我國於2002年加入世界貿易組織，市場之開放勢必對我國生技製藥產業帶來衝擊。在法制方面，為改善現有管理制度，期與國際管理規定接軌，並順應世界貿易組織「與貿易有關之智慧財產權協定」之相關規定，我國藥事法於民國94年2月5日增訂第40條之2，一則獎勵新藥研發，遵守國際義務，強化智慧財產權之保護，以符合世界醫藥法規潮流，再者兼顧國內製藥業之發展。其中藥事法第40條之2第1項係關於藥品專利登錄制度之規定，此項新規定，可能因新藥許可證申請人揭露無關該新藥之專利而衛生主管機關又無餘力審核之情況下，延誤後續學名藥之上市時程；而其中藥事法第40條之2第5項則係關於試驗例外之規定，此項新規定則與專利法試驗例外規定有關，其之適用對於以製造學名藥為主之我國藥廠亦將有相當影響。有鑑於此，本論文擬就我國生技製藥產業因前開法制規範增訂所可能面臨之爭議問題進行探討。 本文將生技製藥產業涉及專利法及競爭法之爭議問題分為二個面向討論，第一面向係上游階段，即藥品開發階段之相關專利法及競爭法爭議問題，主要包括研究工具專利試驗例外及授權等相關問題，第二面向則為下游階段，即藥品開發完成後之相關競爭法爭議問題，主要係關於藥品專利登錄制度可能衍生之競爭法相關問題。 首先，關於上游階段之研究工具專利試驗例外問題，本文認為，未經專利權人同意而實施研究工具專利之學名藥廠，其臨床試驗與申請上市許可之行為雖可主張藥事法上之試驗例外，然其尋找候選藥物之行為卻不該當專利法上之試驗例外規定，而仍構成專利權之侵害。其次，關於上游階段之研究工具專利授權問題，本文認為，針對第二種態樣之研究工具專利聯盟，由於其同時涵蓋所有互補性及替代性專利，因此，不論以產品市場、技術市場或創新市場之觀點，其皆有可能構成獨占地位之濫用以及搭售，而有違反競爭法相關規定之虞。最後，關於下游階段之藥品專利登錄制度問題，本文建議，可參酌美國鼓勵學名藥上市之立法例及司法實務，於藥事法中訂定確認訴訟及反訴之相關規定，且訂定第一個提起確認之訴者可享有180天之獨占銷售權，以鼓勵欲生產新藥學名藥版之學名藥廠，主動向法院提起確認之訴，確認其未侵害系爭專利，以除去經檢附之不適當專利。

本論文主要是在探討延展性權利金(reach-through royalty)條款的競爭法規制。首先，本文對於研究工具專利及延展性權利金條款的意義及概念作一說明，接著簡介目前各國之競爭法制與專利法制的權衡概況，並探討一些與延展性權利金條款有關之授權條款，以了解目前競爭法對於延展性權利金條款所可能導致之相關效應的評價，作為後續分析該條款適法性的基礎，再來整理美國實務及學說對於延展性權利金條款的看法，最後綜合檢討相關論述，提出本文見解。經研究後，本文認為，延展性權利金條款有其促進競爭效應(如提供風險分攤機制、幫助起始公司解決現金壓力問題以及提供授權雙方較佳的協商估價基礎)亦有其限制競爭效應(如降低被授權人研發誘因而有限制研發的效果及權利金堆疊效應)，因此一概禁止或一概允許此種條款皆非適當，而應視個案情形依合理原則的標準加以權衡，以決定系爭行為的適法性。 / The present article discusses the antitrust regulation for reach-through royalty provisions which mainly used in biotechnology research tool patent licensing. First, this article introduces the meanings of research tool patent and reach-through royalties. Second, it illustrates antitrust regulations for patent licensing in foreign countries specifically in U.S., European Union, together with R.O.C. and, furthermore, it also discusses provisions similar or related to reach-through royalties. Third, this article introduces the discussions about reach-through royalty provisions in U.S., including the NIH Guideline, case law regulations and other related discussions by scholars. Finally, the present article analyzes the effects of reach-through royalties more deeply based on the mentioned discussions and makes a suggestion for the regulation of reach-through royalties. This article argues: since reach-through royalties have both anti-competitive and pro-competitive effects, a total ban or allowance is not appropriate and a “rule of reason” inspection should be applied to such provisions for better efficiencies.

制定專利法的本意，不僅是給予發明人在一定期限內擁有一定限度的獨占權，以鼓勵發明人揭露新穎發明，亦在於提升科技發展、提高經濟成長，使社會大眾可從既有發明中再進行卓越科技研發，以節省社會研發成本。專利法賦予專利權人禁止任何未經授權之他人製造、使用、販賣、為販賣之要約，以及為上述目的進口該專利權技術之排他權利。但為達促進產業進步的目的，各國專利法並增列研究、實驗的免責條款(experimental use exception)來平衡專利權人及社會大眾的利益。研究實驗免責的前提必須對專利權人權益造成微量或是最低限度的干擾(de minimums)，即是希望對專利權人的權益造成最小傷害，同時又可以達到促進產業發展及鼓勵更多研發工作進行的目的。 我們將實驗免責條款分為二類，一種是純為好奇心，僅針對專利技術內容作實驗，研究如何改善該發明，此為狹義的實驗免責；第二種則是應用於醫藥產業，此類實驗並非改善發明內容，而是重覆實施其發明，再進行其他研究及實驗，可視為廣義的實驗免責，此即美國在1984年修正Hatch-Waxman法案之醫藥產業的實驗免責條款，只要是為提交FDA之相關實驗資料時，則可主張實驗免責，目的為使已享受二十年專利期之發明儘快成為公共財，以供大眾利用。 研究工具專利的實施方法即作為研究及實驗目的，醫藥產業上可以是生物材料，亦可以是篩選新藥方法。由於具有研究及實驗的特性，若在研究實驗免責條款下，非專利權人企圖以研究實驗免責方式來規避其侵權行為時，專利權人行使權利時，則可能遭遇不少困難。若研究工具專利又被主張為提交FDA相關資料之實驗免責時，此行為對於專利權人權益並非造成微量或是最低限度的損失，發明人未因該專利而獲益，又無法實施專利權，則會降低申請專利的意願。 專利權的效力，應給予專利權人較大權利使發明人願意揭露技術、促進社會科技進步，抑或是應給予較大實驗免責範圍，使研發機構不會受到專利權限制而阻礙社會科技發展的動力，此二種考量方向，如同位於天平的兩端，呈現兩難局面。目前法院實務案例則以執行研究工具專利會落入藥物開發之實驗免責規範為主要認定，但筆者認為應就實施研究工具專利的行為、內容、目的作一探討及了解，並顧及公平性，才是評估研究工具專利是否適用實驗免責條款之依據。 因此，專利權人應如何管理或應用其研究工具專利，並可真正執行專利權而不至落入實驗免責條款? 可由數個方向進行：一、產品形式保護研究工具專利：將研究工具的執行方式以產品形式包覆，以銷售產品的方式跳脫實驗免責之框架，未必需要經由專利授權的方式來取得利益；二、進行全球化佈局：於申請研究工具專利之前，分析其發明深度及可能競爭對手，並在可能進行製造、使用、行銷、及進口相關於此發明技術之國家申請專利，以未來如何執行及如何獲利作為考量全球佈局之策略；三、成立契約研發中心(contrast research organization，CRO)：當研究工具專利在執行專利權有困難，不易跳脫實驗免責範圍，則可使用營業秘密 (Trade Secret) 方式保護其發明，不以公開技術方式，而是應用研究工具成為新藥篩選中心，提供研發服務；四、授權國家單位：即是採用類似NIH之OTT模式，將研究工具專利權直接授權給政府，由政府支出其授權金並可擴展至更多研發機構。 至於非專利權人，如一般之研發機構，應如何利用研究工具專利，且不落入專利侵權的疑慮? 除了取得專利授權外，亦可採用：一、從已授權國家單位取得技術：即如同NIH之OTT模式，由已取得研究工具專利授權之政府單位進行非專屬授權，該發明具較合理之授權金，並可被更多研發機構善加利用；二、落入實驗免責範疇：針對研究工具專利之實質發明內容進行改良及應用，再利用其方式以進行其新藥研發實驗，則可適用於實驗免責的規定；三、交互授權(Cross-license)：使用研究工具專利之研發機構與原本專利權人合作，經由交互授權方式成為合作伙伴，則可達到雙贏；四、成立開放社群，共同分享技術：如多數國家成立之GenBank，或BIOS (Biological Innovation for Open Society)社群之概念，收集對人類具有重大意義之研究工具，如基因序列等，以開放原始碼(Open source)之社群相互分享，使後續研發工作更加快速及順暢。 除了上述方法外，專利法可仿照著作權法，增定合理使用（fair use）之相關規定，亦即除了試驗例外、第三人繼續使用權、私人領域內之非營利性使用外，賦予第三人一般而全面性的專利權合理使用範圍，或以自願性參與集體授權機制（voluntary collective rights licensing）以支付合理權利金，促進社會公益。實驗免責條款可使得發明人願意持續公開其發明，同時使新穎發明公諸於世，兼顧社會公益，促使社會經濟及產業的進步，使國家社會整體因研發創新而真正獲益。 / The original purpose of the patent law not only offers the exclusivity to the inventors in a limited periods and in a limited rights in order to inspire the inventors to disclose more novel inventions, but also encourages the development of the technology and increases the growth rate of economics to the publics. The more new inventions the inventors provide, the more cost of R&D will be saved in whole society. The right of the exclusivity for the patentee is when someone without authority from the patentee, he can’t makes, uses, offers to sell, or sells any patented inventions, within the countries, or imports into the countries. But in order to enliven the industrial growth, the experimental use is added as a legal exception in many countries to balance the benefits of the patentee and the public interests. We should minimize interference to the patentee’ rights when the experimental use exception of the patents is claimed. We can divide the experimental use exception into two classes. One is the narrowly-defined experimental use exception only for the curiosity, for testing the content of the patents. The use aims to find out how to improve the inventions. The broadly-defined experimental use exception that is applied in the medical industry. This kind of use does not improve the technology of the invention, but repeat the invention again without changing any content. Such kind of broadly-defined experimental use exception is created after Hatch and Waxman Act in 1984. The experimental use exception in the medical industry is described that if the result of the experience is for submitting the drug information for the FDA examination, it is claimed non-infringement of the patent and protected by “safe harbor” of 35 USC 271 (e)(1). The purpose is to practice the inventions of the patents earlier and save the cost of R&D through public use. Research tool patent are used for the purpose of research and experiment and improves the speed of the experiment. In the medical industry, the research tool patent may be the biological material or the method of screening the new drug. Because of the experimental characteristics, the non-patentee may claim the experimental use exception and cause persecutions to the patentee. This kind of experimental use exception is not fair to the patentee and damage patentee’s benefit, especially in the research tool patentee. The patentee will not be able to receive the royalty from the non-patentee who claims the experimental use exception. As a result, it would reduce the will of filing such kind of patents. Should the effect of the patent right grant the patentee a broader right to patentees to encourage the inventors to release new technology which benefits the social and scientific progress? Or it should offer a large range of the experimental use exempt for the research institutes to encourage the using in the experimental use exception? It is difficult to judge which direction is better than the other one. The court are taking the side of the range of experimental use exception, allowing the research tool patents in the pre-clinical tests or experiment for submitting to FDA. This thesis proposes that there should be more criteria other than FDA, such as the purpose and the practical condition of use. Only when the whole situation and justice are taken into consideration will there be a suitable explanation of the experimental use exception. This thesis offers some suggestions concerning the management and application of research patent tools for the patentee and the non-patentee. It also assert that regulations about the fair use, such as experimental use exception, non-profit private use, voluntary collective rights licensing with rational royalty, can be added to the patent law to urge the patents to be put into practice. The reasonable experimental use exception can encourage the inventors to release his invention and the R&D departments to improve the technology more aggressively, realizing social and industrial advancement through the patent applications.

論文內容著重在以下三個重點: 試驗免責、延展性授權與延展性專利範圍、書面描述要件。首先是35 U.S.C. § 271(e)(1)之Safe Harbor 緣由、案例、Integra v. Merck 一案之過程與後續影響以及271(e)(1)的試驗免責與研究工具的關係, 最後提出建議應限縮試驗免責範圍, 以強制授權或是明定專利法中的試驗免責範圍緩和基礎研究專利範圍過大現象(第二、三章)。 研究工具專利開發者多所採用之延展性授權與延展性專利範圍無非是想多獲得利益, 而研究工具專利對於生物科技發展是相當重要的, 第四章先以四方角色(大藥廠、大學與非營利機構、小藥廠與政府單位)討論研究工具對於本身的利益考量, 並且因試驗免責範圍不明, 延展性授權契約已是普遍存在, 詳細地討論其存在的意義, 並且分析已探討延展性授權金/契約議題文章, 另外對於延展性專利保護範圍, 明確指出哪一些核准專利是延展性保護範圍, 雖然2001年的三方會議已經明確地限制此類專利的核准, 由於Rochester v. G.D. Searle一案, 法院認為Rochester 專利包含延展性保護範圍, 歸因於未揭露出清楚的書面描述要件, 於是進行第五章書面描述要件的討論。 進而較詳細地探討生物機轉的途徑特性、功能性敘述必要性以及書面描述上的困難, 然後進行相關案件探討, 提出自己對於專利文件之書面描述要件的看法, 希望能在生物類研究工具專利保護範圍與書面描述要件中取平衡, 適切地保護研究工具發明。最後並提出總結與建議。 / Over the last twenty years, the biotechnology industry has grown very rapidly, and increased our understanding of incurable diseases. Research tools are playing important role to form the core of the pharmaceutical research, development, and testing. Because this industry is so research tool intensive, numerous problems have arisen stemming from the competing interests of the many players in this field. From the legislative history, the Hatch-Waxman Act embodies the legislative compromise balancing the competing interests of the pioneer pharmaceutical and allied research-based products industries with those of the generic drug industry. And the section 35 U.S.C. § 271(e)(1) statute provides a “safe harbor” from patent infringement based on activities that are reasonably related to obtaining FDA regulatory approval of drug products, but the plain language is fairly ambiguous. In Eli Lilly v. Medtronic, Supreme Court held the safe harbor extends to medical devices, despite the fact that § 271(e)(1) does not refer specifically to medical devices. Recently, for the case of Merck v. Integra, Federal Circuit announced that the term “solely” limits the safe harbor exemption from extending beyond uses of patented inventions that are reasonably related to those specified in § 271(e)(1). But Supreme Court rejected and held that § 271(e)(1) applies to uses of patented inventions that are reasonably related to the development and submission of any information to the FDA. The Court was silent on the potential applications and opened the questions of the safe harbor's application to patented research tools. These problems may be the reason that research tool providers attempt to request royalties such as reach-through royalties for covering the downstream compounds or products. They also try to file the patent application with the reach-through claim for claiming a future invention. However, the use of reach-through royalties is still controversial and causing a decrease in innovation. Patentees attempt to obtain reach-through claims for covering a future invention without actually describing in the written description. The Federal Circuit's holding in Rochester v. G.D. Searle that the Rochester's patents failed the written description requirement, and Rochester should curtail the use of reach-through claims. So far the USPTO has not been uniform in its application of written description requirement. We therefore propose a new test to determine whether, and under which circumstances, functional claiming may satisfy the written description requirement. One should not overreach the scope of the inventor’s contribution to the field of art as described in the patent specification. The approach would provide sufficient incentive for pioneering inventions, preserve room for the future, and thus expect to promote progress and to advance the purposes of patent law.