genetics
27 February 2013 by Rosalind English
Updated: 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.
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3 December 2012 by Rosalind English
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.
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22 October 2012 by Rosalind English
The recognition of a right to life, liberty, and the autonomy of the individual and the mandate of government to secure these rights is being threatened by an increasingly illiberal notion of “human dignity”, says evolutionary psychologist Stephen Pinker.
His 2008 broadside in The New Republic took to task a now defunct body, the US President’s Council on Bioethics whose publication Human Dignity and Bioethics is shot through with disquiet about advances in biotechnology. It could not be more different from the enlightened report issued earlier this year by the Council’s successor calling on the current administration not to stifle biomedical research with over-restrictive regulation (see my post). Does the contrast between the present advisory body’s recommendations and the report put before the previous President signal a fundamental change in the way we approach progress in this field? Probably not. Only two weeks ago, Sir John Gurdon (the Nobel physiologist whom schoolteachers had written off as a scientist) bemoaned the regulatory restrictions that make important therapies too costly to pursue. Pinker’s dismay at the “scientific illiteracy” of society rings true today:
Ever since the cloning of Dolly the sheep a decade ago, the panic sown by conservative bioethicists, amplified by a sensationalist press, has turned the public discussion of bioethics into a miasma of scientific illiteracy. Brave New World, a work of fiction, is treated as inerrant prophesy. Cloning is confused with resurrecting the dead or mass-producing babies. Longevity becomes “immortality,” improvement becomes “perfection,” the screening for disease genes becomes “designer babies” or even “reshaping the species.” The reality is that biomedical research is a Sisyphean struggle to eke small increments in health from a staggeringly complex, entropy-beset human body. It is not, and probably never will be, a runaway train.
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18 October 2012 by Rosalind English
I have posted previously on the logistical difficulties in legislating against genetic discrimination.
The prospect that genetic information not only affects insurance and employment opportunities is alarming enough. But it has many other implications: it could be used to deny financial backing or loan approval, educational opportunities, sports eligibility, military accession, or adoption eligibility. At the moment, the number of documented cases of discrimination on the basis of genetic test results is small. This is probably due to the relatively few conditions for which there are currently definitive genetic tests, coupled with the expense and difficulty of conducting these tests. But genetic discrimination is a time bomb waiting to be triggered and the implications of whole genome sequencing (WGS) are considered in a very interesting and readable report by the US Presidential Commission for the Study of Bioethical Issues Privacy and Progress in Whole Genome Sequencing.
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20 September 2012 by Rosalind English
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.
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9 May 2012 by Rosalind English
The late US law Professor Paul Miller reflected recently that Beethoven, Stephen Hawking and Elton John were examples of individuals whom, if they had been tested for serious genetic conditions at the start of their careers, may have been denied employment in the fields in which they later came to excel.
Earlier this month the Association of British Insurers announced the latest extension on the moratorium on the use of genetic test results for insurance purposes. But is this “Concordat” sufficient protection? Genetic technologies are becoming increasingly available and profound questions are arising in relation to life and health insurance and employability as genetic screening becomes cheaper and widespread.
According to the Human Genetics Commission (HGC)
The advent of cheap whole-genome sequencing, and greatly reduced costs for genetic tests in general, will provide the platform for genetic testing to be used for novel and unpredicted purposes. (Report on The Concept of Genetic Discrimination, Aril 2011)
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24 May 2011 by Rosalind English
We reported last week the Supreme Court ruling in R (on the application of GC) (FC) (Appellants) v The Commissioner of Police of the Metropolis (Respondent) in which the majority found that they could interpret the DNA retention provision in the Police and Criminal Evidence Act (PACE) in such a way that it would be compatible with article 8 of the ECHR.
Not only that; the Court concluded that such a reading could still promote the statutory purposes: ” Those purposes can be achieved by a proportionate scheme.”
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