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The TFDA Is Moving Forward to Implement the Patent Linkage Laws in Taiwan

On September 11, 2018 the Taiwan Food and Drug Administration (TFDA) published a draft version of the new regulations on patent linkage titled "The Enforcement Rules for Patent Linkage" for public comment. The provisions relating to Taiwan's new patent linkage system were set out in the Pharmaceutical Affairs Act, passed on 27 December 2017 and promulgated by the president on 31 January 2018.


Two hearings were held by the TFDA in November.  Analysis of the new Regulations and the TFDA’s announcements made in the hearings, which reveals several aspects that will have a significant impact on patent linkage operations.


Biological patents and biosimilar products
The first and arguably most important aspect relates to biological patents and biosimilar products. Biological patents will be classified as “new drugs” and therefore eligible for listing in the new system as long as they are not process patents. However, according to the TFDA’s latest announcement on November 27, even after biological new drug application (NDA) holders have listed their patents, applicants seeking biosimilar marketing approval would not need to make a declaration under Paragraph IV and the marketing approval applications will not be stayed for one year, because the patent linkage legislation does not define biosimilar products as “generics.”


Patent listing eligibility
It was an issue whether patents which claim different polymorphs of a medicinal ingredient are eligible for listing. One side of the industry supports that different crystalline, amorphous, hydrated and solvated forms of approved medicinal ingredients should be eligible for listing. The other side proposes that patents covering non-commercialized polymorphs should not be eligible. The TFDA made it clear on November 27 that patents covering non-commercialized polymorphs are basically eligible for listing.


Patent listing methodology
The new regulations confirm that patent listings will need to be made via the TFDA's online database. Listing will be performed entirely electronically. The TFDA has formally informed local NDA holders and ask them to submit lists of products to the TFDA by late December identifying products eligible for listing. As the master manager of the patent listing online system, the TFDA would crate “accounts” in the system in accordance with the products on the lists submitted by NDA holders, so that NDA holders would be able to list patents when entering into the system in the future. 


Though the TFDA yet to formally announce the date of implementation, the new patent linkage laws and regulations are expected to be implemented in January 2019. It seems that the TFDA does try to expedite the preparation for the implementation.