Taiwan’s Patent Linkage System for pharmaceuticals came into effect on August 20, 2019, and its legislative purpose is to resolve disputes on patent invalidity and infringement among brand drug companies and generic drug companies in a more rapid manner. Specifically, after the issuance of the certificate of marketing approval of a new drug, the brand drug company can actively disclose patent information related to the new drug in the patent linkage system, known as Orange Book, established by the Ministry of Health and Welfare (MHW), so as to facilitate the generic drug companies to catch up the patent status of the drug proactively, turn to design around and clear any infringement concerns during the 12-month period of suspension of the issuance of the certificate of marketing approval of the generic drug. When the first generic drug company successfully challenges or evades the relevant patent, a 12-month marketing exclusivity period will be granted.
What is a “new drug” and what is its scope? It is an important issue in the patent linkage system, but viewpoints of the court judges have not yet been unanimous. Moreover, there has been discrepancy in recent judgments on whether the information disclosure on the Orange Book should be regarded as a decision by the MHW or simply an action of the holder of the certificate of marketing approval of a new drug. In the former case, the disclosure can be removed by the MHW ex officio and, consequently, the certificate holder enjoys less procedural protection.
As explained in our report last year, the Taipei High Administrative Court ruled in its two judgments rendered on May 12, 2022 that “new drugs” of which the relevant patent information may be disclosed on the Orange Book are limited to “new chemical entities, new indication/combination, or preparations with new administration route”, as referred to in Article 7 of the Pharmaceutical Affairs Act, and should not include “preparations with new dosage form, new administration dose, or new unit strength.” In addition, in these judgments, the Administrative Court regarded that the disclosure by the MHW of the patent information submitted by the holder of the new drug certificate of marketing approval is an “administrative decision”, and therefore the MHW has the right to revoke its previous decision on the disclosure of the patent information relating to the drugs that were actually not eligible for publication.
However, in two more recent judgments which were rendered on December 29, 2022, another panel of judges of the same Court thought otherwise. In these two more recent judgments, it was pointed out that the submitted information of the linked patent is automatically disclosed on the Orange Book the next day following the submission, and the disclosure need not be approved by the MHW. Therefore, the act of disclosing the patent information relating to the disputed drug on the Orange Book should be characterized as the certificate holder’s own action, rather than the MHW’s decision which it can later revoke ex officio.
The Taipei High Administrative Court further pointed out that according to Articles 48-6 and 48-7 of the Pharmaceutical Affairs Act, changes or removals of patent information are to be initiated by the holder of a new drug certificate of marketing approval; even if a third party questions the eligibility or correctness of the patent information, the MHW can only pass on the questions to the holder of the new drug certificate of marketing approval for change or removal of the information. The MHW, although in the capacity of a competent authority, has no right to intervene any patent information disclosure on the Orange Book. Therefore, if the MHW takes the initiative to remove or change any linked patent information published on the Orange Book, this move shall be deemed to go beyond the authority referred to in the Patent Linkage Chapter of the Pharmaceutical Affairs Act, and would undermine the legislative goal to alleviate the competition between brand drug companies and generic drug companies through the transparency of patent information relating to new drugs.
As for the definition of “new drugs”, the Taipei High Administrative Court pointed out in these two more recent judgments that—
- The introduction of the patent linkage system for pharmaceuticals as referred to in the Patent Linkage Chapter of the Pharmaceutical Affairs Act is a regulatory improvement for Taiwan to join the Trans-Pacific Partnership (TPP). By this token, the legislators should have no intention to interpret the “new drugs” referred to in that specific Chapter of the Pharmaceutical Affairs Act as those referred to in Article 7 of the same Act.
- The term “new drug” in the Patent Linkage Chapter of the Pharmaceutical Affairs Law, as can be seen from the relevant provisions, refers to any brand drug that has newly obtained a certificate of marketing approval. If the submitted patent information associated with the new drug relates to inventions of “compound, composition or formulation, or medical use” (as required by Article 48-3.2 of the Pharmaceutical Affairs Act), its listing should be allowed, as long as the timeline to list such information is met. The legislative intent, namely to strive for the balance of the time efficacy between the brand drug and the generic drug, has nothing to do with the nature of the drug itself.
- In other words, regardless of whether obtaining a new drug certificate of approval is meant for “a drug with a chemical entity, new indication/combination, or preparations with new administration route”, or for “preparations with new dosage form, new administration dose, or new unit strength”, as long as the drug involves the patent right of “compound, composition or formulation, or medical use”, it is under the realm of patent challenge or roundabout design of generic drug. So long as the holder of a new drug certificate of marketing approval is willing to proactively submit patent information, he should be allowed to participate in the balance mechanism established through the patent linkage system referred to in the Patent Linkage Chapter of the Pharmaceutical Affairs Act.
While the two issues have, in reality, touched upon the core of the patent linkage system for pharmaceuticals, the opinions of the judges of the Taipei High Administrative Court are divided. Given that appeals against the judgments rendered by the Supreme Administrative Court would inevitably be filed, we will continue to pay attention and report in due course.