Association for Molecular Pathology et al v Myriad Genetics Inc, et al, United States Supreme Court 13 June 2013 – read judgment
The headlines are misleading. Myriad Genetics has lost some, but not all of its patent protection as a result of this final ruling in the long running litigation concerning the company’s BRCA 1 and BRCA 2 breast cancer gene patents.
According to the American Council on Science and Health, the Court’s decision is
a groundbreaking moment in the history of biotechnology, and a case that will surely rank among the most noteworthy biomedical decisions of our time.
I have posted here, here and here on previous stages in the Myriad patent case, in the United States and Australia, so will not set out the facts again (although for anyone who is interested, the Supreme Court judgment provides a superbly clear explanation of the molecular biology underlying the issues). Continue reading
is what the technology giant Myriad calls the US First Amendment and other human rights arguments raised by their opponents in the litigation concerning Myriad’s patents over cancer gene sequences BRCA1 and BRCA2.
We’ve been here before, in this previous post and in this, and next week the US Supreme Court starts hearing arguments in the latest round of this battle. The only reason for mentioning the issue now is to draw attention to a fascinating article by US science historian Daniel Kevles in a recent edition of the New York Review of Books.
The author provides a dispassionate view of patent law, from its roots in the philosophy of the American revolution, which gave birth to the “Progress Clause” in the American Constitution. Clause 8 authorises Congress
to promote the Progress of Science and useful Arts, by securing for limited Times to Authors and Inventors the exclusive Right to their respective Writings and Discoveries. Continue reading
I posted previously on the decision by the US Court of Appeals for the Federal Circuit to uphold the patents on the genetics company Myriad’s gene sequences for breast cancer research and therapy. In September 2012 the American Civil Liberties Union once again petitioned for Supreme Court review. The Court should decide today whether to review the case.
The whole question of proprietary claims over genetic information is not limited to patents and is very much open to debate. In my piece on the US Bioethics Commission’s report to the Obama administration I discussed the challenge faced by lawmakers in regulating the increasing flow of genomic information so as to protect people’s privacy without shutting down the flow of data vital to biomedical research. Whilst it is true that the availability of patent protection creates vital incentives for such research, genetic testing companies like Myriad can extend their exclusivity beyond their patented products by creating limiting access to private databases containing information vital to interpreting the clinical significance of human genetic variations. There is concern that this threatens to impede the clinical interpretation of genomic medicine. The Genomics Law Report Journal reports that
National health systems and insurers, regulators, researchers, providers and patients all have a strong interest in ensuring broad access to information about the clinical significance of variants discovered through genetic testing. Continue reading
Yes, says the US Court of Appeals for the Federal Circuit, upholding the validity of human gene patents related to breast and ovarian cancer (Association for Molecular Pathology and others v the Patent Office and Myriad Genetics – read judgment) UPDATED
The three judge panel ruled in a 2-1 decision that the biotechnology company Myriad was entitled to its patents on the molecules because each of them represented “a non-naturally occurring composition of matter”. The court also upheld Myriad’s patent on a technique for identifying potential cancer therapies by monitoring effects on cell growth, but denied their claim on assessing cancer risk by comparing DNA sequences because the method is based on “abstract, mental steps” of logic that are not “transformative”.
This fascinating judgment is a model of clarity and fluency in this difficult area. But what does this intellectual property tussle have to do with human rights? Well, there is nothing unfamiliar to human rights lawyers in litigation over the availability of life-saving treatment (patient B, the Herceptin case and the antiretroviral litigation in South Africa are three examples that spring to mind). And much of it begins in the laboratory, with the critical allocation of exclusivity rights. Continue reading