Recommendation to exempt US gene patents from infringement

14 October 2009

Earlier this year, the US Secretary's Advisory Committee on Genetics, Health and Society (SACGHS) released a draft report on gene patents and their impact on patient access to genetic tests for public consultation (see previous news). Following on from this, the final version of the draft report from the Task Force on Gene Patents and Licensing Practices was discussed at a SACGHS meeting last week. 

The group concluded that ‘Patents do not serve as powerful incentive to conduct genetics research, to disclose genetic discoveries, or to invest in the development of genetic tests’ and that their benefits in the area of genetic testing are therefore limited (see presentation). They also noted that patient access to genetic tests, whilst not in general affected adversely by patents, had in some cases been restricted (especially for poorer patients) when offered exclusively by a single or limited number of providers. This is typified by the exclusive US patent to the BRCA1 and BRCA2 genes held by Myriad Genetics, the subject of a legal challenge in May this year (see previous news). 

The Task Force therefore made two recommendations for longer-term statutory changes:
  1. The creation of an exemption from liability for infringement of patent claims on genes for anyone making, using, ordering, offering for sale, or selling a test developed under the patent for patient care purposes.
  2. The creation of an exemption from patent infringement liability for those who use patent-protected genes in the pursuit of research. Related health care and research entities also should be covered by this exemption.

Meanwhile, the Task Force on Gene Patents and Licensing Practices proposed that the Secretary of Health and Human Services (HHS) should discourage simple association patent claims – that is, those claiming a basic gene sequence, as opposed to applications relating to that sequence – because they ‘represent basic laws of nature that cannot be invented around’. Other suggestions included that the HHS should establish an advisory board to assess the public health impact of gene patenting and licensing practices, and that stakeholders should work together to develop consensus policies in this area, including steps to ensure patient access. The final report is expected by the end of the year.

The SACGHS meeting also considered the Genetic Information Nondiscrimination Act (see previous news), ethical issues associated with genomic data sharing, genetics education and training, and ditrect-to-consumer genetic testing. Presentations are available from the meeting website.

Comment: The proposed measures, if enacted, would effectively mean that individuals or organisations could perform research or offer tests relating to patented genes without licensing agreements from the patent holders. This could mean a substantial loss of revenue for the patent-holders, who might otherwise enjoy exclusive rights to such applications and charge fees to others who wanted to use them. In practice, many gene patent holders do not attempt to enforce their legal entitlements. Of note, the proposed exemption for those engaged in research already exists in the UK, where it is widely considered to be a beneficial measure, but this is quite different from provision of tests. 

The patenting of basic gene sequences is highly contentious – and possibly increasingly redundant in the light of the increasing ease and low cost of whole genome sequencing; efforts to ensure reasonable patient access to genetic tests are also desirable, However, care may nevertheless be needed to ensure that the commercial sector retains sufficient financial incentives to continue research and development of genetic tests and related applications.

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