Biobank Law

Myriad Case: The Empire strokes back (?)

 

The Court of Appeal for the Federal Circuit riversed the decision made by the District Court of New York. The latter invalidated the patent owned by Myriad Genetics and the University of Utah Research Foundation over the genes BRCA1 and BRCA2, on the base of the doctrine of "products of nature": isolated DNAs are not “markedly different” from native DNAs, so such molecules are patent-ineligible because they already exists in nature.

 

The Court of Appeal ruled that "isolated DNAs, whether limited to cDNAs or not, are directed to patent-eligible subject matter under § 101". Furthemore, the decision voided the methods developed by Myriad for the analysis of DNA: they are mental processes and so they do not respect the requirement of "machine or transformation". On the contrary, the Court admitted the patentability of the method for screening potential cancer therapeutics via changes in cell growth rates (in this case, the claim included transformative steps, an “important clue” that it is drawn to a patent-eligible process).

 

See the Appeal from the United States District Court for the Southern District of New York in Case No. 09-CV-4515, Senior Judge Robert W. Sweet