D’Arcy v Myriad Genetics Inc  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
There’s a crisis in South Africa’s mortuaries – in the investigation of death.
This is due to a number of problems – incompetent staff who fail to gather forensic evidence, creaking and inadequate facilities, and the sheer number of dead bodies waiting to be processed. In a gripping but bleak documentary about Salt River Mortuary, which is responsible for processing cadavers in the Western Cape, the figures will make you gasp and stretch your eyes:
For the Western Cape alone, 3,000 bodies are handled by this Mortuary each year. Of this number, 65% are unnatural deaths (accidents, suicides, homicides). Of that number (approx 2,000) a staggering 80% are homicides – in other words, Salt River is responsible for providing the forensic evidence for reconstructing the crime scenes leading to 1,600 murders a year.
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
Cancer Voices Australia v Myriad Inc 13 February 2013 – read judgment
Another battle in the war against gene patenting has been lost, this time in Australia.
The US litigation is still ongoing, with the US Court of Appeals for the Federal Circuit upholding Myriad’s patents on DNA sequenced in the laboratory: see my post on that judgment. On 30 November 2012, the US Supreme Court announced that it would hear an appeal in the Myriad case. The US law in relation to the patentability is therefore not likely to be settled until the Supreme Court reaches it own decision on the issue.
This Federal Court ruling in Australia has now endorsed the government’s rejection of calls for an outright ban on the patenting of genes by ruling that isolated nucleic acid (including isolated DNA and RNA) is patentable. Continue reading
A 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
This week David Cameron announced plans to introduce whole genome mapping for cancer patients and those with rare diseases within the NHS.
Single gene testing is already available across the NHS ranging from diagnosing cancers to assessing patients’ risk of suffering side effects from treatment, but this initiative will mean that the UK will be the first country in the world to introduce the technology within a mainstream health system, with up to 100,000 patients over three to five years having their whole genome – their personal DNA code –sequenced. According to Chief Medical Officer Professor Dame Sally Davies
The genome profile will give doctors a new, advanced understanding of a patient’s genetic make-up, condition and treatment needs, ensuring they have access to the right drugs and personalised care far quicker than ever before.
What will this mean for medical confidentiality? The official announcement ends with the following declaration:
1. Genome sequencing is entirely voluntary. Patients will be able to opt out of having their genome sequenced without affecting their NHS care.
2. Whole genome sequence data will be completely anonymised apart from when it is used for an individuals own care.3. A number of ways to store this data will be investigated. The privacy and confidentiality of NHS patients will be paramount in this decision. 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