第三章 生物製劑價格競爭和創新法案（BPCIA）
第一節 專利舞蹈相關規定
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第三章 生物製劑價格競爭和創新法案（BPCIA）
第一節 專利舞蹈相關規定
基於 Hatch-Waxman 法案的專利連結制度，FDA 被賦予的任務為維持並公開與核可 藥品有關的專利資訊，該等專利資訊公開於「具相同藥效之核准藥品目錄（Approved DrugProducts with Therapeutic Equivalence）」，即通稱之「橘皮書（Orange Book）」。
橘皮書之專利登錄提供原開發藥廠專利資訊之揭露，使學名藥可進行專利迴避設計，
降低開發成本並減少專利訴訟。然而，橘皮書之專利登錄可說是學名藥 ANDA 申請時 進行聲明的基礎，也是 Paragraph IV 訴訟中爭議的起點。但生物製劑因為沒有如小分 子藥的橘皮書之專利連結制度，因此在生物製劑價格競爭和創新法案中設計了一套交 換專利資訊的制度。
生物相似藥的上市審查被規定於美國法典 Title 42, Chapter 6A，第 262 條 k 項 中，故以下簡稱生物相似藥的上市申請案為 (k) 申請案。在 k 項之後的 l 項，是針 對 (k) 申請案設計的一套專利相關制度，該制度從上市申請提出的第一天起就開始影 響(k)申請案，而且是從規定生物相似藥開發商（以下簡稱 (k) 申請人）與生物製劑原 廠藥商以下簡稱原廠）之間的資訊交換開始，有人稱之為專利舞蹈(patent dance)。
1. 機密資訊揭露
首先是(k)申請人在提出(k)申請案時即負有一揭露(k)申請案相關機密資訊的義務
30。有受揭露權利的人有 (1) 一或多名沒有辦理過參考藥品相關專利申請案且非原廠 員工的外部律師，(2) 一名沒有辦理過參考藥品相關專利申請案的原廠所屬內部律 師，(3) 在參考藥品相關專利係受專利權人專屬授權予原廠但專利權人保有訴權或是 參與訴訟之權的前提下，一名專利權人代表。而揭露機密資訊的唯一目的就是讓受揭
30 42 U.S.C. § 262(l)(1)(B)(i) (2011) (“PROVISION OF CONFIDENTIAL INFORMATION.—When a subsection (k) applicant submits an application under subsection (k), such applicant shall provide to the persons described in clause (ii), subject to the terms of this paragraph, confidential access to the information required to be produced pursuant to paragraph (2) and any other information that the subsection (k) applicant determines, in its sole discretion, to be appropriate (referred to in this subsection as the“confidential information.”)”)
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31 42 U.S.C. § 262(l)(1)(D) (2011) (“USE OF CONFIDENTIAL INFORMATION.—Confidential information shall be used for the sole and exclusive purpose of determining, with respect to each patent assigned to or exclusively licensed by the reference product sponsor, whether a claim of patent infringement could reasonably be asserted if the subsection (k) applicant engaged in the manufacture, use, offering for sale, sale, or importation into the United States of the biological product that is the subject of the application under subsection (k).”)
32 42 U.S.C. § 262(l)(2) (2011) (“SUBSECTION (k) APPLICATION INFORMATION.—Not later than 20 days after the Secretary notifies the subsection (k) applicant that the application has been accepted for review, the subsection (k) applicant— (A) shall provide to the reference product sponsor a copy of the application submitted to the Secretary under subsection (k), and such other information that describes the process or processes used to manufacture the biological product that is the subject of such application.”)
33 42 U.S.C. § 262(l)(2)(B) (2011) (“may provide to the reference product sponsor additional information requested by or on behalf of the reference product sponsor.”)
34 42 U.S.C. § 262(l)(3)(A)(i) (2011) (“a list of patents for which the reference product sponsor believes a claim of patent infringement could reasonably be asserted by the reference product sponsor, or by a patent owner that has granted an exclusive license to the reference product sponsor with respect to the reference product, if a person not licensed by the reference product sponsor engaged in the making, using, offering to sell, selling, or importing into the United States of the biological product that is the subject of the subsection (k) application.”)
35 42 U.S.C. § 262(l)(3)(B)(ii)(I) (2011) (“a detailed statement that describes, on a claim by claim basis, the factual and legal basis of the opinion of the subsection (k) applicant that such patent is invalid, unenforceable, or will not be infringed by the commercial marketing of the biological product that is the subject of the subsection (k) application.”)
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36 42 U.S.C. § 262(l)(4)(A) (2011) (“IN GENERAL.—After receipt by the subsection (k) applicant of the statement under paragraph (3)(C), the reference product sponsor and the subsection (k) applicant shall engage in good faith negotiations to agree on which, if any, patents listed under paragraph (3) by the subsection (k) applicant or the reference product sponsor shall be the subject of an action for patent infringement under paragraph (6).”)
37 42 U.S.C. § 262(l)(4)(B) (2011) (“FAILURE TO REACH AGREEMENT.—If, within 15 days of beginning negotiations under
subparagraph (A), the subsection (k) applicant and the reference product sponsor fail to agree on a final and complete list⋯the provisions of paragraph (5) shall apply to the parties.”)
38 42 U.S.C. § 262(l)(5)(B)(ii)(I) (2011) (“⋯the number of patents listed by the reference product sponsor under clause (i)(II) may not exceed the number of patents listed by the subsection (k) applicant⋯”)
39 42 U.S.C. § 262(l)(5)(B)(ii)(II) (2011) (“If a subsection (k) applicant does not list any patent under clause (i)(I), the reference product sponsor may list 1 patent⋯”)
40 42 U.S.C. § 262(l)(6)(A) (2011) (“ACTION IF AGREEMENT ON PATENT LIST. —If the subsection (k) applicant and the reference product sponsor agree on patents as described in paragraph (4), not later than 30 days after such agreement, the reference product sponsor shall bring an action for patent infringement with respect to each such patent.”)
41 42 U.S.C. § 262(l)(6)(b) (2011) (“ACTION IF NO AGREEMENT ON PATENT LIST. —If the provisions of paragraph (5) apply to the parties as described in paragraph (4)(B), not later than 30 days after the exchange of lists under paragraph (5)(B), the reference product sponsor shall bring an action for patent infringement with respect to each patent that is included on such lists.”)
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人，(k)申請人在(k)申請藥上市販售前至少 180 天還負有告知原廠的義務。原廠獲得(k) 申請人的上市預告後，原廠得就曾經被列出包含增補清單但未在上述程序中進行訴訟 的專利被侵害為由申請暫時禁制令以阻止量產、銷售(k)申請藥的行為。若原廠向法院 聲請暫時禁制令，原廠與(k)申請人應當互相配合以儘速完成相關的證據開示程序。8. 限制確認之訴
此外，兩造均不得在(k)申請人提出上市預告之前提起確認專利侵權、無效或無法 實施之訴。但是當(k)申請人沒有盡到上述程序所賦予之義務時，原廠（且唯有原廠有 資格）得提起確認侵權之訴42。
圖 3-1 總結了上述生物製劑價格競爭和創新法案（BPCIA）中相關的資訊交換流 程，俗稱專利舞蹈。很明顯地，BPCIA 有一套相當繁複的上市前專利訴訟機制，過程 需歷經漫長的信息交換及談判，來界定首次涉訟專利與訴訟範圍，一般將耗費約 8 個 月左右的時間。此外，法規中限制雙方不得任意提起確認訴訟，只有原廠藥廠可以在 談判結束後、或(k)申請人未照法定程序進行時，可以向(k)申請人提告；或者，在原廠 藥公司收到(k)申請人所發出的藥品上市前通知之後，雙方始可提確認訴訟。甚者，原 廠藥廠還可以向法院申請禁制令，阻止(k)申請人在訴訟結果確認前上市，而美國訴訟 的審理時間多半很長，原廠藥藥廠多會使用甚至濫用訴訟來拖延生物相似藥上市。
生物相似藥廠商若遵循上述法規，除了對產品上市時程形成一定程度影響之外，許 多生物相似藥公司亦認為 BPCIA 制定信息交換機制，要求生物相似藥公司過度揭露商 業秘密信息，致生物相似藥公司商業秘密有外流的極高風險，生物相似藥企業陷入左 右為難。
整體而言，「專利舞蹈」無疑形成了生物相似藥進入市場的一道阻礙。許多生物相 似藥公司都在嘗試繞開專利舞蹈的方式，因而引發了許多生物相似藥廠與原藥廠或專 利所有權人間的專利訴訟。
42 42 U.S.C. § 262(l)(9)(B) (2011) and 42 U.S.C. § 262(l)(9)(C) (2011).
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圖 3-1: 專利舞蹈機密資料揭露
第一份專利清單
回覆第一份專利 清單
第二份專利清單 談判交集
有交集 無交集
限時起訴
上市預告
限制確認之訴