche Supreme Court decision in Stanford v. Roche came down on June 6th. Universities and research organizations had been closely following the case due to its potential impact on inventors' assignment rights.

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