Wednesday, August 28, 2019

MALLINCKRODT case raises significant 101 questions

Judge Newman's dissent which began as follows raised significant issues with the way the CAFC treated the 101 issue in this case:

I concur in correction of the technical error, where the
district court included in its decision some claims that were
not there at issue. However, I respectfully dissent from the
majority’s rulings that the claims at issue are ineligible for
patenting under Section 101. The claims are for a method
of medical treatment—a class of subject matter whose eligibility under section 101 is established by precedent.

Judge Newman discussed past 101 cases [102 and 103 were not implicated in this case]:

Heretofore, Federal Circuit precedent has been reasonably consistent in holding that
methods of medical treatment are eligible for patenting. See Athena Diagnostics,
Inc. v. Mayo Collaborative Servs., LLC, 927 F.3d 1333,
1367–68 (Fed. Cir. 2019) (Newman, J., dissenting from denial of rehearing en banc)
(collecting cases on eligible methods of treatment and ineligible methods of diagnosis).
The subject matter herein routinely complies with section 101;
the court mis-steps in holding that “[t]he natural phenomenon here is undisputed,” whereby the method of treatment
is also deemed to be a natural phenomenon. Maj. Op. at 9.


The majority’s argument that a method of treatment of
an affliction affecting human physiology is ineligible under
section 101 contravenes precedent. See, e.g., Rapid Litig.
Mgmt. Ltd. v. CellzDirect, Inc., 827 F.3d 1042, 1048–49
(Fed. Cir. 2016) (method of treating disease “to achieve ‘a
new and useful end,’ is precisely the type of claim that is
eligible for patenting” (quoting Alice Corp. Pty. Ltd. v. CLS
Bank Int’l, 573 U.S. 208, 217 (2014))). My colleagues
acknowledge that the claims include “[a] treatment step of
administering,” Maj. Op. at 11, but state that this step is
“not the focus of the claimed invention,” id., and that “[t]he
claimed invention is focused on screening for a natural
law,” id. at 14–15. However, patent eligibility is determined not for isolated steps, but for the claimed invention
as a whole. Eligibility does not depend on whether some of
the claim steps were known. The Court reiterated in Diamond v. Diehr, 450 U.S. 175 (1981):


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