Newsletter
PHARMACEUTICAL AFFAIRS ACT AMENDMENTS
The Pharmaceutical Affairs Act has recently been amended twice: a new Article 40-1 was enacted in 2004, and on 5 February 2005 a new Article 40-2 was also added, which took effect on 7 February 2005. The main points of the amendments are as follows:
When a pharmaceuticals company applies for a license to manufacture or import a pharma-ceutical product, the Department of Health may, in the public interest, publish related information submitted by the applicant, such as the formulation and product literature. But trade secrets regarding a new pharmaceutical product must be kept confidential.
When issuing a license for a new pharmaceu-tical product, the DOH should publish the patent number or patent application number of any already published patent or patent appli-cation submitted by the applicant.
For five years following the issuance of a license for a new pharmaceutical product based on a new drug, another pharmaceuticals company may not apply for registration based on data originating from the first license holder, except with the consent of the first license holder. But if the product concerned has previously been licensed for sale in another country, the above provision applies only if the application for registration in Taiwan is filed with the DOH within three years after the foreign license was issued. In brief, data exclusivity for proprietary information on a new drug is protected for a period of five years from the issuance of a license.
For five years following the issuance of a license for a new pharmaceutical product, another company cannot obtain a license for the same product. But from three years after the issuance of such a license, another company may file an application for registration of a product with the same formulation, dosage form, dosage, and unit dosage, for a license to be issued five years after the issuance of the original license.
Patent rights in a new drug do not extend to re-search, teaching, or trials conducted before the pharmaceuticals company applied for registra-tion of the drug.