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Human germline genome editing could be curbed by patent law

6 September 2021
Appeared in BioNews 1111

Patent laws could be used to restrict the use of genome editing technologies from being used to change the germline.  

Researchers in the USA and Denmark suggest that this could be a way to impose an ethical framework in a complex field with inconsistent regulation. It could function as an additional layer of regulation or safeguarding in countries that have more permissive policies or simply lack relevant regulation.

'A lot of policymakers and medical practitioners are concerned with some of the genomic editing technologies... there is no international enforcement agency out there that's going to stop people from engaging in genetic medical tourism.' said co-author Jacob Sherkow, professor of law at the University of Illinois.

The suggestion follows the recent World Health Organisation report (see BioNews 1103) that explored the international governance tools for human genome editing and ultimately focused on national implementation of governance as a mechanism to control how and why human germline genome editing is implemented.

The paper, published in the Journal of the American Medical Association explains that patent protection allows patent holders to set ethical limits on the use of their intellectual property as part of the licensing process. This effectively excludes others from using the technology unless they agree to the ethical conditions, or face infringement lawsuits that could result in severe financial penalties. In the USA, the implementation of ethical licensing restrictions is growing and is already being used in CRISPR-based applications. 

This approach has the advantage of potentially being more agile than legislation, which can be slow to make and difficult to keep adequately updated. 

'It's not a complete solution by any means, as it relies on private interests to police the social harms of a private activity,' said Professor Sherkow, 'But patents present an opportunity to combine the tools of commercialisation and ethical behaviour in a manner not readily available in other enforcement mechanisms'.

However, setting limits on social policy in this way rather than through legislative processes could be viewed as undemocratic. 

Governing human germline editing through patent law
JAMA |  30 August 2021
Paper: Use patent law to curb unethical human-genome editing
University of Illinois |  30 August 2021
Patent law may curb unethical human-genome editing
DT Next |  1 September 2021
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