Lawyer Monthly Magazine -December 2019 Edition

Should You Be Able to Patent Genes? A draft bill is due to be brought to the US Senate, providing greater protection to organisations seeking patents for gene research methods. This draft bill follows several Supreme Court rulings on what – and, more saliently, what does not – qualify as patent eligible subject matter in the United States. The so-called “Myriad case” ruled that genes should be considered a natural phenomenon and therefore non- patentable. The defendants in that case – MyriadGenetics – had developed amethod toisolateDNAsequences. However,because the DNA sequences occurred in nature, the Court ruled that Myriad had no grounds to patent a diagnostic method based on detecting the sequences. This opened the door for a number of competitors, including mail-order spit-kit operations like 23andMe. Restrictions on the patentability of diagnostic methods has meant that companies are more reluctant to fund the often costly, time consuming research needed to bring these tests to market. It is hoped that the proposed reforms have the capability to change this. On the other hand, as you will know, the genetic testing industry is now big business. Not only is this industry a bit of a Wild West in terms of regulation, it has also seen a huge boom popularity. This new bill is likely to cause a real headache for US companies such as 23andMe, who have a global outreach. Consequently, this might open the door for a widespread change in the industry. 40 WWW.LAWYER-MONTHLY.COM | DEC 2019 Special Feature Written by Rosie McDowell, EIP