On January 5, 2021, the Orange Book Transparency Act of 2020, H.R. 1503, was signed into law. H.R. 1503 amends provisions of the Federal Food, Drug, and Cosmetic Act (“FDCA”) related to patent information that new drug applicants must submit to the Food and Drug Administration (“FDA”) and FDA must publish in the “Orange Book.”[1] See H.R. 1503, 116th Cong. § 2(a)–(d) (2021). The amendments require “manufacturers to share complete and timely patent information with the . . . (FDA), ensure that periods of exclusivity listed in the Orange Book are promptly updated, and clarify that patents found to be invalid through a court decision or a decision by the Patent Trial and Appeal Board would be required to be removed from the Orange Book promptly, but not before time for appeal has expired.” H.R. Rep. No. 116-47, at 3–4 (2019). The amendments also require FDA and the Comptroller General to submit reports to Congress about the types of patents that should and should not be listed in the Orange Book. See H.R. 1503 § 2(e)–(f).

Submission of Patent Information for Publication in the Orange Book. The FDCA already required new drug applicants to submit patent information for the Orange Book on any patent that “claims the drug for which the applicant submitted the application or which claims a method of using such drug” and that could reasonably be asserted in litigation. 21 U.S.C. § 355(b)(1) (2018). The corresponding FDA regulation explained that the contemplated “patents consist of drug substance (active ingredient) patents, drug product (formulation and composition) patents, and method-of-use patents.” 21 C.F.R. § 314.53(b). The new law explicitly codifies the existing regulations and practice. See H.R. Rep. No. 116-47, at 6 (“H.R. 1503 would codify current regulations and practice regarding the types of patent and exclusivity-related information listed in the Orange Book.”). Specifically, H.R. 1503 amends the law to include the explanation in the statute; it now states that new drug applicants should submit information for patents that (1) “claim[] the drug for which the applicant submitted the application and is a drug substance (active ingredient) patent or a drug product (formulation or composition) patent” or (2) “claim[] a method of using such drug for which approval is sought or has been granted in the application.” H.R. 1503 § 2(a)(1). It also amends § 355 to expressly prohibit submitting patent information outside the categories listed above: “Patent information that is not the type of patent information required by subsection [21 U.S.C. § 355](b)(1)(A)(viii) shall not be submitted under this paragraph.” Id. § 2(b)(1)(D).

The Act further amends the timing provisions of 21 U.S.C. § 355(c)(2), which already required applicants to submit information for patents that had not “issued when an application was filed or approved” within “thirty days after the date the patent involved is issued.” 21 U.S.C. § 355(c)(2) (2018). Under the amended statute, information for patents that issued before approval must be submitted no “later than 30 days after the date of approval of [the] application.” H.R. 1503 § 2(b)(1)(A).

Exclusivity Data Published in Orange Book. The Act also amends the FDCA to require FDA to include in the Orange Book “any exclusivity period” under various provisions of the FDCA “that is applicable, for which the Secretary has determined the expiration date, and for which such period has not yet expired.” Id. § 2(c) (amending 21 U.S.C. § 355(j)(7)(A)). FDA accordingly must “specify each exclusivity period for drugs listed in the Orange Book,” H.R. Rep. No. 116-47 at 8, including new drug and new chemical entity exclusivities, 180-day exclusivity for first-filed ANDAs, pediatric exclusivity, infectious disease exclusivity, and orphan drug exclusivity.

Orange Book Updates to Remove Invalidated Patents. The Act next codifies the requirement to promptly update the Orange Book when listed patents are invalidated by the PTO or a court. When an invalidating decision issues and no appeal has been or can be taken, and the applicant “determines that a patent for such drug, or any patent information for such drug, no longer meets the listing requirements,” the applicant must notify the FDA “within 14 days of such decision of such cancellation or invalidation and request that such patent or patent information, as applicable, be amended or withdrawn.” H.R. 1503 § 2(d)(1) (amending 21 U.S.C. § 355(j)(7)). Under existing FDA regulations, an NDA holder already “is required to promptly notify FDA to amend the patent information or withdraw the patent or patent information” “if there has been a judicial finding of invalidity for a listed patent, from which no appeal has been or can be taken.” 21 C.F.R. § 314.53(f)(2)(i). The new law requires this regulation’s prompt action to be taken within 14 days. FDA, in turn, must amend or withdraw the patent information, but not “before the expiration of any 180-day exclusivity period under paragraph (5)(B)(iv) that relies on a certification described in paragraph (2)(A)(vii)(IV).” H.R. 1503 § 2(d)(1) (amending 21 U.S.C. § 355(j)(7)). According to the House Committee on Energy and Commerce, the new law likewise “requires that FDA remove a patent from this list promptly.” H.R. Rep. No. 116-47 at 8.

FDA Report on Comment Solicitation and Contemplated Action. The Act also requires FDA to “solicit public comment regarding the types of patent information that should be included on, or removed from, the list” of patent information given in 21 U.S.C. § 355(j)(7), which FDA must publish in the Orange Book. H.R. 1503 § 2(e)(1). After collecting the comments, FDA must provide Congress a “summary of such comments and actions the Food and Drug Administration is considering taking, if any . . .” Id. § 2(e)(2). FDA must complete these tasks within a year of enactment. Id. § 2(e). FDA already took related action, having solicited comments in June “on whether and how the Orange Book can be improved.” Request for Comments on the Approved Drug Products with Therapeutic Equivalence Evaluations (the “Orange Book”), 85 Fed. Reg. 33,165, 33,167 (June 1, 2020). FDA asked for comments on “[w]hat additional information or features (e.g., additional search functions) could be incorporated into the Orange Book to make it more useful.” Id. FDA also solicited “comments on the types of patents currently listed in the Orange Book and the impact that any change to current patent listing practices may have on drug product development.” Listing of Patent Information in the Orange Book, 85 Fed. Reg. 33,169, 33,169 (June 1, 2020). Accordingly, FDA asked for comments on the listing of patents related to device components of combination products, devices referenced in FDA labels, risk evaluation and mitigation strategy (i.e., REMS), and digital applications. Id. at 33,173.

Report from Comptroller General on Orange Book Patent Listing of Device Patents. Finally, the Act requires the Comptroller General of the United States to submit to Congress a report on Orange Book-listed patents “that claim an active ingredient or formulation of a drug in combination with a device that is used for delivery of such drug.” H.R. 1503 § 2(f)(1). The report is due within two years. Id. The Comptroller General must include data on patents “that claim a device that is used for the delivery of the drug, but do not claim such device in combination with an active ingredient or formulation of a drug,” and must analyze the “timing of listing” of these patents and their effect “on market entry of one or more drugs approved under” the ANDA provision of the FDCA. Id. Recommendations must be included on “which kinds of patents relating to devices . . . should be submitted” and which should not “in order to reduce barriers to approval and market entry.” Id. According to Representative Robin Kelly of Illinois, the bill’s sponsor, Congress undertook its “responsibility to close loopholes that allow drugmakers to prevent timely access to information that would lead to new generic drug development, increasing patient access and affordability.” 165 Cong. Rec. H3488 (daily ed. May 8, 2019) (statement of Rep. Kelly).

[1] Food and Drug Administration, Approved Drug Products with Therapeutic Equivalence Evaluations (https://www.fda.gov/drugs/drug-approvals-and-databases/approved-drug-products-therapeutic-equivalence-evaluations-orange-book).