近年來國內資訊科技產業面臨了許多國際大廠的專利侵權訴訟及高額專利權利金追索情勢。為有效因應此發展趨勢，企業必須及早建立完整的專利經營策略與管理制度，刺激研發成果專利化，並積極累積有價值之專利籌碼，以厚實長期競爭力。而要研究專利策略，必先對專利制度的現況加以了解；而專利制度的現況，又往往具體反映在專利爭議之上。 在專利標準的爭奪戰中，誰的標準贏得最後勝利，多半便決定了未來誰能賺錢。雖然大家都希望盡早看到標準出現，但也希望自己選擇的技術能變成普遍的標準。如何決定標準是一件值得關注的事，因為標準對於經濟及社會的影響十分巨大。標準制定的過程必須公平公正，以避免有人藉著左右標準的制定而從中謀取私利。這其中也涉及了許多複雜的法律問題，Rambus控告英飛凌（Infineon）案即是一個明顯的例子。 因此本文擬以與產業標準化相關的專利爭議為研究範圍，借鏡美國產業標準化相關之專利爭議，於參與標準制定過程所面臨的法律問題架構之下，探討我國業者在面臨產業專利爭議與產業標準化問題時應如何因應。

公共健康與藥品專利之間的衝突與調和，一直是世界貿易組織（World Trade Organization，以下簡稱WTO）各會員國所關注的焦點；儘管全球經濟發展迅速，但多數低度開發及開發中國家，卻因為無法獲得足夠且平價的醫療資源及藥品，而有大量人口死於可治療之疾病，人類最基本的健康權在該些國家境內仍無法獲得基本的保護；故WTO 在2001、2003及2005年分別通過數個宣言及決議，試圖透過該些決議，來解決該些國家境內日益嚴重的公共健康問題，並試圖調和藥品專利保護與公共衛生間的衝突。然而，該些決議仍必須透過各國修正內國法律來加以實踐，故本文以加拿大和印度之內國法修正為例，分析後發現該些國家修正專利相關法規後所建立之學名藥品出口機制對於解決上述公衛問題之效果其實相當有限，再加上始終對強制授權機制持反對意見的美國，透過其於國際社會強大之影響力，進一步的阻礙了各國的實踐，故WTO允許透過強制授權出口平價學名藥品至不具製藥能力國家之機制，對於落後國家之實際影響，仍有待未來進一步的觀察。

智慧財產權保護的利益包括道德利益，社會利益與經濟利益，然而三種利益彼此可能互相衝突，醫藥品專利便是其中一種常見案例，若醫藥品在專利權的保護下，價格與可得性皆容易成為取得必需醫藥品的高門檻。關於如何使病人取得所需的專利藥物，「強制授權」制度被認為是一種可使用的彈性手段。 本篇論文旨在分析專利強制授權制度對藥物可近性可能造成之影響。第二章從國際公約中對於強制授權的規範切入，說明目前國際上強制授權的運作條件；第三章說明強制授權的功能，其在專利權制度中可達到之經濟與公共利益的調和與平衡，對於反對者所認為「強制授權造成的經濟傷害」論點予以駁斥，並說明強制授權造成專利權人的經濟損失並不如反對者宣稱的巨大，反而因強制授權制度的存在，能有效減少濫用權利的誘因；第四章則著重分析強制授權對公共衛生政策的影響，對於開發中國家而言，建立起穩定的強制授權制度，有助於他們跨過初始的專利障礙，開始扶植本國藥廠並建立本國的藥物供應鏈，以達到獲取藥物的自主性；第五章以美國、加拿大、印度等國實施強制授權的案例，闡述強制授權在已開發國家與開發中國家的實施和效果，強調無論是以強制授權或是其他更為強勢的手段，在專利的壟斷性下，為社會利益保留一項具有彈性與最後手段的措施之必要性；第六章則就我國的專利法修法沿革分析，提出關於現行專利法中強制授權的彈性不足會造成的影響及修改的方向。 / The protection of intellectual property rights includes moral interests, social interests and economic interests, but the three interests may conflict with each other. Patents of pharmaceutical product are the common cases. If the products are under the protection of patents, the price and accessibility will become the obstacles for obtaining essential medicines. The "compulsory license" system is considered to be a flexible instrument that can be used when patented drugs are required by patients. This research aims to analyze the possible impact of patent compulsory license system on accessibility of medicines. In the second chapter, I points out the rule of operation of compulsory license from international conventions, introducing the current international conditions. Chapter 3 describes the function of compulsory license, that the reconciliation and balance between the economic and public interests can be achieved in the patent system. The opponents consider that economic harm would be caused by compulsory license. However, the actual economic loss of the patent owner is not as great as the opponents describe. In contrast, the incentive for the abuse of the right can be effectively reduced through the existence of the compulsory license system. Chapter 4 focuses on how compulsory license system affects public health policies. For developing countries, the establishment of a stable compulsory license system helps them to cross the initial barriers and start to foster their own pharmaceuticals industry. Building their own medicines supply chain helps them to achieve the accessibility of medicines. Chapter 5 illustrates the attitude toward compulsory license in developed and developing countries. The chapters introduce means of compulsory license in the United States, Canada, India and other countries. It emphasizes that, whether compulsory license or other more powerful means, to retain a flexible method for social interests is important in the patent law system. Chapter 6 analyzes the history of Taiwan's patent law. This chapter emphasizes the impact on lack of flexibility about compulsory license, and it mentions the direction of the amendment to Taiwan Patent Law.

「被忽視」的熱帶疾病(NTDs)中的寄生蟲疾病(Parasitic Diseases; PDs)除對非洲人群健康之危害甚鉅外，並進而對非洲地區社經體系造成嚴重衝擊與造成巨大的「失能調整人年」損失。由於不易取得治療PDs傳統基本藥物的問題，許多非洲民眾便以其部落社區的傳統治療師所採用的傳統草藥來進行PDs的治療，雖然這些傳統草藥容易取得，但是成分的內容和藥效品質甚或產生嚴重的致命副作用。雖然TRIPS協定第31條和杜哈宣言的第五和第六段對於製藥能力不足或大部分皆無製藥能力的貧窮國家，可以基於「國家緊急危難或其它緊急狀況」的事由，以強制授權方式取得專利藥或較便宜的學名藥以解決造成國家危難的特定公共健康事件，但是國際大藥廠認為無利可圖，不願意花費資金投注於預防或治療此類疾病藥物的相關研發外，高收入的國家為保護其大藥廠的藥物專利，也往往使用一些經濟制裁手段逼迫上述國家就制定國內專利法以保護其藥物專利。雖然經杜哈宣言修正TRIPS協定第31(f)條有關強制授權對外出口的障礙，但是出口國對於強制授權程序與是否能取得政治上和藥廠業者的支持，仍充滿困難。應用「專利池」可以減少交易成本或法律爭議而可調和「強制授權」與解決「權利耗盡」的爭議，有助於解決非洲開發中國家取得專利藥物的困境。PDs造成非洲開發中國家民眾失能等長期痛苦與健康生活損失，類推適用SARS模式，可依TRIPS協定第31條(b)與杜哈宣言第五段(c)將之視為「造成國家緊急危難或其它緊急狀況」的重大公共健康的事由而可行使強制授權。雖然「生醫專利池BVGH」的「非獨家個別授權與免授權費」的操作模式與傳統電信技術專利池不盡相同，但因藥廠不願投入治療PDs的傳統基本藥物存在的副作用與抗藥性的新藥研發，為鼓勵對治療PDs的藥物進行創新研發， BVGH彈性的授權方式與免繳交授權費，將有利於解決開發中國家未來取得新專利藥的困境。除BVGH外，建議結合全球獎勵基金以「激勵拉拔」的方式獎助願意投入治療PDs新藥研發並將專利自願授權給BVGH的藥廠。鑒於全球暖化與最近中東難民潮大量湧進歐洲，罕見的PDs可預期會大量傳播開來，將嚴重衝擊歐洲等先進國家良好的公共衛生體系，而使得「NTDs尤其是PDs不再只是專屬於貧窮國家的疾病，亦將常現於富有的先進國家」。這些NTDs疾病將提供藥廠進行新藥研發的利基，然而在未來可能產生專利池的反競爭問題，導致支配市場獨占性的隱憂值得關注。 / Parasitic diseases (PDs) not only cause the huge health hazards to African populations, but also they further severely impact on African socio-economic system as resulting in huge economic and health losses as assessed by disability adjusted life-years. Since it is not easy for Africans to access the essential medicine to treat PDs, many of them will seek for the help of local healers in tribal communities to treat PDs. Although these traditional herbs are readily available, the content and quality of drug ingredients may even cause serious fatal side effects. Poor countries with insufficiencies or lacks of the pharmaceutical capacities may still access the patented medicines or cheaper generics to solve the national crisis caused by the specific public health events through compulsory licensing (CL) based on "national emergency or the other emergency situations" according to TRIPS Article 31 and Doha Declaration on the fifth and sixth paragraph due to that the large international pharmaceutical companies consider unprofitable, unwilling to spend money to invest on the research and development (R&D) of new drugs for prevention or treatment purpose. Moreover, the high-income countries also tend to exert some of the economic sanctions to force those poor countries to enact national patent law in order to protect drug patents. Furthermore, the mandatory obstacle of exportation authorized by CL from the amended TRIPS Agreement Article 31 (f) by the Doha Declaration has been improved; nevertheless, it is still fraught with difficulties in utilization of CL for the exporting countries because this should be dependent on whether they may actually get the supports from political and the pharmaceutical industry. Application of patent pools model may benefit to reduce transaction costs or legal dispute thus reconciling and resolving issues related to CL as well as doctrine of patent exhaustion and that it is beneficial to help solve dilemma for African countries to access patented drugs. Because Africans severely suffer from disabled caused by PDs thus leading to long-term pain and health life losses, African countries can grant CL as PDs may be regarded as national crisis like SARS causing "national emergency or the other emergency situations" as authorized from TRIPS Agreement Article 31 (f) and Doha Declaration paragraph 5 (c). Although the practice of individual licensing with royalty-free for BVGH is somewhat different from that of traditional patent pools, this licensing practice mode is beneficial to innovation in new drugs R&D to improve the side effects and drug-resistance of traditional essential medicines and help African countries to access patented new drugs in the future. Finally, it is recommended to cooperate with Award Foundation to encourage incentive for pharmaceutical companies which contribute most to new drugs R&D and voluntary licensing to BVGH. Owing to global warming and recent emergence of huge refugees into Europe rare PDs will be obviously spread out thus causing severe impacts on well-established public health system as leading to emergence of PDs in developed countries like Europe. Altogether, such situations definitely provide a good incentive in new drugs R&D for pharmaceutical companies; however, it guarantees concerns on anti-competitive and monopoly issues derived by biomedical pools in the future.

本研究以Wendy Gordon教授三要件市場失靈理論為核心-即(一) 市場失靈的狀況現實存在，（二）支持被告的使用模式對社會而言利多於弊，以及（三）允許合理使用抗辯不會對於創作者的創作誘因產生實質損害-試圖以美國實務判決為藍本勾勒出可能的觀察構面與命題，並以此為基準以音樂產業為例推演可能的管理意涵，最後從制度面的角度檢討現行合理使用判決所出現的問題與可能的解決方式，研究結果及建議分述如下： 觀察構面與命題的發展 本研究以美國近二十年來重要合理使用判決為藍本，並將市場失靈區分為交易成本過高與正向外部性兩種類型，歸納出以下命題及觀察構面： 命題一：與著作權利人進行交易的交易成本越高，主張合理使用成功的機會越高。 H1:系爭著作物在使用當時若屬於無法尋得權利人的孤兒著作，成功主張合理使用的機會較高。 H2:系爭著作物若有著作權仲介團體代理或有交易成本低廉的授權平台，成功主張合理使用的機會較低。 H3:系爭著作物若有著作權管理資訊，成功主張合理使用的機會較低。 命題二： 被告利用型態對社會創造的正向外部性越高，成功主張合理使用的機會越高。 H4:系爭著作的利用方式若屬於對原著作物的諷刺或批評，成功主張合理使用的機會較高。 H5: 使用者使用的模式若能減少資訊流通障礙而非單純販售著作重製物圖利，成功主張合理使用機會較高。 市場失靈對著作權人的管理意涵 就正向外部性導致的市場失靈而言，當被告的利用模式產生的正向外部性越大，著作權授權交易無法完成對整體社會造成的效率損失越大，依據市場失靈理論的討論架構，法院支持被告合理使用主張的機會也越大。此時，權利人最佳的管理策略應該是更積極進行授權，並避免過度利用優勢談判地位抬高交易條件，最後導致授權交易無法進行。面對交易成本過高可能導致市場失靈，對權利人來說最佳的管理策略應該是使用各種可能的機制創造最有效率的授權市場，當市場的運行越具效率，交易成本越低，市場失靈的風險越低，法院支持利用人合理使用抗辯的機會也越低。管見以為，授權著作權仲介團體進行授權交易、自建授權平台、創新商業模式或與主流流通平台建立策略聯盟，是對權利人來說降低交易成本最佳的管理策略之一。 此外，從音樂與出版產業的發展歷程可以發現技術、法律與管理是彼此互為影響的構面，對於企業經營者來說，應有任何一項變動即牽一髮而動全身的敏銳，假定任何一項要素恆久不變或外生於其他兩構面的變化，均可能成為策略錯誤的原因。以上發現可歸納為三個命題： 命題三:著作利用產生的正向外部性越大，權利人越應該積極進行授權，避免過度利用優勢談判地位抬高交易條件，導致授權交易無法進行。 命題四: 權利人應積極建立便於使用的授權機制，降低交易成本及合理使用的風險。 命題五：技術、法律與管理模式三構面互相影響，任何一項要素變動，都可能驅動其他兩項要素的變化。 現行合理使用判決的問題與制度面的修正芻議 若市場失靈理論及本研究提出的命題與觀察構面被接受，本研究建議現行著作權法第六十五條第二項規定可修正如下： 著作之利用是否合於第四十四條至第六十三條規定或其他合理使用之情形，應審酌一切情狀，尤應注意下列事項，以為判斷之基準： 「一 利用之目的及性質，包括係為商業目的或非營利教育目的。 二 著作之性質。 三 所利用之質量及其在整個著作所占之比例。 四 利用結果對著作潛在市場與現在價值之影響。 五 利用結果產生的公共利益。 六 覓得著作權人以及取得授權的難易與成本。」 現行法下，法院在合理使用與判斷被告需賠償權利人全額損害兩者間沒有其他選擇，若法院考量正向外部性的存在後，認為被告的利用方式對整體社會有極大利益，並將正向外部性所帶來的好處納入最適授權金的計算，其數額或許將遠低於客觀上填補權利人所失利益與所受損害的價額，判定被告需賠償全額損害有悖於分配效率的要求。反面言之，若被告的利用嚴重損及該著作物最主要的經濟收益，判定合理使用對權利人又將衝擊過大。此時，法院將被迫在合理使用與全額損害賠償間進行二擇一的選擇。為給予法院更多救濟市場失靈的彈性，本研究建議在制度上應盡可能補足全額損害賠償與合理使用光譜的空缺，在立法上似可考慮將現行著作權法第六十五條第三項、第四項規定移至第四項與第五項，並增訂第三項條文如下：著作之利用雖不符合第四十四條至第六十三條規定或其他合理使用情形，但法院審酌一切情狀，尤應注意前項所列事項，得酌減損害賠償金額，若行為人利用方式未達商業規模者，並得免除或酌減行為人違反本法所需負擔的刑事責任。 嚴重市場失靈發生時，因為著作權人的市場利益未受影響，應支持著作利用人合理使用的主張。本此，對於特定類型的嚴重市場失靈，著作權法可以明定為合理使用。本研究建議現行著作權法第五十一條修正如下：「著作於個人或家庭或其他類似範圍內之使用為目的者，若該使用不影響著作權人可合理預期的市場利益者，不構成對著作財產權的侵害。」 / Along with the enlargement of the scope and duration of copyright, it is generally believed that barriers to continual innovation and knowledge distribution also increase. How to leverage fair use to best preserve public interest thus becomes a very important issue. Nevertheless, fair use is called the most unpredictable and difficult problem in copyright law. Using the market failure theory proposed by Wendy Gordon to explain the scope of fair use, this research collects landmark U.S. fair use cases as the basis to develop propositions that help the judiciary to deal with fair use cases, makes management suggestions to copyright holders and proposes several legal reforms to the current Taiwanese fair use law . This study suggests that a defendant’s chance to prevail on his fair use defense increase as the transaction cost increases. For illustration, if the work in dispute is an orphan work, a defendant has a stronger fair use case because the transaction cost he has to incur to find the copyright owner and reach a deal is higher. Similarly, if the work in dispute carries with it clear copyright management information, is managed by efficient intermediaries or placed on an efficient transaction platform, a defendant has a weaker fair use case. The reseach also argues that the higher the positive externality brought by a defendant’s uses, the stronger fair use case he has. If a defendant uses the work in dispute to create a parody or to facilitate information exchange, the defendant has a stronger fair use case due to the positive externality he creates. As managerial suggestions to copyright owners, this study maintains that copyright owners should make their best efforts to reduce transaction costs in connection with licensing and copyright transfers and actively engage in licensing to uses creating significant positive externalities. This helps reduce the possibility that potential users rely on fair use and end up paying nothing to copyright owners. To reduce transaction cost, copyright owners may consider building a licensing platform themselves, using intermediaries or forming strategic alliances with primary sale channels. As for positive externalities, it is suggested that copyright owners pay attention to the public interests recognized in the copyright law. This study also finds that technology breakthroughs, legal reshuffles and innovations in business model and management are inter-related. It is simply a mistake to regard one of the three constructs as being static if another construct has been changing. This research also proposes the following amendments to the current fair use law in Taiwan. As a matter of practice, Taiwanese judges rarely consider factors outside the four listed factors in Article 65(2) of the Taiwanese Copyright Law, even though the statute gives them wide discretion to consider other factors. To encourage the Taiwanese judiciary to apply the market failure theory in fair use cases, it is suggested that “the cost at which a user must incur to obtain a license” be added as the fifth factor and that“the public interests a user creates” be added as the sixth factor in Section 65(2). Secondly, to give judges more flexibility in close cases, it is suggested that judges should be given discretion to reduce the damages a defendant has to compensate copyright holders and discretion to reduce or release him from his criminal duty, even if the criteria for fair use are not fully satisfied. Lastly, if serious market failure occurs, it will be Pareto superior to allow defendants to use the work in dispute free of charge. It is generally recognized that most types of personal uses fall within the scope of serious market failure. This study thus proposes that Article 51 of the Taiwanese Copyright Law be amended to the effect that personal or familial uses are allowed so long as the profits copyright holders can reasonably expect are not adversely affected.