GENERICally Speaking: A Hatch-Waxman Litigation Bulletin 2025 Q2

This quarterly issue of the GENERICally Speaking campaign provides you and your company with some of the knowledge beneficial to remaining attentive to the complexity of ANDA patent litigation.

In this issue:

Jazz Pharms., Inc. v. Avadel CNS Pharms., LLC
(Lumryz®/sodium oxybate)
The Federal Circuit reversed-in-part, vacated-in-part, and remanded the district court’s decision denying Defendant’s emergency motion to stay the injunction relating to its clinical trials under the safe-harbor provision of § 271(e)(1).
Metacel Pharms. LLC v. Rubicon Research Private Ltd.
(Ozobax®/baclofen)
Federal Circuit affirmed summary judgment of no induced infringement when ANDA label merely allows, but does not instruct, the storage of a drug at the claimed temperature range.
Azurity Pharms., Inc. v. Alkem Labs. Ltd.
(Firvanq®/vancomycin HCl)
Because the district court correctly found that the patent owner disclaimed any presence of propylene glycol in the prosecution history of the patent-in-suit, and generic manufacturer’s ANDA product contained propylene glycol, the Federal Circuit affirmed the finding of non-infringement.
Astellas Pharma Inc. v. Zydus, Inc. II
(Myrbetriq®/mirabegron)
The unfairness associated with potential inconsistent outcomes between patents and defendants outweighs the prejudice of litigating an issue that is already a part of the consolidated litigation so the court granted defendants motion for relief from stipulation.
United Therapeutics Corp. v. Liquidia Techs., Inc.
(Tyvaso®/treprostinil)
Given the likelihood that the patent-in-suit was invalid, Plaintiff’s speculative irreparable harm arguments, and the public interest favoring market entry of another product for treating pulmonary hypertension, the court denied Plaintiffs’ motion for a TRO and PI.
Ingenus Pharms., LLC v. Nexus Pharms., Inc.
(cyclophosphamide)
Presiding over cross motions for summary judgment, the court denied plaintiff’s motion for infringement and granted defendant’s motion for invalidity on the basis of indefiniteness.
Liquidia Techs., Inc. v. FDA
(Yutrepia®/treprostinil)
The court dismissed on the basis of lack of standing Defendants’ cross claims challenging FDA’s decision to allow Plaintiff to amend its NDA to add a new indication.
Norwich Pharms., Inc. v. Kennedy Jr.
(Xifaxan®/rifaximin)
(The court granted FDA’s cross motion for summary judgment when it found that FDA’s decision that intervenor-defendant did not forfeit its 180-day exclusivity by (i) failing to market or (ii) failing to obtain approval was not contrary to law.)
Astellas Pharma Inc. v. Zydus, Inc. I
(Myrbetriq®/mirabegron)
The unfairness associated with potential inconsistent outcomes between patents and defendants outweighs the prejudice of litigating an issue that is already a part of the consolidated litigation so the court granted defendants motion for relief from stipulation.