TUTORIAL IT

Amicus Brief Filed By Alnylam Pharmaceuticals Argues That Funk Bros Is About Obviousness Not Patent Eligibility

Alnylam Pharmaceuticals is a biopharmaceutical company based in Cambridge, Massachusetts focused on developing synthetic "small interfering RNAs" (SiRNAs) as therapeutic agents. It has filed an amicus curiae brief in the Myriad gene patent case (AMP v. US PTO) that makes a number of insightful points, particularly in attempting to "debunk myths of Funk Brothers Seed Co. v. Kalo Inoculant Co."

Funk Brothers is generally assumed to be a case about patent eligibility. However, Alnylam points out that Funk Brothers was decided by the Supreme Court in 1948, prior to the enactment of the 1952 patent statute and thus prior to 35 USC 101, which is the statutory basis for the patent eligibility doctrine. Prior to 1952, the Court used the term “invention” to refer to "inventiveness," a concept that subsequent to 1952 and the enactment of 35 USC 103 we refer to as "nonobviousness." The Court in Funk Brothers found the claimed subject matter was not the “product of invention,” but Alnylam argues that post-1952 this statement should be interpreted a finding of obviousness, not patent ineligibility.

I have always found it extremely difficult, if not impossible, to find a principled distinction between the inventions claimed in Funk Brothers and Diamond V. Chakrabarty that would justify finding only Dr. Chakrabartys invention patent eligible. In Funk Brothers, the alleged invention was a novel and useful combination, in a single inoculant, of naturally occurring microorganisms in a combination that did not exist naturally. Chakrabarty’s invention was a novel and useful combination, in a single microorganism, of naturally occurring plasmids in a combination that did not exist naturally. It is important to bear in mind that Chakrabartys invention did not involve any genetic engineering at the molecular level.

In Funk Brothers, it has been pointed out that while the combination of bacteria in a single inoculant was novel, the bacteria function in the same manner and have the same characteristics as they would have in nature. But the same can be said regarding the plasmids Dr. Chakrabarty introduced into a single microorganism. These were naturally occurring plasmids, and in the claimed microorganism they encoded the exact same proteins, and performed the exact same function as they did in their natural state.

In a nutshell, Funk Brothers was a novel combination of naturally occurring bacteria capable of achieving novel and useful function, with the bacteria functioning in the same manner as they do in nature. Chakrabarty was a novel combination of naturally occurring plasmid DNA capable of achieving novel and useful function, with the plasmid DNA functioning in the same manner as they do in nature. I dont see how one invention can be patent eligible and the other not. However, if Funk Brothers was really decided based on obviousness rather than patent eligibility, as argued by Alnylam, the two decisions are easily reconciled.

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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."

Available link for download