INTRODUCTION Contributed by: Andreas von Falck, Hogan Lovells International LLP
for a chemical drug, it had registered Claim 9 of the patent on the China Patent Information Registration Platform for Listed Pharmaceuticals as required under the Measures. This claim was associated with an originator drug that had been approved by the China National Drug Adminis- tration (CNDA). Subsequently, a pharmaceutical company in Sichuan submitted an application for an MA for a generic drug to the CNDA, using the originator drug as the basis for the generic drug and making a Class 4.1 declaration, which had also been accepted. However, the Swedish company argued that the generic drug in ques- tion fell within the scope of protection of Claim 9 of its patent and requested the court to make a declaratory judgment in this sense. On 18 November 2022, the BJIPC issued a judgment affirming that the technical solution for the allegedly infringing generic drug filed by the Sichuan company fell within the scope of protection of the Claim 9 of the patent. The Sichuan company appealed to the IP Tribu- nal at the SPC, arguing that Claim 9 of the patent concerned a patent for a substance in crystalline form, which, it argued, was explicitly excluded from the scope of pharmaceutical patent linkage cases in China under the Measures. The SPC heard the case and held that Claim 1 of the patent in question indeed seeks protection for a crystalline structure and that Claim 9, on the other hand, related to the specific use of this crystalline structure, rather than the pharmaceu- tical use of the active ingredient compound or the pharmaceutical composition containing the active ingredient. Therefore, the SPC confirmed that the claim registered by the Swedish com- pany indeed concerns a patent concerning a crystalline form which was explicitly not eligible as a legal basis to initiate the litigation in ques-
tion under Article 5 of the Measures and Article 76 of the Patent Law. The SPC confirmed that in pharmaceutical patent linkage disputes, the People’s Courts are required to assess whether the patent in question qualifies as a registrable patent type and is not explicitly excluded under the Measures. Any litigation filed under Article 76(1) of the Patent Law must arise from a dispute regarding the patent rights of a pharmaceutical product for which registration has been sought. If the patent asserted by the parties does not qualify as a registrable patent under the Meas- ures, the People’s Court is obliged to dismiss the case. Based on the foregoing analysis, the SPC ultimately rejected the civil ligation brought by the Swedish company. This case serves as a reminder to pharmaceu- tical patent holders that not all chemical drug patents are eligible for inclusion in China’s pat- ent linkage system under the Measures. Notably, patents related to intermediates, metabolites, crystalline forms, preparation methods, test- ing methods, and other such areas are explic- itly excluded. Therefore, such patents should undergo thorough analysis and evaluation before being registered on the platform, particularly before initiating any infringement litigation. Determination of acceptable claim amendments in patent invalidation proceedings In April 2024, the SPC announced its list of the top ten most influential IP cases in China for 2023. The only patent case selected was an administrative patent invalidation case in which the SPC ruled that, in patent invalidation proce- dures, the extent of claim amendments must not exceed (i) the scope of information disclosed in the original patent document, or (ii) the original patent’s scope of protection. The determination of whether a claim amendment constitutes a
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