Taiwan legislated a new chapter for patent linkage of drugs into the Pharmaceutical Affairs Act about two years ago. Since August 20, 2019, the Pharmaceutical Affairs Act along with a new statute titled the Enforcement Rules for Patent Linkage of Drugs have become effective. Pharmaceutical or generic drug companies of interest should pay close attention to this new patent linkage system and act timely.
Market Approval Holder On A New Drug
- To engage in patent linkage, a holder of market approval (MA) on a new drug shall list, within 45 days from receiving TFDA’s MA, related information about the new drug’s patent(s), which may be any of
- Substance, referring to the active ingredient of a drug;
- Composition or formulation, of the active ingredients of a drug; or
- Medical use, corresponding to all or a part of indications specified in a MA.
- To engage in the same, a holder of a MA granted before the effectiveness of the amended Pharmaceutical Affairs Act shall list, within three (3) months from the effectiveness (namely, November 20, 2019), related information about the drug’s patent(s).
- At the online Patent Linkage Listing System (https://plls.fda.gov.tw/) offered and maintained officially by the TFDA, the MA holder shall fill in a form for each one of patent(s) along with submission of additional information:
- Patent certificate or patent gazette showing the patent information;
- Power of attorney, if retaining a representation;
- Permission from the patentee or the exclusive licensee, or an exclusive license; and
- Other supportive documents necessary.
For any changes to patent information, the MA holder bears the duty to update the same.
Generic Drug Applicants
- To seek a generic drug market approval the generic drug applicant must certify clearance of patent barriers, due to either
- No patents associated;
- Patent expired;
- TFDA’s issuance of approval after patent expiration;
- Patent invalidity or non-infringement.
- For certification of invalidity or non-infringement, the generic drug applicant shall make a detailed statement along with sufficient supportive evidence to serve the same to the holder of patented drug MA and TFDA. And then TFDA shall place a stay of 12 months against generic approval when the MA holder files for an infringement suit within 45 days from the service. To lift the stay, the generic drug applicant shall make request to the TFDA in detail under several circumstances such as the infringement suit is dismissed or conflict is otherwise settled.
Other New Drugs
Biosimilars, except those permitted for clinical trials before effectiveness of patent linkage (namely, August 20, 2019), shall be governed as well under the patent linkage system.