The recent Association for Molecular Pathology v. United States Patent & Trademark Office, 2011 U.S. App. LEXIS 15649 (Fed. Cir. Jul. 29, 2011) ("Molecular Pathology") [enhanced version available to lexis.com subscribers / unenhanced version available from lexisONE Free Case Law],
decision, in which the Federal Circuit held that an isolated gene
is patent eligible subject matter had an interesting twist: The two
judges in the majority agreed on eligibility, but disagreed on the test
to apply, while the concurring and dissenting judges agreed on the test
to apply but disagreed on eligibility.
By way of background, Supreme Court in Funk Bros. Seed Co. [enhanced version available to lexis.com subscribers / unenhanced version available from lexisONE Free Case Law] and Diamond v. Chakrabarty,
447 U.S. 303 (1980) [enhanced version available to lexis.com subscribers / unenhanced version available from lexisONE Free Case Law], held that a specific combination of bacteria
species was ineligible for patent protection because the individual
species were unchanged from their natural state. Later, in Diamond v. Chakrabarty,
447 U.S. 303 (1980), the Court held that a man-made bacterium that,
unlike any naturally occurring bacteria, could break down oil, was
eligible. Distinguishing Funk Bros., the Court stated:
by contrast, the patentee has produced a new bacterium with markedly
different characteristics from any found in nature and one having the
potential for significant utility. His discovery is not nature's handiwork, but his own; accordingly it is patentable subject matter under § 101.
447 U.S. at 310 (emphasis
added.) Does the reference to "utility" simply reflect the fact that §
101, in addition to requiring that a claimed invention fall into one of
four specified categories, separately requires that the claimed
invention be useful, or does the reference to utility mean that a
composition of matter, to be eligible, must not only be physically
different from its natural counterpart, it must also have a utility that
its natural counterpart lacks? Judge Lourie, in the opinion of the
court, went with the former while the concurring and dissenting judges
went with the latter.
Molecular Pathology can
be read to mean that an isolated gene would satisfy either test such
that, barring reversal, the question of the eligibility of gene patents
is probably settled. However, it appears that going forward, courts
addressing the question of eligibility of other compositions with a
natural counterpart will have to grapple with the question of whether a
new utility is required for eligibility.
For a discussion of patent eligibility, see Milgrim on Licensing §§ 2.13-2.25 online at Lexis.com or for purchase here.
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