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The solid-state structure of an active pharmaceutical ingredient (API) can profoundly affect its properties. Stability and solubility are functions of the solid-state structure of APIs. This seminar will introduce the science behind such solid forms and then discuss how solid forms are protected as valuable intellectual property. We will provide examples of how a solid-form patent strategy is integrated into life cycle management and drug repositioning, the nuts and bolts of obtaining such patents at the USPTO, and how the courts have viewed such patents over the past 15 years. Although the focus will be on US practice, elements of European practice will also be presented.
Remdesivir is the first approved therapy for COVID-19, having first received an Emergency Use Authorization and then finally full approval on October 22, 2020. As a fully approved drug, the FDA has provided the public with both regulatory exclusivity and patent information. In this presentation, we will review that information, discuss what it means, and relate that to typical strategies used by innovator companies to protect valuable assets.