Taiwan’s Patent Act provides a patent term extension (PTE) system for pharmaceutical patents. Under Article 53 of the Act, the extendable patent term cannot exceed “the length of time during which the invention could not be implemented due to the need to obtain drug approval from the Ministry of Health and Welfare (MOHW).”
In practice, applicants often submit additional materials late after the initial application, causing delays in obtaining drug approvals. Since indiscriminately allowing such delays to justify patent term extensions would be unreasonable, the MOHW adopts the test of “whether the delay is attributable to the applicant” in such cases.
A December 2024 decision by the Intellectual Property and Commercial Court (IPC Court) clarified how this test is applied in a real case. In this case, the drug approval was collected 54 days after the applicant received the notice of allowance for drug approval. The Taiwan Intellectual Property Office (TIPO) found that this delay constituted inaction attributable to the applicant and, therefore, excluded it from the patent term extension. The court agreed with TIPO for the following reasons:
- While the Regulations for Registration of Medicinal Products clearly require the submission of a “Certificate of Pharmaceutical Product (CPP) by Ten Advanced Countries” for imported new drug approvals, the applicant did not submit the CPP until the day they collected the drug approval.
- During the 54-day delay, the applicant submitted an updated pharmacokinetic analysis report supporting information about elderly patients in the package insert. However, they could have submitted this report during the application process, as the report had been completed before the MOHW notified the applicant of the allowance of the drug approval.
- The applicant took 54 days to collect the drug approval, an unreasonably long period that indicates a failure to exercise due diligence. This constitutes a clear instance of attributable delay under the Patent Examination Guidelines.
- The court emphasized that whether a delay is attributable to the applicant must be determined based on objective facts, rather than subjective factors. The impact of external factors must be so significant that it renders the applicant unable to make the required decisions or take the necessary actions. Human-caused events must be comparable in severity to natural disasters, war, or terrorist attacks to qualify. As such, communications between the applicant and the Center for Drug Evaluation regarding package insert modifications are considered subjective factors. Therefore, the delay allegedly resulting from these communications cannot be deemed non-attributable to the applicant.
As the reported IPC Court’s judgment demonstrates, the court not only supports but also further elaborates on the test TIPO applies when examining an applicant’s delay in obtaining a drug approval in the context of a PTE request. Given these developments, pharmaceutical patent holders should carefully assess their application strategies for applying for and collecting drug approvals. Obtaining drug approvals in normal course without delays may become even more important than before, not least because it allows patentees to secure the legal status to implement their patent rights more quickly.