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Biotech vows to 'defend women's rights' by contesting Myriad lawsuit

23 June 2014
Appeared in BioNews 759

Pathway Genomics, a biotech company based in San Diego, announced it will 'vigorously defend itself' against a patent infringement suit filed by Myriad Genetics and others.

The lawsuit came after Pathway's launch of their saliva-based BRCATrue test, which screens for mutations in the BRCA1 and BRCA2 genes that are associated with a heightened risk of developing breast, ovarian and other cancers.

For several years, Myriad held patents on the BRCA genes, effectively barring other companies from producing rival tests. However, last year the US Supreme Court ruled that natural human DNA could not be patented, invalidating Myriad's claim (reported in BioNews 709).

Myriad retains many other patents on its test technology and its intellectual property portfolio can be difficult for rivals to negotiate. In March this year, for example, Myriad tried and failed to obtain a preliminary injunction to prevent a competitor, Ambry Genetics, from offering BRCA-related genetic testing products (see BioNews 746).

'Given [Myriad's] pattern of filing lawsuits against other companies broadening access to this life-saving technology in clear disregard of the Supreme Court's decision last year, this lawsuit is not unexpected', Jim Plante, the CEO of Pathway Genomics, said.

Plante argues that, by charging less than half the cost of Myriad's equivalent test and offering free screening to some women who are unable to pay for it, their aim is to make genetic testing 'more accessible and affordable'.

'Every person should have access to vital information about their own body', Plante contends in a press release subtitled 'Pathway defends the rights of all women to receive BRCA testing'.

In response, Ron Rogers, a spokesperson for Myriad, told The Scientist that his firm's infringement suit relates to patents the company holds on synthetic DNA and the method of genetic screening, not those that were disallowed last year. The current litigation is 'completely unrelated to the Supreme Court case', he said.

He added that Myriad's own Financial Assistance Program provides uninsured women with free BRCAnalysis testing.

As co-patent holders, the following organisations are also suing Pathway: The University of Utah; University of Pennsylvania, The Hospital for Sick Children in Toronto, and Endorecherche, a company based in Quebec.

The Progress Educational Trust is organising a free public event in central London on the evening of Thursday 3 July, entitled 'Breast Cancer Risk: Facts, Fictions and the Future'.

See here for further details, and book your place now by emailing

Myriad Challenges Pathway Genomics' BRCATrue Test
Bio-IT World |  16 June 2014
Pathway Genomics Responds to Myriad Genetics Lawsuit, Defends the Rights of All Women to Receive BRCA Testing Regardless of Socioeconomic Status
Pathway Genomics (press release) |  16 June 2014
Yet Another Lawsuit over Genetic Tests
The Scientist |  17 June 2014
23 May 2016 - by Antony Starza-Allen 
Myriad Genetics has been hit by a complaint filed by the American Civil Liberties Union (ACLU) on behalf of four patients who are seeking a right of access to all their genetic information held by the company...
12 October 2015 - by Cait McDonagh 
An isolated gene sequence cannot be patented, Australia's highest court has unanimously ruled. It is the latest and final decision in litigation that has lasted over five years...
2 February 2015 - by Cait McDonagh 
Myriad Genetics has settled litigation with competitors who had been using genetic testing for breast cancer genes...
8 September 2014 - by Matthew Thomas 
Gene sequences isolated from the human body are patentable, according to a ruling by the Australian federal court...
17 March 2014 - by Patricia Cassidy 
Myriad Genetics has failed to obtain a preliminary injunction to prevent a competitor, Ambry Genetics, from offering BRCA-related genetic testing products...
15 July 2013 - by Ruth Retassie 
Myriad Genetics is suing two other companies who are offering genetic tests for BRCA1 and BRAC2 gene mutations for patent infringement...
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Direct-to-consumer genetic tests were called into question by the US authorities last week. An undercover investigation by the US Government Accountability Office (GAO) found that test results were often inaccurate and misleading....
17 May 2010 - by Rosemary Paxman 
Personal genetic testing kits are to be sold in US pharmacies for the first time, US biotech firm Pathway Genomics has announced...
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