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.