US report says that genetic tests should be exempt from patent protection

A report prepared by an advisory committee to the Secretary of Health & Human Services in the United States has recommended that US patent law should be amended to create an exemption from liability for persons who infringe patents for genetic testing technologies.  The committee’s recommendations arise from concerns over patient access to genetic tests and the restrictive licensing arrangements between patentees and licensees to administer and exploit the genetic testing technology.

The report has drawn strong dissent from the US Biotechnology Industry Organization (BIO) and from universities like the University of Wisconsin who are worried that, if the committee’s recommendations are implemented, they will lead to a stifling of research into genetic testing technologies and of university-industry partnerships to commercialise these technologies.  The dissenters argue that the report makes “reckless policy considerations” and ignores the fact that patents are a useful tool to encourage the research and development of new technologies. More information on BIO’s response to the report can be found here.

Once the report is finalised it will be provided to the Secretary of Health & Human Services who will have to decide whether to implement the report’s recommendations.

It will be interesting to see if the recommendations of the US report are picked up by the Australian Senate Community Affairs Committee who have been asked to investigate the issue of gene patents in Australian law.  Submissions to the Committee regarding its investigation have closed however more information regarding the Senate inquiry can be found here.

About the Author

James Ellsmore
James is a senior associate with King & Wood Mallesons' Intellectual Property team in Sydney. James assists clients to resolve intellectual property disputes, with a particular focus on patents, pharmaceuticals and the life sciences. He has acted for a variety of clients in matters concerning patent infringement and revocation proceedings in the Federal Court of Australia, patent opposition proceedings before the Commissioner of Patents, and matters arising from patent licence and technology agreements. James also has experience in the preparation of commercial, R&D and IP agreements for leading universities, research organisations and pharmaceutical companies. He also advises clients on regulatory issues affecting clients in the industrials, consumer and health sectors.
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