Thursday, February 28, 2008

Comiskey and Its Implications for Biotechnology Patents

In In re Comiskey, 499 F.3d 1365 (2007), the Federal Circuit held that claims reciting a “method for mandatory arbitration resolution regarding one or more unilateral documents,” which encompassed modes of practicing the method independently of a computer, were invalid under Section 101 for claiming unpatentable “mental processes.” However, the court held that other claims in the application that were limited to computer-implemented modes of performing the process could be patentable, stating that “[w]hen an unpatentable mental process is combined with a machine, the combination may produce patentable subject matter.”

Why do I bring up Comiskey on a blog dedicated to biotech IP? The decision includes a fascinating discussion of the interplay between patentable subject matter under 101 and nonobviousness under 103. The court opines that “[claims limited to computer-implemented modes of performing the method] at most merely add a modern general purpose computer to an otherwise unpatentable mental process []. The routine addition of modern electronics to an otherwise unpatentable invention typically creates a prima facie case of obviousness. Moreover, there is no pertinent evidence of secondary considerations because the only evidence offered is of long-felt need for the unpatentable mental process itself, not long-felt need for the combination of the mental process and a modern communication device or computer.” (footnotes omitted)

In other words, this panel of the Federal Circuit seems to be seriously suggesting that software that carries out a process that could be performed mentally is prima facie obvious, even if the underlying process is itself nonobvious. This would call into question the validity of a large number of software and business method patent claims.

But what most interests me is the implications for biotechnology and the patenting of genetic and biology-based inventions. “Laws of nature” and “natural phenomena” are clearly unpatentable under Supreme Court precedent, and thus it is well established that genes as they exist in nature (e.g., in the human body) are not patentable. It is only by isolating or chemically synthesizing a gene, or engineering it into a recombinant construct, that the genetic sequence is rendered “made by man” and hence patentable. Likewise, the discovery of a biological correlation cannot be patented per se.

But if the suggestion in Comiskey is correct, then could one not extrapolate and argue that an unpatentable phenomenon of nature (e.g., a naturally occurring genetic sequence, signaling pathway, or biological correlation), when combined with an obvious practical application of the phenomenon (e.g., an isolated polynucleotide or genetic construct embodying the genetic sequence, a process for inhibiting the signaling pathway, or a process of detecting and recognizing the correlation) is likewise prima facie obvious? Under the rationale proposed in Comiskey, this would apparently be the case even if the underlying phenomenon was itself nonobvious. What would be the ramifications for the validity of many gene patents, or patents broadly claiming the detection of genetic mutations or polymorphisms (think Myriad’s BRCA patents), or methods of correlating levels of metabolites in the human body (think LabCorp v. Metabolite), or methods of inhibiting a biological signaling pathway (think Ariad’s NF-kB patent and its litigation with Lilly and Amgen)? I think the ramifications could potentially be quite significant, particularly when considered in conjunction with KSR and In re Kubin (depending upon how the Federal Circuit decides that important case for biotechnology).

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