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Stanford loses patent dispute over HIV test

supreme court.jpgThe US Supreme Court today upheld Roche’s claim to an HIV diagnostic test, overruling Stanford University’s argument that the intellectual property belonged solely to the university because it was developed by a Stanford researcher.

In a 7-2 decision, the court held that Stanford’s Mark Holodniy signed away patent rights to the discovery when he entered into a collaboration with Cetus, a company that has since been acquired by the Swiss pharmaceutical firm Roche. The test was developed during that collaboration, leading to an intellectual property squabble that some say threatened to undermine the integrity of the Bayh-Dole Act giving universities the right to own patents on federally funded discoveries. (See ‘Bayh-Dole on trial’ for more.)

Writing for the majority, Justice Roberts said that Stanford’s interpretation of Bayh-Dole assumed that “Congress subtly set aside two centuries of patent law” by arguing that the phrase “invention of the [federal] contractor” (in this case, Stanford) automatically covers all inventions that the contractor’s employees make using federal money. That, wrote Roberts, would give universities the rights to inventions developed using only a single dollar of federal funds, and to inventions conceived before the inventor became an employee of the university. “Had Congress intended such a sea change in intellectual property rights it would have said so clearly,” he wrote.

Updated: In a press release, Stanford University countered that the decision threatens the federal government’s rights in such cases, and undercuts assurances that royalties generated by inventions would then be fed back into scientific research and education.

Updated: Much of this case rested on the phrasing that Stanford used in the documents that employees sign to hand over patent rights to the university. Those documents said that employees would assign their inventions to Stanford, implying an assignment at some ambiguous future date. This left Roche open to argue that Stanford’s rights were superseded by the agreement with Cetus, which immediately confirmed patent rights to the company. (For more on this, see our earlier post here.)

On 7 June, Robin Rasor, president of the Association of University Technology Managers (AUTM), wrote on her blog that many US universities have used language similar to Stanford’s, but that they are taking action to address the matter. Still, the decision does not necessarily pose a widespread threat to university patents, she writes: “While the decision leaves open the possibility that title could be called into question to inventions made and assigned under “promise to assign” language, the fact remains that the Holodniy invention is the only case in which there have been dueling assignments in almost 250,000 invention disclosures submitted over 30 years.”

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    Kim said:

    I would hope these two organizations could put their differences and disagreements aside and focus on the things they both agree on: resolving AIDS. Re:solve is raising money to get a promising AIDS vaccine through testing and approval so that it can be distributed to everyone who needs it. http://bit.ly/e4ehI7

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