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Patent Litigation - Abbreviated New Drug Application (ANDA) Litigation

Experienced and creative advocates who understand the business concerns of innovators

Since being involved in the very first ANDA litigation, Finnegan has been a leading firm representing innovative pharmaceutical companies before federal district courts and the U.S. Court of Appeals for the Federal Circuit. Our attorneys have represented nearly 50 brand companies in almost 200 ANDA litigations involving revolutionary drugs such as Abilify®, Crestor®, and Cymbalta®. In 2014 alone, Finnegan represented 15 brand-drug companies in 54 new ANDA-related cases involving multiple generic challengers.

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 ANDA 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. Our successes derive from a deep bench of experienced and technically sophisticated attorneys who understand the long-term plans of innovative pharmaceutical companies as well as the legal particularities of ANDA litigation under the Hatch-Waxman Act and the nuances of pharmaceutical patent law. 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 65 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.

Making it stand up on appeal

Finnegan attorneys have briefed and argued more cases before the U.S. Court of Appeals for the Federal Circuit than any other law firm, including 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.