Draft rules for pharmaceuticals cause concern

In order to comply with chapter 18 (on intellectual property) of the TPP, the amendment may affect the domestic pharmaceutical industry and therefore some scepticism that it may have a negative effect on the Taiwanese pharmaceutical sector has arisen.

Data exclusivity

The amendment clarifies that the Taiwan Food and Drug Administration (TFDA) will not accept or process any applications for market approval of drugs that cite data for the same (existing) new ingredient drug within three years of that product’s approval. In addition, rival market approval will only be granted after five years from the approval of a drug with a new ingredient, meaning the owner of an approved new drug essentially enjoys a five-year duration of market exclusivity.

On the other hand, the duration of data exclusivity for a new therapeutic indication will be three years from approval, or five years if the clinical trials are performed in Taiwan. For new drugs or new indications granted with market approval from a foreign authority, the aforementioned exclusivity will be applicable only when the application for Taiwanese marketing approval is submitted within a specified time period from the foreign approval, namely three years for new drugs, or two years for new indications.

Patent linkage

The amendment includes a new chapter, 4-1, which specifically provides patent linkage to connect a drug’s IP protection and regulatory approval for marketing. According to the new provisions of the patent linkage system, a new drug owner, usually a patentee, should list the patents and submit required information within 45 days of receiving marketing approval or patent issuance, whichever is later.

Eligible subject matter for patent-listing includes pharmaceutical substances, compositions or formulations, and medicinal use. In some circumstances of changes to patent status, the updated patent information should be reported within 45 days of the occurrence.