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).
Keywords: Roche / Stanford / Patents / HIV / US /
Supreme Court
