Task Force Advises Making Gene Patents Exempt from Infringement

NEW YORK (GenomeWeb News) – The Department of Health and Human Services committee charged with advising the agency on genetics policy has recommended in a new draft report making gene patents exempt from infringement liability — a move that would allow researchers and clinics to use and offer genetic information and genetic tests even on genes that are patented.

If implemented, such policies could make it difficult or impossible for holders of patents on some genes and genetic testing technology to sue others using those genes.

The recommendations in the report are not final and are being discussed at a meeting taking place in Washington, DC, today and tomorrow. The task force is expected to issue a final report by the end of the year.

The Secretary's Advisory Committee on Genetics, Health and Society draft report claims that while "strong arguments can be made that patents enable innovation," genes and gene-based diagnostics are unique and that "patent-enabled exclusivity primarily results in a narrowing of offerings to patients and physicians."

In the report, James Evans, chair of the SACGHS Task Force on Gene Patents and Licensing, wrote that after a review of dozens of reports, public comments, and case studies, the task force found that patents are not necessary to drive research that "leads to the availability of genetic testing."

The report concludes that "[a]lthough patented discoveries are developed into tests, unpatented genetic discoveries are routinely developed into clinical genetic testing services."

Evans also argued in the report, and in his discussion of it this morning at the SACGHS meeting that not only are patents not "powerful" incentives for conducting genetics research, disclosing genetic discoveries, or investing in development of genetic tests, but that they limit clinical access to genetic tests.

The task force also said that it found that exclusive licensing of genetic tests from a sole provider can limit patient access to tests, but that broadly licensed tests do not appear to inhibit patient access.

The practice of exclusive licensing through a sole provider also causes problems when it is combined with a multi-payer healthcare system and "often results in patient access problems," the report states. "Sole providers fail to secure coverage from some major payers, including out-of-state Medicaid programs," which makes it difficult for some patients to get genetic testing covered.

The task force also heard from the public that having a sole provider for genetic testing can make it difficult for patients to obtain second opinions – even when tests have implications for major decisions – and difficulty has been reported receiving newborn screening when only one lab offers a test.

The draft report also advises the HHS secretary to "discourage the seeking, the granting, and the invoking of simple association patent claims," because "these claims represent basic laws of nature that cannot be invented around."

The task force report also recommends that HHS should create norms to ensure access to genetic tests, that it should take specific steps to enhance transparency in licensing practices, and that it set up an advisory board that would assess the impact of gene patenting and licensing practices.

While gene patenting has always been a controversial subject, the spotlight was turned up on the issue earlier this year when the American Civil Liberties Union joined with other plaintiffs to file a lawsuit alleging that the BRCA gene patents "stifle research that could lead to cures and limit women's options regarding their medical care."

The suit was filed against Myriad Genetics, the US Patent and Trademark Office, and the University of Utah Research Foundation, which holds the patents to the BRCA1 and BRCA2 genes. The research foundation exclusively licensed the rights to perform diagnostic tests on the genes to Myriad, which provides genetic testing for ovarian and breast cancer.