The U.S. House of Representatives unanimously passed two bills yesterday, H.R. 1520 (Purple Book Continuity Act of 2019) and H.R. 1503 (Orange Book Transparency Act of 2019).
The Purple Book Continuity Act of 2019 would require the Purple Book to publish lists of patents associated with approved biological products, but would not require publication of such patent listings until a patent dance has begun: “Patent Information.—Not later than 30 days after a list of patents under subsection (l)(3)(A), or a supplement to such list under subsection (l)(7), has been provided by the reference product sponsor to the subsection (k) applicant … the reference product sponsor shall provide such list of patents (or supplement thereto) and their corresponding expiry dates to the Secretary, and the Secretary shall … include such information for such biological product.“ The Senate had also introduced a bill to modify the Purple Book in March of this year, titled the “Biologic Patent Transparency Act,” but no further action has been taken yet on this bill.
The Orange Book Transparency Act of 2019 clarifies information related to patent listing and the types of patents that should be listed in the Orange Book, and would require, among other things, that invalidated patents be removed “promptly” but not before the expiration of any 180-day exclusivity period that relies on a paragraph IV certification that such patent is invalid.
Stay tuned to Big Molecule Watch as we continue to monitor these legislative developments.
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