On January 5, 2021, the President signed H.R. 1503 (the Orange Book Transparency Act of 2020). The Orange Book Transparency Act of 2020 clarifies information related to patent listing and the types of patents that should be listed in the Orange Book. The Act also requires that NDA holders notify FDA within 14 days of a final decision if an Orange-Book listed patent is invalidated by the PTAB or a court, and that, FDA remove or amend the patent information in the Orange Book in accordance with the decision, but not before the expiration of any 180-day exclusivity period that relies on a paragraph IV certification that such patent is invalid.
As we reported previously, an earlier version of the Orange Book Transparency Act of 2020 was passed unanimously by the House of Representatives in May 2019. The Senate unanimously passed an amended version on December 7, 2020, which was approved by the House on December 10, 2020 and sent to the President on December 24, 2020.