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Rudolph J.R. Peritz

11. Three statutory regimes at impasse: Reverse payments in pay-for-delay settlement agreements between brand-name and generic drug companies Rudolph J.R. Peritz Bayer AG recently paid $398 million to generic competitors in exchange for their promise to stay off the market for Ciprofloxacin for the next six years.1 Cipro, as it is called, is a widely used antibiotic. In these agreements to settle patent infringement cases, Bayer made reverse payments – so called because they were paid by the plaintiff patent holder to the accused infringers.2 There is outrage

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Tobias Mahler

Generic Top-Level Domains 1.    Introduction This book examines the regulatory framework for introducing and managing generic Top-level Domains (TLDs) on the Internet. Since 2012, the Internet Domain Name System (DNS) has undergone the most substantial alteration since its inception. Over 1000 TLDs have been added, 1 and many more will be added in the future. Companies like Google and Amazon have applied for new names, such as <.app> for applications, <.blog> for weblogs and <.google> as a company’s main web presence. These are added to the existing

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Vincenzo Di Cataldo

the competitive and positive effect of the role that word was 3 The formula ‘development into a common name’ appears in one of the many drafts of the proposal, which led to Directive (EU) No. 2436/2015 of 16 December 2015 to approximate the laws of the Member States relating to trade marks [2015] OJEU L 336/1, as the title of Article 20. It has been abandoned by the last version that uses the title ‘trade mark having become generic or misleading indication as grounds for revocation’. Columns Design XML Ltd / Job: Ghidini

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Tobias Mahler

Generic Top-Level Domains 13.  Concluding remarks This is the beginning, rather than the end. The addition of new generic Top-Level Domains (gTLDs) to the Internet Domain Name System (DNS) has significantly increased the number of existing TLDs available to registrants. Although there is no prospect that new gTLDs will significantly affect the dominance of <.com>, they provide an additional supply of available names for registrants. These new names will remain with the Internet for as long as domain names are relevant. In this sense, the programme has

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Zhiwen Liang

, and how this protection prohibits a specialized governmental agency (the National Medical Products Administration, NMPA) from using the clinical test data submitted by a brand-name pharmaceutical company when the NMPA examines a marketing application for a generic medicine. Article 34 of the Regulations of the Drug Administration Act of the People's Republic of China (hereinafter ‘Regulations/Drug Administration Act’) provides that: The State protects undisclosed clinical data or other data submitted to authorities in China as required in support of applications

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Zhao Xiaoping

complex parallel proceedings giving rise to contradictory decisions on generic names have arisen in this case, which suggests that a more simplified approach to GI protection in China is very desirable. Qinzhouhuang Millet obtained protection from AQSIQ as a PGI in 2003. 11 In the region of origin for Qinzhouhuang Millet , there were mainly two millet companies before 2000 – one is Qinzhouhuang Co. Ltd 12 and the other is Tanshanhuang Co. Ltd 13 From 2006 to 2013, the protracted legal disputes regarding Qinzhouhuang Millet between the two companies went through

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Michael A. Carrier

analysis  19.41 D. Doryx : ignored regulatory regime  19.45 E. Namenda : robust regulatory analysis, improper coercion focus  19.49 4. CONCLUSION  19.54 1. INTRODUCTION 19.1  One of the most pressing issues in antitrust law involves “product hopping”. A brand-name pharmaceutical company switches from one version of a drug (say, capsule) to another (say, tablet). The concern with this conduct is that some of these switches offer only a relatively minor medical benefit while at the same time significantly impairing generic competition

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Tobias Mahler

Generic Top-Level Domains 11.  ‘Public interest’ regulation This chapter focusses on the Internet Corporation for Assigned Names and Numbers’ (ICANN’s) attempt to regulate the new generic Top-level Domains (gTLDs) in terms of the global ‘public interest’. The key regulatory mechanism in this context is a set of rules called ‘public interest commitments’ (PICs), which were inserted into the Registry Agreement between ICANN and registries for new gTLDs. In addition, questions of ‘public interest’ were raised in the case law generated by disputes during the

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Mike Koehler

Strategies for Minimizing Risk Under the Foreign Corrupt Practices Act and Related Laws 5    The FCPA’s books and records and internal controls provisions The FCPA has always been a law much broader than its name suggests. The anti-bribery provisions that were the focus of Chapters 2 – 4 are just one prong of the FCPA. The other prong is the books and records and internal controls provisions (collectively the accounting provisions) and these provisions are applicable to issuers – FCPA speak for companies (both U.S. and foreign) with shares registered

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Generic Top-Level Domains

A Study of Transnational Private Regulation

Tobias Mahler

This topical book examines the regulatory framework for introducing generic Top-Level Domains on the Internet. Drawn up by the Internet Corporation for Assigned Names and Numbers (ICANN), these rules form part of a growing body of transnational private regulation, complementing national and international law. The book elucidates and discusses how ICANN has tackled a diverse set of economic and regulatory issues, including competition, consumer protection, property rights, procedural fairness, and the resolution of disputes.