Relations Committee Report
Gene patents! How can anyone patent my genes? Absurd!
Genetic IP (intellectual properties) around genes, coding regions,
specific sequences, targeted mutations and clinical
correlations tends to be viewed negatively by practicing
molecular pathologists. Most of my clinical colleagues view
gene patents as a moral issue and as an obstacle to patient
access to genetic testing, vigorously opposing any barrier
to self determination of laboratory menu. Now that we have
begun to move into acceptance from the reluctance of
CMS to introduce a genetic testing specialty into CLIA, gene
patenting has emerged as the most emotionally charged topic
in AMP today, a topic on which few are neutral and even
fewer are positive.
I know this to be true because as Chair of the Professional
Relations Committee (PRC) and member of AMP Council, I have been
specifically immersed in this topic for the last several
months and, as a practicing laboratorian, more generally
involved for the last many years. This Fall the
PRC revised the 1999 AMP statement on Gene Patents and
Exclusive Licensing of Genetic Discoveries
Final_Nov2008.pdf and chose, 7 to 0 (one abstention)
to maintain our position that gene patents are “wrong”.
For what it’s worth:
I represent the abstention and, as a minority opinion holder, I do
not oppose gene patents. This is not because I work in a
for-profit environment – rather, I can choose to work in a
commercial laboratory because I do not oppose genetic IP. I
do, however, oppose any factor that precludes patient access
to appropriate testing and I maintain that licensing
practices by both commercial and academic patent holders is
the more important issue to address in this regard. In my
opinion, we dilute our position by choosing not to focus on
this one, most critical, aspect of the issue.
The genes as they exist in our bodies are not patentable.
My genes belong to me, including those that I would prefer
not to have. However, isolated genes, purified away from
our bodies are indeed patentable under U.S. law. Moreover,
a recent evidenced based study commissioned by Secretary’s
Advisory Committee on Genetics, Health, and Society (SACGHS
Patent_Session_Monday_AM JPE FINAL 12-4-2008.pdf
preliminarily concludes that it is licensing practices and their
enforcement rather than the patents themselves that lead to
barriers to patient access to appropriate testing. SACGHS
reports that conflicts arise “when the interests of both
patients and practitioners are not considered during the
licensing process or when exclusive licenses are issued”,
such as have occurred with breast cancer, Canavan disease,
spinocerebellar ataxia and many other genetic tests that are
associated with patent protection. It seems reasonable to
me that exclusive testing can lead to several undesirable
consequences, including, but not limited to, delay in
development of optimal testing platforms, opacity and
potential decrease in testing quality based on lack of
competition and external proficiency testing, selective
patient access due to lack of public-insurance contracts
with exclusive testing providers and patient thickets for
AMP will provide comment to the SACGHS draft report early in 2009.
We will be asked to weigh in on several different public
policy options designed to protect the public, which are
summarized below (almost) verbatim from the URL cited above
and a few of which are amplified:
Advocacy efforts by key stakeholders to ensure access:
A coalition of industry, academic institutions,
and patients could develop a code of conduct to encourage
broad access to genetic IP for diagnostic use and to
encourage these stakeholders and owners of IP to work
together to resolve conflicts using best practices and
published guidelines. “Professional societies should work
cooperatively to forge consensus positions with respect to
gene patients and licensing policies”.
Enhancing transparency in patents and licensing:
IP holders should make their patent license
(type, field of use and scope) publicly available and allow
disclosure of this information by licensees. The Secretary
of HHS should seek statutory authority to enable the FDA and
CMS to require that patented DNA-based in vitro diagnostic
tests to require disclosure of patent information on reagent
or kit packaging and on manufacturer’s websites
Filling data gaps:
“… the Secretary of HHS should develop a
voluntary reporting system to encourage researchers and
medical practitioners who order, use or perform genetic
tests to report access problems”. Simply stated, “More data
are needed to understand the landscape of gene patenting and
the licensing arrangements that are being used to
commercialize these inventions”. These data could be
reviewed by an advisory board to the Secretary to “provide
ongoing advice about the public health impact of gene
patenting and licensing practices”.
Federal efforts to promote broad licensing and patient access.
Licensing policies governing federally funded research to
Study federal implementation of IP laws.
Improving and clarifying USPTO policy.
Seeking statutory changes.
It is a fact that the stakeholders in the gene patent controversy
have distinct interests, only one of which is the desire of
laboratory directors to have freedom to operate. However,
deontologically-driven arguments against gene patents smack
of genetic exceptionalism and moral arguments for gene
patents are utilitarian. SACHGS seeks resolutions that do
not deny inventors the protection they require for
innovation, allow laboratorians the opportunity they desire
to offer appropriate testing and provide patients the access
to testing that they deserve. I applaud the efforts of
SACGHS and look forward to offering input through AMP. This
is a critical issue on which AMP must offer expertise to
emerge as an opinion leader and to provide a practice-based
perspective that keeps patient interests right, left and
center. It is my own personal opinion that our policy
efforts should be directed at the issues of licensing that
preclude appropriate patient access and not the patents
themselves; although the former is more difficult to
regulate and cannot be easily addressed through the courts,
we have an obligation to encourage innovation and patient
access to genetic tests of the highest quality.
This Newsletter article reflects the opinion of the author
only. It neither reflects a consensus of the PRC nor the
opinion or interests of any commercial entity.
I appreciate the opportunity to express a minority opinion and I
respect the consensus of the Committee and Council. I look
forward to serving as your PRC Chair again in 2009.