Tips from the First Life Science Patent Ruling of the IP Tribunal of the Supreme Court
• Determination of the objective technical problem requires consideration of both the distinguishing technical feature and technical effects disclosed in the patent description. There is no need to consider whether the technical effects are supported by experimental data.
• Specific and concrete teaching/revelation from the prior art, rather than just general research direction, needs to be considered to avoid hindsight in inventiveness assessment.
On December 6, 2019, the IP tribunal of the Supreme Court issued the 2nd instance judgment on the first bio-tech patent case since its establishment as the appellant court of all technology-related IP proceedings across the country early this year.
The patent application in-suit (No.: 201210057668.0) relates to a method for production of a VH heavy chain-only antibody, filed by Erasmus University Medical Centre Rotterma ("Rotterma"). The application was rejected by CNIPA due to lack of inventiveness over combination of a prior art (which disclosed a camelised VH heavy chain antibody) with common genetic engineering means. The PRB maintained the rejection de. Rotterma appealed to the Beijing IP Court who later reversed the PRB decision.
The Supreme Court upheld Beijing IP Court's decision in that the PRB decision No. 129924 erred in its inventiveness assessment of the patent application in-suit. The Supreme Court held that:
a. In determining the technical problem to be solved by the patent, both the distinguishing technical features and their technical effect that can be achieved as understood by those skilled in the art after reading the content described in the description should be considered. In this case, the court decided that the PRB decision erred in determining the technical problem to be solved by only considering the technical effects supported by experimental data. Moreover, the court ruled that the issue of technical effects supported by experimental data should be considered in assessment of "sufficient disclosure" under Article 26.3 or "supported by the description" under Article 26.4, rather than inventiveness under Article 22.3;
b. It is easy to underestimate the inventiveness of an invention by identifying the technical teaching/revelation given by the prior art solely based on the consistency of research directions or abstract research needs in the field. In order to avoid such kind of hindsight, the technical teaching that could be learned by those skilled in the art from the prior art should in principle be specific and includes clear technical means, rather than just abstract ideas or general research directions. In this case, the court held that even though there was a general need in the field to reduce the immunogenicity of antibodies and improve the therapeutic effect by using human-derived gene fragment to produce antibodies, the patent has inventiveness because it overcomes the recognition that natural human VH heavy chain antibodies would aggregate or adhere in replacing the "camelized V gene fragment" with "human-derived V gene fragment" and obtains a new human-derived monoclonal antibody with better water solubility.
Strategic takeaways for patent owners in the life sciences field
1. In response to inventiveness attacks, patent owners could consider:
- arguing that the technical problem to be solved by the patent in-suit is determined by distinguishing technical feature(s) over the prior art and its technical effect as described in description, with or without support of experimental data;
- presenting evidence to prove that prior to the filing date, there was specific difficulty for the person skilled in the art to be motivated to explore the distinguishing technical feature(s) to obtain technical effect(s); and
- arguing that the patent in-suit has inventiveness over the prior art because of advantageous technical effect described in the description, with or without support of experimental data.
2. If the patent does not disclose experimental data and was attacked on only an inventiveness ground, patent owners could consider arguing that the issue of whether experimental data is needed should be assessed under the sufficient disclosure ground or support ground, rather than under the current inventiveness assessment. In this manner, the patent owner could get a higher chance to maintain the patent.