This bill — the Orange Book Transparency Act of 2019 — would increase access to lower-cost generic drugs and bolster competition within the generic drug marketplace to help reduce drug costs by ensuring that patents listed in the Approved Drug Products with Therapeutic Equivalence Evaluations Publication (aka the Orange Book) are valid and relevant to the approved product. It’d also strengthen requirements surrounding the removal of invalidated patents from the Orange Book.
Specifically, this bill would:
- Clarify the types of patents listed in the Orange Book (and require the removal of invalidated patents);
- Require a list of applicable exclusivities for listed drugs;
- Create a private-sector mandate requiring drug manufacturers to promptly submit a patent withdrawal or removal to the FDA for patents found invalid by the Patent Trial and Appeals Board or another court; and
- Empower the FDA to: 1) add additional patents to the Orange Book if necessary, 2) promptly remove patents from the Orange Book which are found to be invalid, and 3) reconsider the types of patents listed in the Orange Book within one year of enactment.
This bill would also clarify that device patents aren’t required to be listed in the Orange Book, but should still be shared with the FDA to prevent efforts to delay generic drug competition based on the delivery mechanism.
This bill would also require the FDA to solicit public comments regarding the types of patient information to be listed in the Orange Book. Within a year of this bill’s enactment, the FDA would then give Congress an evaluation of such comments, including any recommendations about the types of patent information that should be included in or removed from the Orange Book.
This bill would also direct the Government Accountability Office (GAO) to conduct a study that analyzes certain patents with claims relating to devices listed in the Orange Book, and evaluates the extent to which listing such patents have affected the timing for the entry of generic drugs into the market. A report of the GAO’s findings would be due to Congress within a year of this bill’s enactment.
The Orange Book is a list of drug products approved by the FDA under the Federal Food, Drug, and Cosmetic Act that includes patent and exclusivity information and identifies whether a drug is currently being marketed or has been discontinued.