G 2/21 – Follow-up on “encompassed by the technical teaching and embodied by the same originally disclosed invention”
As set forth in our previous post on admissibility of post-published evidence according to G?2/21, a “patent applicant or proprietor may rely upon a technical effect for inventive step if the skilled person, having the common general knowledge in mind, and based on the application as originally filed, would derive said effect as being encompassed by the technical teaching and embodied by the same originally disclosed invention.”
In the meantime, some Board of Appeal decisions have been issued, which apply the guidance of G?2/21 regarding the above requirement:
T?116/18; T?873/21; T?1329/21; and T?2465/19 (technical effect could be taken into account); and
T?258/21 (technical effect could not be taken into account).
The case underlying G?2/21 (T?116/18) was quite straight forward, since the claimed effect was a synergistic interaction of two compounds and this “synergistic effect” was explicitly mentioned in the original application, which also explained what synergistic means (in accordance with common understanding): “… can produce a greater effect than would be expected when both of the compounds individually are applied solely”. Hence, the proprietor was allowed to rely on post-published evidence.
In the original application underlying T?873/21, no synergistic effect was explicitly mentioned. The original application merely referred to an “improved” effect of the combination therapy when “monotherapy with one or more dopamine receptor agonist is insufficient ” (Reasons, 3.3.2). The Board also acknowledged that the claimed compounds clearly were the preferred combination of compounds (Reasons, 3.3.3). On this basis, the objective technical problem was formulated as the “provision of?a?further?combination?of?active?agents containing?compound?(B) for use in the treatment of EMS, equine PPID and/or laminitis?in?an?equine?animal?which?provides?a synergistic effect on insulin resistance”.
We would like to note that when two compounds provide better therapy than one compound, this does not necessarily mean that there is a synergistic effect, i.e. an effect which is more than “additive effect”. For example, the “Highest Single Agent”-approach for defining synergism requires that the combination is better than the highest single agent effect (whereas in the present case we only know the insufficiency of the dopamine receptor agonist but not of the other agent, i.e. we do not know the highest single agent effect). A useful review of Duarte et al. on synergistic effects can be found here: https://www.sciencedirect.com/science/article/pii/S259025712200030X. What is also quite surprising in T?873/21 is that the Board stated that a synergistic effect was “encompassed” by the original teaching since it was clearly the preferred combination of compounds in the original application. However, the fact that two compounds represent the preferred combination does not mean that they have a synergistic action.
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In any case, there was some basis in the original application underlying T?873/21 which allowed formulating an improvement vis-à-vis the prior art.
However, what still remains to be seen is how the case law will evolve regarding the question to which extent any effects which are disclosed in the original application may be used as the basis for a non-mentioned more specific technical effect. In the case of T?873/21, the generic disclosure of a "combined effect" of two compounds was seen as the basis for the more specific "synergistic effect" which may have not yet been know at the filing date.
Furthermore, the inclusion of a high number of speculative effects into a patent application (based on educated guessing) might provide a basis for identifying the "real effect" later which can then be supported by post-published evidence in line with G 2/21.
Whether this approach will impact the strength of a later granted patent in infringement actions will have to be seen.
Stay posted!
Dr. Thomas Sonnenhauser