Polsinelli’s Hatch-Waxman team has experience leading Abbreviated New Drug Application (ANDA) cases and has represented some of the world’s largest, best-known, and most influential generic, brand, and specialty pharmaceutical companies. Our attorneys have litigated the blockbuster products of the last three decades, many in first-to-file cases, as well as smaller market drugs, and we understand that each case, and each client, requires its own approach. We partner with our clients to develop a strategy to achieve favorable results in a cost-effective manner that align with their individual business goals.

Our attorneys have first-chair experience litigating Hatch-Waxman cases in key venues. We are skilled courtroom advocates, and we bring to bear our 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:
  • ACTOplusMet XR® (pioglitazone+metformin HCl)
  • Adenoscan® (adenosine)
  • AndroGel® (testosterone gel)
  • Argatroban Injection
  • Avodart® (dutasteride)
  • Baytril 100® (enrofloxacin antimicrobial injectable solution)
  • Bepreve® (bepotastine besilate ophthalmic solution)
  • Biaxin® (clarithromycin)
  • Carbatrol® (carbamazepine)
  • Cardizem CD® (diltiazem HCl)
  • Cenestin® (synthetic conjugated estrogens, A)
  • Claritin® (loratadine)
  • Clarinex® Syrup (desloratadine)
  • Combigan® (brimonidine tartrate+timolol maleate ophthalmic solution)
  • Enablex® (darifenacin hydrobromide)
  • Exelon® (rivastigmine tartrate) 
  • Fortamet® (metformin HCl)
  • Hysingla® (hydrocodone bitartrate)
  • Intermezzo® (zolpidem tartrate) 
  • Istalol® (timolol maleate ophthalmic solution)
  • Jalyn® (dutasteride+tamsulosin HCl)
  • Latisse® (bimatoprost ophthalmic solution)
  • Lidoderm® (lidocaine patch)
  • Lumigan® (bimatoprost ophthalmic solution)
  • Miralax® (polyethylene glycol)
  • Nasocort AQ® (triamcinolone acetonide)
  • NuLev® (hyoscyamine sulfate)
  • Oxecta® (oxycodone HCl)
  • Paxil® (paroxetine HCl)
  • Pepcid® Complete® (famotidine + antacid)
  • Periostat® (doxycycline hyclate)
  • Precedex® (dexmedetomidine)
  • Prevacid® (lansoprazole)
  • Prevacid® SoluTab™ (lansoprazole ODT)
  • Prilosec® (omeprazole)
  • Prolensa® (bromfenac ophthalmic)
  • Rapaflo® (silodosin)
  • Reclast® (zolendronic acid)
  • Remeron® (mirtazapine)
  • Sancuso® (granisetron)
  • Seldane® (terfenadine)
  • Suprep® (sulfate salt solution)
  • Ultracet® (acetaminophen+tramadol HCl)
  • Vanos® (fluocinonide cream)
  • Velcade® (bortezomib)
  • Viagra® (sildenafil)
  • Welchol® (colesavalam HCl)
  • Xyrem® (sodium oxybate)
  • Zantac® (ranitidine HCl)
  • Zofran® (ondansetron)
  • 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 defendants Genpharm and Kremers Urban in In re Omeparazole Patent Litigation, opening the generic market to AstraZeneca’s original “purple pill” blockbuster PRILOSEC®.