[Ip-health] Pharmalot's coverage of Stanford v. Roche

Thiru Balasubramaniam thiru at keionline.org
Tue Mar 1 04:20:06 PST 2011


Who Owns Patents Generated By Federal Dollars? Make a comment

By Ed Silverman // February 24th, 2011 // 10:41 am

On Monday, the US Supreme Court will hear this debate, which involves  
a dispute between Roche and Stanford University over the rights to HIV  
test kits (see here). The case is expected to clarify the implications  
of a 1980 law that allocates patent rights among the government,  
investors and institutions that receive federal funding.

Here’s the background: 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 Stanford under the auspices of  
the Bayh-Dole Act, which established a framework for determining  
ownership interests in federally funded inventions. In 2009, a federal  
appeals court ruled that Stanford lacked standing to sue Roche for  
patent infringement.

Stanford argues the appeals court decision raised uncertainty about  
patents that were generated by hundreds of billions of dollars in  
research. The US Solicitor General, by the way filed an amicus brief  
that sides with the university and is expected to appear before the  
court on Monday as well. Similarly, the American Association of  
Universities, among others, has also filed such a brief in support of  
Stanford, while BIO has lined up behind Roche with this brief.

In its own brief, Roche argued this: “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…

“…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” (here is the  
first Roche brief).

In a more recent brief, Roche added: “Hundreds of billions of dollars  
of private investment flow annually to innovative research in this  
country without need for a federal statute ‘vesting’ ownership in  
anyone but the inventor, and the Bayh-Dole Act itself has operated for  
30 years without any suggestion (before this case) that it “vested”  
title. If anything, it is Stanford’s position that would harm  
innovation by upsetting contractual expectations and discouraging  
private firms from collaborating with the academy” (here is the brief).


Thiru Balasubramaniam
Geneva Representative
Knowledge Ecology International (KEI)
thiru at keionline.org

Tel: +41 22 791 6727
Mobile: +41 76 508 0997

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