[Pharm-policy] Researchers Feel Threatened by Disease Gene Patents

[James Love]

Not new, but another good explanation of why compulsory licensing is
important in both developed and developing countries.

Jamie


http://www.the-scientist.com/yr1999/oct/bunk_p7_991011.html

Scientist 13[20]:7, Oct. 11, 1999

   News 

 Researchers Feel Threatened by Disease Gene Patents

    By Steve Bunk 

Do patents on genetic information hinder research? That long-festering
debate arose again recently, following a report in the Guardian
newspaper that Great Britain and the United States are negotiating an
intergovernmental agreement aimed at preventing entrepreneurs from
profiting on such patents.1 Although the accuracy of the report, which
drew on documents received under the Freedom of Information Act, was
denied by a spokesperson for the Office of Science and Technology
Policy's director, Neal Lane, it sparked interest from other U.K. media,
including the British Broadcasting Corp. (BBC) and
    Nature. 

   [snip]


Jon F. Merz, an assistant professor in the University of Pennsylvania's
Center for Bioethics, likens disease gene patents--which claim all
methods for diagnosis of a particular genetic condition--to patenting of
HIV by a private company that could then prevent anyone but licensees
from working on therapies. He says his own inquiries reveal there are
currently more than 40 broad disease gene patent claims. In a recent
paper, he wrote that many patents are being licensed exclusively to
large clinical laboratories that then may prevent molecular pathologists
and geneticists from performing the patented tests. "Other cases where
someone has monopolized a medical service, especially by patent, are
hard to imagine."2 

He offers examples of exclusive patent rights on diagnostic tests for a
hereditary hemochromatosis gene mutation; the BRAC1 and BRAC2 genes
implicated in ovarian and breast cancers; the spinocerebellar ataxia
type 1 gene; the Charcot-Marie-Tooth disease type 1A gene; and
apolipoprotein E genotyping for late-onset Alzheimer's disease. 

Disease gene patents often aren't granted until two years or longer
after first publication of a discovery. By then labs that have adopted
the test may face patent or licensing fees, or even prohibition against
performing the test. "It's a strong disincentive," he notes. "If you
think something is being patented, why spend resources to do the test?
So this may mean the test won't be widely disseminated." 

Late last year Myriad Genetics Laboratories Inc. of Salt Lake City, sent
a letter to the University of Pennsylvania. The university's Genetics
Diagnostics Laboratory was performing BRAC1 diagnostic tests for other
institutions. The Myriad letter announced that, having been awarded U.S.
patents for the sequences of the BRAC1 gene, the company would allow the
lab to continue this work, under restrictions, if a fee was paid for
each test. 

 Arupa Ganguly, research and development director in the university's
lab, is involved in screening disease genes, but the Myriad letter
excluded such screening of the coding sequences of the BRAC1 gene. Since
Myriad first introduced commercial BRAC1 tests in October 1996, the
company has detected hundreds of novel mutations, and prohibitions in
its patents against unlicensed observation of the gene are broad.
Ganguly claims the royalties that would be due Myriad for diagnostic
tests performed at the university for other institutions would make such
tightly budgeted, nonprofit work untenable. As co-principal investigator
on a project funded by the National Cancer Institute (NCI) that includes
eight institutions nationwide in a Cancer Genetics Network, she says
when she tried to get permission to run BRAC1 tests on samples from the
other network participants, Myriad refused. "It seems that in this
country, if you have a patent, that's it. You can monopolize testing,"
she fumes. "It's outrageous." She believes "this will happen with every
gene that can be patented." 

Myriad president Gregory C. Critchfield points out that 13 institutions
in the country have taken up the limited access offer to test for the
gene. "Myriad's position is to not require a research license for
anybody," he asserts. "That's an extremely liberal stance for a
biotechnology company." Separate research and commercial licenses are
issued by many biotech companies, he says, but Myriad is concerned only
with commercial infringement. The company is in the business of full
sequence analysis; thus, screening for new mutations in their genes is
work that could have commercial applications. "We have to ask, what is
the research question?" He argues that patenting of such medical
services ensures quality, because it justifies the immense expenditures
that go into developing technology and methodologies. "The University of
Pennsylvania is the only institution, to my knowledge, that we've had
problems with, and it's primarily because of commercial considerations,"
he says. "We will be speaking with the NCI about this very shortly and
will get the matter resolved." 

Meanwhile, Deborah Leonard, president-elect of the Association of
Molecular Pathologists and director of the Molecular Pathology
Laboratory at the University of Pennsylvania School of Medicine, is
involving representatives of five other professional specialist
organizations in discussions of how to influence policy to protect
researchers against potential inhibition of their work by patent or
license holders. "I think technology transfer offices need to understand
the impact this is having," she says. In many cases, academicians make
gene mutation discoveries, but exclusive rights may then be sold through
the school's technology transfer office to a private concern. "They see
it as a business use, but the business of that company is medicine." 

  [snip]


Steve Bunk (sbunk@uswest.net) is a contributing editor for The
Scientist. 

D. Hencke et al., "Blair and Clinton push to stop gene patents,"
Guardian, Sept. 20, 1999. www.newsunlimited.co.uk 

J.F. Merz, "Disease gene patents: overcoming unethical constraints on
clinical laboratory medicine," Clinical Chemistry, 45:324­30, March
1999. 
-- 
James Love, Consumer Project on Technology
v. 1.202.387.8030, fax 1.202.234.5176
love@cptech.org, http://www.cptech.org