'Branded or Generic,' the Legal Analysis and Strategic Management of Pharmaceutical Patent Disputes - The Taiwan Model

Because of intensive research and innovation in pharmaceutical industries, legal disputes and strategic management of intellectual property (IP) has become increasingly critical between competing pharmaceutical manufacturers. From specialized IP jurisdiction, industrial capacity and pharmaceutical market prospective, Taiwan is an appropriate research model for industries to elucidate patent disputes between branded and generic pharmaceutical companies. After analyzing recent pharmaceutical patent decisions held in the IP Court of Taiwan, and comparing them with China Patent Act and the U.S. patent laws and precedents, a three-stage model was developed to categorize pharmaceutical patent disputes between global branded and local generic companies. First, in the preparation stage, either branded or generic companies apply different legal strategies to extend or exempt of patent exclusivity respectively. Second, in the injunction stage, this article demonstrates why specialized IP jurisdiction, financial burden for countersecurity and abuse of IP rights affect generics to stay in the market. Third, in the litigation stage, This article illustrates how indirect infringement protection, validity of patents, and physicians' defense play the crucial roles of patent litigations in Greater China area. Finally, to integrate the strategic considerations and commercial effects of these legal battles, this patent dispute model in pharmaceutics provides a useful guideline and some suggestions for both generic and branded companies that intend to develop or sustain their pharmaceutical business in Asia or globally.