Understanding the calculation of PTE
The length of extendible time for PTE is calculated by adding two periods: (i) the duration of domestic clinical trials and (ii) the time taken for regulatory approval review. This sum is then adjusted by excluding any delay attributable to the MA holder. The maximum extendible term is 5 years. When calculating PTE, the MA-relevant periods (i) and (ii) are only counted after the date of patent issuance.
The clinical trial period refers to the time taken for domestic clinical trials conducted under the approval of the Korean regulatory authority, from the enrolment of the first patient until the last patient has completed the trial. On the other hand, the regulatory review period begins when the approval procedures are initiated, such as upon receipt of an Application for Drug Approval or a Request for Review of Specification and Test Method, Safety and Efficacy, Good Manufacturing Practice (GMP), or Drug Master File (DMF), whichever is earliest; it concludes with the receipt of the Certificate of Drug Approval.
Delays attributable to the MA holder include those caused by pending requests for supplementary data or other factors within the control of the MA holder.
Early patent issuance/longer PTE: Accelerated Examination
In Korea, among the MA-relevant periods, only the time taken after the patent issuance is counted in PTE calculation. Therefore, obtaining early patent issuance is crucial for maximising the benefits of PTE. Accelerated Examination, such as the Patent Prosecution Highway (PPH), is recommended in order to advance the prosecution process. The PPH offers shorter examination periods and is commonly used by pharmaceutical companies with global patent portfolios. If no allowable claims are found in a counterpart patent, or if the allowed claims are overly narrow, alternative forms of Accelerated Examination may be considered.
It is highly recommended that Accelerated Examination be requested well in advance, at least 4 months before the expected starting date of clinical trials or regulatory approval procedures, particularly if these are imminent.
PTE for multiple candidates: divisional applications
PTE is available only once per patent in Korea. This means that if a patent covers multiple active substances and respective multiple approvals have been obtained, PTE can be granted only once for that patent. To secure additional opportunities for PTE, it is advisable to pursue multiple candidate compounds separately in multiple patent applications. Divisional practice in Korea is allowed for overlapping claim scope and cascading divisionals, providing ample flexibility in the timing of divisional filings. However, divisional applications cannot be filed after a patent has been issued.
PTE for multiple patents based on a single Marketing Authorisation: coordination of timing
In Korea, PTE can be obtained for each of the multiple patents based on the same Marketing Authorisation. For example, if a drug product is covered by multiple patents (Patents 1, 2, and 3) and obtains MA), it is possible to obtain PTE for Patents 1, 2, and 3 based on MA.
To optimise this opportunity, it is essential to coordinate the timing of prosecution and the filing of PTE, especially when the patents have been examined at different times. Accelerating the examination process of pending applications is advisable if some patents have already been issued while others are still pending.
Conclusion and outlook
By understanding the features of the Korean PTE system and implementing the recommended strategies, one can maximise the advantages involved. Such strategies include using Accelerated Examination to secure early patent issuance and filing divisional applications to seek opportunities for PTE for multiple candidate compounds included in a single patent application.
Compared to other jurisdictions, Korea’s PTE practice offers favourable conditions for obtaining longer PTE for a drug product. PTE is available for all patents involved in a single approval, and unlike in the US or Europe, there is no 14- or 15-year limit from the date of receiving regulatory approval. However, proposed amendments to the Patent Act are on the horizon, and it is possible that soon the restrictions on PTE may resemble those in other nations. By acting swiftly to take advantage of the current system, patent holders can maximise the potential benefits of PTE in Korea.
FICPI's view and involvement
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Next steps
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