Hatch-Waxman Litigation

The complex statutory and regulatory schemes governing generic pharmaceuticals and U.S. patent law complicate generic pharmaceutical litigation. At Robins Kaplan LLP, our Hatch-Waxman attorneys work across the full spectrum of Hatch-Waxman/ ANDA matters.  Our experience includes representation of small and large start-ups, generic pharmaceutical and innovator pharmaceutical companies, and companies that do both. We also draw on the knowledge and experience of the attorneys and scientists throughout the firm who have relevant technological backgrounds, including advanced degrees in biology, chemistry, biochemistry, biomedical engineering, pharmacology, and physics. Together, our trial litigation and technical breadth offers clients a big-picture perspective on what’s needed when pursuing matters under the Hatch-Waxman Act and informs our strategic ANDA counseling and advice to industry members.

In addition, we publish GENERICally Speaking: A Hatch-Waxman Litigation Bulletin to help clients and subscribers stay on top of industry news and outcomes, follow trends in the judiciary and the steps others are taking, and keep informed of recently enacted rules and legislation. Each quarter, we summarize and provide insight into relevant case decisions, and list newly filed cases, settlements, ANDA approvals, and generic drug launches.

Selected Case Results*

  • Represented Amneal Pharmaceuticals LLC in a Hatch-Waxman patent litigation concerning a drug for treating secondary hyperparathyroidism in adult patients with chronic kidney disease on dialysis. Amgen Inc. v. Amneal Pharmaceuticals LLC, 16-0853-GMS (consolidated) (D. Del.).
  • Represented Amneal Pharmaceuticals LLC in a Hatch-Waxman patent litigation concerning a drug for the treatment of ADHD. Alza Corp. v. Amneal Pharmaceuticals of New York, LLC, 16-0914-RGA (D. Del.).

  • Represented Torrent Pharmaceuticals in a Hatch-Waxman patent litigation concerning a drug for treating COPD. Takeda GmbH v. Torrent Pharms. Ltd., 3:15-cv-03375-FLW-DEA (consolidated) (D.N.J.).

  • Counsel to Collegium Pharmaceutical, Inc. in a series of related cases involving six patents owned by Purdue and related entities related to oxycodone. Obtained a judgment of invalidity of the three Orange Book listed patents in Purdue Pharma LP v. Collegium Pharm. after succeeding in a motion to transfer the action from the District of Delaware to the District of Massachusetts

  • Represented Amneal Pharmaceuticals in a Hatch-Waxman patent litigation concerning a drug for treating pain. Appeals in the Federal Circuit are ongoing.

  • Auxilium Pharmaceuticals v. Upsher-Smith Laboratories: Lead defense counsel for Upsher-Smith Laboratories in a Hatch-Waxman patent infringement case in which we obtained a summary judgment of non-infringement of 10 patents claiming a transdermal testosterone gel and method of treating hypogonadism before Judge Sue Robinson of the Federal District Court in Delaware. The opinion was filed on December 4, 2013. The technology related to claimed macrocyclic penetration enhancers for increasing the rate of passage of an androgen through the skin. We were successful in demonstrating to the court that the case warranted an exception to the court’s ordinary practice of declining to hear summary judgment motions in Hatch-Waxman cases.

  • Braintree Labs., Inc. v. Novel Labs., Inc., 749 F.3d 1349 (Fed. Cir. 2014): Represented Novel Labs. Inc., now a division of Lupin Ltd., in a Hatch-Waxman patent litigation concerning a pre-colonoscopy bowel prep drug. Successfully appealed in the Federal Circuit, re-tried the case, which was appealed again, and ultimately settled.

  • Purdue Pharmaceutical Products L.P., et al. v. Novel Laboratories, Inc: Represented Novel Laboratories, Inc., a pharmaceutical company seeking to market a generic version of Intermezzo®. Intermezzo® is a sublingual formulation of zolpidem indicated for middle-of-the-night insomnia. Following a 10-day bench trial, the judge found in favor of our client, ruling the asserted claims of all three patents invalid for obviousness. The Federal Circuit confirmed the invalidity findings in a summary affirmance.

  • Medicis Pharmaceutical Corporation v. Upsher-Smith Laboratories, et al.: Defended Upsher-Smith Laboratories in a bench trial patent suit where all claims asserted were invalidated during an ex parte re-examination based on the same arguments and evidence we presented during the bench trial. 

  • Representing generic client in Inter partes review before the Patent and Trademark Appeal Board. 
  • Represented Teva Pharmaceuticals in Hatch-Waxman litigation involving seven Orange Book listed patents for the extended-release Alzheimer’s drug, Namenda XR®.  Six patents were invalidated on indefiniteness grounds prior to trial.  Forest Labs., Inc. v. Teva Pharms. USA, Inc., C.A. No. 14-121, 2016 U.S. Dist. LEXIS 322 (D. Del. Jan. 5, 2016).  Upon completion of a four-day bench trial on the remaining patent, the matter settled for value.  (Prior to joining Robins Kaplan LLP.)
  • Represented Teva Pharmaceuticals in Hatch-Waxman litigation concerning OxyContin®.  After an eight-day bench trial, the court found that each asserted patent was either not infringed and/or invalid.  Purdue Pharma L.P. v. Teva Pharms., USA, Inc. (In re OxyContin Antitrust Litig.), 994 F. Supp. 2d 367 (S.D.N.Y. 2014).  This decision was upheld at the Federal Circuit.  Purdue Pharma L.P. v. Epic Pharma, LLC, 811 F.3d 1345 (Fed. Cir.), cert. denied, 137 S. Ct. 475 (2016).  (Prior to joining Robins Kaplan LLP.)   
  • Represented Breckenridge Pharmaceuticals in a Hatch-Waxman litigation relating to a cachexia drug, Megace ES®.  Settled for value.  Par Pharmaceuticals, Inc. v. Breckenridge Pharmaceutical, Inc. (Prior to joining Robins Kaplan LLP.)
  • SmithKline Beechman Corp. v. Pentech Pharmaceuticals, Inc.: Represented client on generic Paxil® (paroxetine); seminal case led to demise of “universal seeding” tactic by name-brand companies. Settled for value. (Prior to joining Robins Kaplan LLP)
  • Warner Chilcott Laboratories Ireland Limited v. Impax Laboratories, Inc.: Represented client in central portion of litigation, including critical claim-construction briefing and testimony portion, for generic Doryx® (doxycycline) antibiotic. Client prevailed at trial on non-infringement turning on claim construction. (Prior to joining Robins Kaplan LLP)

  • Lundbeck A/S/ v. Alphapharm Ply Ltd.: Represented client to bring to market generic Lexapro® (escitalopram oxalate) anti-depressant. Leveraged settlement for value at spoliation hearing on eve of trial. (Prior to joining Robins Kaplan LLP)

  • UCB S.A. v. Mylan Inc.: Defended client’s right to sell generic Keppra® (laevetiracetam) anti-epileptic. Settled for value for client. (Prior to joining Robins Kaplan LLP)

  • AstraZeneca AB v. Genpharm Inc.: Represented client in “first-wave” litigation to get client’s generic Prilosec® (omeprazole) anti-ulcer drug to market. Invalidated strategic patents allowing client to waive exclusivity and gain value from competitor’s entry. (Prior to joining Robins Kaplan LLP)

  • Genentech, Inc. v. Bio-Technology General (Israel) Ltd.: Represented biologics company seeking to market a follow-on Humatropin® (somatropin) human growth hormone in an ITC proceeding. (Prior to joining Robins Kaplan LLP) 

  • GlaxoSmithKline plc v. Various Generic Companies: Protected the flagship GSK Zantac® (ranitidine HCI) franchise for a number of years. (Prior to joining Robins Kaplan LLP)

  • Trial counsel for Japanese pharmaceutical company in multiple patent litigations under the Hatch-Waxman Act involving drug for treating ear infections. After prevailing at trial, the patent was held invalid on appeal. (Prior to joining Robins Kaplan LLP)

  • Trial counsel for U.K. and U.S. pharmaceutical company in multiple patent litigations under the Hatch-Waxman Act involving antidepressant and smoking cessation medication. (Prior to joining Robins Kaplan LLP) 

  • Trial counsel for U.K. and U.S. pharmaceutical company in multiple patent litigations under the Hatch-Waxman Act involving oral syrup for anti-ulcer medication. (Prior to joining Robins Kaplan LLP)

  • Trial counsel for U.K. and U.S. pharmaceutical company in patent litigations under the Hatch-Waxman Act involving serotonin 5-HT3 receptor antagonist used to prevent nausea and vomiting caused by cancer chemotherapy, radiation therapy and surgery. (Prior to joining Robins Kaplan LLP) 

* Past results are reported to provide the reader with an indication of the type of litigation we practice. They do not and should not be construed to create an expectation of result in any other case, as all cases are dependent upon their own unique fact situation and applicable law.

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