1. Background

Taiwan has a resolute aspiration to join the "Trans-Pacific Strategic Economic Partnership Agreement" (TPP). The full text of the TPP agreement was released by the TPP Parties on 5 November 2015. The final version of the Intellectual Property (IP) Section (Chapter 18) contains issues regarding cooperation (patent examination, traditional knowledge), trademark, geographical indication, patent/undisclosed test data, industrial design, copyright and related rights, implementation, and ISPs. Most of the IP laws and regulations in Taiwan are in line with those in the IP Section. However, on measures relating to pharmaceutical products, there are discrepancies regarding patent linkage and data exclusivity for pharmaceuticals and biologics.  Therefore, the Taiwan Food and Drug Administration (TFDA), the Central Competent Health Authority, has drafted amendments of the Pharmaceutical Affairs Act (PAA) and held public hearings on the newly drafted amendments of the PAA. 

  1. Data and Marketing Exclusivity

Under current Article 40-2 of the PAA, only drugs containing a new active ingredient enjoy five-year data and marketing exclusivity. The TFDA amended the PAA by newly introducing Article 40-3 to confer data and marketing exclusivity for a drug with new indication (the 1stBill) and held a public hearing on 17 November 2015. Under the newly added Article 40-3 of the 1st Bill, within three years after the issuance date of a market approval for a drug with new indication, other applicants, without the approval holder's consent, shall not cite for the purpose of applying for a market approval the information submitted in the approval holder's application, and a generic version cannot be approved for five years. However, the new Article 40-3 also sets a limitation to the application of exclusivity right. That is, if the applicant files a market approval for a drug with new indication in another country first, the applicant must file the application for the same drug with the new indication within two yearsin the ROC (Taiwan) after the issuance of the market approval in another country. The 1st Bill was approved by the Cabinet on February 4, 2016 and has been submitted to the Parliament for legislation.

  1. Patent Linkage

Taiwan does not have a patent linkage system currently. To join the TPP, the TFDA drafted amendments to the PAA by adding Articles 48-2 to 48-21 (the 2nd Bill) and held a public hearing on 27 January 2016. These newly added articles concern patent listings, patent declarations certified by an applicant filing an Abbreviated New Drug Application (ANDA), notification of the ANDA filing by the ANDA applicant to the New Drug Application (NDA) holder, stay of issuing market approval to the generics by the TFDA, and marketing exclusivity provision conferred to the first ANDA applicant who successfully defends a patent infringement suit. Please note that the 2nd Bill might be subject to further revisions by the TFDA.

  1. Patent listings

According to Article 48-2 of the 2nd Bill, an NDA holder must list patents and claims that cover the drug within 45 days of issuance of an NDA market approval. In addition to patent information (such as patent number, patent expiry date, patentee, exclusive licensee etc.), the NDA applicant should specify claims relating to the drug. Generally speaking, drug substance patents, composition patents, formulation patents and medical use patents can be listed. It is not yet clear whether other types can be listed. According to our understanding, the TFDA will create guidelines on the listing details in the future.

Article 48-5 of the 2nd Bill provides that a third party who alleges that the listed patent information is incorrect can notify the TFDA with a written explanation and evidence attached. The TFDA will notify the NDA holder of the third party's notification and relevant documents within 20 days of receipt of the notification.

  1. Patent certifications certified by generic drug company when filing ANDA

According to Article 48-8 of the 2nd Bill, the ANDA applicant shall simultaneously or separately select the following item(s) as a declaration for each of the listed claims claimed by the NDA holder.

  1. No patent information has been listed for the new drug;
  2. The patent corresponding to the new drug has extinguished;
  3. The TFDA will issue the generic market approval after the extinguishment of the patent(s) corresponding to the new drug; and
  4. The patent corresponding to the new drugs should be revoked or will not be infringed by the generic drugs for which market approval is sought.
  1. Notifying the NDA holder of the ANDA filing by the ANDA applicant and stay of issuing market approval to the generics by the TFDA

According to Article 48-11 of the 2nd Bill, the ANDA applicant having a declaration of Item (iv) of Article 48-8 shall inform the NDA holder and the TFDA with a written notification no later than 20 days after the day that all the required documents required for filing the market approval have been completed and well-prepared. After the NDA holder, patentee or patent exclusive licensee receives the notification, he or she can file a patent infringement suit within 45 days after the receipt of the notification under Article 48-12 of the 2nd Bill. Under the same Article, the TFDA shall stay the issuance of the market approval within 15 months after the patentee or patent exclusive licensee receives the notification and files a patent infringement suit. However, the stay can be lifted if the ANDA applicant obtains a judgment that the patent has not been infringed.

  1. Marketing exclusivity provision conferred to the first ANDA applicant who successfully defends a patent infringement suit

According to Article 48-16 of the 2nd Bill, the first ANDA holder who successfully defends a patent infringement suit is granted a twelve-month period of marketing exclusivity. The TFDA shall not issue a market approval to other applicants for generic market approval until the expiration of the aforementioned 12-month period. However, under Article 48-18 of the 2nd Bill, if the first ANDA holder fails to market the drug within180 days after the date on which the issuance of the market approval is issued by the TFDA, the first ANDA holder will forfeit the 12-month period of marketing exclusivity. It is also specified in Article 48-19 of the 2nd Bill that the TFDA and the Taiwan Fair Trade Commission (TFTC) should be notified of any settlement agreement on patent linkage-related arrangements between NDA holder and the ANDA applicant or the first ANDA holder to clear any pay-for-delay or other reverse payment concerns. The TFDA and the TFTC should work together to establish guidelines on the details of such notification in the future. Parties who fail to notify the TFDA and the TFTC might be subject to certain administrative penalties according to Article 92-1 of the 2nd Bill.