Research on defense of uncertainty to patent infringement of generic drug commissioned development
JIN Chun-yang
HE An-qi
Abstract：The defense of uncertainty protects the interests of the party who performs first in a dual contract where there is an agreement on the order of performance.However,in the case of generic drug development contracts,the defense of uncertainty based on the risk of patent infringement faces a difficult determination.Theoretically,the court's determination of the defense of uncertainty mainly examines whether the party claiming the right has fulfilled the burden of proof and the duty of notification.In practice,the court mainly makes separate judgments on form and substance and identifies them according to the characteristics of the industry involved.The obstacles to establishing the defense of uncertainty include the Bolar exception exemption,failure to provide notification,and the difficulty of proving patent infringement.The successful assertion of the defense of uncertainty requires specificity and compre-hensiveness in the formation of the contract and honesty and integrity in the performance of the contract.Considering the special characteristics of generic drug development,adequate prior patent infringement risk assessment,control of raw and auxiliary materials and reference preparations,as well as the early resolution of pharmaceutical patent disputes are conducive to eliminating the limitations of the defense of uncertainty.
Keywords：defense of uncertaintypatent infringementgeneric drug development
Publication Date：2025-02-27
Online Publishing Date：2026-08-14(First online date of this platform, not the publication date of the document)
Pages：6( 358-363 )