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 →
Y and Z (Children), 25 April 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. Continue reading →
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 →
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 →
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 →
Meiklejohn v St George’s Healthcare Trust  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. 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 →
The entanglement of law and ethics is always perilous when it involves the threat of prohibition. When Shenzhen scientists announced two years ago that they had edited the genes of twin human babies whilst still in vitro, voices of disapproval reverberated around the globe. Whilst it seems that gene modification of potential human life fills us with fear and loathing nothing has stood in the way of the race to refine this technology. Efforts to predict and restrict genetic engineering seem quaint and outmoded, from the UNESCO 1997 Declaration on the Human Genome and Human Rights, to the Council of Europe’s Convention in the same year to restrict the modification of the genome to therapeutic purposes only. These agreements, as well as the 2015 call by UNESCO for a moratorium on germline modification, are well past their sell by dates.
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 →
B (Applicant, acting as litigation in person) – and – D (by his litigation friend, the Official Solicitor) (1) The Ministry of Defence (2)  EWCOP 15Respondents – read judgement
Stem cell therapy has been very much in the news recently, as doctors have saved the life of a seven year old boy with a genetic disorder that caused the top layer of his skin to blister and flake away. After years of struggling with this painful and dangerous disease – antibiotics, bandages and even skin transplants were to no avail – the boy was on the point of death from bacterial infection. The skin contains its own supply of specialised stem cells, which allows the epidermis to be constantly renewed throughout our lives, with cells turning over roughly every month. This also allows scientists to grow grafts in culture, simply by taking a small sample. Specialists in Germany cultured centimetre wide pieces of his skin and engineered this tissue to accept the correct gene through viral transfer. The healthy patch of skin was then grown in the laboratory until enough of it was ready to be grafted back on to the boy’s body. Ultimately the team was able to replace 80% of the child’s skin. He is now understood to be leading a normal life at school, playing soccer and generally not displaying any of the dangerous side effects of gene therapy.
The relevance of this success story to this Court of Protection case will soon become obvious. In this hearing Baker J, deciding the best interests of D, a young man severely brain damaged after being assaulted by another soldier, had to determine whether his strongly held desire to travel to Serbia for stem cell treatment should prevail over the medical opposition to such a step. This was not a case of scarce allocation of public resources as D had the money from his compensation award to spend on this treatment. 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.
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 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.
International Stem Cell Corporation v Comptroller General of Patents  EUECJ C-364-13, 18 December 2014 – read judgment
This was a referral to the European Court of Justice (CJEU) requesting clarification of Article 6(2) ofDirective 98/44/EC protecting biotechnological inventions (“the Biotech Directive”). We posted earlier about the High Court decision leading up to the referral concerning two GB patent applications that both involve the ‘parthenogenetic activation of oocytes’. The Court asked for clarification on what exactly defines a human embryo and what precisely is the developmental potential of a parthenote.
Ever since scientists came upon the idea of using embryonic stem cells for therapeutic purposes there has been a something of an ethical furore around the topic. So the pressure has been on to find alternatives. Parthenotes – products of unfertilised egg division – have been proposed as candidates. However even research using parthenotes may fall foul of the law’s protection of ‘human dignity’. Continue reading →
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. Continue reading →
The Court of Appeal has held that a mother who consults a doctor in order to avoid the birth of a child with one disability may not recover damages for the costs associated with a different disability.
The respondent, M, was concerned that she may be a carrier of haemophilia and consulted her GP, who arranged blood tests. Those tests, however, could only detect whether she herself had haemophilia, and not whether she was a carrier. She then saw the appellant, another GP, who told her that the results of the tests were normal. This led her to believe, incorrectly, that any child she had would not have haemophilia. The appellant admitted that she had been negligent.
M went on to have a son, FGN, who has haemophilia. Had she known that she was a carrier before she became pregnant, she would have undergone foetal testing, which would have revealed the condition, and she would have had a termination. Therefore, but for the negligence, FGN would never have been born.
FGN has also developed autism, which is unrelated to his haemophilia.
The claim sought the costs attributable to the haemophilia and to the autism.
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