Date: 8 December 2023

【Volume 124】

The Taiwan Supreme Administrative Court issued the rulings on November 23, 2023, November 30, 2023 and December 7, 2023 that a drug with a changed dose is not considered as a new drug as defined in Article 7 of the Taiwan Pharmaceutical Affairs Act. Therefore, the patent information thereof cannot be submitted or registered on the Taiwan Drug Patent Linkage Registration System¹ .

Since Chapter IV-1 “Patent Linkage of Drugs” of Taiwan Pharmaceutical Affairs Act was implemented in 2019, the Ministry of Health and Welfare (the superior entity of the Taiwan Food and Drug Administration) provided the Drug Patent Linkage Registration System for pharmaceutical companies to submit patent information of drugs, wherein the system will automatically read and publish the information. However, after manually examined by the Ministry of Health and Welfare, it was found that certain drugs submitted by some pharmaceutical companies were merely drugs with changed doses, which were not new drugs, and therefore the patent information thereof were not allowed to be submitted. Thus, the Ministry of Health and Welfare determined to withdraw such registrations. Among those who had their registrations withdrawn, four pharmaceutical firms, Merck & Co., Inc. Taiwan Branch (MSD), Allergan Pharmaceuticals Taiwan Co., Ltd., Novartis Taiwan Co., Ltd. and CIMA LABS INC., were dissatisfied and filed a petition, which was dismissed by Executive Yuan. They later appealed the decision to the Taipei High Administrative Court.

The Taipei High Administrative Court ruled against MSD and Allergan. Although they filed an appeal to the Taiwan Supreme Administrative Court, the court handed down the judgment on November 23, 2023 and dismissed the appeal. The Taiwan Supreme Administrative Court specified that if only the dose of a drug is changed without changing its ingredients, it will not become the so-called “new drug” as defined in the Taiwan Pharmaceutical Affairs Act. The court further stated that whether the laws will be amended to expand the scope of definition of “new drug” and change the scope of adopting drug patent linkage system should be determined by the Legislative Yuan, instead of the Executive Court, based on principle of the separation of powers under the Constitution.

On the other hand, the Taipei High Administrative Court ruled in favor of Novartis and CIMA LABS², reckoning that based on the definition in the Paragraph 2, Article 48-3 of the Taiwan Pharmaceutical Affairs Act, it could be concluded that the legislators limited the subject whose drug patent information are allowed to be submitted for registration to invention of “substances”, “composition or formulation” and “medical use”. The legislators did not intend to limit the drug which could be applied to patent linkage system to the “drugs which are of the preparations having new active ingredients, new therapeutic compounds or new method of administration” as defined in Article 7 of the same law. The Taipei High Administrative Court deemed that the “new drug” in the Chapter IV-1 of the Taiwan Pharmaceutical Affairs Act referred to a drug that was granted a brand drug license recently (in a specific time period). Therefore, the court ruled against the Ministry of Health and Welfare. However, the Taiwan Supreme Administrative Court ruled in favor of the Ministry of Health and Welfare on November 30, 2023 and December 7, 2023 with the same reasons as those of the two cases above.

According to these four decisions of the Taiwan Supreme Administrative Court, it is confirmed that a drug with a changed dose shall not be considered as a new drug based on in Article 7 of the Taiwan Pharmaceutical Affairs Act, and therefore the patent information thereof cannot be submitted or registered on the Taiwan Drug Patent Linkage Registration System.