FDA Law for Intellectual Property Lawyers

US Food and Drug Administration (FDA) regulatory considerations shape patent strategy, compliance, and risk management for products reviewed by the FDA. Topics will include the interplay of patents and regulatory exclusivities, impact of FDA oversight on intellectual property safeguards, common challenges attorneys face in this sphere, strategies for meeting regulatory compliance while supporting patent protection, and the recent Supreme Court decision, Amarin v. Hikma, on how the marketing and FDA labeling requirements for generic products affects an infringement analysis.

Speakers

Brian Malkin, Partner, Spencer Fane, Washington, DC

Janet Linn, Counsel, Tarter Krinsky & Drogin LLP, New York, NY