Fundamental Building Blocks for Creating and Enforcing the FDA Orange Book Listable U.S. Patent
Please note that the faculty members listed for this course are subject to change prior to the actual course date.
Today's pharmaceutical small molecule attorneys and agents, whether engaged in patent litigation, patent procurement, or licensing, are required to understand much more than simply patent law. They are called to tailor patent law concepts to counsel an industry drive in large part by Orange Book listed patents to enable life-saving medicines to be brought to market. To provide that counsel in the broad context of the models of innovative and generic pharmaceutical companies, the counselor must have a grasp and appreciation of the interplay between patent procurement, patent defense, pharmaceutical research and development, and regulatory practice.
A large part of the value of pharmaceutical patents derives from the interplay of patent and FDA law. Under the Hatch-Waxman framework, pharmaceutical patentees list patents that cover their product in FDA’s Orange Book and in return are granted unique rights under both patent and regulatory law. Today’s pharmaceutical small molecule attorneys and patent agents, whether engaged in patent litigation, patent procurement, or licensing, must understand this interplay to counsel their clients and maximize the value of their patents. This course provides an overview of these issues coupled with an in depth exploration of the Orange Book listing process.
The practical guidance offered by this course is an absolute essential for anyone with responsibility in any phase of pharmaceutical product patent portfolio development, licensing and litigation.
Exemplary topics include:
- FDA submissions - a strategic overview for the patent counselor.
- Strategic considerations regarding listing in the FDA's Orange Book.
- "Pressure testing" the patent before Orange Book listing.
- Regulatory exclusivities.
- Interfacing between the small molecule patenting process and regulatory submissions.
Target Audience: Pharmaceutical counselors, including patent practitioners, both in-house and external, and pharmaceutical patent litigators, both in-house and external.