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

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.

Agenda:

13:00 Registration
13:30 Welcome Remarks
13:40 The Hatch-Waxman Act and ANDA Litigation
14:15 Orange Book Patent Listing and Patent Certifications
14:50 The Planning and Execution of The Taiwanese Patent Linkage
          （台灣專利連結之規劃及實施）
15:20 Tea Break
16:00 Panel Discussion
17:20 Reception

Moderator: 
Gary C. Ma

Speakers: 
Susan H. Griffen 
William L. Strauss

MCLE Credit:

Finnegan confirms that this activity has been certified for 3.0 hours of California MCLE credit.

Date and Location:

Wednesday, November 16, 2016
International Conference Room, 1F of Tsai Lecture Hall,
College of Law, National Taiwan University
No. 1, Sec. 4, Roosevelt Road, Taipei City, Taiwan
Tel: +886 2 3366 8900
國立臺灣大學法律學院霖澤館1 樓 國際會議廳
臺北市羅斯福路四段一號

RSVP:

Please RSVP by Friday, November 11, 2016. The event is free of charge—space is limited to three registrants per company/organization.