Regulations Governing the Determination of Patent Term Extension Article 4

Regarding pharmaceuticals or their manufacturing procedures, the periods of time allowable in a request for patent term extension include:1. the period of domestic and/or foreign clinical trials conducted for obtaining a pharmaceutical approval from the central competent authority in charge of the business; and2. the examination period for domestic regulatory approval.The “domestic and/or foreign clinical trials” referred to in Subparagraph 1 of the preceding paragraph shall be limited to those confirmed to be necessary for issuing pharmaceutical approval by the central competent authority in charge of the business.Where the request for patent term extension is made pursuant to Paragraph 1, the time period attributable to the requester’s omission of act, the overlapping time period between domestic and foreign clinical trials, and the overlapping period between clinical trials and examination period for regulatory approval, shall be deducted from the period to be granted extension.