One of the major potential stumbling blocks for the field of genome-based diagnostics – particularly as we begin to move into the whole-genome sequencing era – is the unresolved issue of gene patents.
Currently somewhere in the order of 20% of the protein-coding genes in the human genome are covered by some kind of patent protection. However, the legal status of gene patents remains contentious.
Yesterday’s astonishing defeat
of Myriad Genetics in an ACLU-led case before a United States District Court is unexpected, and potentially a positive outcome for companies seeking to offer large-scale genome-based diagnostics. The decision invalidates patents held by Myriad on the BRCA1
genes, mutations in which are associated with increased risk of breast and ovarian cancers, and casts doubt on the validity of thousands of gene patents.
The take-home message: this is a truly astonishing victory for critics of gene patents, but the full implications are yet to become clear. Myriad still has room for appeal, and the legal scope of the case is limited. Vorhaus and Conley argue that the decision should be viewed as just one part of a much larger battle:
In the broader policy debate surrounding gene and biotechnology patents, however, this decision is the latest, unmistakable shot across the bow of gene patent holders, particularly those such as Myriad Genetics that have developed businesses around patent-protected genetic tests supported by exclusive rights in underlying gene patents. As we wrote last summer, and as the SACGHS report pointed out in detail, there is a coming crisis at the intersection of multiplex genetic testing and whole-genome sequencing and biotechnology patents, particularly gene patents. This decision is sure to intensify the public policy discussion surrounding the appropriateness of gene patents, and ratchet up the media and public attention paid to the issue.
If the decision is upheld it seems likely to be a strong positive for companies like 23andMe
, who offer multi-gene scans for genetic variants associated with diseases and other traits, as well as for academic diagnostic labs. It’s also good news (at least in the short term) for those of us interested in affordable personal genomics. [Update:
I've transiently deleted a confusing sentence here until I have enough time to actually write something coherent.]
Added 30/03/10: See the comments below for more useful discussion, including comments by Dan Vorhaus, Keith Grimaldi and 23andMe co-founder Linda Avey.