Hatch-Waxman Litigation

Strategic lawyering backed by scientific acumen

Katten is regarded as a powerhouse in the realm of Hatch-Waxman litigation, with a team that represents many of the largest generic pharmaceutical companies in the world and dedicates a substantial portion of its practice to Abbreviated New Drug Application (ANDA) matters. Our litigators are skilled in defending patent rights in trial and appellate courts, leveraging our comprehensive knowledge of patent law, US Food and Drug Administration (FDA) regulations and administrative procedures. This skill set enables us to craft litigation strategies that are both scientifically informed and legally sound, ensuring that clients' interests are vigorously protected in the courtroom. Comprised of first-chair trial attorneys as well as seasoned appellate and Patent Trial and Appeal Board (PTAB) practitioners, our team is bolstered by numerous professionals who have advanced degrees in chemistry, microbiology, pharmaceutical engineering and other relevant disciplines.

Courtroom titans with a history of trial success

Katten's extensive trial experience is a cornerstone of our Hatch-Waxman practice, having litigated a wide array of cases, including compound, polymorph, formulation and method of treatment (MOT) patents, across major jurisdictions before all district court judges who specialize in pharmaceutical patent matters. Our attorneys are committed to achieving favorable outcomes in high-profile cases, such as successfully genericizing a keystone pulmonary arterial hypertension drug at a highly watched trial, earning Katten a reputation as one of the top five law firms for ANDA litigation in the country and recognition among the top 10 in the Best Performing Law Firms representing Defendants in ANDA litigation (results reported by Patexia, a leading intellectual property analytics company).

Additionally, six attorneys on our distinguished team have been individually ranked as top ANDA litigators, including Partners Deepro Mukerjee, Intellectual Property (IP) department chair, Brian Sodikoff and Lance Soderstrom, Patent Litigation co-chairs, Joseph Janusz and Dr. Jitendra "Jitty" Malik and Associate Jillian Schurr. In short, our attorneys are trusted by household names in the pharmaceutical industry due to their unrivaled experience and track record of success.

Interdisciplinary approach to complex Hatch-Waxman disputes

Beyond our legal acumen, the Katten team’s industry knowledge, gained through its representation of pharmaceutical companies in mergers and acquisitions (M&A), at-risk launches and antitrust actions, helps shape our holistic solutions to complex disputes. In addition, our vigilance in monitoring antitrust developments and understanding the regulatory landscapes, particularly in the wake of FTC v. Actavis, Inc., highlights our ability to navigate the intersection of patent and antitrust law. This business know-how, coupled with our legal prowess, equips Katten to take on the most complex and influential pharmaceutical patent disputes in the world.