Further developments and changes could be made from now to early December. Close monitoring is recommended.
The provisions directed to patent linkage set forth in the Pharmaceutical Affairs Act were passed on December 27, 2017, and promulgated by the President on January 31, 2018. On September 11, 2018, the TFDA published a draft version of the regulations on patent linkage titled "The Enforcement Rules for Patent Linkage" with relevant forms ("Regulations") at https://www.fda.gov.tw/TC/newsContent.aspx?cid=4&id=t428160. The TFDA is collecting public comments and plans to promulgate the Regulations in November or December.
The Regulations provide details on how patent linkage will be implemented in Taiwan. An analysis of the Regulations reveals four major aspects which will bring significant impact to patent linkage operation.
The first aspect, and arguably the most important, relates to biological patents and biosimilar products. Being defined as "new drugs," there is no doubt that biological patents are eligible for listing, as long as they are not process patents. However, under the current Regulations, even after biological NDA holders have listed their patents, applicants seeking biosimilar marketing approval may not need to make a declaration under Paragraph IV and the marketing approval applications may not need to be stayed for 12 months, since biosimilar products are not defined as "generics" as set forth under patent linkage law provisions. The Regulations which do not extend the 12-month stay period to biosimilar drugs might weaken the value of patent linkage.
The second issue refers to eligibility for patent listing. In the process of discussing the content of the Regulations, it was agreed that patents claiming different polymorphs of the medicinal ingredient are eligible for listing. One of the draft versions provided to local industry clearly defined that the term “polymorph” is meant to include different crystalline, amorphous, hydrated and solvated forms of the approved medicinal ingredient. But the Regulations announced on September 11 define "Substance" as "the active ingredient of a drug preparation" without providing further details. It is unclear whether different polymorphs of the medicinal ingredient are eligible for listing.
The third aspect relates to the methodology of patent listing. The Regulations confirm that patent listings have to be made online through the TFDA's database. It would be 100% electronical filing. Written submission is not necessary.
The fourth issue specifies the date of implementation. According to Article 16 of the Matters Requiring Attention in Legal Operation of Central Administrative Agency, regulations enforcing a new law must be completed within six months after the law is passed and can be extended for no more than six months. Accordingly, it is expected that regulations for patent linkage may be implemented in early 2019. Patents covering marketing approvals obtained before the date of implementation can be listed within three months of patent linkage taking effect. It would be quite demanding on NDA holders to complete all patent listings with respect to current drugs within three months after the date of implementation. Practically speaking, it might not be three months as set forth in the law. NDA holders would prefer to complete patent listings in days, for generics' ANDA applications would not be stayed until patent listings have been completed.