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As 2019 quickly approaches, we would like to take a few moments to reflect on the past year of Food and Drug Administration activities and certain big ticket items that made news in 2018. As the Magic 8-Ball would say: “signs point to yes” that everything on the list below will continue to be major areas of focus for both FDA and the U.S. Congress next year and into the foreseeable future.

A federal district court judge recently applied the recent U.S. Supreme Court decision in WesternGeco LLC v. ION Geophysical Corporation, in which the Supreme Court held that lost profits damages could be awarded for infringement occurring under 35 U.S.C.§ 271(f), to cover damages for direct infringement occurring under 35 U.S.C.§ 271(a) (see our prior post here for an overview of the case and the issues before the Court, and here for an overview of the Court’s June opinion). 

Regulatory compliance is often treated as completely independent from development or enforcement of patent rights. This situation is not helped by the absence of coordination between the U.S. Food and Drug Administration (FDA) and the U.S. Patent and Trademark Office (USPTO). Still, companies must understand and appreciate the impact regulatory submissions may have on their patent portfolio.