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Top US court blocks patents on breast cancer genes

By John Liddicoat and Dianne Nicol, University of Tasmania

All nine members of the US Supreme Court have ruled that isolated genetic material cannot be patented – unless the material is markedly different to what exists in nature.

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The court ruled against Myriad Genetics' patents on the BRCA1 and BRCA2 genes, which are linked to breast and ovarian cancer. The primary plaintiff was the Association for Molecular Pathology, although the case was brought on behalf of a range of other stakeholders including medical associations, and breast cancer and women’s health groups.

The US decision may impact on the impending appeal in an Australian in which a Federal Court judge ruled patent claims to isolated genetic sequences were valid.

The US decision

The Association for Molecular Pathology argued that patent claims to “isolated” genomic DNA were not eligible for patent protection because they are products of nature. It is a fundamental tenet of modern patent law that natural phenomena and products of nature cannot be patented. Products of nature are reserved as the basic tools of scientific and technological work.

In the United States, the legal test that courts apply to determine whether a patent claim is a product of nature or not, is that the invention has “markedly different characteristics from any found in nature”.

In a quite simple judgement, the Supreme Court emphasised that brilliant discoveries may not receive patent protection because they are laws of nature. Albert Einsteins' formulation E=mc2 (the finding that energy and mass are different forms of the same...

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