Patent Term Extension in China is now possible for pharmaceutical patents
On June 01, 2021, the fourth amendment of Patent Law in China entered into effect.
This amendment includes significant changes, such as the introduction of Patent Term Extension (PTE) for pharmaceutical patents (Article 42(3) of the Law).
Patent Term Extension extends the duration of the patent granted for an active ingredient of a medicinal product, in compensation for the delay in obtaining a Marketing Authorization (MA) for said product.
Implementing regulations and guidelines still need to be issued, but the main characteristics of Patent Term Extension in China, as mentioned in the current drafts, are summarized below.
When to file a PTE request?
The request must be filed within 3 months from the grant of MA.
The request must also be filed at least 6 months before patent expiry (which means that the grant of the patent must be earlier than the grant of MA).
Who can file the PTE request?
The request must be filed by the patentee. If the patentee and the MA holder are not the same entity, a written consent from MA holder is required for the patentee to refer to the MA in the Patent Term Extension request.
What product can be covered by a PTE?
Medical product can be chosen among a chemical drug, a vaccine or a therapeutic biological product.
However, for a product to be eligible for a Patent Term Extension, it is highly important to note that the product must not have already been approved or marketed in any other country, when MA request is filed in China.
How is the PTE calculated?
The duration of PTE is calculated as follows:
date of the MA in China – date of the patent filing in China – 5 years
- Maximum PTE is 5 years, and
- PTE cannot exceed 14 years from MA grant.
What is the basis patent to be mentioned?
The patent must be in force when the PTE request is filed.
Moreover, the patent covering the product can be chosen among patents relative to a product per se, a process patent or a prophylactic/therapeutic use.
Careful attention should be given when choosing the patent because:
- When the product is covered by several patents, only one PTE can be obtained, and
- Only one PTE can be obtained for a patent, even if the latter covers several products.
Scope of PTE (Rule 85.6)
The scope is limited to the clinical indication(s) as mentioned in MA.
China has now harmonized its legislation with other countries wherein the possibility to request for a PTE already exists (such as United States or in European countries where PTE is known as “SPC - Supplementary Protection Certificate").
This is undoubtedly good news for pharmaceutical companies, even if requesting a Patent Term Extension in China seems to have to be thought out more upstream than in other countries, to ensure that the products have not already been approved or marketed in another country, when seeking a MA in China.
An update will be necessary when the final versions of the implementing regulations and guidelines become available.
The Plasseraud IP Patents team is closely following the issuance of these final versions and will provide you with information in this regard as and when it becomes available.