FICPI Journal Issue 2 (July 2023)

Title
An overview of pharmaceutical patent litigation in Taiwan and case review
Publisher
International Federation of Intellectual Property Attorneys (FICPI)
Author
George Huang (Director, Attorney at Law and Patent Attorney)
Published Date
July 2023

Summary of the article:

The patent linkage system in Taiwan took effect on 20 August, 2019. When applying for a permit, generic drug manufacturers can make a Paragraph IV declaration. If the new drug patentee initiates legal proceedings within 45 days, the Taiwan Food and Drug Administration (TFDA) will stay the issuance of the permit. Otherwise, the permit will be issued. If the patentee is unable to prevail in the lawsuit within 12 months, the first generic drug manufacturer shall be granted a 12-month exclusivity on the market.

The article also brought out recent court decisions and trends on pharmaceutical patents, as well as suggested strategies for pharmaceutical patent litigation in Taiwan.

 

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