2009年的生物藥品價格競爭與創新法(簡稱BPCIA)對生物學名藥之上市審查,設計了另一種專利連結制度。其並沒有事先專利登錄之橘皮書制度,但創造了另一套專利舞蹈程序,與兩階段的專利侵權訴訟。美國最高法院在2017年6月做出Sandoz v. Amgen 案判決 ,涉及學名藥廠是否一定要先循BPCIA的專利舞蹈程序,進行資訊交換及第一階段侵權訴訟,還是可以跳過該程序,直接發出「上市前180天通知」,而進行第二階段訴訟?
美國對生物製藥(biologic product)的專利連結制度,則是2009年的生物藥品價格競爭與創新法(Biologics Price Competition and Innovation Act of 2009,簡稱BPCIA)所規定的另一種方式。大致上來說,其與Hatch-Waxman 法在專利連結制度的差別在於以下幾點:1.其並沒有專利登錄橘皮書制度;2.沒有30個月訴訟等待期;3.針對第一家申請具有可替代性之生物學名藥,提供更長的獨家銷售期(獲准藥品上市後獨賣一年,或經過專利侵權訴訟後法院判決後18個月,或獲准上市後仍在侵權訴訟中則為獲准上市後43個月)。
Michael P. Dougherty, The New Follow-on-Biologics Law: A Section By Section Analysis of the Patent Litigation Provisions in the Biologics Price Competition and Innovation Act of 2009, 65 Food & Drug L.J. 231, 235-36(2010).
42 U.S.C. § 262(l)(2)(“ (2) Subsection (k) application informationNot 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; and (B) may provide to the reference product sponsor additional information requested by or on behalf of the reference product sponsor.”).
42 U.S.C. § 262(l)(1)(C).
42 U.S.C. § 262(l)(3)(A).
42 U.S.C. § 262(l)(3)(B).
42 U.S.C. § 262(l)(3)(B)(ii).
42 U.S.C. § 262(l)(3)(B)(i).
42 U.S.C. § 262(l)(3)(C).
Michael P. Dougherty, supra note 1, at 237.
42 U.S.C. § 262(l)(4).
42 U.S.C. § 262(l)(5).
42 U.S.C. § 262(l)(5)(B)(ii)(II).
35 U.S.C. § 271(e)(2).
42 U.S.C. § 262(l)(6)(A).
42 U.S.C. § 262(l)(6)(B).
Jon Tanakad, “Shall” We Dance? Interpreting the BPCIA’s Patent Provisions, 31 Berkeley Tech. L.J. 659, 680-82 (2016).
Id. at 682.
42 U.S.C. § 262(l)(8)(A)(“The subsection (k) applicant shall provide notice to the reference product sponsor not later than 180 days before the date of the first commercial marketing of the biological product licensed under subsection (k).”).
42 U.S.C. § 262(l)(8)(B).
42 U.S.C. § 262(l)(8)(B)(i).
42 U.S.C. § 262(l)(8)(C).
42 U.S.C. § 262(l)(9)(B).
42 U.S.C. § 262(l)(9)(C).
Sandoz Inc. v. Amgen Inc., 137 S.Ct. 1664 (2017).
Id. at 1672-73.
Id. at 1673.
Id. at 1673.
Id. at 1673.
Amgen Inc. v. Sandoz Inc., 794 F.3d 1347 at 1357, 1360 (Fed. Cir. 2015).