The FDA published a Frequently Asked Question (FAQ) on Patents and Exclusivity on Friday (here). Turns out it is a very nice primer for those new to the generics or 505(b)(2) game or those that need a refresher in the ins-and-outs of two of the most contentious and confusing issues associated with the Drug Price Competition and Patent Term Restoration Act of 1984 (better known as the Hatch-Waxman Act).
The document covers a myriad of topics ranging from how long is a patent, to the issues associated with first-to-file, the 30-month clock, to what periods of exclusivity there are and how they may impact generic approval. There is also a helpful list of where one can find the patent and exclusivity regulations.
The questions also cover more esoteric issues such as untimely filed patents, amendment of use claims, and provides clear and concise explanation of these complex issues.
But my favorite question and answer is the last one:
- Who do I contact with specific questions regarding what patents are eligible for listing in the Orange Book?
- FDA’s patent listing role is ministerial. Generally, we will not respond to specific questions regarding the eligibility of patents for listing.
This supports FDA’s long held position that they are not patent experts but only act in a ministerial way regarding patent listings. This mantra has been repeated since the early days of passage of the 1984 Act and continues today! I think everyone involved in generics and 505(b)(2) applications should read this FAQ document carefully and bookmark it in your browser on your computer because I guarantee that you will want to come back to it again and again!