Original drug manufacturers (Originators) and generic companies (Generics) have been initiating legal battles in the USA ever since the implementation of the Hatch-Waxman Act. Due to the generic exclusivity provisions of the Korean Drug Approval - Patent Linkage System (the Patent Linkage System), the Korean version of the Hatch—Waxman Act, that trend may very well change to initiating the first legal battles between Originators and Generics in Korea. Generics in Korea (contemplating the development/sale of a generic version) are forced to challenge an Originator's patent at the same time as a competitor Generic, typically well before the expiration of a Listed Patent and sometimes before a decision has even been made to pursue a generic version of drug. Originators, on the other hand, are faced with defending multiple challenges to their patents well before the expiration of the patent, and sometimes before the 6-year postmarketing survey (PMS) period for new chemical compounds [1].
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