By Jean Amos Wilson, PhD Chair, Professional Relations Committee e-mail: jamoswilson@bhlinc.com

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 http://www.amp.org/Gov/GenePatentPositionStatement_
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 website: http://oba.od.nih.gov/oba/SACGHS/meetings/December2008/Evans
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 multiplexed assays. 

Going forward:
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 facilitate access.

·         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.