Overview
Steptoe IP partner Robert Kappers authored a chapter of the American Bar Association (ABA)'s publication, "ANDA Litigation: Strategies and Tactics for Pharmaceutical Patent Litigators, Fourth Edition," titled "Initiating Litigation."
The Drug Price Competition and Patent Term Restoration Act (commonly referred to as the Hatch-Waxman Act) aimed to strike a balance between patent exclusivity and market competition. The Hatch-Waxman Act includes provisions for an abbreviated process for FDA approval of generic versions of patented pharmaceuticals through the filing of an Abbreviated New Drug Application (ANDA). The Hatch-Waxman Act is a hybrid of US patent law and FDA regulatory law, and patent litigation in this area is especially complex.
ABA's comprehensive guide covers key steps in the litigation process, examining current and developing law and providing practical strategies for both novice and seasoned pharmaceutical patent litigators.
"Initiating Litigation" details what constitutes a proper plaintiff and defendant in the context of ANDA litigation cases. It further discusses personal jurisdiction and venue, clarifying that in Hatch-Waxman cases, personal jurisdiction is governed by traditional rules and stating that courts must consider numerous factors when considering a motion to transfer.
The chapter also covers the process of filing protective suits, and the statute defining patent infringement. It examines multiple court cases that diverge from ordinary patent infringement, demonstrating that an answer to the fundamental question of infringement under is not always straightforward. Finally, the chapter states that the right to a jury in patent infringement lawsuits depends on the availability of a damages remedy. Specifically, the availability of damages based on actual commercial conduct implicates the right to a jury trial.
For more information and to purchase a copy of "ANDA Litigation: Strategies and Tactics for Pharmaceutical Patent Litigators, Fourth Edition," visit the ABA website.
