GENERICally Speaking - Vol. 3, No. 2

The Hatch-Waxman Litigation practice group at Robins Kaplan LLP is pleased to offer the latest edition of its 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

  • FTC v. Actavis, Inc.
    Reverse-payment settlement agreements may sometimes violate antitrust laws and a rule-of-reason approach guided by antitrust principles should apply.
  • Novo Nordisk A/S v. Caraco Pharma. Labs., Ltd.
    Finding of obviousness affirmed because patentee could not "overcome" prima facie obviousness with evidence of unexpected results, and finding of unenforceability reversed because omissions, although "troubling," were not material.
  • Dey L.P. v. Sunovion Pharma., Inc.
    Clinical trial was not "public use" under 102(b), therefore summary judgment of invalidity was reversed.
  • Aventis Pharma., Inc. v. Amino Chemicals Ltd.
    Reversing and remanding the case finding that the district court misconstrued the term "substantially pure."
  • Allergan, Inc. v. Sandoz, Inc. 
    Appellate court reversed in part district court's finding of non-obviousness when prior art taught claimed combination drug.
  • Bayer Healthcare Pharma., Inc. v. Watson Pharma., Inc.
    Appellate court reversed finding of validity after prior art (i) found to disclose not only hormonal replacement therapy, but also contraceptive applications, and (ii) taken as a whole, did not teach away from claimed invention.
  • Takeda Pharma. Co., Ltd. v. Zydus Pharma. USA Inc.
    Patent-in-suit infringed as a result of meeting particle size limitation as evidenced by expert testing and favorable claim construction; patent-in-suit not invalid given expert witness credibility finding and knowledge of person of ordinary skill.
  • Braintree Labs., Inc. v. Novel Labs., Inc.
    As a result of credibility findings pertaining to the parties' respective expert witnesses, court held patent-in-suit not invalid.
  • Alcon Research, Ltd. v. Apotex, Inc.
    Defendant is able to defeat a summary-judgment motion of no inequitable conduct given the lesser burden than having to prove inequitable conduct at trial, and the court's finding that reasonable trier of fact could conclude that patentees withheld material information from USPTO.
  • Shire Development LLC v. Watson Pharma., Inc.
    Finding expert's testing and testimony credible, court finds ANDA product infringes melting point claim limitations and rejects lack of written description and non-enablement invalidity arguments.
  • Allergan, Inc. v. Apotex, Inc.
    Granting plaintiffs' motions seeking a permanent injunction after finding that the patents were valid and infringed.
  • Purdue Pharma L.P. v. Varam, Inc.
    Patent-in-suit not invalid, particularly in view of the same or similar arguments being raised, and rejected, in previous actions.
  • Takeda Pharm. Co., Ltd. v. TWI Pharm., Inc.
    There is no requirement under the Hatch-Waxman Act that a patent must be listed in the Orange Book in order for a drug manufacturer to bring an infringement action.
  • AstraZeneca LP v. Breath Ltd.
    First patent-in-suit found infringed, but invalid as obvious and anticipated; second patent-in-suit not infringed as a result of court's claim construction of "micronized powder composition."

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.