Purdue Pharma loses at CAFC on appeals of IPR2014-377,378, and 379

Purdue Pharma L.P. (“Purdue”) appeals from the final
written decisions of the United States Patent and Trademark
Office (“PTO”) Patent Trial and Appeal Board (“the
Board”) affirming the patentability of all of the challenged
claims of U.S. Patent 6,340,475 (“the ’475 patent”) and
U.S. Patent 6,635,280 (“the ’280 patent”) in three related
inter partes review proceedings. See Purdue Pharma L.P.
v. Depomed, Inc., No. IPR2014-00377, 2015 WL 4150832
(P.T.A.B. July 8, 2015) (“Purdue I”); Purdue Pharma L.P.
v. Depomed, Inc., No. IPR2014-00378, 2015 WL 4150833
(P.T.A.B. July 8, 2015) (“Purdue II”); Purdue Pharma L.P.
v. Depomed, Inc., No. IPR2014-00379, 2015 WL 4150834
(P.T.A.B. July 8, 2015) (“Purdue III”). Because the Board
did not err in determining that Purdue, the petitioner,
failed to prove that the challenged claims are unpatentable
as obvious over the cited prior art, we affirm.


There is a New Jersey connection:


In 2013, Depomed sued Purdue in the United States
District Court for the District of New Jersey, alleging
infringement of the ’475 and ’280 patents. Purdue then
filed three petitions at the PTO requesting inter partes
review of the asserted claims on grounds that those
claims are unpatentable as, inter alia, obvious over
Baveja et al., Zero-Order Release Hydrophilic Matrix
Tablets of β-Adrenergic Blockers, 39 Int’l J. Pharmaceutics
39 (1987) (“Baveja”), U.S. Patent 5,582,837 (“Shell”), and
other references.



Reason to combine was at issue


the Board found that Purdue failed to establish a
reason to combine the prior art to achieve the claimed
invention with a reasonable expectation of success, Purdue
I, 2015 WL 4150832, at *16, *20; Purdue II, 2015 WL
4150833, at *15; Purdue III, 2015 WL 4150834, at *16.

Specifically, the Board found that, although Baveja
and Shell may have interrelated teachings, Purdue failed
to explain persuasively “how or why” a person of ordinary
skill in the art would have combined the “swelling” and
“substantially intact” features of the Shell formulation
with the Baveja formulation. Purdue I, 2015 WL
4150832, at *16; Purdue II, 2015 WL 4150833, at *15;
Purdue III, 2015 WL 4150834, at *16. The Board also
found that, to the extent that Purdue relied on the nature
of the problem to be solved to supply a reason to combine
the prior art, it improperly used hindsight by defining the
problem with a recitation of the challenged claims.



Consolidated Edison is cited:


We review the Board’s legal determinations de novo,
In re Elsner, 381 F.3d 1125, 1127 (Fed. Cir. 2004), and the
Board’s factual findings underlying those determinations
for substantial evidence, In re Gartside, 203 F.3d 1305,
1316 (Fed. Cir. 2000). A finding is supported by substantial
evidence if a reasonable mind might accept the evidence
to support the finding. Consol. Edison Co. v.
NLRB, 305 U.S. 197, 229 (1938).



Purdue tried to give an expansive reading to KSR:


Purdue argues that the Board erred by deviating from
the Supreme Court’s guidance in KSR that an obviousness
analysis involves an expansive and flexible approach
that accounts for the interrelated teachings of the prior
art and the nature of the problem to be solved. Applied
here, Purdue contends, those principles necessarily
demonstrate how and why a skilled artisan would have
had a reason to combine the interrelated teachings of
Baveja and Shell, as both references teach similar controlled-release
profiles of similar formulations with overlapping
drug-to-polymer ratios. Purdue also argues that
the problem to be solved provides a further reason to
combine Baveja and Shell, for those references already
solved the problem by teaching the drug release profile
and other limitations of the challenged claims. Purdue
maintains that its definition of the problem to be solved
came directly from Shell, not from the challenged claims.



As to evidentiary standards:


As the petitioner before the Board in an
inter partes review proceeding, Purdue bore the burden of
establishing obviousness of the challenged claims by a
preponderance of the evidence. 35 U.S.C. § 316(e). The
Board did not err in finding that Purdue failed to satisfy
that burden.




AND


Although Baveja expresses a preference for
oral dosage forms that exhibit a zero-order release profile
over those that do not, that preference does not amount to
teaching away from dosages forms with a non-zero-order
release profile. See In re Mouttet, 686 F.3d 1322, 1334
(Fed. Cir. 2012) (“[J]ust because better alternatives exist
in the prior art does not mean that an inferior combination
is inapt for obviousness purposes.”).

Nevertheless, the Board correctly recognized that “a
patent . . . is not proved obvious merely by demonstrating
that each of its elements was, independently, known in
the prior art.” KSR, 550 U.S. at 418. Indeed, it remains
“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.”
Id. (emphases added). As the Board correctly recognized,
one may look to “interrelated teachings” of multiple
references, id., or a “problem known in the field of endeavor,”
id. at 420, to determine whether there was an
“apparent reason” to combine the prior art teachings “in
the fashion claimed by the patent at issue,” id. at 418.
Although the obviousness analysis may not be confined
by any formalistic test, or by overemphasis on the
explicit teachings of prior art publications, a petitioner
must nevertheless make a sufficient showing that is more
than “mere conclusory statements,” to establish a reason
that would have prompted a skilled artisan to combine
the prior art teachings in the way of the claimed invention.
Id. at 418–19. As we have explained, a patent
challenger must demonstrate that a skilled artisan would
have had reason to combine the teachings of the prior art
references to achieve the claimed invention, and that the
skilled artisan would have had a reasonable expectation
of success from doing so. See PAR Pharm., Inc. v. TWI
Pharm., Inc., 773 F.3d 1186, 1193 (Fed. Cir. 2014).



Of "problem to be solved"


The Board
therefore did not err in finding that Purdue improperly
relied on hindsight in formulating the problem to be
solved. Insite Vision Inc. v. Sandoz, Inc., 783 F.3d 853,
859 (Fed. Cir. 2015) (“Defining the problem in terms of its
solution reveals improper hindsight in the selection of the
prior art relevant to obviousness.”).



link: http://www.cafc.uscourts.gov/sites/default/files/opinions-orders/15-2029.Opinion.3-22-2016.1.PDF