genetics


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21 October 2019 by

Cambridge University Institute of Continuing Education

Law in a changing genetic landscape (25 February – 12 April 2020)

Law creates artificial relationships between non-related people and entities. It even gives person-hood to non-biological beings such as companies and partnerships (although not yet to non-human species). Genetics describe the underlying relationship of all biological beings. For centuries, law and genetic science developed in parallel with very little overlap. But as genetic discoveries ride the crest of the technological revolution, law finds itself on the back foot. Legal instruments, such as property law and the law of obligations between non-related individuals were crafted in feudal times with the aim of protecting property beyond the death of the owner. With genetic discoveries, we face a myriad of questions, from ownership of gene editing techniques to the dangers of discrimination based on genetic predisposition for disease.

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Related posts:

“Genetic affinity” an actionable head of damage against IVF clinic

14 February 2018 by

ABC v Thomson Medical Pte Ltd and others, Singapore Civil Court of Appeal  [2017] SGCA 20 – read judgment

It is a trite reflection that law should change with the times but every so often we see the hair-pin bends in law’s pursuit of modern technology.  This case from Singapore about reproductive rights and negligence in an IVF clinic is just such an example. As the judge said at the outset, the need for the law to adjust itself to the changing circumstances of life is clearest  in the area of medical science,

where scientific advancement has made it possible for us to do things today which would previously have been unimaginable a few decades ago. This has brought untold prosperity to many, and hope to those who previously had none; but it has also given us greater capacity for harm.

Background facts

The Appellant, a Chinese Singaporean, and her husband, a German of Caucasian descent, sought to conceive a child through in-vitro fertilisation . The Appellant underwent IVF treatment and delivered a daughter, referred  to in the judgment as “Baby P”. After the birth of Baby P, it was discovered that a serious mistake had been made: the Appellant’s ovum had been fertilised using sperm from an unknown Indian third party instead of sperm from the Appellant’s husband. It turned out that the clinic had processed two semen specimens inside one laminar hood at the same time and failed  to discard the disposable pipettes that had been used after each step of the IVF process.  This had resulted in a baby being born on 1 October 2010, whose DNA did not match her father’s.
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No duty of care to disclose to pregnant daughter father’s genetic disease – High Court

20 May 2015 by

12280487228o6zg0ABC v St George’s Healthcare NHS Trust and others [2015] EWHC 139, Nicol J – read judgment

Philip Havers QC  and Hannah Noyce, and Elizabeth-Anne Gumbel Q.C. and Henry Witcomb  of Crown Office Row represented the defendants and claimant respectively in this case. None of them have had anything to do with the writing of this post.

I have blogged before on the Pandora’s box of ethical problems and dilemmas emerging out of our increasing understanding of genetic disorders (see here, here and here), and here is a case that encompasses some of the most difficult of them.
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Irish Supreme Court struggles with outcome of surrogacy arrangements

20 November 2014 by

orig-src_-susanne-posel_-daily_-news-dna_baby_womb

M.R. and D.R.(suing by their father and next friend O.R.) & ors -v- An t-Ard-Chláraitheoir & ors [2014] IESC 60 (7 November 2014) – read judgment

The definition of a mother, whether she is “genetic” or “gestational” for the purpose of registration laws was a matter for parliament, not the courts, the Irish Supreme Court has ruled.

At the core of the case was the question whether a mother whose donated ova had resulted in twin children born by a surrogacy arrangement should be registered as their parent, as opposed to the gestational mother who had borne the twins.

The genetic mother and father sought her registration as “mother” under the Civil Registration Act, 2004, along with a declaration that she was entitled to have the particulars of her maternity entered on the Certificate of Birth, and that the twins were entitled to have their relationship to the fourth named respondent recorded on their Certificates of Birth.
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The patentability of living things: the latest in the BRCA gene saga

7 October 2014 by

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

13 June 2013 by

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).
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Genetic testing of children up for adoption

27 April 2013 by

12280487228O6zG0Y and Z (Children), 25 April 2013 [2013] EWHC 953 (Fam) – read judgment

Having children is a lottery. No judge or court in the land would sanction the regulation of childbearing, however feckless  the parents, unsuitable the conditions for childrearing, or unpromising the genetic inheritance.

Adoption on the other hand is stringently regulated, set about with obstacles for prospective parents, and strictly scrutinised by an army of authorities backed up by specialist family courts and a battery of laws, statutory instruments and guidance papers. Usually the filtering is in one direction only: the suitability of the parents to the child or children up for adoption. But sometimes it goes the other way, and this case raises the fascinating and somewhat futuristic question of whether children’s chance of finding a suitable home might be increased by genetic testing.

The circumstances were somewhat exceptional here, since the local authority had ascertained from the biological father  of the two young boys in question that they might have a chance of inheriting a rare genetic disorder of the central nervous system. Huntington’s Chorea is caused by a single gene mutation on chromosome IV and causes damage of the nerve cells and areas of the brain which in due course leads to severe physical, mental and emotional deterioration. Anyone whose parent has the disease is born with a fifty per cent chance of inheriting the gene. Anyone who inherits the gene will, at some stage, develop the disease. 
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Frivolous Atmospherics

13 April 2013 by

1563029463_f7bb4c814fis 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.
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The Patentability of Human Genes: more developments

20 March 2013 by

Breast Cancer in DNA StrandsCancer 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.  
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Would resurrected Neanderthals have human rights?

11 March 2013 by

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. 
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Fine tuning medical diagnoses to rare genetic disorders

9 March 2013 by

298x232-dna_genetic_test-298x232_dna_genetic_testMeiklejohn v St George’s Healthcare Trust [2013] EWHC 469 (QB) – read judgment

Richard Booth of 1 Crown Office Row acted for the claimant in this case. He is not the author of this post.

There is no doubt that medical diagnosis and therapy are struggling to keep pace with the genetic information pouring out of the laboratories and sequencing centres. And the issue of medical liability is being stretched on the rack between conventional treatment and the potential for personalised therapy. Treatment of disease often turns out to be different, depending on which gene mutation has triggered the disorder. However fine tuned the diagnosis, it may turn out to be profoundly wrong in the light of  subsequent discoveries.

This is perhaps an oversimplified characterisation of what happened in this case, but it exemplifies the difficulties facing clinicians and the courts where things go wrong, against the backdrop of this fast-moving field of scientific endeavour.
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The small farmer and Goliath Monsanto

27 February 2013 by

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.
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Should any genetic information be a trade secret?

3 December 2012 by

dna_infograph1I 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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The march of “dignity” – an anti-libertarian force?

22 October 2012 by

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

20 September 2012 by

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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