Amicus Briefs In Remand of Myriad

Today is the deadline for filing amicus briefs for the Federal Circuit to consider when it decides the Myriad gene patent litigation, i.e. The Association for Molecular Pathology v. US Patent and Trademark Office, on remand. The first time the Federal Circuit heard the case, I joined with Robert Cook-Deegan in filing a brief arguing that the isolated DNA claims should not be declared patent ineligible, but rather that their validity should be assessed under the more conventional requirements of patentability, i.e., novelty, nonobviousness and enablement. This time I went it alone, and filed a brief on my own behalf, available here (I believe that Bob will also likely be filing his own brief).

In my latest brief, I focus largely on the nature of genomic DNA and cDNA, and the processes by which they are "isolated," and argue that the challenged isolated DNA claims (when properly interpreted) are limited to synthetic molecules that did not originate in the human body, and which are substantially different from naturally occurring chromosomal DNA both structurally and functionally. I also address an argument made by the US government in its amicus brief, i.e., that cDNA is fundamentally different from isolated genomic DNA, and as a result claims limited to isolated cDNA should be considered patent eligible, while claims encompassing isolated genomic DNA are not patent eligible. To the contrary, I argue that isolated genomic DNA and cDNA are quite analogous, and are not different in a way that would justify differential treatment under the patent eligibility doctrine.

I also point out that the Federal Circuit’s earlier decision includes a number of unfounded assumptions regarding the utility of isolated genomic DNA, and the impact of isolated DNA patents on genetic testing and whole genome sequencing. The brief concludes by observing that a determination that any of the challenged isolated DNA claims is patent ineligible could cause serious unintended collateral damage to biotechnology, and should not be made cavalierly based on an overly simplistic and imprecise interpretation of the claims and speculation as to their potential preemptive effect.

Protein Sciences Corporation has filed its own Amicus brief, available here, which argues that:

Prometheus applies to method claims and does not change this Court’s correct decision as to the Representative Composition Claims, i.e., that isolated DNA molecules and cDNA are patent eligible subject matter under § 101; and that applying Prometheus to the Comparing or Analyzing Claims produces the same result as in Myriad, because the “transformed cells containing an altered BRCA1 gene causing cancer” are not naturally occurring cells, [and thus] the growing of those cells in the presence and absence of a putative cancer therapeutic in the Growth Rate Claim cannot be a method calling for applying a law of nature.

Eli Lilly has also submitted a brief, available here, which does not address the isolated DNA claims, but argues that claim 20 (the method claim reciting the use of BRCA gene in cell-based assay to screen for potential drug candidates) is patent ineligible if it includes a "mental step."