August 16, 2012

Genetics or Chemistry? Federal Circuit Again Upholds Gene Patents

The Federal Circuit has just issued its newest opinion in the gene patent case, Association for Molecular Pathology v. Myriad Genetics (AMP v. USPTO). This case was reargued before the court in late July, so this is a quick turnaround (see here). This case is a challenge from a coalition of patients, researchers and medical organizations to the validity of granting patents on isolated genes; specifically, the BRCA1 and BRCA2 breast cancer genes. The Federal Circuit had previously issued a ruling in 2011 which upheld patent claims to genes and DNA primers, while it invalidated method claims that relied on comparing DNA sequences to identify mutations.This latest appeal was directed to the decision on the genes (compositions of matter in patent terms) – and followed a petition to the Supreme Court, which remanded back in view of the Mayo v. Prometheus decision this year. In an opinion again authored by Judge Lourie, the court has returned to much of its reasoning in 2011, holding that isolated genes are not “products of nature” and also do not bear on a law of nature. The court rejects the arguments that the native coding sequences of the isolated genes are identical to natural DNA sequences (and make them products of nature), and finds that the laboratory manipulations that produce the extracted gene are enough to qualify as inventive work. Judge Moore, while concurring, was more receptive to considering how Mayo, although directed to method claims, provides analytic help in evaluating the patentability of genes. She dissected the various patent claim types (primers, cDNAs, genes) to find that the patenting of genes is most problematic because the isolated gene has most of the natural character, and continues to find them valid. There is a hint that she might have ruled against the gene claims ("on a blank slate"), but is constrained by the awareness of the long-standing PTO practice and “settled expectations;” she declares an implicit approval of gene patenting by Congress after its failure to carve out any special legislative treatment for genes, despite a number of bills that have been introduced to do so. Judge Bryson dissented and would have invalidated the patent claims to isolated genes and DNA fragments that mimic natural molecules. He suggests a focus on genetics, not chemistry, in evaluating function, not just structure, and because function is retained, he concludes that the isolated gene is a natural compound ineligible for patenting (that is also my analysis of these patent claims, as I argued here). Bryson also rejects any deference to the PTO or undue concern for any settled practices, noting that there can be no adverse possession claim for patent rights. The ACLU (lead attorneys for plaintiffs) was disappointed in the ruling, calling it a "devastating decision for a woman's health" (PubPat is co-counsel on the case). What’s next? A likely appeal for an en banc review by the full Federal Circuit or another petition for certiorari to the Supreme Court. The Supreme Court will take a more expansive view of the similar policy underpinnings between its Mayo decision and the AMP case, and could take the opportunity to clarify broad principles of patent eligibility that transcend claim categorization.  

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