Patent Act Article 57May 1, 2019

Invalidation of patent term extension

Any person may file an invalidation action of the granted patent term extension to the Specific Patent Agency, together with document(s) of proof, under any of the following circumstances:

1. where it is unnecessary to obtain the regulatory approval to exploit the invention patent concerned;
2. where neither the patentee nor licensee has obtained the regulatory approval;
3. where the granted term of extension exceeds the period during which the patent cannot be exploited;
4. where the requester of the patent term extension is not the patentee;
5. where the regulatory approval of extension request is not the first approval, or a request for extension based on the said regulatory approval has been made;
6. where the pharmaceuticals involved in the granted patent term extension are veterinary drugs.

If an invalidation decision revoking the patent term extension has become final and binding, the granted patent term extension shall be deemed non-existent ab initio. However, if such final and binding invalidation decision of revocation is rendered due to violation of Subparagraph 3 or Subparagraph 6 of the preceding paragraph, only the exceeding period of the extension shall be deemed non-existent.

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