CAFC analyzes "skepticism" in Neptune Generics case

Neptune Generics loses to Lilly at the CAFC in pemetrexed disodium case:


Because the Board did not err in its obviousness analysis,
substantial evidence supports its underlying
fact findings, and subject matter eligibility is not properly
before the court in an appeal from an IPR decision, we affirm.



Of skepticism:


Evidence of industry skepticism is a question of fact
that weighs in favor of non-obviousness. WBIP, LLC v.
Kohler Co., 829 F.3d 1317, 1335 (Fed. Cir. 2016). The
Board found that evidence of skepticism of others, particularly the FDA,
supported a conclusion of nonobviousness.
J.A. 87. During Lilly’s clinical trials for pemetrexed, a
number of fatalities occurred. In response, Lilly recommended supplementation
with folic acid and vitamin B12.
The FDA responded that the “medical officer does not support
adding vitamins to the ongoing . . . trial.” J.A. 8748
(capitalization changed).

(...)

Petitioners argue that the Board legally erred in holding this evidence sufficient
to support a finding of skepticism because, despite the FDA’s concerns, it allowed the
trial to continue. It argues skepticism must be premised
on whether it is “technically infeasible,” “unworkable,” or
“impossible” that the claimed subject matter would work
for its intended purpose. Appellants’ Br. 51. This position
is not consistent with our caselaw, which recognizes a
range of third-party opinion that can constitute skepticism.
See, e.g., Circuit Check Inc. v. QXQ Inc., 795 F.3d 1331,
1337 (Fed. Cir. 2015) (holding testimony that third parties
were “worried” or “surprised” was sufficient to establish
skepticism). The FDA’s concerns in this case fall well
within that range. While evidence that third parties
thought the invention was impossible might be entitled to
more weight, that does not mean the Board erred in giving
weight to the skepticism evidence here. Accordingly, the
Board did not err in finding that skepticism supported a
conclusion of nonobviousness.


As to a 101 challenge in an IPR:


We do not agree. Congress expressly limited the
scope of inter partes review to a subset of grounds that can
be raised under 35 U.S.C. §§ 102 & 103. 35 U.S.C. § 311(b)
(stating that in an “inter partes review,” a petitioner is
limited to only grounds that “could be raised under section
102 or 103”). The ground of patent eligibility arises under
§ 101. Accordingly, we may not address it on appeal of an
IPR