4 th Amendment to the China Patent Law (pharmaceutical domain)
With the entry into force of the 4th revision of the Chinese patent law on June 1, 2021, the following aspects are to be noted :
First, a possible compensation for unreasonable procedural delay (similar to the US PTA) is created : upon request of the owner, if a patent is granted 4 years after filing AND within 3 years from the examination request, then the office compensates the unreasonable delay, unless it is caused by the owner.
A compensation for the delay of examination and approval of a new drug (similar to the US PTE) is also created : upon request of the owner, the office can grant a compensation for the duration of the patent for an invention related to a new drug for which a marketing authorization is obtained in China. The compensated term must not exceed 5 years, AND the total effective patent term must not exceed 14 years from the date of the new drug's MA.
The provisions for PTAs and PTEs in China are approximately the same as the American ones. The owner applying for a PTE will obtain a maximum of 5 years of protection in addition to the 20-year term of patent protection. The extension granted by the PTA is not yet determined, but should be identical to that provided in the US.
Finally, the law adds the possibility of a linkage between the regulatory procedure and the patent procedure ("linkage"):
During the regulatory process for a drug, if a dispute arises between an applicant (generic company) and a patentee or a third party with a patent on the drug for which registration is sought, the latter may take legal action to determine whether the drug for which registration is sought is not already covered by the patent. In such a case, the regulatory agency may suspend the procedure for granting the marketing authorization until the litigation is concluded.