The patent law reform in China has yet to deliver the Implementing Rules to the new patent law effective on June 1, 2021. In order to ensure the implementation of the amended patent law, which is still in the process of revision, the CNIPA has formulated a set of Interim Measures dated May 24, 2021 relevant to basic examination matters under the new law to be implemented as of June 1, 2021. Applicants, especially those within the pharmaceutical industry, need to review the Interim Measures in order to take timely action.
The Interim Measures contain 10 Articles which are summarised below:
- Article 1 states that design patents relating to a partial shape can now be filed as of June 1, 2021 and will then be examined under the amended patent law.
- Article 2 states that the new novelty grace period relating an emergency or an extraordinary situation that occurs in China can be claimed for applications filed after June 1, 2021.
- Article 3 states that the domestic priority of a prior Chinese design patent filing can be claimed for design patent applications filed after June 1, 2021.
- Article 4 states that the amended Article 30 (relating to claiming priority) with regards to the new rules for submitting a copy of the priority application shall apply for all patent applications filed after June 1, 2021.
- Article 5 states that for invention patents that have been granted since June 1, 2021, the patentee may apply for a patent term adjustment under amended Article 42 within three months from the date that the patent right is granted by physical submission of a paper form. Relevant fees shall be paid in accordance with the payment notice issued by the CNIPA.
- Article 6 states that starting from June 1, 2021, the patentee may apply for a patent term extension under amended Article 42 within three months from the date of approval of the new drug marketing authorisation request, by physical submission of a paper form requesting compensation for the duration of the patent term, and then paying the relevant fees in accordance with the payment notice issued by the CNIPA.
Note: The paper form template for a request under Articles 5 and 6 has meanwhile been provided. Article 6 requests that it is necessary to state the name of the drug and the approved indications (including the document number of the drug marketing authorisation certificate). The requester should identify the claims related to the drug that has been approved for marketing and explain the reasons why the technical solution incorporated in the drug falls within the protection scope of the identified claims referring to the reference materials. The requester should also name and justify the calculation basis for the requested patent extension term and clarify the exact technical solution to be protected during the compensation period. For these statements, supplementary sheets can be used. It is also required to provide proof that the holder of the drug marketing authorisation agrees to the patentee’s request for compensation for the duration of the drug patent, if the patentee and marketing authorisation holder are different. The requester may also be required to add information regarding the manufacturing process of the drug that is being applied for.
- Article 7 states that starting from June 1, 2021, patentees may voluntarily declare using a paper form in order to implement an open license for their patents in accordance with Article 50 of the amended patent law.
- Article 8 states that starting from June 1, 2021, the accused infringer may request the CNIPA to issue a patent evaluation report in paper form in accordance with Article 66 of the amended patent law.
- Article 9 states that starting from June 1, 2021, the CNIPA shall conduct preliminary examination and substantive examination in accordance with the amended patent law under the new principles of Article 20 (1) (relating to good faith and potential harm to the public) as well as Article 25 (1), Item (5) (relating to nuclear transformation methods) of the patent law, both in examination and re-examination proceedings.
- Article 10 states that the patent term of design patents for which the filing date is on or before May 31, 2021 is still ten years counting from the filing date.
Applicants should immediately and carefully review how the Interim Measures affect their IP protection strategies. A review of planned patent filings, existing patent filings and regulatory approval dates may be necessary for best utilisation of the amended terms, and to identify opportunities under the new Chinese patent law. Inextensible deadlines should be noted and attended to.
We will keep you updated on further developments in Chinese patent law as they happen. Please reach out to us if you have further questions.