「专利连结」研讨会(20161116)

Event
Framework and Procedures for Patent Linkage: Guidance to Respond to Taiwanese Patent Linkage by Referencing U.S. Experience

Online Registration

Patent linkage was adopted in the United States with the goal of balancing two competing interests.  First, patent linkage seeks to ensure a period of patent and marketing exclusivity to innovator drug manufacturers that would enable them to recoup their investments in drug development.  Second, it also is intended to increase the availability of lower priced generic versions of branded drugs.  The Drug Price and Competition Restoration Act of 1984 (Hatch-Waxman Act) attempted to achieve these goals through two mechanisms:   (1) extending the term of certain patents where marketing of the claimed product was delayed by regulatory review and (2) allowing generic drug manufacturers to apply for approval to market versions of brand-name drugs without exposure to damages for infringing unexpired patents covering such drugs.

Historically, Taiwan has not recognized a U.S.-style patent linkage system.  Recently, however, patent linkage has become a critical issue in free trade agreement and Trans-Pacific Partnership negotiations between Taiwan and the United States.  As a consequence, Taiwan’s Ministry of Health and Welfare, in consultation with the Taiwan Intellectual Property Office (TIPO) and the Taiwan Food and Drug Administration, has drafted a statute that implements patent linkage. The Executive Yuan has accepted the plan, and final approval is now up to the Legislative Yuan.

The speakers will address the statutory framework that governs patent linkage law in the United States as well as the proposed legislation pending in Taiwan.  The presentations will be followed by a panel discussion during which questions from the audience will be entertained. Some important and practical questions with respect to patent listing will be raised by the moderator in the panel discussion.  The seminar is aimed at providing the audience a clear guidance on how to respond to the upcoming patent linkage operation in Taiwan.