Patent Law and Theory
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Patent Law and Theory

A Handbook of Contemporary Research

Edited by Toshiko Takenka

This major Handbook provides a comprehensive research source for patent protection in three major jurisdictions: the United States, Europe and Japan. Leading patent scholars and practitioners join together to give an innovative comparative analysis both of fundamental issues such as patentability, examination procedure and the scope of patent protection, and current issues such as patent protection for industry standards, computer software and business methods. Keeping in mind the important goal of world harmonization, the contributing authors challenge current systems and propose necessary changes for promoting innovation.
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Chapter 23: Challenges to the Sui Generis Regime of Pharmaceutical Patents

John R. Thomas


John R. Thomas 1 Introduction Nowhere is the social impact of intellectual property more keenly felt than in the discipline of pharmaceutical patents. When we confront both glaring inequities in the global health care system, and the list of loathsome diseases for which no treatment is available at any price, the patent system appropriately stands at the center of the discussion. For the pharmaceutical industry may be the sole market segment where traditional accounts of the patent system hold true. Pharmaceutical patents almost invariably support a single supplier for the innovative drug company for the full length of their term. And for many drugs, the very day relevant patents expire is the moment generic competition begins.1 This commonplace reality provides strong testimony to the significance of patents to the drug industry. Yet nowhere in the world, it seems, are pharmaceuticals subject to a garden variety patent law. Jurisdictions have modified the everyday patent law regime in different ways when it comes to drugs. Many countries include detailed statutes allowing compulsory licenses that, although generally worded, are effectively specific to pharmaceuticals.2 Other patent statutes enumerate provisions establishing precise standards of inventive step that will govern the granting of pharmaceutical patents.3 Still others supplement patent rights with new forms of intellectual property, data protection and marketing exclusivities, that effectively time the commencement of patent litigation.4 In the United States, this level of specificity has perhaps gone the furthest of any 1 Rebecca S. Eisenberg, Patents, Product Exclusivity, and Information Dissemination: How Law...

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