Branded Hatch-Waxman (ANDA) Litigation and Trials

While Finnegan has been recognized as the “go-to” firm for protecting blockbuster products, and many of the cases we litigate are “bet-the-company” engagements, we understand the importance of all products to our clients, regardless of their sales amounts, and thus custom tailor our litigation teams to best protect those products. The size of our firm and extensive branded Hatch-Waxman litigation experience provides us with a unique ability to custom fit our teams to the technology at issue in the most cost effective manner to meet the client’s objectives. We work hand-in-hand with clients to develop creative, coordinated, and successful litigation strategies.

Harnessing the underlying science to develop persuasive positions

ANDA cases are often won, or lost, on a firm’s ability to master the science underlying a patented invention, and to present that technology in a compelling way. With approximately 80 professionals holding advanced degrees in the biological or chemical sciences, Finnegan has the ability to harness the underlying science to develop winning positions. About one-third of the attorneys in the practice hold doctorate degrees in relevant sciences, and even more joined Finnegan after holding positions in industry, at universities, or having served as examiners with the U.S. Patent and Trademark Office (USPTO). Having technical expertise helps us seamlessly interface with inventors and experts, take advantage of subtle but important details, and craft concise and persuasive, yet easy-to-understand arguments.

Early preparation is key

Success in ANDA litigation often begins months or even years before litigation begins. Clients retain us prior to Paragraph IV challenges to analyze relevant patent portfolios to, for example, determine and obtain optimal claim coverage, and assess, evaluate, and address potential vulnerabilities—including those that could be challenged in adversarial proceedings before the USPTO. Whether you are anticipating receipt of a Paragraph IV notice letter or still in late-stage clinical trials, it is never too early to start preparation. 

ANDA trials demand courtroom experience and scientific insight

When trial is the best or only option in ANDA litigation, Finnegan brings the right mix of technical expertise and trial and appellate experience. For 60 years, we have successfully litigated hundreds of cases involving the most technologically advanced and complex pharmaceutical patents and argued the decisions on appeal by intentionally setting the trial record and fully preserving issues. Before and throughout trial, we leverage our deep scientific knowledge to clarify complex issues, anticipate and counter opposing arguments, and present cases that are accurate, compelling, and easy for judges to understand. The result is advocacy that is both intellectually rigorous and highly effective.

Making it stand up on appeal

Finnegan attorneys have briefed and argued hundreds of cases before the U.S. Court of Appeals for the Federal Circuit—quite possibly more than any other law firm—achieving successful outcomes protecting innovative drugs such as Abilify®, Claritin®, Crestor®, Naprelan®, Strattera®, and Zyprexa®. Approximately 40 of the firm’s attorneys have served as law clerks to judges on the Federal Circuit or its predecessor courts. As clerks, they worked closely with the judges, helping to draft opinions and gaining insight into the deliberative process and protocol of the court further enhancing our depth of experience and keen understanding of the law. This unparalleled appellate experience and industry expertise helps us protect our client’s pharmaceutical innovations throughout the ANDA process.