GENERICally Speaking - Vol. 4, No. 4

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 Pharms., Inc. v. FDA
    The issue here concerns whether the Hatch-Waxman Act requires ANDA applicants to certify as to both an original and a subsequent reissue patent.
  • Sandoz Inc. v. Amgen Inc.
    The issue here is whether an alleged infringer can file declaratory judgment action seeking a finding of non-infringement and/or invalidity of patents when the alleged infringer has not filed an application with the FDA.
  • Par Pharm., Inc. v. TWI Pharms., Inc.
    Par sued TWi for infringing its patent related to the use of nanosized megestrol formulations to “increase the body mass in a human patient suffering from anorexia, cachexia, or loss of body mass.”
  • Warner Chilcott Co, LLC v. Teva Pharms. USA, Inc.
    The issue here concerns whether the district court was correct in granting summary judgment in favor of the defendants, finding that the asserted claims of the patents-in-suit were invalid due to obviousness.
  • Bristol-Myers Squibb Co. v. Teva Pharms. USA, Inc.
    The issue here concerns whether the Federal Circuit should conduct an en banc hearing regarding the issue of whether evidence that post-dates the effective filing date of the patent may be used to demonstrate unexpected results to defeat an obviousness challenge.
  • Spectrum Pharms., Inc. v. Sandoz Inc.
    Because the ANDA product did not meet the claimed dosage strength, summary-judgment of non-infringement was granted; issues concerning invalidity were not amenable to summary judgment as disputes of material fact remained.
  • Allergan, Inc. v. Actavis, Inc.
    The FDA responded to the application by identifying various deficiencies.
  • Cubist Pharms., Inc. v. Hospira, Inc.
    Cubist alleged that Hospira’s ANDA products infringe the asserted claims of the patents-in-suit. The court held a five-day bench trial.
  • Takeda Pharms. USA, Inc. v. West-Ward Pharm. Corp.
    Hikma launched the accused product, Mitigare, an oral single-ingredient colchicine product indicated for prophylaxis of gout flares in adults.
  • The Medicines Co. v. Mylan Inc.
    Generic drug manufacturer was liable for patent infringement as a matter of law when the level of acceptable impurities described in the manufacturer’s ANDA included the range of acceptable impurities claimed in the patent, and its invalidity defenses—anticipation, obviousness, non-enablement, and inequitable conduct—were rejected by the court.
  • Pfizer Inc. v. Mylan Pharms. Inc.
    When a POSA would have to undertake significant guesswork to vary the parameters of prior-art compounds in order to formulate the claimed composition, and prior-art lead compounds taught away from the claimed composition, the court found the patents-in-suit not obvious.
  • Glenmark Generics Ltd. v. Ferring B.V.
    Glenmark, who was not the first ANDA filer, was attempting to obtain FDA approval to market a generic version of drug claimed by the ’340 patent.

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.