Saul Ewing Scores Trial Victory in Invokana Patent Infringement Case


Charles M. Lizza and Sarah A. Sullivan of Saul Ewing’s Newark Office secured a precedent-setting victory in a patent infringement case in the Federal District Court for the District of New Jersey involving Janssen Pharmaceuticals, Inc.’s (“J&J”) and Mitsubishi Tanabe Pharma Corp.’s (“MTPC”) blockbuster type 2 diabetes drug, Invokana. The trial, which was held remotely via Zoom before the Honorable Chief Judge Freda L. Wolfson, U.S.D.J., was the first Hatch-Waxman case tried remotely from start to finish in the District of New Jersey and one of the first nationally.

The trial, which was originally delayed because of the Covid-19 pandemic, came after more than three years of litigation regarding three Orange Book-listed patents covering endocrinology drugs Invokana® and Invokamet®, which are sold by MTPC’s marketing partner, J&J. Five generic producers originally challenged these patents, and all except Zydus Pharmaceuticals Inc. relinquished their invalidity defenses after a rigorous fact and expert discovery process.

After seven total days of virtual testimony and argument before Chief Judge Wolfson, the Court issued a precedent-setting, 63-page opinion, holding that the patents-in-suit are not invalid as obvious and that the latest-expiring patent is not invalid for obviousness-type double patenting. In making the latter ruling, Judge Wolfson rejected Zydus’s argument that J&J and MTPC were trying to improperly extend the life of one of the patents through “obviousness-type double patenting,” a doctrine that aims to prevent inventors from obtaining a second patent for claims that are not patentably distinct from an earlier patent's claims.

The Saul Ewing team was led by Charles M. Lizza and Sarah A. Sullivan, and also included William C. Baton and Alexander Callo. The Saul Ewing team tried the case along with co-counsel Eric Dittmann, Isaac Ashkenazi, Dana Weir, Max Yusem, Katie Daniel, and Michael Werno of Paul Hastings LLP.

Saul Ewing’s Intellectual Property and Hatch-Waxman litigation practice advises clients on important, complex IP matters, providing innovative solutions for our clients’ challenges with a track record of success in high-stakes, bet-the-company patent and trade secret litigation and other IP disputes in trials and appeals courts. The practice is highly-ranked by Chambers, Benchmark, and other industry publications.