Spencer v Anderson (Paternity Testing)  EWHC 851 (Fam) – read judgment
A fascinating case in the Family Division throws up a number of facts that some may find surprising. One is that this is the first time the courts in this country have been asked to direct post-mortem scientific testing to establish paternity. The other is that DNA is not covered by the Human Tissue Act, because genetic material does not contain human cells. One might wonder why the statute doesn’t, given that DNA is the instruction manual that makes the human tissue that it covers – but maybe updating the 2004 law to cover genetic material would create more difficulties than it was designed to resolve.
The facts can be briefly stated. The applicant had been made aware of his possible relationship to S, who had died of bowel cancer some years before. When S had presented with the disease, it turned out that there was a family history of such cancer. The hospital treating him therefore took a blood sample and extracted DNA from it to test for high-risk genes. If the applicant was the son of the deceased he would have a 50% risk of inherited predisposition to bowel cancer. This risk would be mitigated by biannual colonoscopies. Continue reading
JM (a child), Re  EWHC 2832 (Fam), 7 October 2015 – read judgment
Mostyn J, ruling in the Family Division that a child should receive surgical treatment for bone cancer against the wishes of his parents, has referred to Ian McEwan’s “excellent” novel The Children Act (Jonathan Cape 2014), which is about a 17 year old Jehovah’s Witness refusing a blood transfusion. The judge noted however that the book was in fact “incorrectly titled”:
a question of whether a medical procedure should be forced on a 16 or 17 year old should be sought solely under the High Court’s inherent jurisdiction, and not under the Children Act.
This case on the other hand concerned a ten year old child, J. The NHS Trust sought permission to perform urgent surgery of a serious nature on his right jawbone, where he has a very rare aggressive cancer. Its medical name is a craniofacial osteosarcoma, presenting a tumour in the bone of about 4 inches long and 1½ inches wide. The unambiguous medical evidence before the court was that if it was not removed very soon then in 6 months to a year J would die “a brutal and agonising death”. The oncologist had spelt this out in unflinching detail:
J will not slip peacefully away. The cancer will likely invade his nerve system affecting basic functions such as speaking, breathing and eating. His head will swell up grotesquely. His eyes may become closed by swelling. A tracheostomy may be needed to allow breathing. Above all, the pain will likely be excruciating.
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.
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. 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
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