China Pharma Update - Draft Patent Examination Guidelines contain proposals on Patent Linkage Invalidation, Patent Term Extension and Patent Term Adjustment
On 3 August 2021, the China National Intellectual Property Administration (“CNIPA”) published the draft amendments to the Patent Examination Guidelines (the “2021 Draft Amendments”) for public consultation until 22 September 2021. The 2021 Draft Amendments are comprehensive and contain provisions addressing the amendments contained in the new Patent Law (2021) and its draft Implementing Regulations. This article covers the CNIPA’s proposals on patent linkage invalidation proceedings (“Patent Linkage Invalidation”), patent term extension (“PTE”) and patent term adjustment (“PTA”).
I. Patent Linkage Invalidation
The 2021 Draft Amendments introduce a new type of patent linkage invalidation related to the Patent Linkage Implementing Measures (for more information about the Measures, please see Bird & Bird article - News flash - Patent Linkage Implementing Measures came into force in China on 4 July 2021).
1. Definition
A Patent Linkage Invalidation refers to the patent invalidation petition filed by a generic drug market authorization (“MA”) applicant against a patent registered on the China Marketed Drug Patent Information Registration Platform (the “Patent Platform”), after it has submitted a Category IV certification in accordance with Patent Linkage Implementing Measures.
2. Documentation
To commence a Patent Linkage Invalidation, the Petitioner must indicate in the Petition that the patent in dispute is registered on the Patent Platform and a Category IV certification has been submitted, together with the generic drug MA application acceptance notice and a copy of the certification.
3. Review sequence
If several Patent Linkage Invalidations have been filed by multiple generic MA applicants against the same patent, the CNIPA will review the cases in an order that is based on the petition dates. This differs from the usual practice in normal patent invalidations that the CNIPA will consolidate proceedings for several petitions if…
