英文摘要 |
In the U.S., once a patent owner’s patent(s) is declared as invalid, he cannotbring an infringement suit against other implementers any more. Therefore, when ageneric drug company successfully challenges patent(s) validity in a Hatch-Waxman litigation, the US FDA will not grant other 30-month stays of regulatoryapproval to brand-name drug company because the patent(s) corresponding to newdrugs is invalid. However, patent law in Taiwan follows the bifurcation system.Accordingly, although Taiwan civil courts are allowed to decide the validity of patentright at issue, its opinion binds only the parties in suits. For that reason, afterthe patent linkage system is implemented in Taiwan, the statutory 12-months stayswill be triggered automatically if the patent(s) corresponding to new drugs have notbeen revoked, even the civil courts had decided the patent(s) is invalid based on themerit of the case. Obviously, patent linkage system in Taiwan’s bifurcated patentlitigation system will delay the latecomer generic drug companies who sell thesame drug entering the market. The generic pharmaceutical industry and the right to access medicine in Taiwan will subsequently be jeopardized. Furthermore, Taiwancivil courts are not allowed to invalidate a patent or decide whether patent(s)corresponding to new drugs is infringed by a counterclaim or declaratory judgement.On top of that, it is still unknown that whether the generic drug companycould question the patent information in the Hatch-Waxman litigation if it seemsinappropriate. As a result, this article digs into U.S. Statute law revision and suggestsTaiwan civil courts should shoulder the burden of verifying the informationafter requested by the generic drug company in the litigation with the objective ofstriking a balance between brand-name and generic drug company. |