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Alarm over proposal to overturn US ban on patenting human genes

10 June 2019
Appeared in BioNews 1001

A bill that would nullify the US Supreme Court decision that banned the patenting of human genes is being debated by the US Congress. 

Scientists and patient advocacy groups have expressed concern that proposed changes to Section 101 of the Patent Act would restrict the public exchange of information and latest research findings. This could impede the development of novel tests, treatments, and targeted therapies, leading to increased costs for patients, researchers and healthcare systems.

The draft bill would result in a 'quagmire of patent claims and legal impediments to the normal scientific exchange', according to Professor Harold Varmus a cancer biologist at Weill Cornell Medicine, New York. 'It's in the interest of virtually everyone to keep ideas and basic discoveries about the laws and products of nature in the public domain.'

The contentious issue of patenting human genes was often in the news (see BioNews 543) until 2013, when Myriad Genetics' patents on BRCA1 and BRCA2 were revoked by the US Supreme Court (see BioNews 709), ending their monopoly and allowing other laboratories to enter the testing marketplace. Myriad had been sued by the American Civil Liberties Union (ACLU) who argued that genes should not be patentable because they are 'products of nature'. The Supreme Court agreed, holding that 'laws of nature', 'natural phenomena' and 'abstract ideas' cannot be patented. 

The proposed bill would amend Section 101 of the Patent Act, removing these and any other 'judicially created exceptions to subject matter availability' and abrogating 'all cases establishing or interpreting those exceptions'. The bill aims to improve innovation within the pharmaceutical sector and see new therapies developed. However, because these would have monopolies, they could be more expensive to patients. 

The ACLU released a letter appealing to lawmakers, supported by 169 signatories representing organisations including scientific societies, research institutions and patient advocacy groups. 

Senator Christopher Coon, who proposed the bill said: 'I want to be clear on one thing…Our proposal would not change the law to allow a company to patent a gene as it exists in the human body.' 

Professor Arti K Rai, a patent law expert at Duke University in Durham, North Carolina, agrees that the novelty requirement for a patent rules out patenting most genes since the human genome is already in the public domain. However, she told Wired that the proposed law could affect applications to patent methods to estimate a person's disease risk across multiple genes, such as polygenic risk scores, where patents are already being sought. 

Coalition Letter Opposing Draft Legislation of Section 101 of Patent Act
American Civil Liberties Union |  3 June 2019
Congress is debating - again - whether genes can be patented
Wired |  5 June 2019
Controversial US bill would lift Supreme Court ban on patenting human genes
Science |  26 May 2019
Who Controls Our Genes? Congress Is Deciding Right Now and It Could Harm Our Health
American Civil Liberties Union |  3 June 2019
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...
22 June 2015 - by Paul Waldron 
Australia's highest court will decide whether isolated molecules of DNA linked to a gene mutation associated with an increased risk of hereditary breast and ovarian cancers are patentable under Australian law....
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 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....
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....
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