The patentability of living things: the latest in the BRCA gene saga

298x232-dna_genetic_test-298x232_dna_genetic_testD’Arcy v Myriad Genetics Inc [2014] FCAFC 115 (5 September 2014) - read judgment The recent ruling from the Full Federal Court of Australia allowing the breast cancer gene isolated in the laboratory to be patented contrasts sharply with the ruling by the US Supreme Court last year that a naturally occurring DNA segment is a “product of nature” and therefore not patent eligible merely because it has been isolated. The implications of this ruling for gene testing and patenting of biological products have been eloquently discussed elsewhere and I will not attempt to cover the same ground – see for example the excellent discussion posted by the Enhanced Genetic Services Project. All I want to point up in this post – apart from the obvious need for intellectual property law to encompass the development of science and technology – is the Australian court’s focus on how easily misled one may be by semantics in this sort of dispute. This ruling upholds an earlier decision that gene patenting is permissible under Australian law, declaring that “the boundaries of the conception of patentability are not dictated only by deductive logic from the linguistic premises formulated in the scientific knowledge of a particular age”. The concept of patentability has been broadening since the first quarter of the 17th century, and there is no reason why it should reach an artificial wall erected by unfathomable and unexplained “laws of nature” (a premise much relied upon by the US Supreme Court). I posted last year on the decision of the US Supreme Court in Association for Molecular Pathology v Myriad Genetics Inc. It will be remembered that that Court held that a sequence of DNA mimicking the BRCA breast cancer mutation could not be patented because DNA’s information sequences and  all the other processes that allow the information to manufacture bodily tissues occur naturally within human cells.  Continue reading

Human genes may not be patented, but synthesised ones can, rules US Supreme Court

298x232-dna_genetic_test-298x232_dna_genetic_testAssociation 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

Would resurrected Neanderthals have human rights?

mm75890804271827A newsflash on the eve of the May 2010 elections was instantly eclipsed by the news of the coalition-bartering in the days that followed. But it concerned one of the most important scientific discoveries of the year, if not the century.

Evolutionary biologists at the Max Planck Institute for Evolutionary Anthropology in Germany had finished sequencing the Neanderthal genome. In the publication of their results the team pointed up the similarity between the four billion pairs of Neanderthal DNA and stretches of the human genome, suggesting  that humans and their ancient hominid cousins must have interbred some time after modern Homo Sapiens left Africa, meaning that elements of Neanderthal genome is present in non-African modern humans. The study found that 2.5 percent of the genome of an average human living outside Africa today is made up of Neanderthal DNA.  Continue reading

The small farmer and Goliath Monsanto

Feb22_2013_34044559_Soybeans_MonsantoMistakeHeadline4325411721Updated: The Supreme Court has now ruled on this case, rejecting Bowman’s appeal: see judgment. On Tuesday 19 February, the US Supreme Court heard  opening arguments in the latest stage of the battle between a 75 year old farmer and the agri-giant Monsanto, over whether patents on seeds — or other things that can self-replicate — extend beyond the first generation of the products.  The dispute in  Bowman v Monsanto goes to the heart of the debate over the patenting of living organisms. This of course is also at the centre of the Myriad breast cancer gene litigation which I covered here.

The case is fascinating not just because it exposes the limits of patent law in an era of fast-growing biotechnology, but because it seems to speak to the concerns of the anti-GM lobby – the stranglehold of big corporations over farmers, the fear of transgenic organisms themselves and their consequences for agriculture. But Green woo about the dangers of genetically engineered crops will not find judicial endorsement in this litigation, despite the multiple briefs filed in support of Bowman, attacking GM technology.  This is an inquiry into the reality or otherwise of patenting nature, not the morality thereof.  As The Atlantic summarises it:

 It’s a story about technology and innovation and investment, about legal standards and appellate precedent and statutory intent, about the nature of nature and how the law ought to answer the basic question of who owns the rights to the seeds of planted seeds. Continue reading

Can an individual claim ownership of “life’s instructions” – a human gene?

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