Drug Repositioning and Lifecycle Management: A Solid-Form Patent Strategy
Small molecule therapeutics are traditionally first protected by composition of matter patents claiming the new chemical entity either specifically or generically. Such patents are the springboard for protecting additional developments in a therapeutic pipeline, such as methods of treatment, formulations, processes, metabolites, and pro-drugs to name a few.
Some of the patents directed to these additional developments beyond the composition itself are eligible for listing in the Orange Book, and these patents can protect aspects of a therapeutic program past the expiration date of the original composition of matter patent. In some cases, this will afford substantial protection against generic entry. A thoughtful strategy to effectively achieve this end goal is required.
Join Gene Quinn, President & CEO of IPWatchdog.com and twice named one of the top 50 most influential people in IP by Managing IP, on Tuesday, December 1, 2020, at 12pm EST, for a wide-ranging conversation of the strategies available to protect developments in small molecule therapeutics. Joining Gene will be Eyal Barash, IP Counsel and Founder of Barash Law, LLP, and Steef Boerrigter, a Group Leader of Materials Science for AMRI.
In addition to taking as many questions from the audience as possible, the panel will focus on:
- How the solid-state structure of an active pharmaceutical ingredient (API) and can profoundly affect its drug delivery properties;
- Strategies and practice tips associated with patent protection for solid-state drugs;
- 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 of the panel discussion will be on US practice, elements of European practice will also be explored.