Amendment to China Patent Law Offer PTA, PTE and Patent Linkage

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

Patent term adjustment (PTA), patent term extension (PTE), and patent linkage were made available in China as of June 1, 2021. While there are certain rules to be finalized and settled, it is advisable that patentees and drug marketing authorization holders (MAHs) take action now. Provided here is a summary of the main elements of PTA, PTE and patent linkage, as well as suggestions on how to leverage such new opportunities.

Amendment to China Patent Law

As the 4th amendment to China Patent Law entered into effect as of June 1, 2021, patent term adjustment (PTA), patent term extension (PTE), and patent linkage are finally available in China. The specific rules will not be finalized for months to come, but the China National Intellectual Property Administration (CNIPA) and National Medical Products Administration (NMPA) have issued interim measures on how to proceed provisionally. It is advisable to request PTA and PTE and list patents according to the current interim rules in order to preserve the opportunity to seek them later under final rules.

Patent Term Adjustment (PTA)

So far the interim guidance for PTA includes:

1. Deadline to request PTA – within 3 months after the patent is issued.
2. Retroactivity – PTA does not apply to patents issued before June 1, 2021. Only patents issued on or after June 1, 2021 may be eligible.
3. Interim measures – Patentees may file PTA requests for invention patents issued on or after June 1, 2021, but the requests will not be examined until the amended Implementing Regulations are finalized and become effective.

Suggestions: We suggest patent owners consider filing PTA requests for all important patents for invention issued 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 requesting substantive examination.

Patent Term Extension (PTE)

So far the interim guidance for PTA includes:

1. Deadline to request PTE – Within three months from the date of approval of the new drug marketing authorization (MA). Failure to meet this deadline will risk losing the opportunity to seek PTE in the future.
2. Period of PTE – Maximum extension available is 5 years, and the resulting total effective patent term shall not exceed 14 years from the approval for marketing of the new drug.
3. Drug/patents eligibility requirements – Not finalized yet.
4. Retroactivity – According to CNIPA, PTE does not apply to drugs approved on or before May 31, 2021, which means that only drugs approved on or after June 1, 2021 may be eligible.
5. Interim measures – PTE request may be filed before the above deadline but will not be examined until the amended Implementing Regulations are finalized and become effective months later.

Suggestions: We suggest stakeholders consider applying for PTE once any new drug is approved in China, keeping in mind the above-mentioned deadline.

With regard to retroactivity, although CNIPA has said that PTE does not apply to drugs approved on or before May 31, 2021, the CNIPA’s decisions are normally subject to judicial review and the courts’ attitude on the retroactivity of PTE is not clear yet. Therefore, for very important drugs approved in China before June 1, 2021, it might be worthwhile to consider requesting PTE within the above-mentioned deadline, and, after the PTE application is rejected by CNIPA, appealing to the courts.

Listing the Patents for Patent Linkage

So far the interim guidance for patent linkage includes:

1. Deadline to list patents – Remains unfinalized.
2. Listable patents –
   Chemical drugs: patents to API compound, pharmaceutical composition comprising API, and medical use patents.
   Biological products: active ingredient sequence structure patents, and medical use patents.
   Patents to intermediates, metabolites, crystal forms, preparation methods, and detection methods are excluded.
3. Retroactivity – Remains unsettled. However, drugs approved before June 1, 2021 and patents issued before June 1, 2021 are not explicitly excluded and thus likely to be qualified.
4. Interim measures – Patent information may be submitted to a patent information registration platform of NMPA.

Suggestions: Since patents that are not listed will not be qualified for patent linkage, we suggest (a) listing all eligible patents as soon as possible for drugs that have been approved; (b) listing any new eligible patent as soon as possible and within 30 days after the patent is issued; and (c) updating patent information that has been submitted within 30 days after the patent information changes.