On October 3, 2023, Knowledge Ecology International (KEI) sent a letter to the FDA asking the agency to publish its historical Orange Book data. The Orange Book identifies patent and exclusivity data for FDA approved drug products. The FDA publicly publishes this data on its website, but it is limited to unexpired patents. Our letter notes that historic data is important for researchers and policymaker to see trends over time and to study issues such as:
- “Over time, how many FDA-approved products have one or more patents in the Orange Book that have disclosed (or should have disclosed) federal rights in the patented invention, and which funding agencies were involved?
- Over time, how many and what type of patents end up in the Orange Book for specific products, and how does this change over the time period that a product is on the market?
- How does the number of patents in the Orange Book relate to product revenues or the time for generics to enter the market?”
KEI’s full letter is available here: KEI-Letter-FDA-Orange-Book-Transparency-3Oct2024