Today, on 1 June 2021, the fourth amendment to the Chinese patent law will enter into force. In addition to an overall strengthening of the patent system, as we reported previously, significant changes have been introduced that are relevant to the pharmaceutical field.
Here, we want to alert you to the introduction of a completely new patent term extension system in China for pharmaceutical products. The mechanism is strongly inspired on the Patent Term Extension (PTE) system in the US and the analogous Supplementary Protection Certificates (SPCs) in Europe, but there are significant differences as well.
Chinese PTEs are introduced by Art. 42(3) of the Patent Law. Most of the practical details are clarified in the amendments to the Implementing Regulations and Guidelines for Examination, which are still in the draft stage. The system will be available for “new drugs” that have been approved in China. The term calculation is similar to the European system, namely subtracting the period between patent filing and marketing authorization with 5 years.
The overall PTE duration is restricted to 5 years after normal patent expiry or 14 years after marketing authorization (14 years corresponding to the US situation, whereas this would be 15 years in Europe). Contrary to the European and US systems, there does not appear to be a possibility to obtain a further pediatric extension. The PTE must be requested at the latest 6 months before patent expiry, which is stricter than the European system (just before patent expiry) or the US system (before patent expiry, but extensions are available).
Similar to the US and Europe, the scope of the PTE is restricted to the drug that was approved for marketing, but otherwise confers the same rights. Per drug, one patent can be selected and each patent can be extended in relation to only one drug. Based on the current drafts and contrary to the European and US situation, the system appears not to be available for veterinary products.
Furthermore, based on the draft Guidelines, it does not appear to be possible for a patent holder to obtain an extension without approval of the Marketing Authorization holder in China. Although the legal mechanism would be different, the outcome would be similar to the US situation. In contrast, it is in principle possible to obtain an SPC in Europe without consent of Marketing Authorization holder, although recent case-law significantly reduced the possibility.
Overall, the amendments to the Chinese patent law provide great benefits to pharmaceutical innovators that are active in China and allow for a compensation of the significant time required to bring new drugs to the market. GEVERS and its China Desk are happy to provide further information and support your intellectual property position in China and beyond.
Stijn Lagaert – European and Belgian Patent Attorney
Henry Puchu Yang – Patent Engineer