Treatise (D.M.A.)--University of Texas at Austin, 2006. / Vita. Includes bibliographical references.

Canada’s Patented Medicines (Notice Of Compliance) Regulations fail to achieve the intended purpose of balancing innovation with timely generic market entry. An examination of the inefficiencies created by the Canadian regulations reveals that key features of U.S. pharmaceutical law should be adopted to improve the disjointed regulatory system that impedes generic competition. Specifically, the regulations should be amended to consolidate multiple proceedings into one cause of action that evaluates patent validity. An economic incentive to challenge weak patents should also be introduced in Canada. These features encourage competition without deterring pharmaceutical research and development because only patents that are not truly inventive will be invalidated after a full inquiry. As such, the intellectual property laws will continue to satisfy Canada’s international intellectual property obligations and protect innovative medicines and allow recovery of costs and monopoly profits to new and useful pharmaceutical products.

Canada’s Patented Medicines (Notice Of Compliance) Regulations fail to achieve the intended purpose of balancing innovation with timely generic market entry. An examination of the inefficiencies created by the Canadian regulations reveals that key features of U.S. pharmaceutical law should be adopted to improve the disjointed regulatory system that impedes generic competition. Specifically, the regulations should be amended to consolidate multiple proceedings into one cause of action that evaluates patent validity. An economic incentive to challenge weak patents should also be introduced in Canada. These features encourage competition without deterring pharmaceutical research and development because only patents that are not truly inventive will be invalidated after a full inquiry. As such, the intellectual property laws will continue to satisfy Canada’s international intellectual property obligations and protect innovative medicines and allow recovery of costs and monopoly profits to new and useful pharmaceutical products.

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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.

This paper attempts to estimate the change in sales associated with pharmaceutical patent expiration. Using data from the Medical Expenditure Panel Survey and patent expiration information from historical Orange Book publications, I estimated monthly sales associated with choice pharmaceutical patents. I then used a fixed-effects model to estimate the average change in sales before and after initial patent expiration, controlling for patent extension factors. My findings support that pharmaceutical patent expiration results in a statistically significant drop in sales by 38% on average within this sample, and further, that patent extensions had a negligible effect on this relationship. The question of patent expiration’s effect on sale is economically important for the sake of evaluating the efficacy of pharmaceutical patent law in protecting the interests of brand-name and generic drug manufacturers as well as paying consumers.

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

Le télescope ANTARES pour detecter les neutrinos de haute énergie est un réseau tridimensionnel de photomultiplicateurs répartis sur 12 lignes, installés sur le fond marin de la Méditerranée. Le détecteur a été utilisé dans des configurations partielles depuis Mars 2006 et le déploiement a été achevée en mai 2008. Le principal objectif de l'expérience est la recherche de neutrinos de haute énergie à partir de sources astrophysiques . Un télescope à neutrinos dans l'hémisphère Nord inclut le centre galactique dans son champ de vision et il peut être considéré comme complémentaire au télescope IceCube en Antarctique. Le détecteur est optimisée pour la détection de neutrinos muoniques, au delà de la seuile de 1 TeV et en détectant les muons issus des interactions, particules chargées qui peuvent voyager kilomètres et sont presque colinéaires avec les neutrinos originaires. Les neutrinos de haute énergie peuvent avoir différentes origines : ils pourraient être créés lors de l'interaction des rayons cosmiques énergétiques élevés avec le CMB ou dans des phénomènes cosmologiques tels que restes de supernovae ou AGN. Il y a d'autres sources possibles en raison de nouvelles théories dans le domaine de la physique au-delà du Modèle Standard. Dans ma troisième année de thèse, j'ai effectué la recherche pour des neutrinos muoniques extraterrestres d'énergie ultra-haute (dans la gamme dynamique de 100 PeV - 10 EEV) issus de sources non résolues . Si la sensibilité des techniques de recherche de sources ponctuelles est trop petit à détecter flux de neutrinos de corps célestes individuels, il est possible que les sources ensemble pourraient produire un excès d'événements au cours du fond de neutrinos atmosphériques et reconnaissable comme un signal UHE. La sensibilité du détecteur de neutrinos ANTARES à diffuser est évaluée à partir de simulations MonteCarlo, une production dédiée à la gamme d'énergies écrit ci-dessus. L'absorption des neutrinos par la Terre pour des énergies supérieures que PeV avait été prise en compte, de sorte que la recherche de l' astrophysique signal est limitée près de l'horizon. Dans cette zone angulaire la plus sévère source de fond sont les neutrinos atmosphériques , mais aussi les muons atmospheriques qui même très réduites en nombre, peuvent feindre un signal cosmique. Sachant que les événements UHE déposent une grande quantité de lumière dans le détecteur , six des variables de ce type ont été choisies et ensuite une combinaison d'entre eux a été utilisés pour discriminer le signal du fond. J'ai pris en compte les différentes configurations de détection du Dec. 2008 à Décembre 2011 lors de l'analyse des données , avec une durée de vie équivalente de 800 jours. Les résultats sont représentés et la limite supérieure de flux diffus de neutrinos va être estimé, compte tenu de différents types de flux de UHE astrophysique sources d'accélération , comme AGN , un Waxman - Bahcall comme spectre ou un modèle de GZK coupure , dans le scénario de neutrinos cosmologique.

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.