Patentable subject matter in bioinformatics - USPTO’s January 2019 guidance

In this article, Paul Liu and Ashley Barton from Duane Morris LLP provided some interesting thoughts about ways to obtain US patents in the field of bioinformatics in view of the January 2019 eligible subject matter guidelines from the USPTO. As identified in the article, the new guidelines appear to open interesting ways forward for such inventions, such as by ensuring that the claimed invention is “integrated into a practical application”. This can be achieved for example by including a therapeutic step which is derived from the information acquired through the bioinformatics analysis. Bioinformatics inventions typically include algorithmic or mathematical steps at their core, and such inventions also have to overcome challenges at the EPO. However, these challenges differ from those faced at the USPTO in interesting ways.

In particular, two main hurdles must be overcome at the EPO: (i) subject-matter eligibility, and (ii) inventive step. The first of these can be overcome by reciting at least one technical feature in the claim.  For example, claiming a “ computer implemented” method.  The second hurdle relates to whether a claim includes non-obvious features that produce a technical effect serving a technical purpose. While this at first glance could be considered to be similar to the “ practical application” of the USPTO, there are in fact crucial differences between the two concepts. Indeed, according to the EPO’s current practice, the assessment of a physical property of a biological entity (including in particular the identification of clinically actionable information) is a technical purpose.  This could include, for example, providing a prognosis or predicting whether a patient will respond to a specific treatment.  An active step of putting this information into practice, such as e.g. by treating a patient accordingly, is not necessary for a technical purpose to be established.   In fact, inclusion of a therapeutic step is problematic at the EPO since methods of treatment are excluded from patentability in Europe.

This comes with two pieces of good news, and a word of caution. The good news are that in Europe, it may be possible to obtain claims that: (i) are of significantly broader scope than in the US, and (ii) suffer less from potential issues of divided infringement since the claim can start from the sample and finish with the clinically actionable information, focussing on the analysis part that is more likely to be performed by one and the same entity. The word of caution is that in order to obtain a broad claim, basis in the application as filed for such a claim must be present that meets the EPO’s high standard in relation to added-matter. In other words, if an application has been drafted with a practical application (e.g. therapy) as an integral (non-optional) part of the invention, then it may be difficult to craft a claim that would be allowable in Europe without either adding matter or including excluded subject-matter.

In conclusion, we would encourage applicants in the field to think about Europe as a potentially advantageous jurisdiction, and to think about this early on so that applications can be drafted and prosecuted in an optimal fashion.