Since being involved in the very first Abbreviated New Drug Application (ANDA) litigation in the United States, 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 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. Over the last five years, our attorneys have represented 30 brand companies in almost 400 ANDA litigations involving revolutionary drugs such as Prolensa®, Relistor® subcutaneous, Relistor® tablets, Cymbalta®, and Abilify®.
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.
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.
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.
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.
2:23-cv-00094, 2:23-cv-02364, D.N.J., Judges Cecchi, Padin, Wettre
1:18-cv-01395, D. Del., Judge Connolly
1:18-cv-00664, D. Del., Judge Andrews
3:21-cv-16766, D.N.J., Judges Kirsch, Singh
1:21-cv-00870, D. Del., Judge Hall
Successfully led Kaken and Bausch Health Care in inter partes review (IPR) proceedings, district court litigation, and Federal Circuit appeal related to patent covering Kaken and Bausch Health Care’s Jublia® (efinaconazole) product for the treatment of onychomycosis.
3:18-cv-13635, D.N.J., Judges Martinotti, Goodman
18-2232, Fed. Cir., Judges Newman, O'Malley, Taranto
IPR2017-00190, PTAB, Judges Mitchell, Franklin, Pollock
IPR2017-01429, PTAB, Judges Mitchell, Franklin, Pollock
Conference
3rd Annual Passport to Proficiency on the Essentials of Hatch-Waxman and BPCIA
October 10-26, 2023
Virtual
Federal Circuit IP Blog
August 4, 2023
Prosecution First Blog
Obviousness and Written Description Take Down an Infringed Patent
June 30, 2023
Federal Circuit IP Blog
Parkinson’s Patent Invalid Based on Obviousness of Overlapping Ranges
April 20, 2023
March 22-23, 2023
Virtual
Conference
4th Annual Passport to Proficiency on the Essentials of Hatch-Waxman and BPCIA
October 8-24, 2024
Virtual
Award/Ranking
Five Finnegan Partners Named 2024 Leading Litigators in America by Lawdragon
October 30, 2023
Award/Ranking
Finnegan Receives Tier 1 Benchmark Litigation Rankings; Nine Attorneys Named Litigation Stars
October 5, 2023
Award/Ranking
Finnegan Shortlisted in 10 Categories in the LMG Life Sciences Awards 2023
July 25, 2023
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