SANOFI-AVENTIS U.S., LLC, SANOFI MATURE IP, SANOFI, Plaintiffs-Appellants
DR. REDDY'S LABORATORIES, INC., DR. REDDY'S LABORATORIES, LTD., SANDOZ, INC., Defendants-Appellees FRESENIUS KABI USA, LLC, ACCORD HEALTHCARE, INC., APOTEX CORP., APOTEX INC., ACTAVIS LLC, ACTAVIS ELIZABETH LLC, MYLAN LABORATORIES LIMITED, Defendants-Cross-Appellants
Appeals from the United States District Court for the
District of New Jersey in Nos. 3:14-cv-07869-MAS-LHG,
3:16-cv-05678-MAS-LHG, Judge Michael A. Shipp.
William E. Solander, Venable LLP, New York, NY, argued for
plaintiffs-appellants. Also represented by Katherine Adams,
Dominick A. Conde, Whitney Lynn Meier, Daniel John Minion.
L. Rapalino, Goodwin Procter LLP, Boston, MA, argued for all
Fresenius Kabi USA, LLC, Actavis LLC, Actavis Elizabeth LLC
also represented by Daryl L. Wiesen, Eric Romeo; Aviv
Zalcenstein, New York, NY.
M. Alul, Taft, Stettinius & Hollister, LLP, Chicago, IL,
argued for all defendants-cross-appellants.
Defendants-cross-appellants Apotex Corp., Apotex Inc. also
represented by Roshan Shrestha.
Rodriguez, Windels Marx Lane & Mittendorf LLP, Madison,
NJ, for defendants-appellees Dr. Reddy's Laboratories,
Inc., Dr. Reddy's Laboratories, Ltd. Also represented by
A. Lydigsen, Brinks Gilson & Lione, Chicago, IL, for
defendant-appellee Sandoz, Inc. Also represented by Mark
Herbert Remus, Joshua James.
T. Aly, Schiff Hardin, Chicago, IL, for
defendant-cross-appellant Accord Healthcare, Inc. Also
represented by Helen H. Ji.
Matthew R. Reed, Wilson, Sonsini, Goodrich & Rosati, PC,
Palo Alto, CA, for defendant-cross-appellant Mylan
Laboratories Limited. Also represented by Wendy L. Devine,
Kristina M. Hanson, San Francisco, CA.
Lourie, Moore, and Taranto, Circuit Judges.
LOURIE, CIRCUIT JUDGE.
(collectively, "Sanofi") appeal from the judgment
of the U.S. District Court for the District of New Jersey
holding, after a bench trial, claims 7, 11, 14-16, and 26 of
U.S. Patent 8, 927, 592 (the "'592 patent")
invalid as obvious. Sanofi-Aventis U.S. LLC v. Fresenius
Kabi USA, LLC, No. 14-7869 (D.N.J. Dec. 19, 2017)
(collectively, "Fresenius") cross-appeal from the
same judgment holding claims 1 and 2 of U.S. Patent 5, 847,
170 (the "'170 patent") not invalid as obvious.
Because there was no case or controversy with respect to
claims 7, 11, 14-16, and 26 of the '592 patent when the
district court issued its decision, we vacate the court's
decision concerning those claims. We affirm the court's
judgment that the '170 patent is not invalid as obvious.
owns the '170 and '592 patents, respectively claiming
the compound cabazitaxel and methods of using it. Sanofi
markets cabazitaxel under the trade name Jevtana® to
treat certain drug-resistant prostate cancers. Both the
'170 and '592 patents are listed in the Orange
as covering cabazitaxel.
belongs to a family of compounds called taxanes and is the
third and most recent taxane drug to gain approval by the
Food and Drug Administration ("FDA"). The other two
are paclitaxel, approved in 1992, and docetaxel, approved in
1996. The chemical structures of docetaxel and cabazitaxel
are depicted below:
annotated above, cabazitaxel differs from docetaxel in the
substitution of two methoxy groups for hydroxyl groups. The
carbon atoms to which the right and left meth-oxy groups are
bound are referred to as C7 and C10, respectively. A fully
numbered cabazitaxel is depicted in Appendix A, and the
carbon positions are numbered in the same way in
was the product of a multi-year research program aimed at
identifying taxane analogs with better activity than
docetaxel in resistant tumors. By making substitutions at
multiple positions on docetaxel with various functional
groups, Sanofi scientists synthesized several hundred
compounds and tested their activities. Of this group,
cabazitaxel was one of two compounds that entered into human
studies. It obtained FDA approval in 2010.
and the other defendants-appellees (collectively,
"Defendants") filed Abbreviated New Drug
Applications ("ANDAs") to market generic versions
of cabazitaxel prior to the expiration of the '592 and
'170 patents, prompting Sanofi to sue the Defendants for
infringement in the District of New Jersey. Defendants
counterclaimed for a declaratory judgment of invalidity of
the '592 patent. The case ultimately proceeded to a bench
trial concerning both patents.
while the district court case was pending, the Patent Trial
and Appeal Board (the "Board") of the United States
Patent and Trademark Office instituted inter partes
review of the '592 patent. Soon after the district court
trial began, the Board held claims 1-5 and 7-30 unpatentable
as obvious and denied Sanofi's motion to amend its
claims. Although Sanofi did appeal from the Board's
denial of its motion to amend, it did not appeal from the
Board's decision with respect to claims 7, 11, 14-16, and
26. And on December 8, 2017, Sanofi filed a statutory
disclaimer of those claims (the "disclaimed
claims") in the Patent and Trademark Office and so
informed the district court. J.A. 14135-36; see 37
C.F.R. § 1.321(a).
after the disclaimer, the district court entered a post-trial
order reaching two conclusions relevant to this appeal.
First, despite the statutory disclaimer of the disclaimed
claims, the court concluded that a case or controversy still
existed with respect to those claims and that they were
invalid as obvious. Decision, slip op. at 45-46,
79-83. Second, the court held that the Defendants failed to
prove that claims 1 and 2 of the '170 patent, claiming
the cabazitaxel compound and related pharmaceutical
compositions (and set forth in Appendix B), would have been
obvious over the prior art. Id. at
appealed from the district court's conclusion that a case
or controversy still existed over the disclaimed claims after
Sanofi's statutory disclaimer. Fresenius cross-appealed
from the court's judgment of nonobviousness of claims 1
and 2 of the '170 patent. We have jurisdiction over both
appeals under 28 U.S.C. § 1295(a)(1). We first address
Sanofi's jurisdictional appeal and then turn to
review de novo whether a case or controversy existed
for the district court to enter a declaratory judgment of
noninfringement or invalidity, Prasco, LLC v. Medicis
Pharm. Corp., 537 F.3d 1329, 1335 (Fed. Cir. 2008), and
apply Federal Circuit law, 3M Co. v. Avery Dennison
Corp., 673 F.3d 1372, 1377 (Fed. Cir. 2012).
argues that after it disclaimed the particular claims, there
was no longer a case or controversy regarding those claims,
and the district court thus lacked authority to invalidate
them. Accordingly, Sanofi requests that we vacate the
court's judgment invalidating the disclaimed claims.
respond that there may still have been a case or controversy
over the disclaimed claims depending on the merits of their
potential future issue or claim preclusion defense, which
Defendants could raise if Sanofi succeeds in amending claims
of the '592 patent and then asserts the amended claims
against Defendants. That is, Defendants insist we must
resolve this potential preclusion issue in the first instance
in order to decide whether the district court had
jurisdiction over the disclaimed claims.
III empowers federal courts to adjudicate only
"Cases" and "Controversies," U.S. Const.
art. III, § 2, "appropriately resolved through the
judicial process," Lujan v. Defs. of Wildlife,
504 U.S. 555, 560 (1992) (quoting Whitmore v.
Arkansas, 495 U.S. 149, 155 (1990)). To satisfy the case
or controversy requirement in the declaratory judgment
context, the parties' dispute must be "'real and
substantial' and 'admi[t] of specific relief through
a decree of a conclusive character, as distinguished from an
opinion advising what the law would be upon a hypothetical
state of facts.'" MedImmune, Inc. v. Genentech,
Inc., 549 U.S. 118, 127 (2007) (alteration in original)
(quoting Aetna Life Ins. Co. v. Haworth, 300 U.S.
227, 240-41 (1937)). The case or controversy analysis is
highly similar to that of Article III standing. See
Apotex, Inc. v. Daiichi Sankyo, Inc., 781 F.3d 1356,
1362 (Fed. Cir. 2015). "To have standing, a plaintiff
must 'present an injury that is concrete, particularized,
and actual or imminent; fairly traceable to the
defendant's challenged behavior; and likely to be
redressed by a favorable ruling.'" Dep't of
Commerce v. New York, 139 S.Ct. 2551, 2565 (2019)
(quoting Davi ...