The Orange Book: Listings, De- Listings and Other Matters of Interest
Andrew Wasson
Partner
Haug Partners
Sara Koblitz
Director
Hyman, Phelps & McNamara PC
- What is the Orange Book, what does it contain, and why is it orange?
- FDA’s publication on Approved Drug Products with Therapeutic Equivalence Evaluations
- Understanding the role of Orange Book listings in patent life cycle management and patent portfolio management
- Exploring the continuing dilemma of which patents should be listed, delisted, and held in reserve
- Examining the FDA’s position on not listing a patent
- Understanding the FTC’s new de-listing authority
- Overcoming challenges associated with listing patented information in the product label and indications discovered in clinical testing
- Incorporating long term patent listing strategies into label negotiations with FDA
- Examining the skinny labeling and carve–out conundrum
- Assessing the scope of potential Orange Book listing controversies relative to:
- Device patents
- Product-by-process claims
- Metabolites; polymorphs; intermediates
- Patents on unapproved uses