Law Business Research

The Future of Pharmaceutical Patent Litigation

The patent linkage system in Taiwan was introduced by an amendment to the Pharmaceutical Affairs Act on 29 December 2017, which adjudicates patent validity and infringement issues before the marketing of a generic or biosimilar product. Like the Hatch-Waxman system in the United States, patent linkage in Taiwan permits marketing approval of follow-on biopharmaceutical products only on condition that the patents of the originator’s product have expired.

For a patent which has not been granted or is granted after marketing approval is received, said patent will be listed within 45 days of its issuance. Any changes to listed information, such as patent term extension approvals, patent rights transfers, patent expiration, among others, will be made within 45 days of the date on which the event occurred.

Source: Law Business Research

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