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Ralf Dewenter, Justus Haucap, Christiane Kehder - Wettbewerb und Regulierung in Medien, Politik und Märkten

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Ralf Dewenter (ed.), Justus Haucap (ed.), Christiane Kehder (ed.)

Wettbewerb und Regulierung in Medien, Politik und Märkten

Series: Wettbewerb und Regulierung von Märkten und Unternehmen

Volume 24 2013

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Severin Frank, Wolfgang Kerber Patent Settlements in the Pharmaceutical Industry: An Antitrust Perspective S. 385-414

„… Patent Settlements in the Pharmaceutical Industry: An Antitrust Perspective Severin Frank and …” „… into the pharmaceutical industry. The Commission states that particularly generic competition is a key …” „… generic firms in the pharmaceutical industry and which should promote generic competition. The fact that …”

Titelei/Inhaltsverzeichnis S. 2-10

„… : Ein ökonomischer Überblick 357 Severin Frank/Wolfgang Kerber Patent Settlements in the Pharmaceutical …” „… Industry: An Antitrust Perspective 385 Ulrich Schwalbe Kronzeugenregelungen und die interne Struktur von …”

doi.org/10.5771/9783845249469

Hirotaka Nonaka - FTO (Freedom to Operate) in the Pharmaceutical Industry

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Hirotaka Nonaka

FTO (Freedom to Operate) in the Pharmaceutical Industry

Series: Munich Intellectual Property Law Center - MIPLC Studies

Volume 34 2018

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II. Key features of innovation in the pharmaceutical industry S. 12-15

„… Key features of innovation in the pharmaceutical industry Huge and growing market The world …” „… been increasing since 1970 at the rate of becoming double in ten years.9 The pharmaceutical industry is …” „… outstanding the R&D cost in the pharmaceutical industry is. One of the reason for this costly R&D mainly lies …”

IV. Structure and operation of FTO-licensing markets in the pharmaceutical industry S. 34-57

„… Structure and operation of FTO-licensing markets in the pharmaceutical industry FTO-licensing and …” „… markets in the pharmaceutical industry 36 tive, holding that “As for the agreements providing that the …” „… FTO-licensing markets in the pharmaceutical industry 38 regarded as being anti-competitive86. The types of …”

I. Introduction S. 9-11

„… FTO-licensing in the pharmaceutical industry. There are many characteristic aspects in this in‐ dustry that are …” „… never seen in other industries, which makes the FTO-li‐ censing in the pharmaceutical industry very …” „… scale of the market in the pharmaceutical industry is incomparably large, with an estimated 716 billion …”

III. How to achieve freedom to operate (FTO) S. 16-33

„… found how unique the key features of innovation in the pharmaceutical industry are, and accordingly how …” „… analysis.21 As much of the money and time is in‐ vested in one project in the pharmaceutical industry, it …” „… term extension One unique feature for patents in the pharmaceutical industry is the patent term …”

Titelei/Inhaltsverzeichnis S. 1-8

„… Contents IntroductionI. 9 Key features of innovation in the pharmaceutical industryII. 12 Huge and growing …” „… MIPLC Studies FTO (Freedom to Operate) in the Pharmaceutical Industry Hirotaka Nonaka 34 Nomos34 …” „… Operate) in the Pharmaceutical Industry Nomos The Deutsche Nationalbibliothek lists this publication in …”

List of Works Cited S. 61-64

„… /. European Federation of Pharmaceutical Industries and Associations, The Pharmaceuti‐ cal Industry in Figures …” „… fpia.eu/uploads/Modules/Documents/the-pharmaceutical-industry-in-figures-2016.p df. M. Dickson, J.P. Gagnon, The Cost of New Drug Discovery and Development (June 20, 2009 …” „… / Philip Mendes, Licensing and Technology Transfer in the Pharmaceutical Industry (last visited September 7 …”

V. Conclusion S. 58-60

„… Conclusion The pharmaceutical industry is completely unique compared with other in‐ dustries in …” „… of innovator profits. First of all, in this pharmaceutical industry, the way to perform proper FTO …” „… licensing-in activity is not so easy in the pharmaceutical industry because the patent holder tends to …”

doi.org/10.5771/9783845294018

Monica Donghi - Patent Strategy in Pharmaceutical Industry: Are additional patents valuable?

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Monica Donghi

Patent Strategy in Pharmaceutical Industry: Are additional patents valuable?

Series: Munich Intellectual Property Law Center - MIPLC Studies

Volume 20 2014

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Pharmaceutical Industry – The Development of a New Drug. S. 16-18

„… Background Pharmaceutical Industry – The Development of a New Drug. The development of a new drug …” „… , lines 21-22 (last visited Aug 2, 2012). 14 EFPIA supra note 1 at 7. A. Pharmaceutical Industry – The …” „… maintain a position in this research intensive area of industry. To facilitate the understanding of the …”

Introduction S. 13-15

„… Europe, the researching pharmaceutical industry (constituting the so-called “originator companies”) is …” „… Associations (hereinafter ‘EF- PIA’): The Pharmaceutical Industry in Figures, 2012 Edition, found at …” „… situation has led the pharmaceutical industry to pay more attention to the patent portfolio and to invest …”

Periodical Materials in English S. 77-80

„… generic competition and patent strategies in the pharmaceutical industry, 3 J. Intell. Prop. L. & Pract …” „… biopharmaceutical industry, 32 Drug Inf. J. 745 (1998). Edd Fleming, Philip Ma, Drug life-cycle technologies, 1 Nat …” „… Hemphill, Bhaven N. Sampat, Evergreening, patent challenges, and effective market life in pharmaceuticals …”

Lifecycle Management: Criticism and Supports S. 42-45

„… , Patenting Strategies of the EU Pharmaceutical Industry Crossroad between Patent Law and Competition Policy …” „… figure product improvements and product line extensions.110 Members of the generic industry argue that …” „… , Bhaven N. Sampat, Evergreening, patent challenges, and effective market life in pharmaceuticals, 31 J …”

Speeches and Reports S. 83

„… Federation of Pharmaceutical Industries and Associations: The Pharmaceutical Industry in Figures, 2012 …” „… Pharmaceutical Sector Inquiry Report, (July 8, 2011) available at …” „… http://ec.europa.eu/competition/sectors/pharmaceuticals/inquiry/staff_working_paper_part1.pdf. Institute for Quality and Efficiency in Health Care, IQWiG Reports – Commission No. A11-24 …”

Press release S. 83

„… Federation of Pharmaceutical Industries and Associations: The Pharmaceutical Industry in Figures, 2012 …” „… Pharmaceutical Sector Inquiry Report, (July 8, 2011) available at …” „… http://ec.europa.eu/competition/sectors/pharmaceuticals/inquiry/staff_working_paper_part1.pdf. Institute for Quality and Efficiency in Health Care, IQWiG Reports – Commission No. A11-24 …”

Others S. 83-84

„… Federation of Pharmaceutical Industries and Associations: The Pharmaceutical Industry in Figures, 2012 …” „… Pharmaceutical Sector Inquiry Report, (July 8, 2011) available at …” „… http://ec.europa.eu/competition/sectors/pharmaceuticals/inquiry/staff_working_paper_part1.pdf. Institute for Quality and Efficiency in Health Care, IQWiG Reports – Commission No. A11-24 …”

Statutes S. 82-83

„… Federation of Pharmaceutical Industries and Associations: The Pharmaceutical Industry in Figures, 2012 …” „… Commission, Communication from the Commission – Executive Summary of the Pharmaceutical Sector Inquiry Report …” „… http://ec.europa.eu/competition/sectors/pharmaceuticals/inquiry/staff_working_paper_part1.pdf. Institute for Quality and Efficiency in Health Care, IQWiG Reports – Commission No. A11-24 …”

Innovation Tracks S. 45-62

„… patent strategies in the pharmaceutical industry, 3 J. Intell. Prop. L. & Pract. 226, 229 (2008). 202 G …” „… benefit not only the industry but also the public. Such research needs incentives but it is debatable …” „… formulations was carried out not only by the originator but mainly by Santen Pharmaceutical (Novagali). Their …”

Titelei/Inhaltsverzeichnis S. 2-10

„… Patent Strategy in Pharmaceutical Industry: Are additional patents valuable? Nomos BUT_Donghi_0991-5 …” „… . 16 Pharmaceutical Industry – The Development of a New Drug. A. 16 New Drug Approval RegulationsB. 18 …”

doi.org/10.5771/9783845251288

Hyewon Ahn - Second Generation Patents in Pharmaceutical Innovation

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Hyewon Ahn

Second Generation Patents in Pharmaceutical Innovation

Series: Munich Intellectual Property Law Center - MIPLC Studies

Volume 19 2014

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V. IMPLICATIONS OF THE PATENTABILITY REQUIREMENTS ON INNOVATION AND COMPETITION IN THE PHARMACEUTICAL INDUSTRY S. 185-245

„… meaningful innovation in the pharmaceutical industry. Most importantly, the inordinate delay for marginal …” „… Implications on the competition in the pharmaceutical industry Introduction According to Schumpeter, the …” „… . Implications on the competition in the pharmaceutical industry 223 variety of minds try.1193 This provides …”

III. SPECIFICITIES IN PHARMACEUTICALS AND RECENT DEVELOPMENTS S. 60-95

„… all dependent on the industry.211 The pharmaceutical industry has attracted attention among regulators …” „… distinguish the process of R&D and innovation in the pharmaceutical industry from that of other technological …” „… high regulatory burdens on initial innovations as the pharmaceutical industry.212 Without regulatory …”

Bibliography S. 334-355

„… Pharmaceutical Industry’s Grand Challenge, 9 Nat. Rev. Drug Discov. 203 (2010). Bibliography 347 Peterson, John M …” „… ). Angell, Marcia, The Pharmaceutical Industry: To whom Is It Accountable?, 342 New Eng. J. Med. 1902 (2000 …” „… Pharmaceutical Industry in a Productivity Crisis?, in: Jaffe, Adam B., Lerner Josh, and Stern, Scott (eds …”

I. INTRODUCTION S. 22-28

„… INTRODUCTION Overview “Over the past two decades, the pharmaceutical industry ‘has moved very far …” „… pharmaceutical industry may be regarded as one of those industries in which the economic rationale for patents …” „… 23 the pharmaceutical industry is facing numerous challenges, such as major capital losses in revenue …”

VI. PROPOSALS S. 246-312

„… second generation inventions in the pharmaceutical industry will be analyzed and recommendations will be …” „… , these decisions1356 were decided a century ago when the pharmaceutical industry was arguably not yet a …” „… this sector.1379 Burk and Lemley distinguish the pharmaceutical industry from other industries, such as …”

II. PHARMACEUTICAL INVENTIONS, INNOVATIONS & PRODUCTS S. 29-59

„… technological fields, this thesis will focus on those in the pharmaceutical industry. Pharmaceutical selection …” „… pharmaceutical industry. In the Klinische Vera) 63 Voet, 2011, 59. 64 Kraßer, 2009, 130 et seqq.; Bacher/Melullis …” „… pharmaceutical industry. In this context, we must question whether current patent protection for pharmaceuticals …”

VII. FINAL CONCLUSIONS S. 313-321

„… (“NMEs”). The pharmaceutical industry differs from other industries in various ways. It is one of the few …” „… , many of these decisions were taken a century ago1681 when the pharmaceutical industry was arguably not …” „… medical uses. Secondly, given that the pharmaceutical industry is one of the few that is sensitive to the …”

Titelei/Inhaltsverzeichnis S. 1-21

„… . 59 Innovating and inventing in pharmaceutical industryA. 59 Specificities in the drug development …” „… . 218 Implications on the competition in the pharmaceutical industryD. 222 Introduction1. 222 …” „… the public” in the pharmaceutical industry (1) 287 A patent as a double-edged sword to NMEs(2) 289 …”

IV. STANDARDS OF PATENTABILITY FOR PHARMACEUTICAL SELECTION INVENTIONS S. 96-184

„… for pharmaceutical innovation. Based on these observations, such as high regulation in the industry …” „… STANDARDS OF PATENTABILITY FOR PHARMACEUTICAL SELECTION INVENTIONS So far we have explored …” „… specificities and recent developments in the field of pharmaceuticals. As noted, patent protection is crucial …”

doi.org/10.5771/9783845250861

Christine Godt - Differential Pricing of Pharmaceuticals inside Europe

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Christine Godt (ed.)

Differential Pricing of Pharmaceuticals inside Europe

Series: Schriftenreihe des Zentrums für Europäische Rechtspolitik der Universität Bremen (ZERP)

Volume 58 2010

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Joint Declaration adopted by the German Federal Ministry of Health and the research-based pharmaceutical industry S. 199-200

„… the Research-based Pharmaceutical Industry 10. Juni 2008 • The Federal Ministry of Health and the …” „… research-based pharmaceutical industry reaffirm the Joint Declaration made at the Bremen Conference on …” „… states. • The Federal Ministry of Health and the research-based pharmaceutical industry note that the …”

Valérie Paris Pharmaceutical Pricing Policy in a Global Market – Cross-border Impact on the Availability and Prices S. 155-169

„… pharmaceutical policies with strategies of the pharmaceutical industry. Confronted with regulation, the …” „… pharmaceutical industry seeks to minimise spill-over effects of pricing policies. Spill-over effects refer to …” „… , unpublished Working Paper, 2005. 16 Prices are rather high in Japan but the pharmaceutical industry generally …”

Sabine Richard Differential Pricing of Pharmaceuticals – Lessons from Economic Theory S. 145-155

„… restrictions of pharmaceutical prices because they would threaten the industry’s capacity to develop …” „… structure of the pharmaceutical industry, high income societies are willing to accept monopolistic prices …” „… the pharmaceutical industry, for Germany e.g. IGES, Cassel, Dieter, Wille, Eberhard, WIPO 2006 or for …”

Christian Wagner-Ahlfs Research Incentives from a Public Health Perspective: The Role of Public Funded Research S. 183-190

„… job to the pharmaceutical industry, the US government has a different approach. The National …” „… . 16 Rx R&D Myths: The Case Against the Drug Industry’s R&D “Scare Card” Washington: Public Citizen …” „… the pharmaceutical market fails to fulfill public health needs and therefore a governmental …”

Ortwin Schulte General Political and Economic Conditions Affecting Access to Life-Saving Medicines in the Enlarged European Union S. 15-22

„… appeals procedure for unsuccessful applicants. The pharmaceutical industry endeavoured, before the …” „… the pharmaceutical industry in connection with the national health care system. Securing the …” „… innovation capacity of the European pharmaceutical industry has been in the limelight of the European …”

Geertrui Van Overwalle Differential Pricing: Piercing or Fostering the IP Incentive for Public Health? S. 113-125

„… private actors and is based on the contribution of the pharmaceutical industry, either in a voluntary …” „… governments from the European Union and neighbouring countries invited the pharmaceutical industry to …” „… - 8 J.H. Barton, TRIPS and the Global Pharmaceutical Market. Can the Pharmaceutical Industry Make …”

Christine Godt Introduction S. 9-14

„… pharmaceuticals within Europe – a hot issue not only since the European Court of Justice scrutinised supply …” „… restrictions lately in the Lélos case, and the European Commission has inquired the pharmaceutical sector …” „… competition law and the public regulation of pharmaceutical pricing on board in an additional chapter. The …”

Christine Godt Differential Pricing of Patent-Protected Pharmaceuticals for Life-Threatening Infectious-Diseases inside Europe – Can Compulsory Licenses be Employed? S. 23-74

„… comparatively efficient pharmaceutical generics-industry. The production is also exported, primarily to former …” „… ), see D. Shanker, Brazil, the Pharmaceutical Industry and the WTO, 5 JWIP 2002, 53-104. Differential …” „… economic cost-reduction of 25 % (price-quantities-digression). From the industry’s perspective, this is a …”

Jerome H. Reichman Lessons to be Learned in Europe from the International Discourse on Patents and Public Health S. 133-145

„… and produce the key active ingredients. The pharmaceutical industry knows this as well as public …” „… . When Canada brought forward its enabling legislation, the originator pharmaceutical industry succeeded …” „… health ministries. The former head of the Brazilian public sector drug industry always said: “Before I …”

Heinz Goddar Price Differentiation and the Conundrum of Exhaustion Principles S. 125-133

„… clear that this conclusion was “highly specific to the pharmaceutical industry in its current condition …” „… Pharmaceuticals and Price Differentiation It is generally accepted that effective drugs, even the most modern and …” „… order to achieve this goal, it is first of all necessary that effective pharmaceuticals are …”

The Bremen Declaration 2007 S. 195-199

„… pharmaceutical industry, - to facilitate access to affordable treatment - to enter into partnerships with the …” „… Research-based Pharmaceutical Industry 10. Juni 2008 • The Federal Ministry of Health and the research-based …” „… pharmaceutical industry reaffirm the Joint Declaration made at the Bremen Conference on "Responsibility and …”

Hanns Ullrich European Competition Law, Community-wide Exhaustion and Compulsory Licenses – Disintegrating the Internal Market in the Public Interest S. 89-113

„… pharmaceutical industry’s strategic investment in research and development. By contrast, the Court of Justice …” „… innovation-dependent industry as is the pharmaceutical industry.58 According to the Court, the effect which parallel …” „… pharmaceutical industry,90 high obstacles would be raised to intermediate trade’s preference for (parallel …”

Nadia laneva Protection and Regullation of Pharmaceuticals in Bulgaria S. 169-175

„… pharmaceutical generics-industry.1 Former industrial policy has fostered the production of generics. This has led …” „… 169 Protection and Regulation of Pharmaceuticals in Bulgaria Nadia Ianeva* A. The Bulgarian …” „… Pharmaceutical Sector In comparison with other Eastern European States, Bulgaria hosts a comparatively efficient …”

Aleksei Kelli Intellectual Property Rights and Access to HIV Medicines in Estonia S. 175-183

„… Estonian pharmaceutical industry has only a limited capacity. It concludes that Estonia is dependent upon …” „… pharmaceuticals policy document (Basis of the Estonian Pharmaceuticals Policy until 2010), points out that the …” „… /$file/Ravimipoliitika_alused_2010.pdf> (28 Sept. 2008), p. 4. 29 The Association of Pharmaceutical Manufacturers in Estonia …”

Titelei/Inhaltsverzeichnis S. 2-8

„… Declaration adopted by the German Federal Ministry of Health and the research-based pharmaceutical industry …” „… Christine Godt (ed.) Differential Pricing of Pharmaceuticals inside Europe Exploring Compulsory Licenses …” „… of Patent-Protected Pharmaceuticals for Life-Threatening Infectious-Diseases inside Europe – Can …”

doi.org/10.5771/9783845223124

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