Search Results for: gene


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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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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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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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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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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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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Supreme Court Revisits Wrongful Birth Claims: an extended look — Robert Kellar QC and Owain Thomas QC

24 June 2021 by

In Khan v. Meadows [2021] UKSC 21 the Supreme Court has revisited the principles to be applied in “wrongful birth” claims: claims for the cost of bringing up a disabled child who would not have been born but for a doctor’s negligent medical advice/treatment. However, the judgment has implications beyond the world of clinical negligence litigation. The Supreme Court has taken the opportunity to clarify the components or ingredients of the tort negligence more generally. In particular, the Court has affirmed the importance of the “scope of duty” principle: a principle which limits the recoverability of damages wherever it applies. In particular, it is not sufficient for a claimant to establish that – with competent advice – they would have made a different decision about their treatment or care. They must also demonstrate that the particular harm that they have suffered fell within the scope of the defendant’s duty of care.


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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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Enforceable ethics in the age of gene enhancement

4 June 2019 by

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.


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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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From base pairs to the bedside: medical confidentiality in a changing world

12 December 2012 by

DNA database impact on human rightsThis 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.
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Experimental treatment? “All of life is an experiment” – New Podcast

13 November 2017 by

B (Applicant, acting as litigation in person) – and – D (by his litigation friend, the Official Solicitor) (1) The Ministry of Defence (2) [2017] EWCOP 15 Respondents – 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.
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2021 Reviewed

22 December 2021 by

Photo by the author

And so we come to the end of another year. The Covid-19 pandemic has continued to dominate the news, particularly with the very concerning surge of the Omicron variant this month. Many reading this will be separated from loved ones over Christmas. The year has also seen the return to power of the Taliban in Afghanistan after the US withdrawal at the end of August, the resumption of military rule in Myanmar and the ongoing persecution of the Uyghurs by the Chinese government, this year recognised by the House of Commons and the US government (as well as many other bodies and organisations) as constituting a genocide. So, one could say that this year has rivalled last year for infamy.

And yet, any year contains light as well as darkness. Also in 2021, researchers at Brown University successfully transmitted brain signals wirelessly to a computer for the first time (hopefully a breakthrough in treatment for paralyzed people), 124,000 new trees were planted in Sumatra as part of reforestation efforts, the WHO gave approval for widespread use of a groundbreaking malaria vaccine and almost nine billion Covid vaccinations have so far been administered worldwide since the first dose given in the UK 12 months ago, for a virus which only arrived 12 months before that.

But what, I hear you ask, about the law? As always, this year has been packed with fascinating and important legal developments — many of which you may have caught, but some of which may have passed under the radar. And so, please refresh your glass (or mug) and join me on another adventure as we review the 10 cases that defined 2021.


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The importance of patents in biotechnology – John Butcher

21 February 2020 by

The following article comes from a student of IP law at Georgetown University in Washington DC. Although somewhat outside the range of subjects usually covered by UKHRB I feel it is sufficiently important to keep up to date with this difficult and fast moving area, as law tries to keep pace with technological developments in this field. So here we have John Butcher’s survey of the field.

Inventors come from many different disciplines and fields of study. Arguably one of the most important are biotechnicians whose inventions dramatically help to improve our standards of living. From healing the body of diseases to restoring the environment, biotechnology pervades all aspects of life. 

While that sounds really nice, you might be wondering what exactly falls under biotechnology?

What is Biotechnology?

Biotechnology in the United Kingdom is the industry of organisms that manufacture commercial products. Interestingly, it can be quite controversial at times i.e. stem cells and gene cloning. Despite this, biotechnology is integral to advancements in the healthcare and pharmaceutical industry. 

Currently, most industrial biotechnological expenditure in the UK is in the field of healthcare. Consequently, the UK is the leader in Europe in the development of biopharmaceuticals – by quite a lead.


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Can we keep our genomes quiet? Some suggestions from the US

18 October 2012 by

DNA database impact on human rights

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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Aarhus Abortion Abu Qatada Abuse Access to justice adoption ALBA Allison Bailey Al Qaeda animal rights anonymity Appeals Article 1 Protocol 1 Article 2 article 3 Article 4 article 5 Article 6 Article 7 Article 8 Article 9 article 10 Article 11 article 13 Article 14 Artificial Intelligence Asbestos assisted suicide asylum Australia autism benefits Bill of Rights biotechnology blogging Bloody Sunday brexit Bribery Catholicism Chagos Islanders Children children's rights China christianity citizenship civil liberties campaigners climate change clinical negligence Coercion common law confidentiality consent conservation constitution contempt of court Control orders Copyright coronavirus Coroners costs court of appeal Court of Protection covid crime Cybersecurity Damages Dartmoor data protection death penalty defamation deportation deprivation of liberty Detention diplomatic immunity disability disclosure Discrimination disease divorce DNA domestic violence duty of candour duty of care ECHR ECtHR Education election Employment Employment Law Employment Tribunal enforcement Environment Equality Act Ethiopia EU EU Charter of Fundamental Rights EU costs EU law European Court of Justice evidence extradition extraordinary rendition Family Fertility FGM Finance football foreign criminals foreign office France freedom of assembly Freedom of Expression freedom of information freedom of speech Gay marriage Gaza gender genetics Germany gmc Google Grenfell Health high court HIV home office Housing HRLA human rights Human Rights Act human rights news Huntington's Disease immigration India Indonesia injunction Inquests international law internet Inuit Iran Iraq Ireland Islam Israel Italy IVF Jalla v Shell Japan Japanese Knotweed Judaism judicial review jury trial JUSTICE Justice and Security Bill Land Reform Law Pod UK legal aid legality Leveson Inquiry LGBTQ Rights liability Libel Liberty Libya Lithuania local authorities marriage Maya Forstater mental capacity Mental Health military Ministry of Justice modern slavery monitoring music Muslim nationality national security NHS Northern Ireland nuclear challenges nuisance Obituary ouster clauses parental rights parliamentary expenses scandal Parole patents Pensions Personal Injury Piracy Plagiarism planning Poland Police Politics pollution press Prisoners Prisons privacy Private Property Professional Discipline Property proportionality Protection of Freedoms Bill Protest Public/Private public access public authorities public inquiries public law Regulatory Proceedings rehabilitation Reith Lectures Religion RightsInfo Right to assembly right to die right to family life Right to Privacy Right to Roam right to swim riots Roma Romania Round Up Royals Russia Saudi Arabia Scotland secrecy secret justice sexual offence sexual orientation Sikhism Smoking social media Social Work South Africa Spain special advocates Sports Standing statelessness Statutory Interpretation stop and search Strasbourg Supreme Court Supreme Court of Canada surrogacy surveillance Syria Tax technology Terrorism tort Torture travel treaty TTIP Turkey UK Ukraine UK Supreme Court unduly harsh united nations USA US Supreme Court vicarious liability Wales War Crimes Wars Welfare Western Sahara Whistleblowing Wikileaks Wild Camping wind farms WomenInLaw YearInReview Zimbabwe
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