Who Owns Patents Generated By Federal Dollars?

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patent-ideasThis question is being hotly debated in a case before the US Supreme Court involving Roche and Stanford University, which are battling over the rights to HIV test kits. And the US Solicitor General has filed an amicus brief that sides with the university, a move that has, not surprisingly, greatly upset the drugmaker.

Here’s the backdrop: Stanford sued Roche in 2005 for patent infringement over technology to detect HIV levels blood using PCR, or polymerase chain reaction. The underlying discovery was made years earlier by a Stanford researcher, Mark Holodniy, who also worked with a company called Cetus that was later bought by Roche. However, the initial funding came from the federal government.

At issue is whether Holodniy had the right to assign his interest to Cetus or whether the rights belonged to Roche under the auspices of the Bayh-Dole Act, which established a framework for determining ownership interests in federally funded inventions. A year ago, a federal appeals court ruled that Stanford lacked standing to sue Roche for patent infringement.

But the acting Solicitor General, Neal Katyal, disagreed. “The court of appeals’ decision upsets the balance struck by Congress and allows individual inventors to control the disposition of rights in federally funded inventions.” And in doing so, the court’s decision “turns the Bayh-Dole Act’s hierarchy on its head” (here is the brief).

In response, Roche yesterday filed a brief that pulls no punches: “The government’s assertion that ‘the patented process was developed by researchers at (Stanford) using federal funds’ is wrong. The invention was conceived and the assay completed at Cetus before Stanford performed any work using federal funds….The government’s proposed resolution of the question it urges on the Court is both unsupported by the Bayh-Dole Act and misguided as a matter of policy.”

Bui here is the kicker: “The Bayh-Dole Act governs funding agreements between the government and federally-funded research institutions; it does not confiscate intellectual property rights from non-funded entities whose private resources and expertise lead to the conception of inventions. The government’s rule would chill collaboration between universities and private research firms; indeed, it would put privately-funded firms in a worse position than entities who take federal funds” (you can read the Roche brief here).

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  1. Yikes! Could this also lead to more gridlock in congress?

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