GENERICally Speaking - Vol. 5, 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 

  • Teva Pharms USA, Inc. v. Sandoz, Inc.
    Patent claim is indefinite when a patentee gives conflicting definitions of the term during prosecution.
  • Shire Development, LLC v. Watson Pharms., Inc.
    Claim construction relying solely upon the claims, specification, and file history is subject to de novo review despite the district court’s hearing expert testimony.
  • Novartis Pharms. Corp. v. Watson Labs., Inc.
    Appeals court affirms finding of non-obviousness as to one defendant given lack of proof evidencing motivation to combine relevant prior art references; and affirms finding of non-infringement as to second defendant because certain inactive ingredient is not a “antioxidant” as the claim requires.
  • Classen Immunotherapies, Inc. v. Elan Pharms., Inc.
    Activities related to the filing of an sNDA are exempt from infringement under 271(e)(1) safe harbor.
  • AstraZeneca LP v. Breath Ltd.
    To prove obviousness, only a reasonable expectation of success, not a guarantee, is needed.
  • Takeda Pharms. U.S.A., Inc. v. West-Ward Pharm. Corp.
    Vague product-labelling language, coupled with speculation about a physician’s medical practice, is not enough to show a likelihood of success in proving induced infringement.
  • Insite Vision Inc. v. Sandoz, Inc.
    Failure to demonstrate that one of skill would have a reasonable expectation of success for a proposed combination dooms an obviousness challenge.
  • AstraZeneca AB v. Apotex Corp.
    50 percent reasonable royalty was proper; "entire market value" rule was inapplicable in this case; and no damages may be awarded on post-expiration sales during period of pediatric exclusivity.
  • Veloxis Pharmaceuticals, Inc. v. FDA
    FDA’s decision to delay final approval of a related application during the three year exclusivity period was not arbitrary or capricious.
  • Spectrum Pharms., Inc. v. Burwell
    FDA’s approval of an ANDA carving out a specific indication was not overturned, even if the generic drug was in practice prescribed for the carved-out indication.
  • Braintree Labs., Inc. v. Novel Labs., Inc.
    Finding of infringement resulted from the finding that the proper approach to analyzing clinical trial safety data was to use a means statistical analysis, not a percentage analysis.
  • Amarin Pharms. Ireland Ltd v. FDA
    FDA’s decision not to award five-year exclusivity was set aside because of inconsistencies in construing the term “active ingredient.
  • Otsuka Pharmaceutical Co., Ltd. v. Burwell
    The FDA may approve an ANDA, which carves out an indication protected by orphan drug exclusivity as long as the ANDA with that carved out label remained safe and effective for the remaining non-protected conditions of use.
  • In re Bendamustine Consolidated Cases
    Specification providing a list of alternative compounds may form the basis for the disclosure-dedication rule to preclude a claim of infringement under the doctrine of equivalents.
  • GlaxoSmithKline LLC. v. Glenmark Generics Inc., USA
    Claim for induced infringement dismissed when generic label contains proper carve-out language, and claim for contributory infringement remains when accused products—although used in non-infringing ways—are for the most part used in accordance with the patented method.
  • Bayer Intellectual Property GmbH v. Warner Chilcott Co.
    Words of degree—i.e., “high,” “low,” “satisfactory” and “reliable”—found within a disputed claim term rendered that term invalid as indefinite.
  • Otsuka Pharm. Co., Ltd. v. Torrent Pharms. Ltd., Inc.
    Denying Otsuka’s request for an injunction because the defendant drug manufacturer’s products did not contain the pharmaceutical combination required by the claims of Otsuka’s patent.
  • Purdue Pharma L.P. v. Amneal Pharms., LLC
    Claims directed to incorporating gelling agents to combat potential drug abuse found infringed but invalid as 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.