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Legislative Changes to FDA’s Orange Book and Purple Book Listing Requirements

Recent legislative developments include amendments to expand upon Orange Book and Purple Book listing requirements.

Amidst the breathtaking sweep of activities in the Trump Administration’s waning days in office, the Orange Book Transparency Act of 2020 (the “Orange Book Act”) and the so-called Purple Book Continuing Act (the “Purple Book Act”) were both signed into law with relatively little public fanfare. Both of these bills largely codify in statute the patent-listing and related requirements currently incorporated in FDA’s regulations and guidance. Nevertheless, the recent codification provides additional regulatory clarification and certainty, and, more notably, includes additional substantive requirements. Each of these Acts is summarized below.

The Orange Book Act was signed into law on January 5, 2021. It amends the federal Food, Drug, and Cosmetic Act to largely refine the longstanding statutory patent-listing and related regulations. Such amendments include language to flesh out with greater specificity the specific types of patents required to be listed; namely, patents that claim the drug include drug substance (active ingredient) patents and drug product (formulation or composition) patents, and patents that claim a method of using the drug for which approval by FDA is sought or has been granted.

Notably, however, the Orange Book Act also includes a more substantive change. Specifically, it amends Section 505(j)(7) of the FDCA – the section of the statute that governs Orange Book updates for patents subsequently invalidated – to now also include patents that have been canceled or invalidated pursuant to a final decision by the U.S. Patent Trial and Appeal Board, as well as those rendered invalid or non-infringed by a final court decision. The FDCA also requires that the NDA holder notify FDA, in writing, within 14 days of any such decision. Upon receiving such notification, FDA is required to amend or remove the applicable information, except that FDA may not do so until expiry of any applicable 180-day exclusivity period.

The Purple Book Act is a set of provisions that are included in the Omnibus Appropriations Bill enacted into law on December 27, 2020. Specifically, these provisions are at Section 325 (“Biological Product Patent Transparency”). The Purple Act similarly codifies some of what FDA has in place – albeit voluntarily – but also expands upon those substantive requirements.

The Act amends the Public Health Service Act to require FDA to publish, in searchable electronic format, a listing of all BLA products, the date of licensure, application number, and licensing and marketing status, including any applicable Reference Product or interchangeable biosimilar exclusivity period in effect. Notably, however, the Act requires that certain patents also now be listed in the Purple Book. Specifically, the Act requires the Reference Product sponsor – within 30 days of the Reference Product sponsor providing a biosimilar applicant with a patent list pursuant to the so-called patent dance of the PHSA – to also provide FDA with that list and expiry dates. FDA must then include that patent information in the Purple Book listing. In addition, FDA is required to update the Purple Book every 30 days with all of the required information.

If a BLA is subsequently revoked or suspended for safety, purity, or potency reasons, the BLA holder must notify FDA that the product should be immediately removed from the Purple Book and notice of that removal is required to be published in the Federal Register.

Finally, the Purple Book Act requires FDA to solicit public comments to the Purple Book listing requirements, including comments on the type of information that should be removed or added, and to include that information in a report to Congress. Given the expansion of the Purple Book to include patent-listing information, and the longstanding debate about its pros and cons, it seems likely that, even if nothing else, there will at least be many public comments providing different views on that issue.

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