By: Maureen Kingsley

The draft document seeks to determine the effects of patents and licensing on the development of genetic tests, as well as analyze other possible patenting and licensing benefits. The authors also aim to learn the effects of patents and licensing practices on clinical and patient access to genetic tests and on the quality of those tests. The potential effect of patents and licensing practices on genetic testing innovations is studied as well.

 

In preparing the draft, the committee found that “a near perfect storm is developing at the confluence of clinical practice and patent law.” Knowledge of human genetics and the role they play in wellness and illness is growing rapidly while the cost of genetic analysis is dropping. Yet trends in patent law, according to the committee, appear to pose serious obstacles to the promise of developments in molecular diagnostics and personalized medicine. Patenting in the United States has “moved upstream,” the committee writes. A patent holder can claim a purified form of a gene, which, in the committee’s estimation, can be detrimental. “While new technologies enable simultaneous evaluation of multiple genes through multiplex testing, parallel sequencing, and whole-genome sequencing, fragmented ownership may create a host of problems,” some of which have already surfaced. “Indeed, already, some laboratories using multiplex tests have chosen not to report to patients or clinicians the results for certain patent-protected genes for fear of being sued,” the committee writes. Evidence cited in the report indicates that patents have already limited the potential of these tests.

 

The committee points to the difficulty of circumventing gene and association patents the way patents in other fields might be invented around. And “even when inventing around is possible, it is inadvisable,” the committee states. 

U.S. patent law “threatens medical progress” and “may also drive valuable genetic research to countries with a more hospitable legal climate,” the report asserts, offering the example of Belgium, which makes research on or with isolated gene molecules exempt from infringement. 

 

Furthermore, the committee concludes that patents “do not appear to be necessary to stimulate research and genetic test development.” Committee members’ research demonstrates that those researching genetics have strong incentives other than those pertaining to patents. “Academic research is curiosity- and reputation-driven,” the committee states. And because the federal government and nonprofit organizations fund so much of this type of research, the committee does not accept the view that patents are particularly valuable as a means for fund raising for research. 

 

Despite these conclusions, SACGHS does not recommend a ban on patenting genes or associations. Instead, it suggests an exemption from liability for anyone who infringes a patent on a gene while “making, using, ordering, offering for sale, or selling a genetic test for patient care purposes.” Where exclusivity does not exist or is not enforced, “as in the cases of cystic fibrosis, Huntington disease, Lynch syndrome and myriad others, a thriving market appears in which laboratories—both public and private—compete on the basis of service and quality.”

 

The second legal change SACGHS proposes is the creation of an exemption of patent infringement liability for those who use patented genes for research.

 

Other recommendations put forth in the report include promoting adherence to norms designed to ensure access, enhancing transparency in licensing, establishing an advisory body on the health impact of gene patenting and licensing practices, providing needed expertise to the U.S. Patent and Trademark Office, and ensuring equal access to clinically useful genetic tests.

Taking a harder line than SACGHS, a New York federal court recently ruled that patents on genes associated with hereditary breast and ovarian cancer are invalid. (See “Patents on Breast Cancer Genes Ruled Invalid,” IVD Insight blog, March 31, 2010.) The precedent-setting ruling marks the first time a court has found patents on genes unlawful. Patent holders Myriad Genetics and the University of Utah Research Foundation lost their exclusive right to perform diagnostic tests on the BRCA1 and BRCA2 genes and to prevent any researcher from looking at the genes without first obtaining permission. How this ruling will affect the final SACGHS report is unclear.