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GENERICally Speaking - Vol. 7, 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

  • Mylan Institutional LLC v. Aurobindo Pharma Ltd.
    District court improperly applied the “function, way, result” test in granting a preliminary injunction concerning process patents, but properly evaluated obviousness and irreparable harm for a purity patent.
  • Braintree Labs., Inc. v. Breckenridge Pharm., Inc.
    Affirming previous claim construction in related case, the district court erred in finding that proposed label would not induce physicians to practice the claimed method.
  • Helsinn Healthcare S.A. v. Teva Pharms. USA, Inc.
    A sale that is conditioned on FDA approval is still a sale for the purposes of the on-sale bar and the AIA’s amendments to the on-sale bar did not change its scope with regards to public disclosure.
  • The Medicines Co. v. Mylan, Inc.
    Because the “efficient mixing” term was a claim limitation in both patents-in-suit, the district court’s finding of infringement with respect to one of those patents was reversed.
  • Forest Labs., LLC v. Sigmapharm Labs., LLC
    Because the word “excitation” in the claim does not include within its scope “mania,” the patent-in-suit, which is not obvious and meets all the requirements of Section 112, is not infringed.
  • The Medicines Co. v. Mylan Inc.
    The Federal Circuit’s decision on the issue of infringement precludes a trial on remand as to the doctrine of equivalents.
  • Sebela Int’l Ltd. v. Actavis Labs. Florida Inc.
    Finding of non-infringement is warranted where 18 peaks, each identified by wavenumber, are claimed but only 17 peaks are found in the accused product; asserted method claims are held invalid as obvious when all the claimed limitations are within the prior art and secondary considerations mostly weigh in favor of obviousness.
  • GlaxoSmithKline LLC v. Glenmark Pharms. Inc., USA
    Because plaintiffs may rely on circumstantial evidence to prove intent related to their inducement claim, the court recommended denial of defendants’ motion for summary judgment.
  • Teva Pharms. USA, Inc. v. Sandoz Inc.
    Transfer was appropriate when there was pending litigation in another district involving the same patent and parties.
  • Horizon Pharma Ireland Ltd. v. Actavis Laboratories, UT, Inc.
    The formulation of Pennsaid 2% was not a result of routine optimization of the formulation of Pennsaid 1.5%, therefore the claims were not obvious.
  • Par Pharm., Inc. v. Luitpold Pharms., Inc.
    Allegations of infringement about a would-be formulation and seeking discovery about highly confidential, competitive information concerning that would-be formulation necessitated an exceptional case finding and an award of fees and costs.
  • Alza Corp. v. Amneal Pharmaceuticals of New York, LLC
    Motion for judgment on the pleadings was denied where claim construction and expert discovery was necessary to decide the issue of non-infringement.

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.