Eric E. Bensen on the Federal Circuit's Holding That Isolated Genes Are Patent Eligible

Eric E. Bensen on the Federal Circuit's Holding That Isolated Genes Are Patent Eligible

Addressing patent eligibility for the third time in less than a year, the Federal Circuit affirmed the long-standing rule that an isolated gene is patent eligible subject matter. However, it was the concurring and dissenting judges that agreed on the test to be used to determine eligibility. The fractured nature of the decision underscores the difficult questions that eligibility can present. In this Analysis, Eric Bensen dissects Ass'n for Molecular Pathology v. United States PTO, 2011 U.S. App. LEXIS 15649 (Fed. Cir. July 29, 2011) [enhanced version available to subscribers / unenhanced version available from lexisONE Free Case Law] and examines the decision's implications. He writes:

Transcription & Reverse Transcription:

District Court Decision

     The District Court concluded that all of the challenged claims were invalid as drawn to ineligible subject matter. With respect to the isolated gene sequence claims, the court concluded that "defining characteristic" of DNA-its physical embodiment of the information required to synthesize proteins-is identical in its native and isolated forms and, thus, the structural and functional differences between the native BRCA genes and the isolated genes claimed by the patents did not render the isolated gene "markedly different" from the native gene. Although cDNA is artificially synthesized and, unlike naturally occurring DNA sequences, does not contain introns, it too was ineligible subject matter in the court's view because it sequences were otherwise identical to sequences found in native DNA. That fact that the isolated gene molecule can be used in ways that native gene cannot did not render it markedly different in the court's view because those uses depend on the isolated gene molecule having the identical nucleotide sequence found in native gene.

     The method claims faired no better. The court concluded that the Analyzing Claims were directed to the abstract mental process of "comparing" or "analyzing" gene sequences. Also, although the sequencing process as a whole may require the transformation of physical items, such transformations were merely preparatory steps to the claimed process that were not themselves recited in the claim language. It added that even if the preparatory steps were recited in the claim language, they would amount to nothing more that data gathering steps, which would be insufficient to render the mental process patent eligible.


The Federal Circuit's Decision

     Although the Federal Circuit ultimately concluded then an isolated gene patent is patent eligible, the two judges in the majority had different reasons for so concluding. Needless to say, the dissent had a very different view. The Federal Circuit's decision, then, can best be understood by looking at the individual opinions of the three judges.

     Judge Lourie (Opinion of the Court). Judge Lourie concluded that isolated genes are patent eligible subject matter because the claimed gene molecules were "markedly different" from the molecules that exist in nature. Specifically, each claimed molecule was a portion of, and thus different from, the much larger native DNA molecule. Judge Lourie focused on the fact that a gene molecule is "cleaved" from the DNA molecule, i.e., its covalent bonds to the larger molecule are broken. As a result, each gene molecule had a "distinctive chemical identity in nature" from the native molecules.

     Judge Lourie rejected the argument that the gene molecules were merely "purified" molecules and, thus, products of nature. As he explained, "[p]urification makes pure what was the same material, but was previously impure." An isolated gene molecule, on the other hand, is a distinct chemical entity.

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