GENERICally Speaking - Vol. 5, 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

  • Cubist Pharms., Inc. v. Hospira, Inc.
    Certificate of correction correcting structural diagram of a claimed compound did not broaden the patent’s claims nor did it render the patent invalid on written-description grounds.
  • Prometheus Labs., Inc. v. Roxane Labs., Inc.
    Species patent is obvious in view of genus patent where all of the claim limitations in the species patent were present in the prior art and the differences between the prior art and the instant claims are insubstantial.
  • Spectrum Pharms., Inc. v. Sandoz, Inc.
    The substantially pure claimed compound was obvious when both the 50/50 mixture and the pure compound were known in the art; the ANDA product also does not infringe the patent when the dosage strength is well below the claimed amount.
  • Helsinn Healthcare S.A. v. Dr. Reddy’s Labs., Ltd.
    All of the patents-in-suit were valid and enforceable, and all but one—because of a different dosage strength associated with the proposed ANDA product—were infringed.
  • Otsuka Pharm. Co., Ltd. v. Zydus Pharms. USA
    To properly bring a claim for induced infringement, plaintiff must make allegations—supported by fact so as to make those allegations plausible—regarding Defendants’ specific intent or any specific acts taken to encourage direct infringement.
  • Cumberland Pharms., Inc., v. Mylan Institutional LLC,
    FDA correspondence in connection with a pending NDA did not render the patent-in-suit invalid on the basis of derivation; also, the FDA approval letter and approved package insert did not render that patent invalid on the bases of anticipation and obviousness.

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.