A patent linkage system, established in an attempt to resolve disputes on patent invalidity and infringement among brand drug companies and generic drug companies in a more rapid manner, was introduced into the amended Pharmaceutical Affairs Act taking effect on August 20, 2019.
According to the amended Pharmaceutical Affairs Act, brand drug companies are required to submit, within 45 days from receipt of approval of a new drug, to Taiwan FDA a list of patents associated with the new drug and relating to inventions of compounds, compositions or formulations, or medical uses of the new drug, if any. Taiwan FDA will publish in a patent linkage registration system, known as Orange Book, information regarding the patents associated with the new drug for public inspection. In addition, a three-month transitional period is specially offered for the recordation of not-new previously approved new drug licenses. See our newsletter published at the end of 2018 on our website.
What is a “new drug”? According to Article 7 of the Pharmaceutical Affairs Law, it means any drugs that have been reviewed and determined by the FDA to be new chemical entities, new indication/combination, or preparations with new administration route. However, Article 39.2 of the Guidelines for Drug Review and Recordation for Patent Linkage System to which the Pharmaceutical Affairs Law applies mutatis mutandis also set out that new drugs include preparations with new dosage form, new administration dose, or new unit strength. Therefore, there has inevitably arisen a dispute as to whether the “new drugs” subject to the patent linkage system are limited to the three drugs specified in Article 7 of the Pharmaceutical Affairs Act, or whether they could include drugs with new dosage form, new administration dose, or new unit strength.
The Taipei High Administrative Court discussed the above issue in two Judgments rendered on May 12, 2022.
In the two administrative lawsuits, the plaintiffs, Merck Sharp & Dohme, MSD and Elligen Pharmaceutical Co., Ltd. both reported to Taiwan FDA, the defendant, all necessary patent associated information on their drugs with “new administration dose” and “new unit strength” within the transitional period of three months offered by the amended Pharmaceutical Affairs Law. After the information was interpreted through the pre-set automatic procedures as proper, Taiwan FDA recorded the new drugs and published the information for public inspection. However, after the expiration of the three-month transitional period, Taiwan FDA found through a manual investigation that the recorded drugs are not articulated in the definition of the three drugs as stipulated in Article 7 of the Pharmaceutical Affairs Act. As a consequence, the patent information associated with the drugs was removed from the Orange Book ex officio.
Not being satisfied with the decisions rendered by Taiwan FDA, the two companies then filed respective appeals and, in turn, administrative litigations with Taipei High Administrative Court. According to the Judgments rendered by the Court, Article 7 of the Pharmaceutical Affairs Law mandates in a clear-cut manner that the scope of new drugs is limited to drugs with new chemical entities, new indication/combination, or new administration route, and Taiwan FDA is endowed with the authority to examine and determine whether a new drug applied for recordation on the Orange Book falls within the definition of “new drugs” referred to in the Pharmaceutical Affairs Law. The High Administrative Court further pointed out that the Pharmaceutical Affairs Law which offers the definition of new drugs has not been subject to any change since the implementation of the Pharmaceutical Affairs Law, and therefore the definition of new drugs is still applicable when determining what “new drugs” is. Given that drugs with new dosage form, new administration dose or new unit strength do not belong to “new drugs” defined in Article 7 of the Pharmaceutical Affairs Law, the FDA was not improper to remove the relevant patent information from the Orange Book. It is especially true under the circumstance that when there is a conflict between Pharmaceutical Affairs Act, and the Guidelines for Drug Review and Recordation for Patent Linkage System, the former shall prevail. As the plaintiffs in both cases did not file appeals, the Judgments were then deemed conclusive and final.
It is worth noting that as the aforementioned three-month transitional period has long expired, it is no longer possible to have patent information related to a previously approved new drug license recorded. On the other hand, in view of the 45-day time limit from receipt of the drug license for the new drug defined in Article 7 of the Pharmaceutical Affairs Law, a new drug license holder can only submit the patent information to the patent link system within 45 days after the certificate is obtained, and once the 45 day time limit has passed, submission of patent information will not be permissible. In other words, according to the current practice, the license holders of drugs that are not the three new drugs defined in the Pharmaceutical Affairs Act would not be given any opportunity to submit patent information to be recorded on the Orange Book from the very beginning. Therefore, the removal of patent information on new drugs as discussed in the above two cases would not occur any longer.
In fact, in 2017, the Taiwan FDA did propose a draft amendment to Article 7 of the Pharmaceutical Affairs Law, intending to include new dosage forms, new administration dose, and new unit strength in the definition of new drugs, but the proposal was not approved. Notwithstanding this, in tandem with the implementation of the patent linkage system and the development of Taiwan’s pharmaceutical industry, it is still possible that such draft amendment will be adopted in the future law amendment. We will keep an eye on the development.