Prosecuting Bioinformatics Patent Applications in Europe

This article discusses challenges in prosecuting bioinformatics patent applications before the European Patent Office (EPO). The EPO determines the subject-matter eligibility of bioinformatics patent applications under Articles 52 and 56 of the European Patent Convention. Article 52 governs what is considered patent eligible subject matter.[1] Article 56 governs whether a bioinformatics patent claim involves an inventive step.[2] While Article 56 is not directly related to eligible subject matter determinations, the EPO uses this Article to screen bioinformatics patent application for eligible subject matter issues. Four points of concern and consideration related to the subject-matter eligibility of bioinformatics patent applications in Europe are discussed below.

First, under Article 52, the EPO may incorrectly reject a bioinformatics patent claim as being directed to (1) discoveries, scientific theories, and mathematical methods, or (2) schemes, rules and methods for performing mental acts, playing games or doing business, and programs for computers.[3] One way patent applicants can argue that a bioinformatics patent claim is not directed to either category is to explicitly recite a computer or physical step (e.g., tying bioinformatics method claim to specific technical equipment) to support technical character in the claim.

Second, under Article 56, the EPO may overlook a technical purpose of a bioinformatics patent claim. In response, patent applicants can argue that the technical purpose is the biological rationale for performing the bioinformatics analysis. For example, the biological rationale can be related to diagnosing a disease or assessing a particular physical property. Patent applicants should be cognizant that issues may arise when arguing that the features fundamental to solving the biological problem (e.g., aligning gene sequences) are the biological rationale. This is because such features may not be considered by the EPO to sufficiently provide the requisite biological rationale.

Third, under Article 56, the EPO may incorrectly reject a bioinformatics patent claim because the claim does not have a sufficient number of claim features that contribute to the claim’s biological rationale. This can occur when the EPO incorrectly excludes claim features as part of the inventive step analysis. For example, the EPO can exclude claim features that (1) do not serve the biological rationale, (2) are not functionally limited to the biological rationale, (3) are defined at a high level of generality, and (4) are not considered technical by the EPO, such as presentation of information, conceptual aspects of software design and development, and/or mathematical algorithms. Patent applicants can rebut the EPO’s exclusions by explicitly reciting features (with an appropriate level of detail) that define how the biological rationale is achieved.

Fourth, the EPO 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 EPO may not distinguish between diagnostic claims where all technical steps are practiced on a human or animal body (which are generally considered patent ineligible)[4] and claims where a portion of the technical steps are not practiced on a human or animal body (which are generally considered patent eligible). One way patent applicants can argue that a claim is directed to a patent eligible diagnostic method is to recite a technical step that is, for example, performed in vitro. Patent applicants should be cognizant of reciting an in vitro step in claims because of potential infringement issues, especially for bioinformatics patent applications having clinical applications.

[1] Article 52 EPC, www.epo.org/law-practice/legal-texts/html/epc/2016/e/ar52.html
[2] Article 56 EPC, www.epo.org/law-practice/legal-texts/html/epc/2016/e/ar56.html
[3] Article 52(2) EPC, www.epo.org/law-practice/legal-texts/html/epc/2016/e/ar52.html
[4] EPO Guidance G01/04

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