Chinese Patent Law Amendments Offer PTA, PTE and Patent Link

Patent Term Adjustment (PTA), Patent Term Extension (PTE) and Patent Coupling have been made available in China from June 1, 2021. Although there are certain rules to be finalized and settled, it is advised that patent holders and medicinal product marketing authorization holders (MAHs) act now. Below is a summary of the main elements of the link between PTAs, PTEs and patents, as well as suggestions on how to take advantage of these new opportunities.

Amendment to Chinese Patent Law

As the 4th Amendment to China’s Patent Law came into effect on June 1, 2021, Patent Term Adjustment (PTA), Patent Term Extension (PTE) and Patent Binding are finally available in China. The specific rules won’t be finalized for months, but China’s National Intellectual Property Administration (CNIPA) and National Medical Products Administration (NMPA) have issued interim measures on how to proceed tentatively. It is advisable to apply for the PTA and PTE and to list the patents according to the current provisional rules in order to preserve the possibility of applying for them later under the final rules.

Patent Term Adjustment (PTA)

So far, draft guidance for PTA includes:

  1. Deadline for applying for the PTA – within 3 months of the grant of the patent.

  2. Retroactivity – The PTA does not apply to cards issued before June 1, 2021. Only cards issued on or after June 1, 2021 may be eligible.

  3. Interim Measures – Patent holders may file PTA applications for invention patents issued on or after June 1, 2021, but applications will not be considered until the amended Regulations are finalized and enter not in effect.

Suggestions: We suggest patentees consider filing APT applications for all significant invention patents granted on or after June 1, 2021, if the patents were granted more than four years from the date of filing and more than three years from the date of the substantive application. exam.

Patent Term Extension (PTE)

So far, draft guidance for PTA includes:

  1. TPE application deadline – Within three months from the date of approval of the marketing authorization (MA) of the new drug. If this deadline is not met, you may lose the opportunity to apply for a PTE in the future.

  2. PTE Period – The maximum extension available is 5 years, and the resulting total effective patent term must not exceed 14 years from the new drug’s marketing approval.

  3. Drug/Patent Eligibility Criteria – Not yet finalized.

  4. Retroactivity – According to the CNIPA, the PTE does not apply to drugs approved on or before May 31, 2021, meaning only drugs approved on or after June 1, 2021 may be eligible.

  5. Interim Measures – The PTE application can be filed before the above deadline but will not be considered until the amended Regulations are finalized and enter into force months later.

Suggestions: We suggest stakeholders consider applying for a TEP once a new medicine is approved in China, keeping in mind the deadline mentioned above.

Regarding retroactivity, although CNIPA has stated that the PTE does not apply to drugs approved on or before May 31, 2021, CNIPA decisions are normally subject to judicial review and the attitude of the courts on the retroactivity of the PTE is not yet clear. Therefore, for very important drugs approved in China before June 1, 2021, it might be worth considering applying for the PTE within the above-mentioned time frame and, after the PTE application is rejected by the CNIPA, appealing to courts.

List of patents for patent matching

So far, tentative guidance for patent matching includes:

  1. Patent Listing Deadline – Remains not finalized.

  2. Listable patents –
    Chemical drugs: patents on an API compound, a pharmaceutical composition comprising an API and medical use patents.
    Biologics: active ingredient sequence structure patents and medical use patents.
    Patents on intermediates, metabolites, crystal forms, methods of preparation and methods of detection are excluded.

  3. Retroactivity – Remains unstable. However, drugs approved before June 1, 2021 and patents granted before June 1, 2021 are not explicitly excluded and therefore likely to qualify.

  4. Interim Measures – Patent information may be submitted to an NMPA patent information registration platform.

Suggestions: Since patents that are not listed will not qualify for patent matching, we suggest (a) listing all eligible patents as soon as possible for drugs that have been approved; (b) list any new eligible carding as soon as possible and within 30 days of carding; and (c) update the submitted patent information within 30 days of the modification of the patent information.

This update is provided by Fan Li, Director, Patent Attorney, Chemical Patent Department at CCPIT Patent & Trademark Law Office, Beijing, China.