2017年6月15日 星期四

最高法院對仿製藥侵權議題的意見 - SANDOZ INC. v. AMGEN INC. ET AL.

[本篇算是冷知識]

2009年生物製劑價格競爭與創新法(Biologics Price Competition & Innovation Act,BPCIA)提供取得美國食品藥物管理局(FDA)對於已經取得許可證的藥品(一般來說是專利藥)的「生物仿製藥(biosimilar)」提供ㄉ認證的捷徑,「生物仿製藥」為利用已有之數據進行仿製製造生產上市的藥品42 U.S.C. 262(k)為取得生物仿製藥許可的規定,一般來說,生物仿製藥在分析研究、動物實驗、臨床實驗的目的下,可以獲得許可證。

42 U.S.C. 262(l)中,還解決了「生物仿製藥」製造商與許可藥的製造商之間可能的專利爭議,主要就是透過資訊交換/透明化來解決可能的爭議,保障生物仿製藥製造商在特定用途上可以免於專利侵權訴訟。但,畢竟無法避免雙方在某些點上仍具有專利爭議,根據42 U.S.C. 262(l)(2)(A)規定,當要申請生物仿製藥的許可,申請人應在FDA接收申請案後20日內提出製造資訊。如此,可以讓仿製藥製造商與原新藥製造商之間交換資訊,以呈現出可能產生的專利爭議。

這時,前述BPCIA將疏通雙方在專利訴訟中的兩個層面,第一層面,讓雙方一起瞭解可能面對專利訴訟的相關專利;第二層面,生物仿製藥應在商業實施前至少180天通知取得許可證的藥品製造商。

如果「生物仿製藥」的製造商沒有符合以上要求(提供申請與製造資訊),可能會有兩個結果:原取得許可證的藥品製造商提出專利侵權訴訟,或是對方專利的無效與權利主張等;若「生物仿製藥」製造商僅提供申請與製造資訊,卻沒有完成相關程序,取得許可證的藥品製造商可以對相關專利提起簡易判決。

此案例中,Amgen宣稱握有製造與使用藥品"filgrastim"的專利,Sandoz則尋求取得FDA同意其仿製藥的製造。當FDA通知Sandoz已經接收其藥品製造的申請,Sandoz按照規定通知Amgen。不過,Sandoz又在之後通知Amgen他不會提出申請與製造的資訊,使得Amgen可以對Sandoz提出侵權告訴

不二話,Amgen在地方法院對Sandoz提出侵權告訴,並主張Sandoz違反不公平競爭法,並且對Sandoz藥品尋求禁制令。Sandoz則反訴主張專利無效與侵權不成立,並且主張他並未違反BPCIA

一整個專利爭議就是因為這個特殊的產業中的BPCIA規定。

在地方法院審理過程中,FDA授權Sandoz製藥,藥品名為Zarxio,這時Sandoz通知Amgen相關商業化的資訊。於是地院同意部分Sandoz的反訴理由,並解除Amgen不公平競爭的主張。

案件進入CAFC,CAFC法官作出Sandoz並未違反BPCIA雙方資訊交換的決定,並要求Sandoz在獲證後應發出第二次通知,而且是在接獲FDA對此仿製藥的藥證許可後180天後通知原藥製造商,之後才能上市Zarxio。

最高法院意見:

最高法院認為,在42U.S.C.262(l)(2)(A)之下無法執行禁制令,不同意CAFC可作出是否因為侵權成立而同意禁制令的決定。而對於本案而言,最高法院認為相關生物仿製藥廠商應在商業實施之前180前通知原取得許可證的專利藥品廠商(規定在商業行銷/販售前180日前),甚至是在FDA發出藥證之前或之後。BPCIA頂多讓原取得許可的新藥製造商可以主張專利侵權的判決,如本案,Amgen在地方法院對Sandoz提出侵權告訴。對於CAFC,最高法院認為CAFC對於被告Sandoz是否及時通知Amgen做出錯誤的決定,且不能僅依照被告是否符合BPCIA規定而判斷是否有不公平競爭的行為,而是在不公平競爭下的議題判斷是否需要發出禁制令。

[相關法條]
https://www.law.cornell.edu/uscode/text/42/262

42 U.S. Code § 262 - Regulation of biological products

...
(k)Licensure of biological products as biosimilar or interchangeable
(1)In general
Any person may submit an application for licensure of a biological product under this subsection.
(2)Content
(A)In general
(i)Required information An application submitted under this subsection shall include information demonstrating that—
(I)the biological product is biosimilar to a reference product based upon data derived from—
(aa)
analytical studies that demonstrate that the biological product is highly similar to the reference product notwithstanding minor differences in clinically inactive components;
(bb)
animal studies (including the assessment of toxicity); and
(cc)
a clinical study or studies (including the assessment of immunogenicity and pharmacokinetics or pharmacodynamics) that are sufficient to demonstrate safety, purity, and potency in 1 or more appropriate conditions of use for which the reference product is licensed and intended to be used and for which licensure is sought for the biological product;
...
(l)Patents
(1)Confidential access to subsection (k) application
(A)Application of paragraph
Unless otherwise agreed to by a person that submits an application under subsection (k) (referred to in this subsection as the “subsection (k) applicant”) and the sponsor of the application for the reference product (referred to in this subsection as the “reference product sponsor”), the provisions of this paragraph shall apply to the exchange of information described in this subsection.
...
(2)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; and
...
(C)Subsection (k) application not provided
If a subsection (k) applicant fails to provide the application and information required under paragraph (2)(A), the reference product sponsor, but not the subsection (k) applicant, may bring an action under section 2201 of title 28 for a declaration of infringement, validity, or enforceability of any patent that claims the biological product or a use of the biological product.
...

最高法院意見:
https://www.supremecourt.gov/opinions/16pdf/15-1039_1b8e.pdf
(備份:https://app.box.com/s/stzs0scgrsy5tlb1lov4vze59bdmrmht

資訊參考:
http://www.lexology.com/r.ashx?i=5756118&l=7V8VT3V

biosimilar:
http://cdnet.stpi.narl.org.tw/techroom/market/bio/2009/bio_09_005.htm

智慧財產局資料:
https://www.tipo.gov.tw/dl.asp?fileName=41218111474.pdf

Ron

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