Prosecuting Bioinformatics Patent Applications in China

This article discusses challenges in prosecuting bioinformatics patent applications before the China National Intellectual Property Administration (CNIPA). The CNIPA determines the subject-matter eligibility of bioinformatics patent applications under Articles 2 and 25 of the Patent Law of the People’s Republic of China. Article 2 requires that a claim involve a set of technical means that adopt laws of nature for solving a technical problem or producing a technical effect (collectively a “technical solution”).[1] Article 25 excludes a claim directed to (1) scientific discoveries, (2) rules and methods for intellectual activities, (3) methods for the diagnosis or treatment of diseases, (4) animal or plant varieties, (5) substances obtained by means of nuclear transformation, and (6) designs mainly directed to marking the pattern, color or the combination of the two of prints.[2] Four points of concern and consideration related to the subject-matter eligibility of bioinformatics patent applications in China are discussed below.

First, under Article 2, the CNIPA may incorrectly reject a bioinformatics patent claim because the claim does not solve a technical problem or produce a technical effect. In response, patent applicants can argue that the technical problem or technical effect is the biological rationale for performing the bioinformatics analysis. For example, the technical effect can be the assessment of a biological entity’s physical property.

Second, under Article 2, the CNIPA may incorrectly reject a bioinformatics patent claim because the claim does not have technical claim features that contribute to solving the technical problem or producing the technical effect. This may occur if the CNIPA incorrectly excluded claim features as being non-technical. Patent applicants can rebut this argument by explicitly reciting features (e.g., aligning gene sequences) that define how the technical problem is solved or the technical effect is produced. Such rebuttal should be argued from the perspective of a person of ordinary skill in the art.

Third, under Article 25, the CNIPA may incorrectly reject a bioinformatics patent claim because the claim involves a diagnostic method. For example, a bioinformatics patent claim may be directed to a method for diagnosing whether a particular genetic variant is benign or pathogenic. But, the CNIPA may fail to distinguish between different types of diagnostic claims. A diagnostic claim (1) practiced on a human or animal body, or (2) where its immediate purpose is to obtain a diagnostic result of a disease or health condition is patent ineligible. On the other hand, a diagnostic claim is patent eligible where a portion of the recited technical steps are not practiced on a human or animal body and its immediate purpose is not to obtain a diagnostic result. One way patent applicants can argue that a claim involving a diagnostic method is patent eligible is to recite a technical step that is, for example, performed in vitro. Patent applicants should be cognizant that reciting an in vitro step may give rise to potential divided infringement issues, especially for bioinformatics patent applications having clinical applications.

Fourth, under Article 25, the CNIPA may incorrectly reject a bioinformatics patent claim because the claim has been mischaracterized as being directed to a diagnostic method. The CNIPA may fail to distinguish between a “true” diagnostic method claim (which is generally considered patent ineligible) and a claim related to a diagnostic method (which is generally considered patent eligible). For example, a claim involving instruments or apparatuses for implementing diagnostic methods or treatment, or substances/materials used in such methods, is patent eligible. Thus, one way patent applicants can argue that a bioinformatics claim related to a diagnostic method is patent eligible is to recite the instruments or apparatuses for implementing the diagnostic method or the substances or materials used in the diagnostic method.

[1] Article 2 of the Patent Law, www.wipo.int/edocs/lexdocs/laws/en/cn/cn028en.pdf
[2] Article 25 of the Patent law, www.wipo.int/edocs/lexdocs/laws/en/cn/cn028en.pdf

This article appeared in the December issue of Global Patent Prosecution.