法學期刊
  • 社群分享
論著名稱: 由美國實務探討逆向付費和解協議於專利法上之適法性(To Study the Legitimacy of Reverse Payment Settlement Agreement under the Patent Law)
編著譯者: 陳文吟
出版日期: 2016.12
刊登出處: 台灣/中原財經法學第 37 期 /1-49 頁
頁  數: 49 點閱次數: 772
下載點數: 196 點 銷售明細: 權利金查詢 變更售價
授 權 者: 陳文吟
關 鍵 詞: 逆向付費和解協議遲延競爭之補償給付簡易上市許可商品名藥學名藥市場專屬權專利排他權利範圍當然違法原則合理原則之快速審查法合理原則
中文摘要: 逆向付費和解協議又名「遲延競爭之補償給付」,協議主要見於醫藥品專利;並常為聯邦貿易委員會認定有違反托拉斯法為由,對專利權人提起訴訟。
西元 2013 年,美國聯邦最高法院於 FTC v. Actavis, Inc. 乙案中,指出逆向付費和解協議有違反托拉斯法之虞,應依反托拉斯法之「合理原則」(rule of reason)審理之。
本文主張採「專利排他權利範圍」之審理標準。惟,其適用前提須先論究專利之有效性,換言之,原告須先證明專利為無效,進而主張專利權人是否逾越其排他性範圍。
至於我國應否採行 ANDA-IV,權衡其利弊,本文以為以我國現有法制,應足以兼顧國民健康與醫藥品專利權人之權益。逆向付費和解協議,無論任何技術領域之專利,仍應以專利是否具有效性為首要議題。
英文關鍵詞: reverse payment settlement agreementpay for delayabbreviated new drug applicationbrand name drugsgeneric drugsmarketing exclusivityscope of the patentper se illegalquick look rule of reason testrule of reason
英文摘要: For the past two decades, reverse payment settlement agreement has become the strategy in pharmaceutical industry to prevent generic drug entering into the market. According to FDCA, if generic drug company can prove pharmaceutical patent invalid or its generic drug will not infringe the patent, it may file application to FDA for ADNA-IV approval, which will gain it 180-day marketing exclusivity. Patentee (brand-name drug company) reaches agreement with ADNA-IV applicant by paying large amount of compensation to the latter in exchange of latter’s refraining from entering into the market. FTC treated reverse payment settlement agreement as a violation of antitrust laws and filed lawsuit against brand-name drug company frequently.
Whether reverse payment settlement agreement is legitimate? Pros believed the agreement saves litigation costs and is within the scope of patent rights, Cons insisted the agreement is anticompetitive. Even among federal courts of appeals, the holdings are conflicting.
In Federal Trade Commission v. Actavis, Inc. (2013), U.S. Supreme Court, at the very first time, decided the issue of reverse payment settlement agreement. The Court held that the agreement might violate antitrust laws, so, the “rule of reason” analysis should be applied to evaluate the agreement. Dissenting opinion written by the Chief Justice Roberts pointed out that patentee has the right to exclude competition as long as he/she is acting within the scope of a valid patent.
The study found that ANDA-IV might discourage pharmaceutical companies to invest on drugs’ R & D, as a result, ANDA-IV would harm the public health. So, it is not recommended to provide ANDA-IV in our domestic law. As to the reverse payment settlement agreement, no matter which industrial fields, applying “scope of the patent” rule is more appropriate than other antitrust rules, but under the condition that the validity of the patent should be confirmed.
目  次: 壹、前言
貳、FDCA之ANDA-IV 條款
一、學名藥之簡易上市許可程序
二、一百八十天之市場專屬權
參、逆向付費和解協議
一、緣由
二、適法性
肆、逆向付費和解協議之審理標準
一、專利排他權利範圍
二、當然違法原則
三、合理原則之快速審查法
四、合理原則-聯邦最高法院的見解
五、評析
伍、ANDA-IV 與逆向付費和解協議於我國產業之適用
陸、結語
相關法條:
相關判解:
相關函釋:
相關論著:
返回功能列