The provisions directed to patent linkage set forth in the Pharmaceutical Affairs Act were passed on December 27, 2017, and promulgated by the President on January 31, 2018. According to Article 16 of the Matters Requiring Attention in Legal Operation of Central Administrative Agency, regulations enforcing a new law must be completed within six months after the law is passed and can be extended for no more than six months. Accordingly, it is expected that regulations for patent linkage may be implemented soon. The TFDA recently completed a draft of "The Enforcement Rules for Patent Linkage" with relevant forms, which provide details of how patent linkage will be implemented in Taiwan.
Patent linkage involves a complex interplay of IP law and drug regulations, and practical application of patent linkage laws and regulations often reveals nuances that are not obvious from reading the laws and regulations alone. Since patent linkage was originally created in the United States, observing and understanding how patent linkage has operated in the United States, and recent developments in the United States, can provide useful guidance and lessons-learned for the implementation of Taiwan’s own patent linkage laws and rules.
Finnegan attorneys Dr. Barbara Rudolph and Dr. William Strauss will provide an update on recent developments in U.S. patent linkage laws and regulations, and discuss how patent linkage laws in the United States work in practice. Speakers from National Taiwan University and Lee and Li, Attorneys-at-Law will provide an update on recent developments in U.S. patent linkage laws and introduce the draft enforcement rules.
09:30-10:00 Opening Remarks
10:00-11:40 1. Introduction to "The Enforcement Rules for Patent Linkage"
2. Status of Law Amendment to the Patent Act
12:40-13:40 Latest Developments in U.S. Patent Linkage Regulations and Court Decisions
13:40-14:40 Practical Examples of Patent Linkage
14:40-15:10 Coffee Break
15:10-16:10 Panel Discussion
Time and Location:
Friday, September 14, 2018
International Conference Hall, College of Law, NTU
Finnegan confirms that this activity has been certified for 5.5 hours of California MCLE credit.
Please contact us to arrange an invitation by September 12, 2018. Because of limited space, each company/organization will be limited to no more than four registrants.
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