IP Law Daily, PATENT—D.C. Cir.: Court upholds FDA’s refusal to approve amended Norwich drug application before 2029, (Jul 7, 2026)

By Patricia K. Ruiz, J.D.

The court found the agency correctly read a Delaware patent judgment as barring final approval of the application regardless of later amendments.

A federal appeals court affirmed summary judgment for the FDA and Salix Pharmaceuticals, holding that the agency correctly interpreted a Delaware patent-infringement judgment as prohibiting final approval of Norwich Pharmaceuticals’ Abbreviated New Drug Application (ANDA) No. 214369 until October 2029. The court concluded that the Delaware judgment unambiguously applied to the identified ANDA itself and that neither the judgment’s text nor its litigation history supported Norwich’s contention that amendments removing an infringing use from the application permitted earlier approval (Norwich Pharmaceuticals, Inc. v. Kennedy, No. 23-5311 (D.C. Cir. Jun. 26, 2026)).

Background. Salix Pharmaceuticals sued Norwich in the District of Delaware, alleging that Norwich’s ANDA for a generic version of Xifaxan infringed Salix patents. The Delaware court determined that the ANDA infringed patents related to treatment of hepatic encephalopathy, while other asserted patents, including patents relating to irritable bowel syndrome with diarrhea, were invalid as obvious.

When crafting final judgment, the parties disagreed about the effect of possible future amendments to the application. Norwich sought language that would allow the FDA to approve ANDA No. 214369 if the company later removed labeling tied to hepatic encephalopathy. Salix argued that the judgment should apply to the ANDA without qualification. The Delaware court adopted Salix’s position and ordered that the effective date of any final FDA approval of ANDA No. 214369 could be no earlier than expiration of the relevant patents, then identified as October 2, 2029, plus any applicable regulatory exclusivity.

Afterward, Norwich amended the application to remove the hepatic encephalopathy indication and sought relief from the judgment under Rule 60(b). The Delaware court denied that request. The U.S. Court of Appeals for the Federal Circuit later affirmed, stating that the order restricted final approval of the entire ANDA until 2029 while noting that nothing in the judgment prevented approval of a new, noninfringing ANDA.

FDA’s approval decision. The FDA declined to grant final approval to Norwich’s amended application and instead issued only tentative approval, concluding that the Delaware judgment barred final approval before October 2029. Norwich then sued in the District of Columbia, claiming the agency acted arbitrarily, capriciously, or otherwise contrary to law (see IP Law Daily, Nov. 2, 2023). The district court granted summary judgment to the FDA and Salix, and Norwich appealed.

Plain language of the judgment. The court held that the FDA’s interpretation followed the judgment’s plain meaning. The Delaware order specifically identified ANDA No. 214369 and directed that final approval of that application could not occur before October 2029. Because the amended application remained the same ANDA number, the court said the agency’s reading “tracks the most straightforward reading of the final judgment.” According to the court, the judgment’s directive that “any final approval” of ANDA No. 214369 be delayed until the specified date meant that the application could not receive approval before then, regardless of subsequent amendments.

Litigation history reinforces the text. The court said the surrounding litigation history confirmed that interpretation. Before entry of final judgment, Norwich expressly sought language permitting immediate approval of an amended ANDA, but the Delaware court rejected that proposal, stating that an amended ANDA was not before it. The court reasoned that the Delaware court’s refusal to include the requested language undermined Norwich’s current argument that the judgment implicitly produced the same result.

The court pointed to Norwich’s own Rule 60(b) filings, which repeatedly characterized the Delaware judgment as preventing FDA approval of the amended ANDA. Those filings, the court said, demonstrated that Norwich itself initially understood the judgment to block approval of the application even after amendment.

The Delaware court denied Norwich’s effort to modify the judgment, and the Federal Circuit interpreted the judgment as restricting final approval of the entire ANDA until 2029. The court said Norwich was now asking for a reading that would effectively insert language the Delaware court had twice declined to adopt.

Rejection of the Ferring argument. Norwich relied on the Federal Circuit’s decision in Ferring B.V. v. Watson Laboratories, Inc.-Florida, arguing that amended ANDAs can be treated differently from original applications. The court found the case distinguishable. In Ferring, the judgment expressly addressed an amended ANDA, and the defendant had committed during trial to amend its application. By contrast, the Delaware judgment in this case did not mention an amended ANDA, and Norwich sought to alter its application only after trial and final judgment. The court further emphasized that the Delaware court had twice rejected Norwich’s request to exclude an amended ANDA from the scope of its order. That procedural history, the court said, made Ferring inapposite.

Disposition.The court concluded that the Delaware judgment barred approval of ANDA No. 214369 until expiration of the infringed patents in October 2029, whether or not the application was amended. Because the FDA followed that judgment, the agency did not act arbitrarily, capriciously, or contrary to law in delaying final approval. The court affirmed the judgment in favor of the FDA and Salix.

The Case is No. 23-5311.

Judge: Walker, J.

Attorneys: Andrew D. Prins (Latham & Watkins LLP) for Norwich Pharmaceuticals, Inc. J. Kain Day, U.S. Department of Justice, for Robert F. Kennedy.

Companies: Norwich Pharmaceuticals, Inc.

Cases: Patent DistrictofColumbiaNews GCNNews