Angelina Jolie. Photograph by Gage Skidmore
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.
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 thing) is a good example.
In this case, the Supreme Court stated that Myriad Genetics Inc did not invent genomic sequence, they only isolated it.
Previous cases on the same gene patents in the United States held that to isolate genomic DNA, chemical bonds were broken and this was sufficient to make the isolated genomic DNA “markedly different” from that in nature. The Supreme Court acknowledged bonds had been broken, but focused on the information content of the material (the genomic sequence) because that was the focus of the patent claims.
The Supreme Court did hint that artificially changing genomic DNA sequences may be sufficient to make isolated DNA markedly different from that in nature. Moreover, it stated that cDNA, a laboratory-made form of (synthetic) DNA, that has very little chemical resemblance to what is found in nature, was patent eligible.
By John Liddicoat, University of Tasmania and Dianne Nicol, University of Tasmania
John Liddicoat owns shares in Genetic Technologies Limited and Benitec Biopharma Ltd.
Dianne Nicol receives funding from the ARC.
1 Comment
OH MY GOD! The Supreme Court finally made a well reasoned ruling instead of pandering to corporate avarice. It’s a miracle. Sadly their Monsanto decisions still stand.