The solid-state structure of an active pharmaceutical ingredient (API) can profoundly affect its properties. Consider, for example, drug delivery. In order for an orally dosed medicament to have biological efficacy, it must release the API in vivo for transport to the target. If the solubility of the API is too low, there will be insufficient API for efficacy. If the solubility is too high, the dose may be too concentrated. In addition, the API needs to be sufficiently stable to reproducibly deliver the correct type and amount of API. Stability and solubility are functions of the solid-state structure of APIs.
Join Gene Quinn, President & CEO of IPWatchdog, Inc. founder and twice named one of the global Top 50 Most Influential People in IP, for a free webinar discussion. Joining Gene will be Eyal Barash, IP Counsel and Founder of Barash Law, LLC, and Steef Boerrigter, a Group Leader of Materials Science for AMRI, who 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.