GENERICally Speaking Hatch Waxman Bulletin

The Hatch-Waxman Litigation practice group at Robins Kaplan LLP is pleased to offer the latest edition of their quarterly publication regarding ANDA patent litigation issues and the generics business.

Vol. 8, No. 2

Summer 2018

Relevant court decisions highlighted in this issue:

  • Impax Labs Inc. v. Lannett Holdings Inc., LLC
    Having found no teaching away and nexus between secondary considerations of non-obviousness and the asserted claims, the Federal Circuit affirmed the validity of the patents-in-suit.
  • UCB, Inc. v. Accord Healthcare, Inc.
    Finding that the district court applied the correct standards, the Federal Circuit majority affirmed the district court’s findings of fact and conclusions of law that the asserted claims were not anticipated, obvious, or invalid for obviousness-type double patenting.
  • Endo Pharms. Inc. v. Teva Pharms. USA, Inc.
    The Federal Circuit affirms the district court’s judgment that the asserted patents were not invalid and were infringed.

Relevant ANDA updates highlighted in this issue:

  • ANDA Approvals
  • ANDA Litigation Settlements
  • Generic Launches
  • New ANDA Cases
Having found no teaching away and nexus between secondary considerations of non-obviousness and the asserted claims, the Federal Circuit affirmed the validity of the patents-in-suit.
Plaintiff proved infringement of method-of-treatment claims under the doctrine of equivalents because in solution, the accused product and the claimed invention dissociate into the identical active ion that is responsible for the claimed treatment.
The court granted summary judgment of infringement because the functional compound in a chemotherapy treatment drug disassociated in administration and thus the initial ionic bond was not relevant.
The court rejects defendant’s invalidity attacks, premised on double patenting and prosecution laches arguments.
Finding that the district court applied the correct standards, the Federal Circuit majority affirmed the district court’s findings of fact and conclusions of law that the asserted claims were not anticipated, obvious, or invalid for obviousness-type double patenting.
The Federal Circuit affirms the district court’s judgment that the asserted patents were not invalid and were infringed.
The court denied dispositive motions for infringement and invalidity, but granted summary judgment that the patents-in-suit claimed patentable subject matter.
Because the prior art did not suggest an injectable pharmaceutical solution that was stable for 24 months, no reasonable fact finder could conclude the asserted claims were obvious.
The district court’s claim construction, which resulted in defendants’ stipulation of infringement, was affirmed in view of the intrinsic evidence.
Finding subject matter jurisdiction under 35 U.S.C. § 271(e)(2) and that an infringement claim may arise under 35 U.S.C. § 271(e)(2)(A) where the asserted patent issued after the ANDA was filed, the Federal Circuit affirmed the district court’s finding of infringement and adequate written description, and also agreed that upon a finding of patent infringement under § 271(e)(2), the district court must order remedies in accordance with § 271(e)(4).

Vol. 8, No. 1

Spring 2018

Vol. 8, No. 3

Fall 2018