ジェトロ・ニューヨーク事務所 知的財産部からのニュースによると、以下のとおり、米国食品医薬品局（FDA）が発行する低分子医薬品のデータベース（Orange book）及びバイオ医薬品のリスト（Purple Book）に関連する法律案が成立したとのことです。今年中にはバイオ医薬品について提供された特許とその有効期間の情報がパープルブックに掲載されるようです。
2021年1月5日、FDAが発行している低分子医薬品のデータベース（Orange book）に掲載される特許の情報を明確化するための法案（Orange Book Transparency Act）にトランプ大統領が署名し、法律として成立しました。
「今回の法改正は、概ね従来の FDA の運用を明確化する内容であるため実務への影響は限定的であると考えられるが、複雑な運用を法律で整理するものである」とのことです。
- 参照: 2021.01.08 JETRO NY 知的財産部ニュース「医薬品データベース（オレンジブック）に関する改正法案に大統領が署名」）。
2020年12月27日、COVID-19の感染拡大を踏まえた9,000億ドルの緊急経済対策を含む包括歳出法案（Consolidated Appropriations Act, 2021）に、トランプ大統領が署名し、法律として成立しました。
- 参照: 2021.01.04 JETRO NY 知的財産部ニュース「商標法改正等を含む歳出法案に大統領が署名」）。
- https://www.congress.gov/116/bills/hr133/BILLS-116hr133enr.pdf（PDF 1755頁以降）
Consolidated Appropriations Act, 2021 – DIVISION BB. PRIVATE HEALTH INSURANCE AND PUBLIC HEALTH PROVISIONS – TITLE III. PUBLIC HEALTH PROVISIONS – Subtitle C. FDA Amendments
SEC. 325. BIOLOGICAL PRODUCT PATENT TRANSPARENCY.
(a) IN GENERAL.—Section 351(k) of the Public Health Service Act (42 U.S.C. 262(k)) is amended by adding at the end the following:
‘‘(9) PUBLIC LISTING.—
‘‘(A) IN GENERAL.—
‘‘(i) INITIAL PUBLICATION.—Not later than 180 days after the date of enactment of this paragraph, the Secretary shall publish and make available to the public in a searchable, electronic format—
‘‘(I) a list of each biological product, by nonproprietary name (proper name), for which, as of such date of enactment, a biologics license under subsection (a) or this subsection is in effect, or that, as of such date of enactment, is deemed to be licensed under this section pursuant to section 7002(e)(4) of the Biologics Price Competition and Innovation Act of 2009;
‘‘(II) the date of licensure of the marketing application and the application number; and
‘‘(III) with respect to each biological product described in subclause (I), the licensure status,
and, as available, the marketing status.
‘‘(ii) REVISIONS.—Every 30 days after the publication of the first list under clause (i), the Secretary shall revise the list to include each biological product which has been licensed under subsection (a) or this subsection during the 30-day period or deemed licensed under this section pursuant to section 7002(e)(4) of the Biologics Price Competition and Innovation Act of 2009.
‘‘(iii) 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 respecting a biological product included on the list published under this subparagraph, 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, in revisions made under clause (ii), include such information for such biological product. Within 30 days of providing any subsequent or supplemental list of patents to any subsequent subsection (k) applicant under subsection (l)(3)(A) or (l)(7), the reference product sponsor shall update the information provided to the Secretary under this clause with any additional patents from such subsequent or supplemental list and their corresponding expiry dates.
‘‘(iv) LISTING OF EXCLUSIVITIES.—For each biological product included on the list published under this subparagraph, the Secretary shall specify each exclusivity period under paragraph (6) or paragraph (7) for which the Secretary has determined such biological product to be eligible and that has not concluded.
‘‘(B) REVOCATION OR SUSPENSION OF LICENSE.—If the license of a biological product is determined by the Secretary to have been revoked or suspended for safety, purity, or potency reasons, it may not be published in the list under subparagraph (A). If such revocation or suspension occurred after inclusion of such biological product in the list published under subparagraph (A), the reference product sponsor shall notify the Secretary that—
‘‘(i) the biological product shall be immediately removed from such list for the same period as the revocation or suspension; and
‘‘(ii) a notice of the removal shall be published in the Federal Register.’’.
(b) REVIEW AND REPORT ON TYPES OF INFORMATION TO BE LISTED.—Not later than 3 years after the date of enactment of this Act, the Secretary of Health and Human Services shall—
(1) solicit public comment regarding the type of information, if any, that should be added to or removed from the list required by paragraph (9) of section 351(k) of the Public Health Service Act (42 U.S.C. 262(k)), as added by subsection (a); and
(2) transmit to Congress an evaluation of such comments, including any recommendations about the types of information that should be added to or removed from the list.
On June 25, 2021, the Biological Product Patent Transparency (BPPT) amendments to 42 U.S.C. 262(k) of the Biologics Price Competition and Innovation Act (BPCIA) will take effect.
Q5: What Purple Book listing requirements were added by the Biological Product Patent Transparency section of the Consolidated Appropriations Act of 2021 enacted December 27, 2020?
A5:The Biological Product Patent Transparency (BPPT) section of the legislation requires that, by 180 days after enactment (June 25, 2021), FDA publish and make available to the public in a searchable, electronic format a list of biological products, by nonproprietary name, for which a biologics license under section 351(a) or 351(k) of the Public Health Service Act (PHS Act) is in effect; the date of licensure of the marketing application and the application number; and the licensure status and, if available, marketing status. The BPPT section also requires that FDA revise the list every 30 days to include any additional products licensed under section 351(a) or 351(k) of the PHS Act. In addition, for each biological product on the list, the BPPT section requires that the Purple Book list each reference product exclusivity period and each first interchangeable exclusivity period for which FDA has determined such biological product to be eligible and for which such period has not concluded.
The BPPT section also requires publication in the Purple Book of patent lists provided by reference product sponsors (i.e., biologics license application (BLA) holders) to FDA for certain licensed biological products. Specifically, a reference product sponsor is required to provide to FDA the list of patents and corresponding expiry dates (referred to here as the “initial list”), not later than 30 days after the reference product sponsor has provided the initial list to a 351(k) applicant under section 351(l)(3)(A) or (l)(7) of the PHS Act. The reference product sponsor is also required to provide to FDA any subsequent or supplemental lists, and their corresponding expiry dates, within 30 days of the provision of such lists to a 351(k) applicant under section 351(l)(3)(A) or (l)(7) of the PHS Act. FDA will begin publishing patent lists in the Purple Book not later than 180 days after the date of enactment (June 25, 2021), or when FDA has received any such lists from reference product sponsors, whichever is later. FDA subsequently will revise the list on a monthly basis to include any additional initial lists and any updates from subsequent or supplemental lists.