United States Court of Appeals
for the Federal Circuit
______________________
SOUTH ALABAMA MEDICAL SCIENCE
FOUNDATION,
Appellant
v.
GNOSIS S.P.A., GNOSIS BIORESEARCH S.A.,
GNOSIS U.S.A., INC.,
Appellees
______________________
2014-1778, 2014-1780, 2014-1781
______________________
Appeals from the United States Patent and Trade-
mark Office, Patent Trial and Appeal Board, in Nos.
IPR2013-00116, IPR2013-00118, IPR2013-00119.
______________________
ON PETITION FOR REHEARING EN BANC
______________________
THOMAS J. PARKER, Alston & Bird LLP, New York,
NY, for appellant. Also represented by DEEPRO
MUKERJEE, YI WEN WU; JITENDRA MALIK, Durham, NC;
KIRK T. BRADLEY, Charlotte, NC; PETER ROGALSKYJ, Law
Office of Peter Rogalskyj, Livonia, NY.
JOSEPH CWIK, Amin Talati & Upadhye, LLC,
Chicago, IL, for appellees. Also represented by JONATHAN
JACOB KRIT.
______________________
2 SOUTH ALABAMA MEDICAL SCIENCE v. GNOSIS S.P.A.
Before PROST, Chief Judge, NEWMAN, LOURIE, DYK,
MOORE, O’MALLEY, REYNA, WALLACH, TARANTO, CHEN,
HUGHES, and STOLL, Circuit Judges.
O’MALLEY, Circuit Judge, with whom WALLACH and
STOLL, Circuit Judges, join, concur in the denial of the
petition for rehearing en banc.
NEWMAN, Circuit Judge, dissents from the denial of the
petition for rehearing en banc.
PER CURIAM.
ORDER
Appellant South Alabama Medical Science Founda-
tion filed a petition for rehearing en banc. A response to
the petition was invited by the court and filed by the
appellees Gnosis S.p.A., Gnosis Bioresearch S.A., and
Gnosis U.S.A., Inc.
The petition was referred to the panel that heard the
appeal, and thereafter the petition and response were
referred to the circuit judges who are in regular active
service. A poll was requested, taken, and failed.
Upon consideration thereof,
IT IS ORDERED THAT:
The petition for rehearing en banc is denied.
The mandate of the court will issue on May 3, 2016.
FOR THE COURT
April 26, 2016 /s/ Daniel E. O’Toole
Date Daniel E. O’Toole
Clerk of Court
United States Court of Appeals
for the Federal Circuit
______________________
SOUTH ALABAMA MEDICAL SCIENCE
FOUNDATION,
Appellant
v.
GNOSIS S.P.A., GNOSIS BIORESEARCH S.A.,
GNOSIS U.S.A., INC.,
Appellees
______________________
2014-1778, 2014-1780, 2014-1781
______________________
Appeals from the United States Patent and Trade-
mark Office, Patent Trial and Appeal Board, in Nos.
IPR2013-00116, IPR2013-00118, IPR2013-00119.
______________________
O’MALLEY, Circuit Judge, with whom WALLACH and
STOLL, Circuit Judges, join, concurring in the denial of the
petition for rehearing en banc.
This is a companion appeal to Merck & Cie v. Gnosis
S.p.A., No. 2014-1779 (Fed. Cir. Dec. 17, 2015). Petitioner
South Alabama Medical Science Foundation “seeks en
banc rehearing for the same reasons addressed” by Merck
& Cie in its petition for rehearing. Pet. for Reh’g 3. I
therefore concur in the denial of rehearing en banc for the
same reasons stated in my concurrence in the companion
appeal. See Merck & Cie v. Gnosis S.p.A., No. 2014-1779
(Fed. Cir. 2016 Apr. 26, 2016) (O’Malley, J., concurring in
denial of rehearing en banc).
United States Court of Appeals
for the Federal Circuit
______________________
SOUTH ALABAMA MEDICAL SCIENCE
FOUNDATION,
Appellant
v.
GNOSIS S.P.A., GNOSIS BIORESEARCH S.A.,
GNOSIS U.S.A., INC.,
Appellees
______________________
2014-1778, 2014-1780, 2014-1781
______________________
Appeals from the United States Patent and Trade-
mark Office, Patent Trial and Appeal Board, in Nos.
IPR2013-00116, IPR2013-00118, IPR2013-00119.
______________________
NEWMAN, Circuit Judge, dissenting from denial of the
petition for rehearing en banc.
This is the companion to Merck & Cie v. Gnosis S.p.A.,
No. 14-1777 (Gnosis I), decided concurrently. As in Gno-
sis I, the panel majority applied the deferential “substan-
tial evidence” standard of review and, in doing so, adopted
the factual findings of the PTAB and affirmed the PTAB’s
cancellation of U.S. Patent Nos. 5,997,915, 6,673,381, and
7,172,778. For the reasons discussed in my dissent to the
denial of en banc rehearing in Gnosis I, I believe en banc
consideration is necessary to realign the appellate stand-
ard of review of these inter partes proceedings with the
statutory purpose of the America Invents Act.
2 SOUTH ALABAMA MEDICAL SCIENCE v. GNOSIS S.P.A.
This case illustrates the pitfalls of the deferential
“substantial evidence” standard. Despite concluding that
the PTAB erred in assessing South Alabama Medical
Science Foundation’s (SAMSF) licensing evidence, the
panel majority affirmed the PTAB’s obviousness determi-
nation, on the ground that it was supported by substan-
tial evidence.
There was extensive evidence of licensing, sublicens-
ing, and relicensing of the SASMF patents. More than
twelve companies have taken sublicenses to the SAMSF
patents, and manufacture or sell products practicing the
patents. The royalty stream for the SAMSF patents
produces millions of dollars in annual revenue. The
PTAB did not mention these as objective indicia of non-
obviousness. Instead, the PTAB dismissed all of SAMSF’s
objective evidence for lack of “nexus.” This was legal
error, as the panel majority held. The majority nonethe-
less affirmed because “that evidence is not enough to
overcome the strong evidence of obviousness . . . relied
upon by the Board to reach its conclusion of obviousness.”
Gnosis II at 8. This too was legal error, for all of the
evidence must be considered together in evaluating obvi-
ousness. Graham v. John Deere Co., 383 U.S. 1, 17
(1966); Leo Pharm. Products, Ltd. v. Rea, 726 F.3d 1346,
1357 (Fed. Cir. 2013) (“Whether before the Board or a
court, this court has emphasized that consideration of the
objective indicia is part of the whole obviousness analysis,
not just an afterthought.”)
This is a crowded field of science, with conflicting ex-
perimental results, from which it was not reasonably
predictable that the compositions that were eventually
developed would be biologically effective and commercial-
ly successful. Objective indicia such as commercial suc-
cess “may often be the most probative and cogent evidence
[of non-obviousness] in the record,” Procter & Gamble Co.
v. Teva Pharm. USA, Inc., 566 F.3d 989, 998 (Fed. Cir.
2009) (modification in original) (quoting Stratoflex, Inc. v.
SOUTH ALABAMA MEDICAL SCIENCE v. GNOSIS S.P.A. 3
Aeroquip Corp., 713 F.2d 1530, 1538 (Fed. Cir. 1983)).
Considerations of biological effect and commercial and
public response are a balance to judicial hindsight. In re
Cyclobenzaprine Hydrochloride Extended-Release Capsule
Patent Litigation, 676 F.3d 1063, 1075-76 (Fed. Cir. 2012)
(“The objective considerations, when considered with the
balance of the obviousness evidence in the record, guard
as a check against hindsight bias.”).
Precedent requires that the objective evidence be con-
sidered together with the other evidence relating to the
question of obviousness. In turn, my colleagues also err
in law, for our appellate role includes assuring that the
correct law is applied by the PTAB. Although the panel
majority finds substantial evidence to support the PTAB’s
conclusion, less than all of the evidence was analyzed and
weighed by the PTAB. On the entirety of the record,
including the objective considerations, the petitioner has
not established invalidity by a preponderance of the
evidence, as required by statute.
Thus I respectfully dissent from the court’s refusal to
reconsider this case en banc.