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Gene patent for breast cancer faces legal challenge

14 June 2010

By MacKenna Roberts

Appeared in BioNews 562

The Australian Federal Court in Sydney is considering groundbreaking legal action on whether private companies can obtain patent on human gene.

Cancer Voices, a cancer advocacy group, and the law firm Maurice Blackburn are suing four biotechnology companies arguing that their patent on BRCA1, the so called 'breast cancer gene', is invalid.

The case follows on the heels of a New York district court decision in March invalidating seven US-issued patents held by Myriad for the same breast and ovarian cancer gene on similar grounds.

The key legal argument before the Court is that isolated genetic material is a discovery of a naturally, pre-existing substance, not an invention, and therefore cannot be patented. Rebecca Gilsenen, the principal acting solicitor, highlighted that there are also additional profound ethical and philosophical questions about whether the body should be privatised: 'It's a healthcare rights issue and an issue of freedom of research into the fundamental building blocks of our being'. The plaintiffs and many experts argue that gene patenting compromises patient healthcare by bottlenecking competition necessary to drive or maintain prices at a low level, encourage innovation and improve testing quality.

Legal experts argue that patents and resulting licensing monopolies provide the necessary incentive to attract investment and talent which fosters innovation. The Institute of Patent and Trade Mark Attorneys of Australia (IPTA) predicts a 'catastrophic' withdrawal of investment in biotechnology from the corporate sector if gene patents become unenforceable.

In the mid-1990s, the University of Utah Research Foundation (UURF) obtained patents for all variations relating to the DNA sequence for the BRCA1 and BRCA2 genes. UURF exclusively licensed these rights to Myriad. Myriad remains the only diagnostic genetic test provider to women in the US for BRAC1 and BRAC2 genetic mutations, legal battles aside.

In Europe, challenges to these patents forced Myriad to revoke or amend its rights, and European laboratories offer most BRCA gene testing for free.

An estimated one-fifth of the human genome is patented or has patent applications pending.

The Age | 08 June 2010
Life Scientist | 08 June 2010
Sydney Morning Herald | 08 June 2010
The Australian | 08 June 2010
The Medical News | 07 June 2010


02 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....
19 December 2011 - by Dr Rebecca Robey 
Women who inherit breast cancer risk genes from their father may be diagnosed with, or even develop, the disease several years earlier than those who inherit the same genes from their mother. This may have implications for screening and treatment strategies for those at risk of hereditary breast cancer...
12 September 2011 - by Sarah Pritchard 
Researchers based in the USA and the Netherlands report study findings that may explain why women with mutations in the BRCA1 gene are more susceptible to breast and ovarian cancer...
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...

19 April 2010 - by Harriet Vickers 
Researchers examining gene patents used in diagnostic tests say these can block competition and slow innovation, rather than spur development of new technologies for assessing the risk of genetic diseases...
01 February 2010 - by MacKenna Roberts 
A landmark US lawsuit is due to begin this week in New York which will question the right of private companies to hold patents on disease-related genes and their exclusive license rights to be the sole provider of genetic tests for those diseases. Last May, lawyers from the American Civil Liberties Union (ACLU) and the Public Patent Foundation, filed a legal action that challenged seven US patents for two genes linked to hereditary breast and ovarian cancers. The action was lau...
10 August 2009 - by Antony Blackburn-Starza 
A Senate Committee in Australia is hearing arguments for and against gene patenting with a view to propose future law reforms in this area. Opponents of gene patents argue that it can restrict access to vital diagnostic techniques, such as breast cancer screening, which identify certain genes that indicate the presence of a disorder. On the other hand...

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