GENERICally Speaking - Vol. 8, No. 2

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, GENERICally Speaking: A Hatch-Waxman Litigation Bulletin.

Taking on an ANDA patent litigation requires significant corporate resources, time, and money. Staying on top of industry news and outcomes, following trends in the judiciary and the steps others are taking, and keeping informed of recently-enacted rules and legislation are critical.

This bulletin provides you and your company with some of the knowledge beneficial to remaining attentive to the complexity of ANDA patent litigation. We hope you find it helpful.

Relevant Court Decisions

  • 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.
  • Sumitomo Dainippon Pharma Co. v. Emcure Pharms. Ltd.
    The district court’s claim construction, which resulted in defendants’ stipulation of infringement, was affirmed in view of the intrinsic evidence.
  • Vanda Pharms. Inc. v. West-Ward Pharms. Int’l Ltd.
    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).
  • Eli Lilly & Co. v. Dr. Reddy’s Labs., Ltd.
    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.
  • Eli Lilly & Co. v. Hospira, Inc.
    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.
  • Shire Orphan Therapies LLC v. Fresenius Kabi USA, LLC
    The court rejects defendant’s invalidity attacks, premised on double patenting and prosecution laches arguments.
  • Pernix Ir. Pain DAC v. Alvogen Malta Operations, Ltd.
    The court denied dispositive motions for infringement and invalidity, but granted summary judgment that the patents-in-suit claimed patentable subject matter.
  • Valeant Pharms. Int’l v. Mylan Pharms.
    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 articles on our Website include some of the publications and papers authored by our attorneys, both before and after they joined our firm. The content of these articles should not be taken as legal advice.