The Taiwan Patent Act was amended on December 21, 2021 with the addition of Article 56. Article 56 stipulates that "the scope of a patent, of which a term extension has been granted, shall be limited to only the effective ingredients and uses stated in the regulatory approval concerned." According to such provision, the extended patent rights do not cover the entire claim scope of the patent. The rights of the extended patent apply only to the substances, uses, or methods corresponding to the effective ingredients and the uses of such ingredients as specified in the regulatory approval within the scope of the patent, and do not extend to the substances, uses or methods that are listed in the patent claims but not in the regulatory approval. The Intellectual Property and Commercial Court ("the Court") discussed the interpretation and application of this stipulation in 111-MinZhuanSuZi-60 rendered on December 29, 2023.

 

The Court first analyzed the technical features of the disputed extended patent ("Extended Patent") in accordance with Article 56 of the Patent Act. The technical features include (1) a certain effective ingredient ("Element A") and (2) the use stated in the regulatory approval ("Element B"). (The Court explained that it determined such use based on the contents of the "indications" column in the regulatory approval). The Court then determined that the effective ingredient of the accused pharmaceutical raw material ("accused PRM") is the same as Element A, and that the indication listed on the regulatory approval of the accused PRM is the same as Element B. Nevertheless, the Court considered that the accused PRM is used to manufacture medicinal preparation and does not have a therapeutic purpose. When registering a pharmaceutical raw material, it is not necessary to submit relevant clinical trial data to support the effectiveness and safety of the indications for such pharmaceutical raw material. Therefore, the Court determined that the indications listed on the regulatory approval of the accused PRM are only for "pharmacological classification," and are not its clinical therapeutic indications; therefore, the accused PRM does not fall within the scope of Element B. The Court then elaborated that an approved extended patent applies only to the effective ingredients and uses stated in its regulatory approval, and therefore does not extend to pharmaceutical raw materials without therapeutic purposes (i.e., upstream ingredients). Furthermore, the Court held that the registration of a pharmaceutical raw material focuses only on the physical and chemical properties of such raw material and the synthetic method steps, without considering the safety and effectiveness for therapy. Therefore, the Court concluded that pharmaceutical raw material should not be considered to fall within the approved pharmaceutical extended patent, nor should it be referred to as an indication based on pharmacological classification.

 

However, according to Article 56 of the Patent Act, the scope of extended patent should be limited by "use." In other words, Article 56 excludes only those "uses" of the patent claims that are not listed in the regulatory approval from the protection scope of the extended patent. The extended patent is not limited to a medicinal preparation. In the present case, even if the accused PRM cannot be directly used for therapy, its "use" seems to be the same as that indicated in the Extended Patent. Further examination may be required to determine whether it is appropriate for the Court to generally exclude the possibility of infringement of an extended patent by pharmaceutical raw materials. In addition, it is worth observing whether the subsequent appeal is upheld by the appellate court.