Chapter 1: Patents and Entry Competition in the Pharmaceutical Industry: The Role of Marketing Exclusivity Effective patent length for innovation drugs is severely curtailed because of extensive efficacy and safety tests required for FDA approval, raising concern over adequacy of incentives for new drug development. The Hatch-Waxman Act extends patent length for new drugs by five years, but also promotes generic entry by simplifying approval procedures and granting 180-day marketing exclusivity to a first generic entrant before the patent expires. In this paper we present a dynamic model to examine the effect of marketing exclusivity. We find that marketing exclusivity may be redundant and its removal may increase generic firms' profits and social welfare. Chapter 2: Why Authorized Generics?: Theoretical and Empirical Investigations Facing generic competition, the brand-name companies some-times launch generic versions themselves called authorized generics. This practice is puzzling. If it is cannibalization, it cannot be profitable. If it is divisionalization, it should be practiced always instead of sometimes. I explain this phenomenon in terms of switching costs in a model in which the incumbent first develops a customer base to ready itself against generic competition later. I show that only sufficiently low switching costs or large market size justifies launch of AGs. I then use prescription drug data to test those results and find support. Chapter 3: The Merger Paradox and R&D Oligopoly theory says that merger is unprofitable, unless a majority of firms in industry merge. Here, we introduce R&D opportunities to resolve this so-called merger paradox. We have three results. First, when there is one R&D firm, that firm can profitably merge with any number of non-R&D firms. Second, with multiple R&D firms and multiple non-R&D firms, all R&D firms can profitably merge. Third, with two R&D firms and two non-R&D firms, each R&D firms prefer to merge with a non-R&D firm. With three or more than non-R&D firms, however, the R&D firms prefer to merge with each other.

專利權具有獨占性，對一國產業發展具有重要影響，為了平衡該權利，各國專利法在給予發明人專利權的同時也加諸某些限制，以我國為例，於專利法第五十七條第一項列舉專利權效力所不及之情形有：(一)為研究、教學或試驗，實施其發明，而無營利行為者。此即所謂之「實驗例外」 (experimental use exception)條款。 實驗例外條款在各國司法實務運作上，最常被引起爭論者向來集中在處方藥市場中專利藥廠與學名藥廠間之競爭議題。因為學名藥廠為了能夠盡早進入市場，不免須在專利期間屆滿前實施原廠專利進行必要之研究、試驗，以符合各國對於藥物上市管理法令之要求。 雖然我國專利法與其他國家一樣也有試驗例外條款，但其中要件嚴格限定為「非營利行為」，從比較法之方式分析，該規定係受美國普通法之影響。美國普通法關於試驗例外係採取嚴格路線，必須行為人之試驗係出於非營利目的，單純追求真相、探求知識理論，或為滿足好奇心，才可主張普通法上之實驗例外，即始係不具營利色彩之公家機關、學術單位從事之試驗，只要背後具有實質的商業目的亦不得主張試驗例外。如此造成要成功適用試驗例外是愈來愈不可能。 國際間對於試驗例外之立法，除美國外，尚存在許多形式值得我國借鏡，以歐洲共同體專利規則草案(Proposal for a Council Regulation on a Community Patent)為例，其區分「私人且非商業性目的之行為」，以及「為試驗目的之行為」，後者要求必須係針對系爭專利技術本身所進行之試驗始非專利權效力所及，若係將該專利技術作為研究工具之用，仍非法之所許。這種區分方法不僅層次分明、無觀念上混淆之虞，判斷上也較具有可預測性。 美國於1984年通過Hatch-Waxman 法案鼓勵學名藥之發展，對於為滿足主管機關關於醫藥品上市要求之試驗，在專利法271(e)(1)明文規定排除在專利權效力之外，即所謂之「Bolar例外」。我國於九十四年二月五日亦增訂藥事法第四十條之二第五項：「新藥專利權不及於藥商申請查驗登記前所進行之研究、教學或試驗」關於Bolar例外之規定。惟或因立法匆促，致法條要件不符合實際狀況，例如限定「申請查驗登記前」之行為，實際上藥廠於提出查驗登記之申請後，往往在主管機關之要求下須進行其他試驗，這些行為均在立法者原欲保護之範圍內，僅因立法用語之不當，造成實務運用之困擾。 筆者最後從法律及商業管理觀點著眼，對國內立法提出下列修法建議，作為本研究之最終成果： 壹、對於專利法第五十七條第一項第一款修法之建議 一、刪除「教學」之行為態樣 二、刪除「而無營利行為」之要件 三、增列關於研究工具之專利則無本條之適用 四、放寬適用範圍為符合主管機關法規要求而實施他人專利亦有實驗例外之適用。 贰、對於藥事法修法之建議 一、刪除「申請查驗登記前」之要件，改以行為目的來限定範圍，即「為通過藥品查驗登記所進行之研究或試驗」，始有本款之適用。 二、明定「物品專利」及「方法專利」均有本條之適用

隨著醫療科技的進展，人類對於疾病的成因、機轉、病程、及治療，在不斷地研究突破下，有著持續的進步而對人類的健康有著不可或缺的貢獻。其中藥品，正是人類對抗疾病最關鍵、也最普遍的方式之一，對公共衛生的重要性自不待言。 其中，由於生命科學的本質使然，開發新的藥品對於研究發展的倚賴，遠勝於其他產業，因此，創新研發藥廠對於開發一項新藥的平均投資，已達十三億美元之譜；此外，由於藥物對人體的生理功能、體內恆定能造成極大的影響，因此世界各國的醫藥衛生主管機關無不對於藥品的上市加以嚴格的管制，使得現今開發一項藥品平均約耗時十至十五年。藥品開發的巨大投入與耗時極長的開發期間，使得製藥產業亟需經由智慧財產權的制度來提供其投入研發創新之誘因。然而，因為智慧財產之保護，也使得新藥往往售價高昂而造成公眾近用之阻礙。而學名藥正是解決這樣的問題的關鍵之一，亦為世界各國所大力推動。在推動學名藥產業上，實驗實施免責為制度上極為重要的考量之一。本文及希望藉由對製藥產業特質之探究，美國普通法上以及成文法上實驗實施免責的探討，我國實驗實施免責之規定與判決之研究，來找出我國當下實驗實施免責的規定於製藥產業中適用時所可能發生的問題，以及相對應的可能改進方案。 本文第二章本章先行探討製藥產業之特質；第三章討論美國普通法上實驗實施免責之概念，並歸結出美國普通法上實驗實施免責的三項適用要件；第四章探討美國成文法上實驗實施免責之立法背景、相關判決以及對生物科技領域各層面的影響；第五章則先行探討世界貿易組織於「與貿易相關智慧財產權協定」中對於專利權之限制基礎。其後探討我國專利法中之一般實驗實施免責以及藥事法中針對製藥產業之實驗實施免責之相關規定，並由學者論述以及相關判決中，探討我國實驗實施免責之相關規定於製藥產業實務上所可能面臨之問題，並提出可能之解決方案。 / With the progress of medical technology, humans have been furthering the understanding of the etiologies, mechanisms, courses, and treatments of diseases. Such continued progresses have contributed significantly to improving human health. Among all the treatments, the pharmaceutical is one of the key and common ways with which humanity fight diseases. Its importance to public health is beyond doubt. Due to the nature of the life sciences, the pharmaceutical industry depends more on research and development than other industries do. Therefore, on average, it costs innovative pharmaceutical companies 1.3 billion U.S. dollars to develop a new drug. Furthermore, countries around the world pose strict regulations on new drugs’ entering the market since drugs cause huge impacts on the physiological functions and internal balances of the human body. Hence, it generally takes ten to fifteen years for a new drug to be fully developed. The enormous investment and lengthy developing period makes the pharmaceutical companies extremely dependant on the intellectual property system to provide them with the incentive for research and development. However, it is also because of the intellectual property protection that makes new drugs expensive and difficult for the public to access. The Generic drug, however, is one of the key solutions to solve this problem and is intensively promoted by countries all over the world. Regarding the promotion of the generic drug industry, the experimental use exemption is one of the vital systemic considerations. There are discussions on the characters of the pharmaceutical industry, on the common law and statutory experimental use exemptions of the United States, and on the related regulations and precedents of the experimental use exemption in Taiwan. Through the above discussions, the thesis is aimed at identifying the possible problems the regulations on experimental use exemption might cause when applied to the practice of the pharmaceutical industry and at proposing possible solutions to such problems. The characters of the pharmaceutical industry are discussed in Chapter two. The concepts and the criteria of the common law experimental use exemptions are discussed in Chapter three. The legislation background, related precedents, and impacts on the field of biotechnology of the statutory experimental use exemptions in the United States are illustrated in Chapter four. Lastly, in chapter five, the restrictions on patent right in the Agreement on Trade-Related Aspects of Intellectual Property Rights of the World Trade Organization is first discussed. The related regulations on experimental use exemptions in Taiwan are later discussed. Lastly, through the scholars’ opinions and related precedents, the possible problems of application of the experimental use exemption in Taiwan are illustrated and the probable solutions are proposed.

面對未來全球人口成長、可耕地減少等現象，生物技術在農業上的應用日益增加。其中，基因改造技術等基因層次相關的平臺應用技術更是提升農作物價值的關鍵—透過跨物種功能應用，大幅提升育種效率。自1996年基改作物商業化種植開始至今，美國都是全球最大種植國家，也是基改作物研發先驅國家。生技農業政策以及和基因改造作物有關法規之制訂使基改作物在美國蓬勃發展，尤其是專利保護對於種子產業之影響尤為深遠。專利權所提供的完善保護使大量資本進入種子產業，投入資源將農業生物技術應用於種子培育上，此舉也促成Monsanto等跨國農業生技公司之興起，主導全球基因改造作物之市場。 Monsanto將研發重心放在基改種子之研發，其在生技種子相關營業比重遠高於同業，同時，其投入特殊性狀之基改種子研發之回收遠高於其他公司之相同營業項目之投資報酬率。Monsanto積極藉由併購取得基因、基因轉殖技術以及種子種源。掌握關鍵基因、基因轉殖技術以及大量且優良種源使含有Monsanto轉殖基因作物在市場上佔有極大的比例。在美國，超過一半以上之主要作物種植面積為基因改造作物，尤其是基因改造大豆，佔大豆總種植面積之比例高達94%。市面上絕大多數基改大豆係Monsanto的抗嘉磷塞（RounupReady，RR1Y）基改大豆種子。藉由智慧財產保護策略，Monsanto並進一步限制RR1Y及其他基改作物之使用方式。 惟RR1Y專利將在2014年到期，農民可在2014年時留種種植基改大豆種子而不用每年購買種子，或購買學名（generic）抗嘉磷塞轉基因大豆種子。在美國所種植之大豆約有四成會外銷，而外銷國家基改作物規範法規是出口與否之關鍵。若未取得歐盟、中國等主要外銷國家基改作物主管機關之批准，呈交包括基因之轉殖植物對環境衝擊之風險評估、包含該基因之轉殖植物所製成食品之安全性評估等基改作物資訊，則抗嘉磷塞基因大豆無法進入該國糧食市場。然而，在目前美國農業生技基改作物相關規範下，學名基改種子廠必須在專利種子專利到期後，才能進行實驗及田間試驗，呈交相關資料以符合基改作物主管機關之要求。透過建立學名基改作物快速獲得核准查驗登記之程序，允許學名廠依賴專利基改作物原廠之實驗及田間試驗資料以建立其學名基改作物之安全性與性狀表現有效性，同時，允許學名基改作物在原基改作物開發廠專利期滿前即可開始進行試驗，可以使學名抗嘉磷塞大豆種子以及其他學名基改種子能在原專利基改作物種子專利到期後順利進入市場，促使基改作物種子價格競爭，並對於專利基改作物研發公司進行適度之補償，以促進產業發展。 / The development of new technologies in plant breeding has led to improvements in the efficiency scientists produce improved plant varieties. Genetic modification is among the developments that support plant breeding. The introduction of genetically modified crops has revolutionized the agriculture industry. With patent protection available on GM traits, varieties and other aspects of seed production, private R&D investments in the seed industry have increased tremendously. Monsanto has been the leading company in investing agricultural biotechnology and has obtained a dominant position in the GM traits found in soybeans, cotton, corn and other commercialized crops. Currently, over 90 percent of soybeans planted in the United States were herbicide-resistant, with Monsanto’s Roundup Ready being the dominant soybeans planted. In 2014, however, the agriculture industry will be facing the expiration of a patent for Roundup Ready soybeans. Despiate the fact that the patent expiration date is approaching, the agricultural biotech industry has no guideline in place to tell its players exactly how to transition seamlessly from patent monopolies to generic competition. The transition problem is espectially significant for soybeans exported to oversea markets as more than 40 percent of the soybeans grown in the U.S. are exported. In order for those soybeans to be accepted in the grain channel, regulatory approvals are required in countries that import soybeans. Obtaining data, which includes scitific data on the trait being developed, for regulatory approvals can take years to complete. If a generic trait is to reach market immediately after the original trait go off patent, the data generation process should begin before patent expiration. A Hatch-Waxman type patent infringement defense for activities necessary to obtain regulatory approvals for biotech traits can ensure that seed companies have sufficient time to obtain registrations for a generic Roundup Ready trait or other generic traits. Current legislation should be modified to adequately oversee the transition to the generic use of genetically modified crops and, in the mean time, ensure the availability of generic modified crops.