Wednesday, November 27, 2019

CAFC says PTAB lacked reasoned basis in Merck case: too cryptic to survive judicial review

The outcome

It is well established that “[t]he agency tribunal must
make findings of relevant facts, and present its reasoning
in sufficient detail that the court may conduct meaningful
review of the agency action.” In re Lee, 277 F.3d 1338, 1346
(Fed. Cir. 2002). “The [Board]’s own explanation must suffice for
us to see that the agency has done its job and must
be capable of being ‘reasonably . . . discerned’ from a relatively
concise [Board] discussion.” In re NuVasive, Inc., 842
F.3d 1376, 1383 (Fed. Cir. 2016) (quoting In re Huston, 308
F.3d 1267, 1281 (Fed. Cir. 2002)).
On appeal, Merck argues that the Board’s decisions
here fail to provide a reasoned basis for upholding claim 18.
For the reasons discussed below, we agree.

The issue

Instead, the question was whether it was obvious to
conjugate the 13 serotypes to the CRM197 protein in a single
vaccine. The Board’s decision rests on its finding that the
study discussed in Peña did not show that “a formulation
comprising each of the thirteen known serotypes conjugated to a CRM197 [protein] . . . was even considered, tried
and successful.” J.A. 44. Standing alone, this finding is
insufficient to support a lack of motivation or a reasonable
expectation of success. Obviousness, unlike anticipation,
does not require a prior art successful formulation. See Par
Pharm., 773 F.3d at 1198. Here, there was conflicting evidence as to motivation and reasonable expectation of success—evidence not discussed by the Board.


“If all
elements of a claim are found in the prior art, as is the case
here, the factfinder must further consider the factual questions of whether a person of ordinary skill in the art would
be motivated to combine those references . . . .” Dome Patent L.P. v. Lee, 799 F.3d 1372, 1380 (Fed. Cir. 2015); see
also KSR Int’l Co. v. Teleflex Inc., 550 U.S. 398, 418
(2007) (“[I]t can be important to identify a reason that
would have prompted a person of ordinary skill in the relevant field to combine the elements in the way the claimed
new invention does.”).

The conclusion:

We conclude that the Board’s decision
is too cryptic to survive judicial review.
Under these circumstances, “we have consistently vacated and remanded for further proceedings.” In re Van
Os, 844 F.3d 1359, 1362 (Fed. Cir. 2017). We therefore vacate the Board’s obviousness findings with respect to claim
18, and remand for further consideration of the parties’ arguments and evidence as to (1) motivation to combine and
(2) reasonable expectation of success and, if the Board finds
a sufficient motivation to combine and reasonable expectation of success, other issues such as secondary considerations.4 We do not reach Merck’s remaining arguments.

See also BloombergLaw post: Merck Gets Second Shot at Axing Wyeth’s Vaccine Patent Claim


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