Regulations for the Patent Linkage of Drugs Article 3

The invention scope of the drug patent set forth in Paragraph 2 of Article 48-3 of the Act shall include the following items:1. Substance: this refers to the active ingredients of drug preparations, including the inventions of polymorphic compounds.2. Composition or Formulation: this refers to the composition or formulation of the active ingredients of drug preparations.3. Medical use: this shall be in accordance with all or part of the indications recorded in the drug permit license.If the invention substance is a different polymorph of the active ingredient of drug preparations as stated in Item 1 of the preceding Paragraph, the test data demonstrated that a drug preparation containing the polymorph perform the equal effectiveness shall be provided when registration.The manufacturing process, intermediates, metabolites or packages of medicaments are exclusive of the inventions involved in the drug patent of Paragraph 1.