GENERICally Speaking: A Hatch-Waxman Litigation Bulletin 2024 Q4

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:

Purdue Pharma L.P. v. Accord Healthcare, Inc.
OxyContin® (oxycodone HCl)
Federal Circuit affirmed finding of obviousness when district court did not err in finding a motivation to combine with a reasonable expectation of success and also did not dismiss Plaintiffs’ secondary consideration arguments.
Teva Branded Pharm. Products R&D, Inc. v. Amneal Pharms. of NY, LLC
ProAir® HFA (albuterol sulfate)
To list a patent in the Orange Book, that patent must, among other things, claim at least the active ingredient; thus, patents claiming just the device components of the product approved in an NDA do not meet the listing requirement of claiming the drug for which the applicant submitted the application.
Galderma Labs., L.P. v. Lupin Inc.
Oracea® (doxycycline USP)
The Court of Appeals affirmed the district court’s finding of no infringement related to a combination immediate/delayed release pharmaceutical formulation.
Novartis Pharms. Corp. v. MSN Pharms., Inc.
Entresto® (valsartan/sacubitril)
The Federal Circuit declined to reconsider and reweigh “highly factual evidence anew” and affirmed the district court’s denial of a preliminary injunction.
Janssen Pharms., Inc. v. Teva Pharms. USA, Inc.
Slynd® (drospirenone)
Formulation claims reciting limitations concerning particle size and dissolution properties were found valid and infringed after a bench trial.
Melinta Therapeutics, LLC v. Nexus Pharms., Inc.
Minocin® (minocycline)
After a bench trial, the court found that the asserted formulation claims were infringed and not invalid.
Novartis Pharms. Corp. v. Becerra
Entresto® (sacubitril/valsartan)
After finding that FDA did not act arbitrarily by excluding part of Entresto’s dosing regimen from the generic manufacturer’s drug label, the court upheld FDA approval for the generic manufacturer.
Exelixis, Inc. v. MSN Labs. Private Ltd.
Cabometyx® (cabozantinib (L)-malate)
Although defendant did not infringe one of the patents-in-suit, the remaining patents-in-suit were found infringed and not invalid on the basis of obvious-type double patenting.
Silvergate Pharms., Inc. v. Bionpharma Inc.
Epaned® (enalapril maleate)
Defendant’s motion for fees on the basis that Plaintiff pursued the litigation for an improper purpose, made arguments that were objectively baseless, and acted in an unreasonable manner in litigating the case, was denied.