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Hatch-Waxman Litigation

Tenacious. Trusted. Talented.

Rothwell Figg is known for our pharmaceutical litigation practice and is recognized as a leading firm for litigation arising under the Drug Price Competition and Patent Term Restoration Act, referred to as Hatch-Waxman litigation. Rothwell Figg has represented numerous clients in scores of Hatch-Waxman cases for more than 30 years, from the mid-1980s up to the present time. These are complex, high-stakes cases that involve sophisticated legal and scientific issues. Many of our litigation attorneys have scientific degrees in areas related to pharmaceuticals including chemistry, biochemistry, pharmacy, biology, microbiology, biotechnology, physics and zoology. Trial and appellate litigation under the Hatch-Waxman amendments forms a significant part of the firm’s litigation practice, with several of our partners devoting nearly all of their time to pharmaceutical litigation. Although we have represented both brand-name pharmaceutical innovators and generic drug manufacturers, the majority of our Hatch-Waxman cases involve representation of generics.

Over the years we have invalidated dozens of pharmaceutical patents, and have successfully pursued antitrust cases arising out of the improper listing of patents in the Orange Book. Notable examples include successful representation of Pfizer and Synthon in litigation involving Teva’s blockbuster drug Copaxone®; representation of Burroughs Wellcome in litigation involving the first AIDS drug, Retrovir® (AZT); successful representation of Zeneca in connection with its prostate cancer drug, Casodex®; successful representation of Mylan in patent/antitrust litigation involving the antidepressant, buspirone; successful representation of Synthon in litigation involving the antihistamine, levocetirizine; successful representation of Mylan in litigations involving the antihistamine fexofenadine and the nitroglycerin transdermal patch Nitro-Dur®; successful representation of Actavis in litigation involving the asthma drug, levalbuterol; successful representation of Sandoz in litigation involving the contraceptives, Yaz® and Yazmin®; and many others.

Hatch-Waxman litigations are notoriously difficult to settle because the economic implications for the patent owner and the patent challenger are vastly different. With aggressive and creative litigation strategies, we have handled numerous Hatch-Waxman litigations in which our clients were able to reach very favorable settlements either shortly before trial or after trial and prior to decision. Examples of such cases include hotly contested litigations involving levalbuterol (Xopenex HFA®), isotretinoin (AbsoricaTM), and fexofenadine (Allegra®). A list of representative matters we have handled in this practice area can be found here. 

Our attorneys are also experienced in handling Administrative Procedures Act (APA) actions in the federal courts in the District of Columbia. The Food Drug and Cosmetics Act (“FDCA”) and the Hatch-Waxman statute, as amended by the Medicare Prescription Drug Improvement and Modernization Act (“MMA”) are complicated, and disputes surrounding issues of regulatory exclusivity and forfeiture often arise in these cases in addition to patent infringement and validity issues. We have decades of experience representing clients in APA actions regarding the interpretation and application of these statutes and the related FDA regulations, either as plaintiff suing the FDA or as a third-party intervenor, and we put our lengthy experience to work for our clients.