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US Supreme Court asked to reconsider gene patents

1 October 2012
Appeared in BioNews 675

The American Civil Liberties Union (ACLU) has asked the US Supreme Court to reconsider its decision to uphold the patent held by Myriad Genetics on two human genes associated with hereditary breast and ovarian cancers.

The lawsuit was filed by ACLU and the Public Patent Foundation on behalf of medical associations including the Association for Molecular Pathology, scientists, patients and women's health groups. It is the latest part of an ongoing battle over the validity of the patents held by Myriad Genetics. The lawsuit claims the patents are illegal and will both hamper scientific research and limit accessibility to medical care.

The ruling over the gene patents has been going back and forth since March 2010, when a district court declared the patents invalid, but was later overturned by the Court of Appeal for the Federal Circuit (CAFC). The decision was passed on to the Supreme Court, which asked the CAFC to reassess their judgement taking into consideration the Supreme Court's recent ruling against a similar patent.

The genes in question, BRCA1 and BRCA2, can be used to detect the risk of breast and ovarian cancer, using tests such as Myriad Genetics BRACAnalysis. Holding patents on the isolated forms of these genes, gives Myriad Genetics exclusive rights to perform these tests.

In a statement from the Association for Molecular Pathology, executive director Mary Steele Williams stated: 'Patents on genes such as BRCA1 and BRCA2 grant diagnostic test monopolies to commercial companies, which often assemble the genetic knowledge acquired through testing in proprietary databases to which the medical community lacks'.

Dr Iris Schrijver, President of the Association for Molecular Pathology, added: 'The result of this lack of competition is increased test costs; decreased patient access; reduced innovation in the development of new test methods; and dramatically reduced knowledge dissemination'.

Following the Supreme Court's instruction to reconsider the case, the CAFC still maintained that although the gene sequences are a product of nature, the process of isolating them requires human intervention that can be patented.

Myriad Genetics President and CEO Dr Peter Meldrum said: 'Importantly, the court agreed with Myriad that isolated DNA is a new chemical matter with important utilities which can only exist as the product of human ingenuity'.

However ACLU attorney Chris Hansen said: 'In our view, the court of appeals did not fully consider or correctly apply the Supreme Court's most recent and relevant patent law decisions'.

Dr Roger Klein, chair of the Association of Molecular Pathology Professional Relations Committee, is 'optimistic the High Court will continue to uphold longstanding precedents that prohibit the patenting of natural phenomena'.

It is likely that Myriad Genetics will be given an opportunity to respond before the Supreme Court decides if the case will be heard or if the CAFC ruling will stand.

ACLU asks Supreme Court to reconsider gene patenting case
Reuters |  25 September 2012
ACLU Files for Second Supreme Court Review of Myriad's Gene Patents
GenomeWeb Daily News |  25 September 2012
AMP Appeals Breast Cancer Gene Patent Case to U.S. Supreme Court
Association for Molecular Pathology |  26 September 2012
Supreme Court: Liberate the Human Genome!
American Civil Liberties Union |  25 September 2012
17 June 2013 - by Dr Sarah Spain 
The US Supreme Court has unanimously rejected a number of patent claims made by Myriad Genetics on isolated forms of two genes, BRCA1 and BRCA2, associated with an increased risk of breast and ovarian cancer....
8 April 2013 - by Ruth Saunders 
A new study has reported that the entire human genome may be under patents held by commercial companies....
18 February 2013 - by Matthew Thomas 
A patent over a gene linked to hereditary breast and ovarian cancers is valid, an Australian federal court has ruled in a landmark case....
20 August 2012 - by Dr Sarah Spain 
In the latest instalment of a highly contested case, the US Federal Circuit Court of Appeals in Washington DC upheld Myriad Genetics' right to patent two genes, BRCA1 and BRCA2,which are associated with the risk of breast and ovarian cancer....
2 April 2012 - by Dr Sarah Spain 
The US Supreme Court has ordered that the two gene patents held by Myriad Genetics be sent back to the US Court of Appeals for the Federal Circuit, to be re-examined...
23 January 2012 - by Ayesha Ahmad 
Myriad Genetics, a leading US molecular diagnostic company, has been granted exclusive rights to an analysis of the RAD51C gene. Mutations of the gene have been associated with an increased risk for hereditary breast and ovarian cancer and the company now hopes to develop a commercial test for RAD51C....
14 November 2011 - by Martin Turner 
In what appears to be the end of a long running legal saga, a ruling by the UK's Supreme Court has found in favour of a patent for a gene and the protein sequence it encodes. Lawyers say that the ruling will make it easier to patent discoveries which do not have a clear demonstrated application, a result that will largely please the private bioscience industry but may alarm many who believe that human genes should not be patentable....
8 November 2010 - by Dr Nadeem Shaikh 
The US Department of Justice (DOJ) has weighed in on the complex issue of gene patenting against the principle that genes should be eligible for patent protection, reversing the government's position on the matter and causing consternation for many biotechnology companies. This week it issued a legal brief as a 'friend of the court' joining a lawsuit challenging the rights of companies to patent genetic technologies....
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