Background - Practices (Details)

Pharmaceutical & Biologics Litigation

Representative Engagements

  • Pfizer, Inc., et al. v. Watson Laboratories, Inc.- Florida. Representing Watson in patent infringement action involving a generic version of Embeda® (sulfate and naltrexone hydrochloride).
  • Watson Pharmaceuticals, Inc., et al. v. Bayer Pharma AG, et al. Representing Watson in malicious prosecution action against Bayer alleging it improperly enforced patents against a generic version of Yasmin® (drospirenone and ethinyl estradiol) oral contraceptive product.
  • The Howard-Florey Institute v. Kleiner, Perkins et al. Representing Plaintiff
    Howard Florey Institute of Neurosciences in dispute over licensing of its IP rights in relaxin and related polypeptides.
  • MorphoSys v. Cambridge Antibody Technology (CAT). Successfully tried a three-week biotech patent jury trial regarding phage display antibody library technology which is the core intellectual property in Abbott's Humira® biologic. CAT's antibody patents were upheld against claims of invalidity.
  • Takeda Pharmaceutical, Co., Ltd., et al. v. Handa Pharmaceuticals, LLC and Par Pharmaceutical, Inc. Represented Par in six-day bench trial in patent infringement action involving a generic version of Dexilant® (dexlansoprazole).
  • Shire Development LLC, et al. v. Watson Pharmaceuticals, Inc., et al. Represented Watson in five-day bench trial in patent infringement action involving a generic version of Lialda® (mesalamine).
  • Bayer HealthCare Pharmaceuticals, Inc. v. Watson Pharmaceuticals, Inc. Represented Watson in patent infringement action involving a generic version of Yaz® (drospirenone and ethinyl estradiol) oral contraceptive product. Successfully appealed to the Federal Circuit resulting in reversal of adverse summary judgment of non-obviousness and a holding by the appeals court invalidating Bayer's patent.
  • In Re Armodafinil Patent Litigation (MDL). Lead MDL trial counsel representing first-filer Mylan in ANDA litigation involving a generic version of Nuvigil® (armodafinil). Defeated motion for temporary restraining order and preliminary injunction, and obtained a favorable settlement.
  • Bayer Schering Pharma AG, et al. v. Sandoz Inc., et al. Represented Watson in ANDA litigation involving a generic version of Yasmin® (drospirenone and ethinyl estradiol) oral contraceptive product. Defeated motion to extend the 30-month stay, resulting in defendant's successful at-risk launch. Obtained Rule 12(c) defense judgment on the pleadings of non-infringement that Bayer's asserted patent did not cover the FDA-approved use of the drug. Argued and obtained affirmance of non-infringement at the Federal Circuit.
  • Cephalon Inc. and CIMA Labs, Inc. v. Watson Pharmaceuticals, Inc. et al. Represented first-filer Watson in a patent infringement action involving a generic version of Fentora® (fentanyl citrate) resulting in a trial court entering judgment of invalidity and non-infringement on both Orange Book-listed patents. Federal Circuit reversed on invalidity and affirmed non-infringement.
  • Duramed Pharmaceuticals Inc. v. Watson Laboratories Inc. Represented first-filer Watson in a patent infringement action involving a generic version of Seasonique® (ethinyl estradiol and levonorgestrel) resulting in successful at-risk launch. Obtained reversal by Federal Circuit of the district court's grant of summary judgment of no invalidity, and defeated subsequent motion for temporary restraining order and preliminary injunction, including defending same successfully at Federal Circuit after emergency and expedited appeals.
  • Teva Women's Health Inc. v. Lupin Ltd., et al. Represented first-filer Watson in patent infringement action involving a generic version of LoSeasonique® (ethinyl estradiol and levonorgestrel) oral contraceptive product and obtained favorable settlement prior to defendant's filing of motion for summary judgment.