負面規定

TRIPS 協定雖建立專利權保障的最低標準，但為了使會員得依照各自的需求 及政策考量調整專利權之範圍，TRIPS 協定在可專利性、專利權之效力等層次均 設有負面具有排除專利權範圍、效力的規定，使會員不致因對智慧財產權之保障 而全然喪失對其他公共利益之促進。此等負面規定增加會員內立法之彈性空間，

部分學者將此等規定稱為TRIPS 協定下的「彈性機制」，對於面臨嚴重公共健康 危機之開發中國家會員而言，具有極高的重要性，有可能成為會員促進藥品取得 之工具。

（一） 可專利性之例外規定

TRIPS 協定對於可專利性抱持寬鬆的態度，僅在例外之情形賦予會員排除可 專利性之權限。TRIPS 第二十七條第二項關於「會員得基於保護公共秩序或道德 之必要， 而禁止某類發明之商業性利用而不給予專利，其公共秩序或道德包括 保護人類、動物、植物生命或健康或避免對環境的嚴重破壞。 但僅因該發明之 使用為會員的法律所禁止者，不適用之。」¹⁵³之規定，以及第三項關於「會員得

151 必須注意者為，依據 TRIPS 協定第二十八條第一項之註腳，專利權人之權利仍受限於 TRIPS

協定第六條關於耗盡原則之規定。

152 TRIPS, supra note 5, art. 28.2 “Patent owners shall also have the right to assign, or transfer by succession, the patent and to conclude licensing contracts.”

153 TRIPS, supra note 5, art. 27.2: “Members may exclude from patentability inventions, the prevention within their territory of the commercial exploitation of which is necessary to protect ordre public or morality, including to protect human, animal or plant life or health or to avoid serious prejudice to the environment, provided that such exclusion is not made merely because the exploitation is prohibited by their law.”

不予專利保護之客體包括：(a)對人類或動物疾病之診斷、治療及手術方法；(b) 微生物以外之植物與動物，及除非生物及微生物方法外之動物、植物產品的主要 生物育成方法。 會員應規定以專利法、或單獨立法或前二者組合之方式給予植 物品種保護。本款於世界貿易組織協定生效四年後予以檢討。」¹⁵⁴之規定，均屬 會員得排除可專利性的例外情狀。

TRIPS 協定第二十七條第二項旨在將「有害之發明」排除於專利保護之客體 外，但「公共秩序」及「道德」的概念非常模糊且涉及價值取捨，具體內涵必須 取決於會員專利主管機關及法院之判斷¹⁵⁵。

至於 TRIPS 協定第二十七條第三項第(a)款規定主要係考量對人類或動物疾 病之診斷、治療及手術方法與人類或動物之生命、健康有直接密切的關係，為使 人類或動物在需要時得以接受適當的診斷及治療，而不受阻礙，在此預留下斟酌 的餘地。一般而言，縱使國家對於此領域的發明給予專利，在未徵得權利人同意 的情形即予以使用，亦甚難構成專利侵權行為¹⁵⁶。值得注意的是，此處允許的除 外客體僅限於診斷、治療及手術之「方法」本身，而不及於適用該方法的裝置 (device)或物品(product)¹⁵⁷。

（二） 專利權之例外規定

TRIPS 第三十條規定，「會員得規定專利權之例外規定， 但以其於考量第三

154 TRIPS, supra note 5, art. 27.3: “Members may also exclude from patentability:

(a) diagnostic, therapeutic and surgical methods for the treatment of humans or animals;

(b) plants and animals other than micro-organisms, and essentially biological processes for the production of plants or animals other than non-biological and microbiological processes.

However, Members shall provide for the protection of plant varieties either by patents or by an effective sui generis system or by any combination thereof. The provisions of this subparagraph shall be reviewed four years after the date of entry into force of the WTO Agreement.”

155 CARLOS M CORREA, INTELLECTUAL PROPERTY RIGHTS, THE WTO, AND DEVELOPING COUNTRIES :THE TRIPS AGREEMENT AND POLICY OPTIONS 62 (2000)[hereinafter CORREA,POLICY

O^PTION].

156 Id. at 67.

157 Id.

人之合法權益下，並未不合理地抵觸專屬權之一般使用，且未不合理侵害專利權 人之合法權益者為限。」¹⁵⁸肯認會員有權就專利權之效力為例外規定，該規定所 使用的字句非常廣泛，內容並無具體之限制，賦予會員制訂專利法規例外規定之 自由空間，在符合要件之前提下，會員有權決定例外效力之類型及範圍¹⁵⁹。由於 此規定之彈性空間甚大，對於會員其他政策之兼顧與執行有其助益存在。

在各國專利法之立法例中，TRIPS 協定第三十條範圍內之例外規定類型大致 包含：私人非商業規模或非商業目的的使用、研究使用、基於教學目的而使用、

基於測試或改進之目的而用以實驗、為了尋求產品在專利保護期間屆滿後核准上 市而用以實驗（即所謂的“Bolar Exception”或前期工作【early working】例外）、

第三人在專利申請日前即善意使用、在徵得專利權人同意的情形下進口在國外行 銷的專利產品等等¹⁶⁰。

在 上 述 例 外 規 定 的 類 型 中 ， 與 藥 品 專 利 有 較 大 關 連 性 者 為 “Bolar Exception”，是考量學名藥在專利期間屆滿後的商業化耗費時日，而允許在專利 期間屆滿前使用受專利保護之發明，以供測試並獲得主管機關之核准上市¹⁶¹。

“Bolar Exception”的目的在於使消費者在專利期間屆滿後，能夠儘速獲得價格較 為低廉的藥品。

（三） 強制授權

在某些特殊情形下，使用人可能亟需使用某種發明，但無法取得專利權人之 授權，為使專利權所保護之技術得以被有效利用，在例外之情況，法律在欠缺意 願的之權利人及有意願之使用人間，成立擬制的授權契約，排除專利權人之獨占

158 TRIPS, supra note 5, art. 30: “Members may provide limited exceptions to the exclusive rights conferred by a patent, provided that such exceptions do not unreasonably conflict with a normal exploitation of the patent and do not unreasonably prejudice the legitimate interests of the patent owner, taking account of the legitimate interests of third parties.”

159 C^ORREA,P^OLICY O^PTION, supra note 155, at 75.

160 Id. at 75-76.

161 Id. at 77.

權能，俾使政府或經政府指派之第三人，在未得到專利權人授權之情形下，仍得 給付相當的補償金，對專利予以使用，而未構成侵權，此即為強制授權之制度。

在政府許可強制授權的情形下，生產者僅須支付合理的補償金，而非專利權人訂 定的高額權利金，也無須投入鉅額的研發成本，成本的減少自然反應於價格的低 廉上。再者，對於相同功能的產品，存有較多的供給者，可降低專利權人對定價 的掌控能力，由於供給者間的競爭，會導致價格降低，總體產出之增加，增加民 眾取得產品的機會。無論是專利制度之提倡者或是批評者，均將強制授權制度視 為是一種策略性的妥協，作為矯正專利制度弊病的機制¹⁶²，一方面得以保存專利 制度之利益，促進研發，一方面亦可減少專利制度帶來之不利¹⁶³，提高大眾對發 明的接近及使用。

巴黎公約於1925 年在海牙修正時引進強制授權制度，肯認聯盟各國都有權 採取立法措施許可強制授權，以防止由於行使專利所賦予的專屬權而可能產生的 濫用（例如：不予實施專利）¹⁶⁴，亦限制聯盟各國以直接取消專利權之極端方法 作為救濟途徑，規定除強制授權的許可不足以防止專利權人之濫用行為外，不應 對專利予以取消¹⁶⁵。在巴黎公約採行強制授權制度後，世界各國專利法的立法例 幾乎均可見到強制授權機制的採認¹⁶⁶，並將許可強制授權之事由擴展至濫用以外 的情事。雖然各國立法例對於強制授權之事由有不同的規定，但大致上可區分為 二種類型：第一種是專利權人對專利權為濫用的行為，例如：反競爭的行為、未 對專利加以利用之行為、阻礙他人研發的行為等等；第二種類型則是基於公共利 益的追求，在某些特殊情形下，立法者認為公共利益的維護應被優先考量，而要 求專利權在此時應有所退讓，例如；政府基於公共目的對專利權予以使用、國家

162 Chien, supra note 111, at 855.

163 Id. at 858.

164 Hague Revision to Paris Convention, art. 5(2).

165 Hague Revision to Paris Convention, art. 5(3).

166 Chien, supra note 111, at 858.

緊急危難之情狀存在、食物或藥物之需要等等¹⁶⁷。

巴黎公約第五條第 A 項雖對於強制授權即定有明文，然而，聯合國貿易與 發展委員會(United Nations Conference on Trade and Development，簡稱 UNCTAD) 於1975 年間曾就專利機制對開發中國家技術移轉之影響進行一項研究，發現開

171 TRIPS, supra note 5, art. 31:” “Where the law of a Member allows for other use of the subject matter of a patent without the authorization of the right holder, including use by the government or third parties authorized by the government, the following provisions shall be respected:

(a) authorization of such use shall be considered on its individual merits;

(b) such use may only be permitted if, prior to such use, the proposed user has made effortsto obtain authorization from the right holder on reasonable commercial terms andconditions and that such efforts have not been successful within a reasonable period of time. This requirement may be waived by a Member in the case of a national emergency or other circumstances of extreme urgency or in cases of public noncommercial use. In situations of national emergency or other circumstances of extreme urgency, the right holder shall, nevertheless, be notified as soon as reasonably practicable. In the case of public non-commercial use, where the government or contractor, without making a patent search, knows or has demonstrable grounds to know that a valid patent is or will be used by or for the government, the right holder shall be informed promptly;

(c) the scope and duration of such use shall be limited to the purpose for which it was authorized, and in the case of semi-conductor technology shall only be for public noncommercial use or to remedy a practice determined after judicial or administrative process to be anti-competitive;

(d) such use shall be non-exclusive;

(e) such use shall be non-assignable, except with that part of the enterprise or goodwill which

制授權」之文字，而是使用「未經權利人授權之其他使用」(other use without authorization of the right holder)之字句，然觀其內容，實質上係屬強制授權之規 範，對於強制授權制度建立一套繁複的架構。

enjoys such use;

(f) any such use shall be authorized predominantly for the supply of the domestic market of the Member authorizing such use;

(g) authorization for such use shall be liable, subject to adequate protection of the legitimate interests of the persons so authorized, to be terminated if and when the circumstances which led to it cease to exist and are unlikely to recur. The competent authority shall have the authority to review, upon motivated request, the continued existence of these circumstances;

(h) the right holder shall be paid adequate remuneration in the circumstances of each case, taking into account the economic value of the authorization;

(i) the legal validity of any decision relating to the authorization of such use shall be subject to judicial review or other independent review by a distinct higher authority in that Member;

(j) any decision relating to the remuneration provided in respect of such use shall be subject to judicial review or other independent review by a distinct higher authority in that Member;

(k) Members are not obliged to apply the conditions set forth in subparagraphs (b) and (f) where such use is permitted to remedy a practice determined after judicial or administrative process to be anti-competitive. The need to correct anti-competitive practices may be taken into account in determining the amount of remuneration in such cases. Competent authorities shall have the authority to refuse termination of authorization if and when the conditions which led to such authorization are likely to recur;

(l) where such use is authorized to permit the exploitation of a patent ("the second patent") which cannot be exploited without infringing another patent ("the first patent"), the following additional conditions shall apply:

(i) the invention claimed in the second patent shall involve an important technical advance of considerable economic significance in relation to the invention claimed in the first patent;

(ii) the owner of the first patent shall be entitled to a cross-licence on reasonable terms to use the invention claimed in the second patent; and

(iii) the use authorized in respect of the first patent shall be non-assignable exceptwith the

(iii) the use authorized in respect of the first patent shall be non-assignable exceptwith the