Spencer Fane attorney Jeremy C. Lowe’s article, U.S. Supreme Court Weighs Inducement Liability Beyond FDA Carve-Out Labels, was recently published by Pharmaceutical Executive.
In the article, originally a blog post, Jeremy discusses recent legal and regulatory developments affecting the pharmaceutical industry, with a focus on patent litigation, generic and biosimilar competition, and FDA policy. The article examines how evolving court decisions and regulatory initiatives are influencing drug commercialization and intellectual property strategies. It also highlights practical considerations for pharmaceutical companies as they navigate an interconnected legal and regulatory environment.
“The through-line is precision. In skinny-label cases, say only what the carve-out permits. In Abbreviated New Drug Application (ANDA) cases, plead and prove infringement at the right level of detail. In BPCIA matters, align patent dance strategy, launch timing, interchangeability, and market access from the start,” Jeremy wrote.
Jeremy leads the firm’s Patent Litigation and Hatch-Waxman and Biologics Litigation Market Teams, focusing on high-value patent litigation engagements across a range of technical sectors and jurisdictions and providing strategic counsel on regulatory compliance, Hatch-Waxman litigation, BPCIA litigation, and Federal Circuit appeals. With more than 24 years of experience as a trial and appellate attorney, he works with both plaintiffs and defendants in state and federal courts to consistently achieve favorable outcomes.
Read Jeremy’s full article here.