Slated for implementation on June 1, 2021, the Fourth Amendment to the Chinese Patent Law expands the rights of patentees and aligns China’s laws with those of many other jurisdictions. Key additions include:
- a grace period for invention disclosures made for public interest,
- increased patent terms for delays caused by the Chinese Patent Office and regulatory review of drugs,
- expanded damages provisions,
- declaratory-judgment options for drugs undergoing regulatory review that may fall within the scope of a granted patent,
- protection of partial designs.
Expanded Pre-Filing Disclosure Protections (Art. 24[1])
Public disclosures made within six months of filing an invention patent application will no longer destroy novelty if the disclosure was made for the purpose of public interest while China is in a state of emergency. Although what constitutes an “emergency” is yet unclear, the COVID-19 pandemic is a likely impetus for the new provision and offers insight into one basis for invoking the grace period.
Expanded Patent-Term Lengths (Art. 42)
Design patents will last 15 years from the filing date rather than 10 years.
Similar to patent-term adjustment (PTA) provisions in the United States, additional patent term will now accrue for unreasonable delay if a patent is not granted within:
- four years of filing an invention patent application, and
- three years of requesting substantive examination.
Unreasonable delay caused by the applicant, however, will not accrue additional patent term.
Similar to patent-term extension (PTE) provisions in the United States, additional patent term will now accrue for regulatory review and approval of new drugs. The additional patent term is capped at five years, however, and the total effective duration of the granted patent shall not extend beyond 14 years from the drug being approved for marketing.
Expanded Damages Calculations (Art. 71)
Three major expansions to damages calculations are contemplated:
- Damages may be increased by up to five times if infringement is found to be willful.
- The statutory-damages cap has been increased from 1,000,000 RMB (approximately $160,000) to 5,000,000 RMB (approximately $780,000).
- If an infringer fails to provide a satisfactory accounting relating to the infringing act, damages may instead be determined based on evidence provided by the patentee.
Actions Against Infringing Pharmaceuticals Under Regulatory Review (Art. 76)
If a new drug undergoing regulatory review is suspected to fall within the scope of a granted patent, the patentee (or another person of interest) and the applicant for regulatory approval may request a declaratory judgment as to whether the drug falls within the scope of the patent. Regulatory review of the contested drug may be suspended during the action.
Partial Designs for Design Patents
Applications filed on and after June 1, 2021 may additionally be directed to partial designs, such as a shape of a part or portion of a product. Although the formal examination guidelines have not yet been released, this presents an opportunity for applicants to more closely align the scope of their Chinese design patent protection with their strategy in other regions.
