GERMANY Trends and Developments Contributed by: Peter Klusmann, Gregor König, Dirk Schüßler-Langeheine and Lasse Christian Weinmann, HOFFMANN EITLE
For Germany, the court found infringement at least by equivalence. The court rejected the defendants’ pros ‑ ecution–history–based arguments, finding that there was no effective disclaimer of the accused buffer. The court also addressed cross–border infringement for 19 additional countries and concluded that each of the examined legal systems would likely treat FYB203 as an equivalent infringement. The court stressed that effective and timely enforcement of patent rights is an important policy goal, especially in cross–border pharma cases. Assessment of arbitrary features by the German FCJ and the UPC In its decision X ZR 50/23 – “ Hohlfaserdialysator ” (hol ‑ low-fibre dialyser), the German FCJ has further refined its case law, according to which inventive step in the case of selection inventions can only be based on features for which the selection is not arbitrary. The disputed patent concerned the technical problem of designing a hollow-fiber dialyzer that achieves uni ‑ form dialysate flow through the fiber bundle. Claim 1 pertained to a filter apparatus, such as a hollow fiber dialyzer for hemodialysis, containing a cylindrical filter housing. The filter apparatus was inter alia charac ‑ terised by a feature defining that the fibre occupancy in the cylindrical filter housing amounts to 60.5% to 70% (feature 4). As document D4, which was used as a starting point for the assessment of inventive step, did not disclose feature 4, the FCJ assessed whether this feature was evident from the prior art. In this context, the court cited its earlier case law and stated that an inventive step cannot be based on a feature that represents an arbitrary selection of several possibilities detached from a specific techni ‑ cal purpose or a specific technical effect (FCJ X ZR 56/03 – “ Injizierbarer Mikroschaum ”; FCJ X ZR 51/21 – “ Schlossgehäuse ” and others), provided that there is no apparent reason for this selection and it proves to be arbitrary in this respect. This applies even if a narrower selection from a known wider range of pos ‑ sibilities is claimed (FCJ X ZR 7/00 – “ Blasenfreie Gummibahn I ”). According to the FCJ, a feature is not arbitrary if it is associated with a technical principle or
mechanism of action (“ technisches Wirkprinzip ”) that produces significant advantages, improvements, or alternatives. These must be disclosed in the patent specification or at least be recognisable to the skilled person based on their common general knowledge (as stipulated in eg, FCJ X ZR 51/21 – “ Schlossgehäuse ”). Thus, in the present case, the FCJ first examined the technical effect of feature 4 (the claimed fibre cover ‑ ing). According to the description of the patent in suit, a fibre occupancy within the claimed range ensured that the dialysate also reached the interior of the fibre bundle during dialysis. The FCJ therefore concluded that feature 4 had a technical effect which could, in principle, result in the affirmation of an inventive step. Nonetheless, the FCJ found that in the case at issue, the claimed invention was obvious from the prior art. To assess obviousness, the court examined whether the prior art provided incentives to arrive at a value within the range defined by feature 4. In this regard, the court considered that it followed from other prior art documents, D6 as well as D9 and D1, that a high a fibre occupancy up to a certain upper limit offers advantages, and that the range specified in feature 4 is at the upper end of the range disclosed in D6 and D1 and only slightly below an upper limit specified in D9. The FCJ therefore held that D6, D9 and D1 provided incentives which made it obvious to select a value within the claimed range defined by feature 4. Although the FCJ and the EPO agree that arbitrary features cannot be used to establish inventive step, their approaches to assessing inventive step remain fundamentally different. This becomes particularly apparent when a feature is not arbitrary but is asso ‑ ciated with an advantageous or surprising technical effect. While the FCJ, like the EPO, requires that a feature is associated with a technical principle or mechanism of action that produces significant (eg, surprising) advantages, improvements or alternatives, the FCJ uses such technical effects merely as a deciding fac ‑ tor to assess whether or not a feature must be taken into account (at all) for the assessment of inventive step. Unlike at the EPO, where surprising technical
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