GENERICally Speaking: A Hatch-Waxman Litigation Bulletin 2025 Q3

By Oren Langer, Christopher Pinahs, Patrick Griffin, Demitri Dawson, and Christy May

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:

Janssen Pharms., Inc. v. Teva Pharms. USA, Inc.
Invega Sustenna® (paliperidone palmitate)
On appeal for the second time, the Federal Circuit rejected generic manufacturer’s arguments that the district court erred in failing to apply a presumption of obviousness and otherwise finding that there was no motivation to combine or reasonable expectation of success.
Mallinckrodt plc v. Airgas Therapeutics LLC
INOmax® (nitric oxide)
(On the eve of trial, the court considered and ruled on multiple summary judgment and Daubert motions.
Radius Health, Inc. v. Orbicular Pharm. Techs. Private Ltd.
Tymlos® (abaloparatide)
After a ten-day bench trial, the court issued findings of facts and conclusions of law finding valid claims in all of the asserted patents.
Novo Nordisk, Inc. v. Mylan Pharms. Inc.
Wegovy® (semaglutide)
In view of the proposed generic product label, the court granted defendant’s Rule 12(c) motion and entered judgment of no direct, contributory, and induced infringement of the asserted patent under § 271(e)(2)(A).
In re Entresto (sacubitril/valsartan) Patent Litigation (Novartis Pharms. Corp. v. MSN Pharms. Inc.)
Entresto® (sacubitril / valsartan)
The unreliability of plaintiff’s reference standard to determine infringement, combined with an adverse inference for plaintiff’s failure to produce the sample, led the court to conclude that plaintiff did not meet its burden to prove infringed by a preponderance of the evidence.
In re Selenious Acid Litigation
Selenious Acid
After finding that defendants were not likely to succeed on their Section 112 defenses and that Plaintiff would be irreparably harmed if defendants launched their generic products, the court entered a preliminary injunction.