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 lexis.com 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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