Application of EPO G-2/21 (plausibility decision) in the Czech Republic in the apixaban and sacubitril-valsartan decisions

In two of its recent decisions (apixaban and sacubitril-valsartan), the Czech Industrial Property Office (CZ IPO) has considered the application of decision G-2/21 (plausibility) of the Enlarged Board of Appeal of the EPO under Czech law. In both decisions, apixaban (where the decision is final) and sacubitril-valsartan (a first instance decision subject to possible appeal) the CZ IPO has applied G2/21 and allowed post-filed evidence to be used as proof of the technical effects that the patentee could rely on in support of inventive step. In both instances the CZ IPO upheld the validity of the patents in suit. (In the Czech Republic, the CZ IPO alone has the power to revoke patents, albeit subject to judicial review oversight.)

In contrast to the position in some other European jurisdictions, the concept of plausibility has never been a major issue under Czech law. While it could conceptually come into play under the requirement that an invention be described sufficiently clearly and fully so that the skilled person was able to replicate it, the plausibility concept had no clear basis in Czech law. Furthermore, the role of post-filed evidence was viewed as problematic in patent revocation proceedings, despite the fact that it was accepted that a patent applicant could supplement the evidence it relied on in support of the technical effect during the examination phase. In fact, the CZ IPO could demand (under s. 26 of the Czech Patent Act) that the applicant demonstrate the technical effect of a claimed invention (this provision was used to defeat the patenting of purely hypothetical inventions – such as the lone inventor’s favourite, the perpetual motion machine).

With the Czech administrative courts ordering the CZ IPO to take EPC law and its interpretation by the EPO Boards of Appeal into account, the CZ IPO has had to carefully consider the impact of decision G-2/21 in two recent cases, apixaban and sacubitril-valsartan:

In the apixaban decision, patent no. CZ/EP 1 427 415 was challenged for lack of novelty, inventive step, added matter and lack of clarity. The CZ IPO, in a now final decision, when addressing inventive step, found that the apixaban compound was identified as a preferred compound with expected increased effects, and that this satisfied the G2/21 test for the claimed effects to be credibly encompassed in the patent for the skilled person. Consequently, it then looked to post-published evidence to conclude that apixaban was in fact effective. In relation to sufficiency of disclosure, it found that the patent description (without need to resort to post-filed data) enabled the skilled person to carry out the invention.

In the sacubitril-valsartan case, concerning patent no. CZ/EP 1 467 728, the CZ IPO, after rejecting the lack of novelty and added matter objections, considered sufficiency of disclosure and lack of inventive step. In its decision, the CZ IPO stressed that in the case of a claim to a pharmaceutical composition, in contrast to a medical use claim, to satisfy the requirements of sufficiency of disclosure, no increased level of disclosure was required; the fact that the skilled person could carry out the invention was sufficient, unless there were strong doubts that the claimed effects existed - which was found not to be the case here. The question of whether a technical effect was achieved was therefore not relevant to the assessment of sufficiency but instead was a matter for consideration under inventive step. On inventive step, the CZ IPO carefully considered whether the patentee could rely on post-filed evidence of the increased effects of sacubitril-valsartan compared to valsartan alone. Applying the test set out in G2/21, it found that that this technical effect was encompassed by the technical teaching, and embodied in the same invention, as originally disclosed in the application. Consequently, the post-filed data could be admitted and taken into account when formulating the relevant objective technical problem for the purposes of assessing inventive step. The CZ IPO then considered the cited prior art and found that that the claimed invention was not obvious starting from any of the cited prior art combinations.

It is thus positive to see not only that the CZ IPO is looking to EPO caselaw, but that it is doing so in a diligent and meticulous manner, on par with jurisdictions better known for their historically established patent expertise.