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Myriad Genetics acquires patent on another breast cancer-linked gene

23 January 2012
Appeared in BioNews 641

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.

Mark Capone, president of Myriad, said: 'This intellectual property will enhance our ability to provide patients and health care providers important information on a patient's predisposition to hereditary breast and ovarian cancer'.

RAD51C was identified in 2010 as a susceptible gene for hereditary breast and ovarian cancer by scientists from the German Consortium for Hereditary Breast and Ovarian Cancers, which shares the patent co-exclusively with Myriad in Germany, working in collaboration with other researchers across Germany.

Myriad holds a portfolio of nine molecular diagnostic tests, including the BRACAnalysis. Last year, the US Federal Court of Appeals allowed Myriad to continue to hold patents it has acquired over tests for BRCA1 and BRCA2 gene sequences after the American Civil Liberties Union (ACLU) and Public Patent Foundation (PUBPAT) organised a claim challenging their validity.

The plaintiffs argued that isolating the BRCA1 and BRCA2 genes from the body is not creating something new - a requirement for awarding a patent - and the US Department of Justice at the time also expressed its opposition to the principle that genes should be eligible for patent protection.

Lawyers for Myriad argued the company had created something new, which was distinct from the way it is found in nature. The discovery of gene sequences are then claimed to be the intellectual property of the investigating scientist or company. The plaintiffs have reportedly filed a petition to appeal to the Supreme Court.

It is thought the majority of hereditary breast and ovarian cancers are considered to be the result of mutations in the BRCA1 or BRCA2 genes. Myriad says that studies indicate pre-symptomatic individuals who carry gene mutations are able to lower their risk of developing ovarian cancer by approximately 60 percent through preventative therapies.

But opponents to so-called gene patents argue that high fees can reduce patients' access to diagnostic tests – Myriad charges up to $3,000 for use of its BRCA1 or BRCA2 test – and prevents competitors from producing cheaper alternatives. Myriad denies that access is hindered and says the test is often part-funded by the US Government and is in most cases covered by insurance.

The Supreme Court is due to decide on whether to grant the petition to appeal early this year.

Gene Patent Case May Head to Supreme Court
MedPage Today |  30 December 2011
Myriad Genetics Acquires Exclusive Rights to RAD51C Gene
Myriad Genetics Press Release |  18 January 2012
Myriad Genetics gets rights to cancer-linked gene
CBS News |  18 January 2012
Myriad Gets Rights to RAD51C Gene
Zacks |  18 January 2012
5 November 2012 - by Antony Starza-Allen 
A group of academics has accused Myriad Genetics, the US biotech company that holds patents over the BRCA1 and BRCA2 genetic tests for increased risk of breast cancer, of keeping secret clinical data obtained from the tests by saying the information is commercially sensitive...
1 October 2012 - by Ruth Saunders 
The American Civil Liberties Union 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...
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...
26 March 2012 - by Sarah Pritchard 
A genetic test could be used to spare breast cancer patients from having to undergo postoperative chemotherapy...
19 December 2011 - by Nishat Hyder 
A patent for a diagnostic test is currently under consideration by the US Supreme Court. The eventual decision may have profound implications for the burgeoning 'personalised medicine' industry which often relies on DNA tests to guide physicians in choosing tailored therapies for patients...
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....
22 August 2011 - by Nishat Hyder 
The NHS may be at risk of being sued over patent infringement, says a new report published by the Human Genetics Commission (HGC), the UK Government's genetics advisory body...
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....
14 June 2010 - by MacKenna Roberts 
The Australian Federal Court in Sydney is considering groundbreaking legal action of whether private companies can obtain patents on human genes....
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