Norwich Pharmaceuticals, Inc. v. Robert F. Kennedy, Jr.

United States Court of Appeals
FOR THE DISTRICT OF COLUMBIA CIRCUIT
Argued December 11, 2025 Decided June 26, 2026
No. 23-5311
NORWICH PHARMACEUTICALS, INC.,
APPELLANT
v.
ROBERT F. KENNEDY, JR., IN HIS OFFICIAL CAPACITY AS
SECRETARY OF HEALTH AND HUMAN SERVICES, ET AL.,
APPELLEES
Appeal from the United States District Court
for the District of Columbia
(No. 1:23-cv-01611)
Andrew D. Prins argued the cause for appellant. With
him on the briefs were Matthew S. Murphy, Nicholas L.
Schlossman, Rachael L. Westmoreland, and Lia Rose Barrett.
Aziz Burgy and Chad A. Landmon entered appearances.
J. Kain Day, Attorney, U.S. Department of Justice, argued
the cause for federal appellees. With him on the brief were
Brett A. Shumate, Assistant Attorney General, and Daniel
Tenny, Attorney. Joshua Dos Santos and Benjamin C. Wei,
Attorneys, entered appearances.

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Bryan Killian argued the cause for appellee Salix
Pharmaceuticals, Inc. With him on the brief were Douglas
Hastings and Brendan J. Anderson.
Before: PILLARD, WALKER and GARCIA, Circuit Judges.
Opinion for the Court filed by Circuit Judge WALKER.
WALKER, Circuit Judge: This case concerns a district
court’s final judgment. The judgment identified a drug
application by its specific number and said that the FDA cannot
approve the application until a specific date.
The question is whether that judgment implicitly permits
the FDA to approve an amended version of that specific
application before that specific date.
Because it doesn’t, we affirm.
I. Background
A. Litigation in Delaware
Salix Pharmaceuticals invented a drug called Xifaxan. It
helps people suffering from irritable bowel syndrome with
diarrhea and from hepatic encephalopathy.1
Norwich Pharmaceuticals wants to market a generic
competitor to Salix’s drug. So Norwich filed an Abbreviated
New Drug Application with the Food and Drug
Administration. The FDA gave that ANDA the number
214369.
1 Hepatic encephalopathy is a type of brain dysfunction due to liver
disease.

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Salix believed that Norwich’s ’369 ANDA infringed
Salix’s patents. So Salix sued Norwich in the United States
District Court for the District of Delaware. That court held
that Norwich’s ’369 ANDA infringed Salix’s patents related to
the treatment of hepatic encephalopathy, but that the rest of
Salix’s patents at issue — including for irritable bowel
syndrome with diarrhea — were invalid as obvious.
The Delaware District Court then asked Norwich and Salix
to propose language for the court’s final judgment. Both
parties agreed that the court’s findings meant that the FDA
could not approve Norwich’s original ’369 ANDA until Salix’s
hepatic-encephalopathy patents expire in October 2029. But
beyond that the parties presented “starkly conflicting” views.
JA 154.
Norwich wanted a final judgment that would allow the
FDA to immediately approve Norwich’s ’369 ANDA if
Norwich amended it to remove labeling related to hepatic
encephalopathy. Salix disagreed. It wanted a judgment that
would “apply to ‘Norwich’s ANDA,’ period.” JA 135.
The Delaware District Court rejected Norwich’s proposal.
The court instead agreed with Salix to bar the FDA from
approving Norwich’s ’369 ANDA until the expiration of
Salix’s hepatic-encephalopathy patents in October 2029. The
court’s final judgment said:
Pursuant to 35 U.S.C. § 271(e)(4)(A), it is hereby ordered
that the effective date of any final approval by the Food
and Drug Administration (“FDA”) of Norwich’s
ANDA No. 214369 is to be a date not earlier than the
date of expiration of the last to expire of the [hepatic-
encephalopathy] Patents (currently October 2, 2029), plus
any regulatory exclusivity to which Plaintiffs are or
become entitled.

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JA 135–36 (quoting Dkt. 4-5 at 3) (emphases added).
Norwich then filed an amended ’369 ANDA with the FDA
that no longer sought approval of the drug for treatment of
hepatic encephalopathy. The next day Norwich filed a Rule
60(b) motion asking the Delaware District Court to change its
judgment. Norwich argued that “the predicate for ordering
[the] FDA to delay the effective date of the approval of
Norwich’s ANDA . . . no longer exists” because of Norwich’s
amendments to its ’369 ANDA. JA 78.
The Delaware District Court denied Norwich’s motion. It
reasoned that Norwich should not be able to “litigate a case
through trial and final judgment based on a particular ANDA,
and then, after final judgment, change the ANDA to what it
wishes it had started with, and win in a summary proceeding.”
JA 116.
On appeal to the Federal Circuit, Norwich argued that the
Delaware District Court should not have ordered the FDA to
delay final approval of its amended ANDA until October 2029.
The Federal Circuit agreed with Norwich’s understanding of
the Delaware District Court’s final judgment — i.e, that the
final judgment “restricted final approval of the entire ANDA,
including the non-infringing indication, until 2029.” Salix
Pharmaceuticals., Ltd. v. Norwich Pharmaceuticals Inc., 98
F.4th 1056, 1068 (Fed. Cir. 2024). But the Federal Circuit
affirmed the Delaware District Court, noting that the District
Court’s final judgment “said nothing that would prevent
approval [by the FDA] of a new non-infringing ANDA.” Id.
(emphasis added).
B. Litigation in the District of Columbia
The FDA declined to grant final approval of Norwich’s
amended ’369 ANDA. Instead, the FDA granted only

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tentative approval. It reasoned that the Delaware District
Court’s final judgment barred it from granting final approval
until October 2029.2
Norwich sued the FDA in the United States District Court
for the District of Columbia. It claimed that the FDA acted
arbitrarily, capriciously, or otherwise contrary to law when it
did not grant final approval of Norwich’s amended ’369
ANDA.
The district court granted summary judgment to the FDA
and intervenor Salix.
Norwich appealed.
We affirm.3
II. Analysis
In this appeal, Norwich does not challenge the lawfulness
of the Delaware District Court’s judgment. Nor does Norwich
argue that the FDA was free not to follow that judgment.
Rather, Norwich says that the FDA misread the judgment to
require a delay of Norwich’s amended ANDA until October
2029.
2 According to the government, the FDA issued a new tentative-
approval decision after the Federal Circuit’s opinion, relying on the
“same reasoning” as the prior decision. Gov’t Br. 28 n.6. That
new decision therefore repeats the same alleged errors as the prior
one, “preserv[ing], rather than moot[ing]” the present
controversy. Union of Concerned Scientists v. Nuclear Regul.
Comm’n, 711 F.2d 370, 379 (D.C. Cir. 1983) (citation omitted).
3 We also affirm the district court’s denial of Norwich’s motion for
a preliminary injunction.

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A. The FDA Applied The Plain Meaning Of The Final
Judgment
Norwich’s interpretation of the Delaware District Court’s
final judgment is incorrect. The final judgment listed
Norwich’s ’369 ANDA by number. JA 68. And it ordered a
delay of that ANDA’s final approval until October 2029. Id.
(“the effective date of any final approval by the Food and Drug
Administration (‘FDA’) of Norwich’s ANDA No. 214369 is to
be a date not earlier than the date of expiration of the last to
expire of the [hepatic-encephalopathy] Patents (currently
October 2, 2029)”). That means Norwich’s ’369 ANDA
cannot be approved until October 2029. And because
“Norwich’s ANDA, even as amended, is still” the ’369 ANDA,
“the FDA’s determination tracks the most straightforward
reading of the final judgment.” JA 154.
B. Context Confirms The Final Judgment’s Plain Text
“That plain-language reading of the final judgment is
reinforced . . . by the extensive briefing and argument that
came before and after its entry.” Id.
Let’s start with Norwich’s briefing before the Delaware
District Court’s final judgment. Norwich asked for express
language allowing the FDA to immediately approve an
amended ’369 ANDA. But the Delaware District Court
refused, explaining that an amended ’369 ANDA “is
immaterial to this analysis” because it “is not before me.”
Dkt. 4-6 at 2. By refusing to issue a final judgment saying
what Norwich wanted the judgment to say, the court refused to
issue a judgment saying what Norwich now says the judgment
means.
Now consider Norwich’s briefing after that final
judgment. Norwich repeatedly said in its Rule 60(b) motion

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that the Delaware District Court’s judgment does not mean
what Norwich now says it means:
• “Here, the circumstances that led to the entry of the
order blocking FDA approval – Norwich’s proposed
ANDA labeling for the HE Indication – no longer
exists.” JA 90 (emphasis added).
• “[I]t is no longer equitable to prospectively enjoin the
approval of Norwich’s Amended ANDA.” JA 90
(emphasis added).
• “Norwich invokes Rule 60(b)(5) to remove the
bottleneck preventing FDA’s approval of Norwich’s
Amended ANDA.” JA 91 (emphasis added).
• “Foreclosing FDA’s approval of Norwich’s
Amended ANDA for seven years poses an extreme
hardship to Norwich.” JA 94 (emphasis added).
• “The prohibition on FDA’s approval of Norwich’s
ANDA Product is also detrimental to the public
interest . . . .” JA 94 (emphasis added).
• “The Court should modify the relief granted in the
Judgment . . . to remove the absolute prohibition on
FDA’s approval of Norwich’s Amended ANDA
before October 2, 2019.” JA 83 (emphasis added).
Finally, recall that the Delaware District Court denied
Norwich’s 60(b) motion to amend its final judgment
“[f]oreclosing FDA’s approval of Norwich’s Amended ANDA
for seven years.” Norwich’s Rule 60(b) Opening Br. at 17 (JA
94). That means Norwich is now arguing “that the final
judgment is best read implicitly to include the qualifying
language that the court explicitly declined to include — twice.”

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JA 156. In addition, it is asking us to read the final judgment
contrary to the Federal Circuit’s interpretation of it. See Salix
Pharmaceuticals, 98 F.4th at 1068 (“[T]he order restricted
final approval of the entire ANDA, including the non-infringing
[part], until 2029.”) (emphasis added).
We decline to do so. The FDA read the Delaware District
Court’s final judgment correctly — as did Norwich at the time,
as did the Federal Circuit, and as did the District Court for the
District of Columbia.
C. Ferring B.V. Does Not Help Norwich
Norwich points to a final judgment by the district court in
Ferring B.V. v. Watson Laboratories, Inc.-Florida, 764 F.3d
1382 (Fed. Cir. 2014). That final judgment distinguished
between an original ANDA and an amended ANDA “when
deciding the issue of infringement,” id. at 1390–91, just as
Norwich believes the Delaware District Court did here. As the
Federal Circuit explained, the Ferring B.V. district court held
“that [the original ANDA] infringed” certain patents but said
the defendant’s “[s]tipulat[ion] to amend its ANDA . . . moots
Plaintiff’s Complaint with regard to [defendant’s] proposed
ANDA amendment.” Id. at 1387 (quoting JA 18).
Unlike in Ferring B.V., however, the final judgment by the
Delaware District Court here made no mention of an amended
ANDA. In addition, the context in Ferring B.V. was different
because the defendant there had promised during trial to
amend its ANDA. 764 F.3d at 1386. Here, Norwich
“litigate[d] a case through trial and final judgment based on a
particular ANDA, and then, after final judgment, [tried to]
change the ANDA to what it wishes it had started with” in an
attempt to “win in a summary proceeding.” JA 116.

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Though we cannot know what the district court in Ferring
B.V. would have done in our case’s circumstances, we know
what the Delaware District Court did. It twice rejected
Norwich’s proposal to expressly exclude an amended ANDA
from its broadly worded final judgment. And it did so in part
because Norwich had not done during trial what the defendant
had done in Ferring B.V.
III. Conclusion
The Delaware District Court’s final judgment means what
the FDA understood it to mean — and what Norwich
understood it to mean when it was issued: Norwich’s ’369
ANDA, whether amended or not, may not be approved until
Salix’s infringed patents expire in October 2029.
The FDA therefore did not act arbitrarily, capriciously, or
otherwise contrary to law by delaying final approval of
Norwich’s amended ’369 ANDA until October 2029.
We affirm.
So ordered.

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