NETHERLANDS Trends and Developments Contributed by: Rutger Kleemans, Jelle Drok, Ruben Laddé and Allard van Duijn, Freshfields
proceedings, as the technical effect on which BMS based the inventive step had not been made plausible in the patent application. The Court therefore rejected the preliminary injunc- tion, and paved the way for generic apixaban in the Netherlands. After the EBA decision G2/21 in March 2023, BMS took the opportunity to file a new prelimi- nary injunction in the hope of obtaining a differ- ent ruling. The main question was whether BMS could rely on the improved (unexpected) tech- nical effect of factor Xa inhibition by apixaban, specifically in light of the EBA decision G2/21. However, the Court did not rule differently and stated that the EBA decision G2/21 does not change the position regarding the rejection of post-published evidence. BMS appealed to the Dutch Court of Appeal and on 30 October 2024 it ruled that post-pub- lished evidence could be taken into account when assessing the inventive step. This deci- sion follows the EBA’s G2/21 guidance. Inventive step is usually evaluated on the basis of EPO’s problem-solution approach (PSA): whether the solution presented to the problem in the patent application is obvious or not to the person skilled in the art. The Dutch Court assessed the PSA to determine inventive step, as explained in EBA decision G2/21: • identifying the “closest prior art”; • comparing the subject-matter of the claim at issue with the disclosure of the closest prior art and identifying the difference(s) between both; • determining the technical effect(s) or result(s) achieved by and linked to these difference(s); • defining the technical problem to be solved as the object of the invention to achieve these effect(s) or result(s); and
• examining whether or not a skilled person, having regard to the state of the art within the meaning of Article 54(2) EPC, would have suggested the claimed technical features in order to obtain the results achieved by the claimed invention. Teva and Sandoz argued that BMS could not rely on the technical effect, since the skilled person would allegedly not derive the effect from the application, and therefore it was not made plau- sible. Based on its interpretation of G2/21, the Court did not agree. The Court recalls the EBA decision in G2/21: “the patentee 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.” There is no obligation that the patent applica- tion must always prove or make plausible that the claimed technical effect actually occurs, eg,. that the patent application contains test results or other evidence, nor is it required that the application explicitly mentions the technical effect that is relied on. If the G2/21 test is met, the patentee may still present evidence during the examination that the alleged technical effect actually occurs. This means post-published evi- dence can be taken into account if the techni- cal effect is derivable for the skilled person from the patent application and is part of its overall technical teaching. Note that earlier in 2024, the Court of Appeal of The Hague decided that post- published evidence may be rejected if the tech- nical effect is not derivable from the application (Galenicum v Insud Pharma).
376 CHAMBERS.COM
Powered by FlippingBook