A recent decision by Taiwan's Intellectual Property and Commercial Court (IPC Court) has set a significant precedent for pharmaceutical patent term extensions (PTE), establishing stricter standards for what constitutes justifiable delays in the drug approval process.
The case centered on a 54-day delay between the notice of drug approval allowance and its actual collection by the pharmaceutical company. The Taiwan Intellectual Property Office (TIPO) determined this delay was attributable to the applicant and therefore ineligible for patent term extension under Article 53 of Taiwan's Patent Act.
Key Factors in Court's Decision
The court supported TIPO's decision based on several critical findings. First, the applicant failed to submit the required Certificate of Pharmaceutical Product (CPP) from advanced countries until the day of approval collection, despite this being a clear requirement under the Regulations for Registration of Medicinal Products.
Additionally, during the 54-day period, the applicant submitted an updated pharmacokinetic analysis report for elderly patients. The court noted this could have been submitted earlier in the application process, as the report was completed before the Ministry of Health and Welfare's (MOHW) notification of approval allowance.
Objective Standards for Delay Assessment
In a significant clarification of policy, the court emphasized that delay attribution must be based on objective rather than subjective factors. The ruling established that only external factors of exceptional severity – comparable to natural disasters, war, or terrorist attacks – could justify delays in the drug approval process.
The court specifically rejected the argument that routine communications between the applicant and the Center for Drug Evaluation regarding package insert modifications could justify delays, categorizing these as subjective factors attributable to the applicant.
Impact on Pharmaceutical Industry
This ruling has substantial implications for pharmaceutical companies operating in Taiwan. The decision underscores the importance of maintaining efficient approval processes and exercising due diligence in collecting approvals promptly after allowance.
The court's interpretation suggests that pharmaceutical companies must now plan their regulatory submissions more strategically, ensuring all required documentation is prepared and submitted in a timely manner. This includes both mandatory requirements like the CPP and any supplementary documentation that could impact the approval process.
Strategic Considerations for Patent Holders
For pharmaceutical patent holders, the ruling emphasizes the need for careful planning in drug approval applications. Companies must now be particularly vigilant about:
- Preparing all required documentation before initiating the approval process
- Promptly responding to regulatory requests
- Collecting approvals as soon as they are granted
- Maintaining detailed records of any external factors that could legitimately delay the process
The decision reinforces that obtaining drug approvals without delays is crucial not only for market entry but also for securing and maintaining patent rights effectively.
