Data Exclusivity (DE) Protection in Korea

In pharmaceutical industry, data exclusivity (DE) protection is an important IP right. DE is to protect the value of extensive pre-clinical and clinical data that establish a drug’s safety and efficacy, clinical indications and uses.

KFDA provides such DE through PMS (Post Marketing Surveillance) system. Before the expiry of PMS period, no generic drug is allowed to market. During PMS period, third parties cannot obtain approval for generic versions of the same product unless they can submit data that are (1) different from the data submitted for the first approval; and (2) equivalent to or exceeds the scope of data submitted for the first approval. There is no real case to obtain before expiry of PMS in Korea so far. Therefore, such PMS system has played an effective Data Exclusivity for drug developers.

Two categories of DE exist in Korea as follows:

1. New Drug (NCE) – 6 years from marketing approval
   1. New Chemical Entity (NCE)
   2. Ethical Drugs different from already licensed drugs in terms of active ingredients or mixture ratios
   3. Ethical Drugs different from already licensed ones in the route of administration, while containing the same active ingredients
       
2. Improvement Drug (NCI) – 4 years from marketing approval
   1. Ethical drugs which are identical to already licensed drugs in terms of active ingredients and route of administration but distinctively different in added indications.
   2. Ethical drugs which are modification of the structure, formulation, or indication of existing drugs. It is generally an improved version of the original drug in terms of safety, efficacy or convenience.