By Leanne M. Rakers, Principal
U.S. FDA Orange Book Refresher Edition
a. What types of patents can be listed on the FDA’s Orange Book?
- Listable = Pharmaceutical-related patents are allowed in the FDA’s Orange Book only if they’re “composition” or “method of use” patents. Such patents may cover the drug compound, specific formulations of the drug, polymorphs, or methods of treating certain diseases by administering the drug.
- Not Listable = “Process patents,” which cover methods for making (chemically synthesizing) the drug compound, are not allowed to be listed in the Orange Book.
B. Why should you list your patent on the Orange Book?
- If an innovator drug company lists its patent in the Orange Book, a generic drug company is required by law to notify the patent owner that it is making (and plans to sell) a drug that arguably infringes the patent.
- Upon receiving notice, the innovator is free to file for patent infringement–without having to see the generic product or conduct expensive chemical testing on it.
- More importantly, the filing of a lawsuit based on a patent listed in the Orange Book automatically invokes a 30-month stay before the generic drug company can sell its drug.
C. How and when should you list your patent on the Orange Book?
- How: Submit either FDA Form 3542 or Form 3542A to the FDA to list a patent on the Orange book:
Use FDA Form 3542 = after approval; When submitting patent information after NDA or supplement approval (e.g., formulation change, add a new indication or other condition of use, change the strength, or to make any other patented change regarding the drug, drug product, or any method of use), and for patents issued after drug approval.
Use FDA Form 3542a = before approval; When submitting patent information with original NDA submissions, NDA amendments and NDA supplements prior to approval.
- When: Submit the appropriate form according to these timelines:
a. within 30 days after approval of an NDA or supplement, or
b. within 30 days of issuance of a patent as required by 21 CFR 314.53(c)(2)(ii) at the address provided in 21 CFR 314.53(d)(4).
**The receipt date is the date that the patent information is date stamped in the central document room. Patents are considered listed on the date received.
**To expedite review, submit an additional copy of this form to the Center for Drug Evaluation and Research “Orange Book” staff.
D. Why is the Orange Book called the Orange Book?
According to FDA information, when the first print edition of Approved Drug Products with Therapeutic Equivalence Evaluations was being prepared in October 1980, staff members in the Office of Generic Drugs had to choose a color for the cover. The project manager suggested, “It’s almost Halloween. How about orange?” Before long, The Orange Book had become a popular short title for this important publication.