Wednesday, June 28, 2017

Brief Blog: Diagnostics Patent Law After MYRIAD and MAYO PROMETHEUS

Two Supreme Court diagnostics patent cases from 2012 and 2013 - Mayo v Prometheus and AMP v Myriad - are so prominent they have their own Wikipedia pages (here and here).  Mayo/Prometheus held that algorithms between biology and clinical outcomes might often be "laws of nature" that are outside the scope of patents.  Myriad held that DNA sequences (even with annotation and purpose) are not per se patentable.

Daughter cases predicated on these two pivotal cases continue to roll out.
  • See Kevin Noonan's discussion of Cleveland Clinic v True Health Diagnostics (blog here, original case here).   
    • Noonan also cites to his April 2016 discussion of another diagnostics case, Genetic Technologies LDT vs Merial LLC (blog here,  original case here.)
  • Both cases tend to roll out and extend what isn't patentable by the "law of nature" exclusion subsequent to Mayo/Prometheus and Ariosa/Sequenom (Wikipedia here).
Generally, Noonan was disappointed in the Supreme Court rulings toward invalidating diagnostics patents and he views the rolling extension of these patent denials as unfortunate and perhaps requiring action by the Hill. Noonan writes,
"Unless the Supreme Court sees the error in its ways, or Congress overrules its Mayo/Alice decisions, technology transfer of university inventions will not be to startups and licensees but to copycats and pirates for the foreseeable future."   
Ouch.  See also Noonan's 2016 Nature Reviews Drug Discovery article here.   For an article on trying to improve diagnostics patentability, Morton & Clarke, here.