The New Pharma Patent Battlefield: Litigation Strategy for the Next Wave of Life Sciences Disputes

Pharmaceutical and biotechnology patent litigation is entering a new phase. Challenges to exclusivity increasingly arise at the intersection of patent law, FDA regulatory frameworks, competition policy and commercial market-entry strategy. Orange Book listing challenges and delisting counterclaims, antitrust scrutiny, aggressive generic launch strategies and evolving approaches to Hatch-Waxman litigation are changing the risk calculus for both innovators and challengers. At the same time, biologics and biosimilars are generating their own disputes under the BPCIA, while emerging therapeutic technologies and increasingly complex patent estates are creating new litigation pressure points.

This panel will take a forward-looking look at the changing life sciences patent litigation landscape and where the next important battles are likely to emerge. Panelists will discuss Orange Book and regulatory strategy, generic and biosimilar launch risk, antitrust and competition claims, the interaction between patent litigation and FDA pathways, and the practical realities of protecting—or challenging—commercial exclusivity. The discussion will focus on how experienced life sciences litigators and in-house counsel assess risk across an entire dispute, how litigation strategy is changing, and what developments should be keeping companies awake at night.