GERMANY TRENDS AND DEVELOPMENTS Contributed by: Dr. Peter Klusmann, Gregor König, Dr. Dirk Schüßler-Langeheine and Dr. Lasse Christian Weinmann, Hoffmann Eitle
The German FCJ on a Reasonable Expectation of Success – Good Times for Patentees? In the past decade, the concept of a reason - able expectation of success has gained con - siderable relevance for patent litigation in Ger - many. According to the established case law of the German Federal Court of Justice (FCJ), in assessing whether it would have been obvious from the prior art to solve a technical problem in a particular way, it may be relevant whether this would have been associated with a reason - able expectation of success, which is generally similar to the EPO’s Boards of Appeal case law. However, the FCJ’s specific approach is different from that of the EPO, as it is performed for each individual step on the skilled person’s path to the invention, rather than assessing the outcome, ie, the claimed invention directly (as at the EPO). In 2023 and 2024, the FCJ further refined this case law. In particular, in its decisions X ZR 77/23 - “Testosterone ester”, FCJ X ZR 83/21 – “Sorafenib tosylate”, and “X ZR 92/23 - “Mirabe - gron”, the FCJ denied such a reasonable expec - tation of success and held that the claims were inventive. These decisions have already impact - ed German and UPC patent litigation practice, particularly in the field of pharmaceuticals and their medical uses. The framework of the earlier FCJ case law In its earlier case law, the FCJ had already established the basic criteria for assessing a reasonable expectation of success. Accord - ing to these criteria, the courts shall determine, with due regard to the technical field in question, the extent of incentives for the skilled person, the effort required for adopting and pursuing a particular approach, and the alternatives in question, if applicable, as well as their respec - tive advantages and disadvantages (eg, FCJ
X ZR 59/17 - “Fulvestrant”, FCJ X ZR 24/19 - “Phytase”, FCJ X ZR 150/18 - “Pemetrexed II”, and FCJ X ZR 65/18 – “Tadalafil”). After these criteria had been formulated by the FCJ in the Fulvestrant case, they initially proved to be a challenging hurdle for owners of some pharmaceutical formulation and dosing patents because the skilled person was seen to take a stepwise approach on their way from the prior art to the claimed invention. In other words, the reasonable expectation of success only needed to suffice for the next step rather than for the claimed subject matter as under the EPO’s prob - lem-solution approach. In the Fulvestrant case, the FCJ specifically asked whether the skilled person would have had a reasonable expectation of success in per - forming animal experiments as the first step to identifying the claimed pharmaceutical formula - tion. The FCJ held that a reasonable expectation of success, and hence obviousness, can already result from the skilled person’s incentive to test the efficacy and tolerability of a formulation in an animal experiment with sufficient predic - tive value for therapeutic use in humans. Thus, according to the FCJ, a claimed teaching may be obvious without requiring or even considering clinical tests. In the Tadalafil case, the FCJ again asked whether the skilled person would have had a reasonable expectation of success to proceed stepwise, ie, to perform each individual step in pre-clinical and clinical development in order to arrive at the (surprisingly) low dosage of tadalafil. The outcome from the first step then provided an incentive to perform the further steps until the claimed subject matter was reached. The fact that the dosage was surprisingly low played no role, contrary to the EPO’s assessment. The
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