Yes / In this paper we study the determinants of the strength of patent enforcement in 43 member countries of the World Trade Organization (WTO) between 1998 and 2011, a period after the signing of the Trade-Related Aspects of Intellectual Property Rights (TRIPS) agreement. We do so by building on and expanding the seminal work of Ginarte and Park (1997) on the pre-TRIPS determinants of patent rights in the years 1960-1990. We find that in the years after TRIPS was signed, the strength of patent enforcement of a country is positively determined by two variables that signify the usage of the patent and intellectual property system, and the number of patent and trademark applications. We also find that the level of research and development expenditure, the quality of human capital, and the level of development of a country have positive effects on the strength of the enforcement of patent law in practice. Intellectual property rights enforcement is one of the key investment-related policies included in the United Nations Conference on Trade and Development (UNCTAD) Investment Policy Framework for Sustainable Development. Identifying the determinants of strong patent systems will help policymakers at the national and supranational levels to design and implement effective policies that strengthen national patent systems, thereby enhancing economic benefits such as greater levels of commercialization of intangible assets and greater levels of international trade and investment.

Since the last century, many wars and violations of Human Rights were direct reasons that set the pace to develop Human Rights laws, especially after the end of World War II and the holocausts associated with it. One of the critical Human Rights is that ‘to life’, relating to the right ‘to health’, hence the fundamental accessibility to healthcare services and products. Nonetheless, the last decades have witnessed a significant growth in pharmaceutical patents leading to increased drug prices. Overshoots in prices prohibit access to medicine. Disputes between States, pharmaceutical corporations, patients, and investors have occurred, some of which were not purely related to monetary aspects but also to Human Rights, such as the right to ‘access to medicine’. These disputes are controversial. The applicable legal regimes are patent laws (e.g., the TRIPS Agreement) and International Human Rights Law (IHRL) including the European Convention on Human Rights (ECHR), European Social Charter, and more. However, it is up to the courts to decide on whether to consider IHRL in the legal decision process. The question turns to whether they consider the two regimes to be intersecting or independent. This thesis tackles the area of intersection between patent law and the right to ‘access to medicine’ in cases of pandemics such as inter alia HIV/AIDS and COVID-19. It investigates whether the right to ‘access to medicine’ exists as a human right by law, to jump to examine whether solutions like Compulsory Licenses (CLs) and patent exceptions are suitable. Then it answers the question whether there should be defragmentation of laws or not. The work analyzes available caselaw to seek a balance between patent laws and the human right to ‘access to medicine’ during pandemics. Caselaw shows that the conflict makes the overlap of laws confusing and in need of determining the set of relevant provisions in the applicable norms. The question on defragmentation in answered by focusing on Section 5 of the TRIPS Agreement and some provisions in IHRL instruments. The thesis proposes a defragmentation of applicable laws that aids in looking at previous solutions to reach the sought balance, and it sheds the light to give recommendations. The work finally recommends being proactive, for times of pandemics like the COVID-19 outbreak, and working on the realization of a unified and harmonized EU patent law to keep up to the objective of delivering quality vaccines/antivirals, on time, within budget, and with supporting applicable laws.

The purpose of this dissertation is to assess the impact of patent rights regulation in universities in Sweden and Germany. Two empirical studies were conducted in order to answer the research question What are the incentive effects of patent rights regimes in the university?. A qualitative study based on interviews with representatives from the public support infrastructure in both countries assessed the role of technology transfer offices and other intermediaries in both countries. The process of patenting and commercial exploitation in Sweden and Germany was presented in stylised models. A quantitative study based on a survey of researchers in Sweden and Germany was carried out in order to find out the factors that impact on the decision to apply for patents. The quantitative results together with the qualitative findings from the interview study allow us to draw a number of conclusions. First of all, the incentive effects of patent rights regimes in universities in Sweden and Germany are rather small. Despite two diametrically opposed patent rights regimes – Sweden with researcher-ownership and Germany with universityownership – the results indicate that patenting is rather unaffected by it. Researchers in both countries are similarly patent-active. Thus, the patent rights regime has only limited explanatory power. Other factors seem to have a stronger impact on the incentives to patent. The infrastructure for patenting and commercialisation has an important role. Researchers that received support were more inclined to get their results patented and the results from the interview study indicate that it is mainly a well-working infrastructure that increases incentives to patent and not the patent rights regime alone. When it comes to the public infrastructure for patenting and commercial exploitation, the role of technology transfer offices etc. and the type of support is different in both countries. Swedish public infrastructure provides primarily support with regard to patenting and financial support aiming at the establishment and development of spin-offs. German public infrastructure focuses primarily on patenting and licensing. The patent rights regime has limited power to explain patenting. Structural factors of research organisations and personal characteristics of the researcher are more important. Structural factors such as research orientation (applied vs. basic) can explain patenting behaviour. Researchers that have previous experience with patenting show a greater propensity to patent. The survey results about hindrances to patenting have shown that a lot of researchers did not apply because they lacked knowledge, regarded the patenting process to be too time-consuming or too costly. This illustrates the importance of experience and infrastructure. Since the university wants the researcher to accomplish all three missions (research, teaching and transfer), it has to induce the researchers to do so. Nevertheless, the analysis of the reward system has shown that this is rarely the case. The empirical results in Sweden and Germany show that salary either directly or indirectly is determined by publications and the extent to which researchers acquire external funding. In addition to career concerns and salary, researchers have the possibility to earn a bonus. This bonus is related to the third mission (knowledge transfer) of universities and can take different forms. It can include honoraria for books or lectures, income from consulting assignments, or income from patents. It is therefore important to acknowledge that there is a broad range of means to transfer knowledge and technology. Consulting seems particularly important. The bonus associated with consulting seems to be less risky than the potential bonus of patenting. The maximum bonus with regard to patents is determined by the patent rights regime. In Sweden, the university teachers can receive the entire bonus, whereas this share is limited to 30% in Germany. The chances that a bonus materialises are uncertain. The basic role of technology transfer offices and other actors that support patenting and commercialisation is to reduce the risks associated with patenting. If the risks can be reduced the chances that a bonus will materialise are larger, which increases the incentives of researchers to exert effort with regard to patenting. / Syftet med avhandlingen är att analysera inflytandet av patenträttsregleringen i universitet i Sverige och Tyskland. Två empiriska studier har genomförts för att få ett svar på forskningsfrågan Vad är incitamentseffekterna av patenträttsregimer i universiteten?. En kvalitativ studie baserad på intervjuer med representanter för den offentliga infrastrukturen i båda länder analyserade tekniköverföringsaktörernas roll. Processen för patentering och kommersialisering i Sverige och Tyskland har illustrerats i grafiska modeller. En kvantitativ studie baserad på en enkätundersökning av forskare i båda länder har genomförts för att veta mer om de faktorer som påverkar beslutet att söka patent. De kvantitativa resultaten tillsammans med de kvalitativa resultaten från intervjustudien gör det möjligt att dra slutsatser. Först och främst så är incitamentseffekterna av patenträttsregimer i universiteten ganska små. Trots två motsatta patenträttsregimer – i Sverige äger forskaren forskningsresultaten (”Lärarundantaget”) i Tyskland universiteten – visar resultaten att patentering inte berörs av detta. Forskarna i båda länderna är lika patent aktiva. Patenträttsregimer har därför begränsad förklaringskraft. Andra faktorer har starkare påverkan på incitament att söka patent. Infrastrukturen för patentering och kommersialisering spelar en viktig roll. Forskare som fått stöd visade en större sannolikhet att söka patent och resultaten från intervjustudien visar att det är främst en väl fungerande infrastruktur som ökar incitament att söka patent och inte bara patenträttsregimen. Den offentliga infrastrukturen i båda länder har lika roller. Den svenska offentliga infrastrukturen stödjer patentering och nystartandet av företag genom finansiellt stöd. Den tyska offentliga infrastrukturen stödjer framförallt patentering och licensiering. Patenträttsregimer har begränsat förklaringskraft. Strukturella faktorer, såsom forskningsorientering (tillämpad vs. grundforskning) kan delvis förklara patentbenägenheten. Forskare som har erfarenhet av patentsystemet har större patentbenägenhet. Enkätresultaten om hinder att patentera har visat att många forskare avstår att söka patent på grund av begränsad kunskap eller på grund av tidsbrist. Detta illustrerar hur viktig erfarenhet och infrastruktur är. Universitet som vill att forskare ska fullfölja alla tre uppgifter (forskning, undervisning och kunskapsöverföring) borde uppmuntra forskarna att satsa på alla tre uppgifter. Ändå har analysen av belöningssystemen visat att så är sällan fallet. De empiriska resultaten i Sverige och Tyskland visar att lönen är direkt eller indirekt beroende av publikationer och i vilken mån forskarna lyckas att attrahera externa medel. Utöver karriären och lönen har forskarna möjlighet att tjäna en bonus. Bonusen är relaterad till tredje uppgiften (kunskapsöverföring) och kan ta olika former. Det kan inkludera arvode för böcker eller föreläsningar, inkomster från konsultverksamhet eller inkomster från patent. Därför är det viktigt att erkänna att det finns olika kanaler för kunskaps- och tekniköverföring. Konsultverksamhet har visat sig särskild viktigt eftersom bonusen i relation till konsultverksamhet är mindre riskabelt än bonusen relaterad till patent. Maximala bonus i relation till patent påverkas av patenträttsregimen. I Sverige kan forskaren få alla intäkter från ett patent. I Tyskland är andelen begränsat till 30 procent av alla bruttoinkomster från patentet. Chansen att en bonus kommer till stånd är osäkert. Tekniköverföringsorganisationer kan reducera riskerna som är relaterad till patent och kommersiell exploatering. Om riskerna kan reduceras och om chanserna att en bonus erhålls ökar, ökar incitamenten för forskarna att anstränga sig att patentera.

"The thesis of this study is that the flexibility within the exceptions to patent rights protecton under the TRIPS Agreement has not sufficiently been exploited at the national level. The study conceptualises the regimes for the protection of the right to health and IPRs not as mutually exclusive but as potentially reinforcing. The contention is therefore that the obligations in respect to the right to health limit the manner in which states can exercise the flexibilty within the patent regime of the TRIPS Agreement. Eventually the study seeks to answer the question: Where does the guarantee for the right to health lie in light of the TRIPS regime? ... The study is divided into three chapters preceded by an introduction. The introduction lays the background for te discussion. Chapter one deals with the definition of important concepts and provides the context in which the study is set. The chapter also discusses the background to the creation of the TRIPS Agreement, with an emphatic discussion on the involvement or lack thereof of Africn and other least developed and developing countries in this process. Chapter two discusses the patent rights exceptions clause under the TRIPS Agreement. Against this background, compuslory licensing, government use and parallel importing as means of making accessibility to drugs a reality under the TRIPS Agreement will be discussed. Chapter three identifies other means of making drugs more accessible and identifying places where they have worked well. In this chapter, generic substitution, establishemnt of a pricing committee, therapeutic value pricing, pooled procurement, negotiated procurement and planned donations will be discussed. Finally a conclusion will be drawn from the discussion and recommendations will be advanced." -- Chapter 1. / Prepared under the supervision of Riekie Wandrag at the Community Law Centre, University of Western Cape, South Africa / Thesis (LLM (Human Rights and Democratisation in Africa)) -- University of Pretoria, 2002. / http://www.chr.up.ac.za/academic_pro/llm1/dissertations.html / Centre for Human Rights / LLM

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

L’étude de la genèse parlementaire de la législation vinicole française sous la Troisième République est une approche fondamentale afin de comprendre les tenants et les aboutissants de l’ensemble du droit positif vinicole. C’est, en effet, entre les années 1880 et 1930 que l’ensemble du droit que nous connaissons aujourd’hui se met en place. L’analyse de la démarche entreprise par le législateur met alors en avant la volonté de mettre en place une politique d’envergure permettant de protéger une production souffrant, de manière récurrente durant cette période, d’une crise de mévente liée à un marché structurellement déséquilibré. La fraude, tant sur la composition du vin, que sur son origine, macule les relations commerciales entretenues, durant les dernières années du XIXe siècle et les premières du XXe, sur un marché dévoyé par la concurrence déloyale et la perte de repères du consommateur. La surproduction endémique de la viticulture française durant la première moitié du XXe siècle, la concurrence des vins étrangers, ainsi que la restriction des débouchés tant nationaux, qu’internationaux, poussent dès lors le législateur à protéger la viticulture nationale par un ensemble de mesures propres à redéfinir les comportements du commerce et de la production, le tout dans un esprit de promotion de la qualité vinicole et de régulation du marché. Protectionnisme et agrarisme triomphent alors au sein du Parlement et des gouvernements afin de protéger le produit phare de l’économie française de la Troisième République. / The study of the genesis of French law surrounding the wine trade under the Third French Republic is essential to understand the ins and outs of French present wine law. Actually, almost the whole present wine law appears between the eighties of the nineteenth century and the thirties of the twentieth century. The analysis of the French legislator’s approach displays the determination to set up a large-scale policy in order to protect a production enduring, during this period, a structural slump crisis. The fraud on the composition of the wine and on its origin, during the last years of the nineteenth century, characterizes the market of the wine. This one is led astray by unfair competition and the loss of consumer’s landmark. Endemic overproduction of French viticulture during the first part of the twentieth century, competition of foreign wines, and restriction of French and international outlets, push legislator into protecting national viticulture by several measures for redefining behavior of the trade and the production. French legislator tries, at the same time, to push for quality and controlling market. Protectionist and agrarian policy triumph in the French Parliament and government to protect this flagship of the French agricultural production in the Third French Republic.