Supplemental experimental data in Chinese pharmaceutical patent practice: acceptable or not?

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Experimental data is of great importance for pharmaceutical patents. The examination and acceptability of supplemental experimental data in China are analyzed in this article, based on recent judicial interpretation issued by the Supreme People’s Court, the Guidelines for Patent Examination issued by the China National Intellectual Property Administration, as well as influential cases in recent years. It is found that both the CNIPA and the courts hold that supplemental experimental data should be examined and can be accepted if the data meet the requirement of ‘obtainable from the original disclosure’. It is suggested that the acceptability of supplemental experimental data be determined on a factual and factor basis in patent prosecution and judicial review. And it is envisioned that reasonable acceptance of supplemental experimental data would enhance the patent protection of pharmaceuticals and promote innovations in the health industry.