The China National Intellectual Property Administration (CNIPA) has announced the “Decisions of the State Council on Amending the Patent Law Implementation Rules,” set to take effect from January 20, 2024. These amendments are particularly significant for the pharmaceutical sector, as they provide detailed regulations on patent compensation terms that were introduced under Article 42 of the Patent Law, which came into effect in June 2021. The updated rules will allow companies to apply for patent compensation starting next year.
Article 42 allows patentees to seek compensation from CNIPA for unreasonable delays in the prosecution of invention patents, particularly when a patent is granted four years from the filing date and three years from the request for substantive examination. Additionally, compensation for delays during the novel drug pre-marketing review and approval process is also permissible. CNIPA can extend the patent term by up to five years upon the patentee’s request, ensuring that the total patent term does not exceed 14 years once the new drug is launched.
The key amendments to the implementation rules include:
- Newly added Article 80: Defines new drug-related invention patents as those related to new drug products, preparation methods, and pharmaceutical use patents that meet regulatory requirements.
- Newly added Article 81: Sets forth requirements for new drug-related invention patent compensation claims, including a three-month window to apply for compensation after market approval in China, and restrictions on the number of patents and drugs that can be linked to a single compensation claim.
- Newly added Article 82: Establishes the patent compensation period based on the difference between the patent application date and the new drug’s marketing approval date in China, minus five years, in line with Article 42(3) of the Patent Law.
- Newly added Article 83: Clarifies that during the patent compensation period, the scope of protection for a new drug-related invention patent is limited to the approved technical solutions for specific indications.
- Newly added Article 84: Outlines CNIPA’s process for examining patent compensation requests, granting compensation if conditions are met, and publishing the decision. If conditions are not met, CNIPA will notify the requesting patent holder.- Fineline.com
