Spencer Fane attorney Brian Malkin will co-lead the New York State Bar Association (NYSBA) webinar, FDA Law for Intellectual Property Lawyers, on October 7.
For this session, Brian will join Janet Linn (Tarter Krinsky & Drogin LLP) to explore the current U.S. Food and Drug Administration (FDA) regulatory landscape and its effect on patent strategy, compliance, and risk management. They will discuss 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 significance of the recent Supreme Court decision, Hikma v. Amarin, on skinny-label infringement liability.
At Spencer Fane, Brian streamlines processes for clients navigating the complex intersection of patent law and food and drug law, leveraging unique public and private sector experience, in-depth creative and strategic analysis, and advanced negotiation tactics to meet and exceed stakeholder expectations. This skill set is evident across his focus areas, which include patent litigation for FDA-regulated manufacturers and pharmacies; patent prosecution for life sciences companies; and robust regulatory counsel for products spanning human and animal drugs and biologics, medical devices, foods and dietary supplements, tobacco products, and cosmetics.
Register for the CLE here.