Polsinelli’s Hatch-Waxman team has experience leading Abbreviated New Drug Application (ANDA) cases and represents some of the world’s largest, best-known, and most influential generic, brand, and specialty pharmaceutical companies. Our attorneys have litigated everything from blockbuster products, to smaller market and specialty pharmaceutical, in both first-to-file and later filer cases. We understand that each case, and each client, requires its own approach, and we partner with our clients to develop a strategy to achieve our client’s specific business goals in a cost-efficient manner.

Our attorneys have first-chair experience litigating Hatch-Waxman cases in key venues, including the federal courts in Delaware, New Jersey, the Eastern District of Texas, the Southern District of New York, and the Northern District of Illinois. We are skilled courtroom advocates, and we bring to bear our team member’s backgrounds in chemistry, organic chemistry, biochemistry, biology, pharmacy, medicine, molecular biology, microbiology, neuroscience, pharmacology, genetics, immunology, and molecular biophysics, among others.

Over the past twenty years, our attorneys have successfully litigated cases involving the following drugs:
  • Abilify® (aripiprazole)
  • ACTOplus met XR® (pioglitazone HCl+metformin HCl)
  • Adenoscan® (adenosine)
  • Angiomax® (bivalirudin)
  • Aptensio XR® (methylphenidate hydrochloride)
  • Avodart® (dutasteride)
  • Bepreve® (bepotastine besilate) ophthalmic solution
  • Brevibloc® (esmolol HCl)
  • Cenestin® (synthetic conjugated estrogens, A)
  • Combigan® (brimonidine tartrate+timolol maleate) ophthalmic solution
  • Enablex® (darifenacin hydrobromide)
  • FazaClo ODT® (clozapine ODT)
  • Fortamet® (metformin HCl)
  • Hysingla® (hydrocodone bitartrate)
  • Intermezzo® (zolpidem tartrate) 
  • Istalol® (timolol maleate) ophthalmic solution
  • Jalyn® (dutasteride+tamsulosin HCl)
  • Latisse® (bimatoprost) ophthalmic solution
  • Miralax® (polyethylene glycol 3350)
  • Mucinex® (guaifenesin)
  • Nexavar® (sorafenib)
  • NuLev® (hyoscyamine sulfate)
  • Oxecta® (oxycodone HCl)
  • Pepcid Complete® (famotidine + calcium carbonate + magnesium hydroxide)
  • PhosLo Gelcap® (calcium acetate)
  • Picato® (ingenol mebutate)
  • Precedex® (dexmedetomidine HCl)
  • Prilosec® (omeprazole)
  • Prolensa® (bromfenac sodium) ophthalmic solution
  • Rapaflo® (silodosin)
  • Reclast® (zoledronic acid)
  • Sancuso® (granisetron)
  • Seldane® (terfenadine)
  • Suprep Bowel Prep Kit® (magnesium sulfate anhydrous + potassium sulfate + sodium sulfate)
  • Treanda® (bendamustine hydrochloride)
  • Velcade® (bortezomib)
  • Viagra® (sildenafil citrate)
  • Xyrem® (sodium oxybate)
  • Zometa® (zoledronic acid)

Our knowledge of the pharmaceutical sciences includes compositions and APIs, formulations (oral dosage forms, controlled release, ODTs, transdermal, topical, ophthalmic, transmucosal, parenteral, etc.), methods of use, polymorphs, enantiomers, drug delivery devices, and methods of manufacture. We assist clients every step of the way—from preparing and filing an ANDA or 505(b)(2) application, through trial, appeal, and/or settlement. Our multidisciplinary team includes trial attorneys, FDA and antitrust counsel, patent attorneys, and agents.

Among other things, we are versed in:
  • Researching and evaluating the landscape of relevant Orange- and non-Orange Book patents
  • Rendering freedom to operate, non-infringement, and invalidity opinions
  • Litigating Hatch-Waxman cases through trial and appeal
  • Representing Watson Pharmaceuticals, Inc. n/k/a Actavis, Inc., Watson Laboratories, Inc. and Watson Pharma, Inc. n/k/a Actavis Pharma, Inc. in pending Hatch-Waxman litigation over LATISSE® (bimatoprost topical solution, 0.03%).
  • Representing Watson Laboratories, Inc. in pending Hatch-Waxman litigation over COMBIGAN® (brimonidine and timolol).
  • Represented Noven Pharmaceuticals, Inc. in Hatch-Waxman litigation over LIDODERM® (lidocaine patch 5%) brought by Endo Pharmaceuticals. Settled one week before trial with early generic entry for Noven. 
  • Represented Watson Laboratories, Inc. – Florida in Hatch-Waxman litigation over AVODART® (dutasteride) and JALYN® (dutasteride and tamsulosin).
  • Representing Watson Pharmaceuticals, Inc. n/k/a Actavis, Inc. and Watson Laboratories, Inc. in pending Hatch-Waxman litigation over VIAGRA® (sildenafil).
  • Represented first-filer Novel Laboratories, Inc. in six-day bench trial over SUPREP® (sulfate salt solution) and on appeal, with Federal Circuit reversing district court’s claim construction and vacating grant of summary judgment of infringement.
  • Representing first-filer Novel in pending Hatch-Waxman litigation over INTERMEZZO® (zolpidem tartrate) brought by Purdue Pharma.
  • Represented Andrx Corp. and other Andrx entities in Hatch-Waxman litigation over FORTAMET® (metformin hydrochloride) to protect against generic entry by Lupin, Mylan, and Nostrum, obtaining favorable settlements following several years of litigation involving at-risk launch and injunctive proceedings.
  • Represented Watson Pharmaceuticals, Inc. and Watson Laboratories, Inc. in Hatch-Waxman litigation over CENESTIN® (synthetic conjugated estrogens, A), obtaining final judgment of no infringement in favor of Watson.
  • Represented Akorn, Inc. in Hatch-Waxman litigation over ADENOSCAN® (adenosine), securing favorable settlement.
  • Representing Watson Pharmaceuticals, Inc. n/k/a Actavis, Inc. and Andrx Labs, LLC in pending Hatch-Waxman litigation over ACTOPLUS MET XR® (metformin hydrochloride and pioglitizone).
  • Representing Watson Laboratories, Inc. and Actavis, Inc. in pending Hatch-Waxman litigation over RAPAFLO® (silodosin).
  • Represented Taro Pharmaceutical Industries Ltd. and Taro Pharmaceuticals U.S.A., Inc. in Hatch-Waxman litigation over VANOS® (fluocinonide) cream 0.1% brought by Medicis Pharmaceutical Corp. Achieved favorable settlement of dismissal with prejudice and early generic entry for Taro.
  • Represented Taro in Hatch-Waxman litigation involving the anticonvulsant drug CARBATROL® (carbamazepine). Obtained a covenant not to sue and license from Shire LLC. 
  • Secured trial verdict and permanent injunction in favor of Takeda Pharmaceutical Company Ltd. in Hatch-Waxman litigation to protect PREVACID® (lansoprazole) from a challenge by Teva, the world's largest generic pharmaceutical company. PREVACID, a proton pump inhibitor, was one of the top-10 selling drugs in the world with annual sales in excess of $4 billion. 
  • Obtained summary judgment of non-infringement and invalidity on behalf of Alphapharm Pty Ltd., Par Pharmaceutical, Inc., Pharmaceutical Resources Inc. and Genpharm Inc. against Organon and Akzo Nobel N.V. involving the antidepressant drug REMERON® (mirtazapine). Successfully pursued antitrust claims on behalf of clients along with State Attorneys General and various class plaintiffs in follow-on litigation. 
  • Obtained a covenant not to sue from GlaxoSmithKline after seeking a declaratory judgment of non-infringement by Mutual Pharmaceutical Company, Inc. involving the anti-emetic drug ZOFRAN® (ondansetron).
  • Represented first wave defendant Kremers Urban in In re Omeparazole Patent Litigation, opening, with an at risk launch, the generic market to AstraZeneca’s original “purple pill” blockbuster PRILOSEC®.
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