On April 30 2025, the Beijing Intellectual Property Court (BIPC) released its annual report on exemplary intellectual property cases of 2024, among which there is a noteworthy case concerning the validity of a polymorph patent related to rocuronium bromide. The BIPC, in revoking an invalidation decision made by the CNIPA, seems to develop a nascent assessment approach over the inventive step of a polymorph patent by underlining the successful marketing of the pharmaceutical crystal, marking a deviation from precedents.

A ‘combination formulation’ refers to a pharmaceutical formulation containing two or more active ingredients. Leveraging synergistic effects, a combination formulation often exhibits better efficacy and fewer adverse reactions than single-component drugs. The inventive step assessment of a combination formulation has been closely watched by practitioners in the pharmaceutical industry. A recent invalidation decision – No. 580332, made by the CNIPA on September 30 2024 – provides some guidance in this regard.

Throughout 2024, China’s patent litigation remained active. The IP Tribunal of the Supreme People’s Court (SPC) has issued decisions providing further guidance on damages calculation in the SEP/FRAND and life sciences sectors. The SPC has also leveraged pertinent decisions outlining the liabilities of patentees acting in bad faith. These decisions showcase the current juridical practice of Chinese courts relating to the said issues, yet it remains to be seen how the jurisprudence will evolve in 2025.

On August 13 2024, the Re-examination and Invalidation Department (previously known as the Patent Re-examination Board) of the CNIPA published the Compilation of Synopses of Exemplary Patent Re-examination and Invalidation Cases in 2023.

In April 2024, China’s Supreme People's Court (SPC), acting as court of appeal, sided with the Beijing Intellectual Property Court (BIPC) in affirming the inventiveness of an enzalutamide compound patent. The SPC overturned an invalidation decision made by the CNIPA on November 5 2018, backing the invalidation action initiated by a Chinese rival, Shanghai Fosun Shinotech Pharmaceutical Co., Ltd., in 2018.

In May 2024, China Judgements Online – the official online database of court judgments – published three Supreme People’s Court decisions (in which it was acting as a court of appeal) in three parallel proceedings involving pharma giant Sanofi’s patents for teriflunomide (brand name Aubagio).

The integration of AI in drug discovery, particularly in the screening of drug compounds, ushers in seismic change to the pharmaceutical industry. AI technologies, especially machine learning and deep learning, have revolutionised how new drugs are identified and developed. The development of AI-driven algorithms fuels drug discovery from detecting and prioritising disease targets, identifying potential drug candidates within large chemical libraries, predicting molecular behaviour, to simulating clinical trial outcomes, which drastically shortens the process and brings down the costs.

The non-obviousness of a claimed invention to persons skilled in the art hinges on whether the prior art provides motivation for applying the distinguishing features of the invention to the closest prior art so as to solve the actual technical problem to be solved. If the technical problems actually solved by the invention are over-generalised, it will fail to identify the accurate improvement of the invention relative to the prior art, thus leading to an erroneous conclusion of obviousness.

Since non-obviousness of the invention is benchmarked against the closest prior art and the technical problem actually solved by the invention, should the technical problem be defined in an overly broad or narrow fashion – in particular, if it incorporates the distinguishing features of the invention or the guidance thereof – the assessment risks being subject to ‘hindsight bias’ and thus leads to a presumption of obviousness.