Issues Concerning the Fair Trade Act after the Implementation of the Patent Linkage System in Taiwan: From the Experiences of the U.S.A.
Patent linkage of drugs has been amended in the Pharmaceutical Affairs Act, and in Article 48-19, the settlement agreements or other agreements signed between parties related to the new drug and the generic drug shall be notified to the Central Competent Health Authority; and if reverse payment agreements are involved, shall also be notified to the Fair Trade Commission. This clearly reveals that the patent linkage system may involve issues of the Fair Trade Act. From the experiences of the patent linkage system in the U.S.A., the most common cases involving anti-trust law are the reverse payment agreements. Improper registration and sham litigation are also involved. In addition to the familiarity with the registration and litigation processes under the patent linkage system, foreign experiences with issues concerning the competition law arising from this system should still be familiar and prepared.