GERMANY Trends and Developments Contributed by: Peter Klusmann, Gregor König, Dirk Schüßler-Langeheine and Lasse Christian Weinmann, HOFFMANN EITLE
bodies against PCSK9. In that case, the first instance CD Munich had closely followed the Nanostring v 10x Genomics approach in the UPC CoA Grabinski pan ‑ el and revoked Amgen’s patent, with the reasoning closely aligned with the recent German Federal Court of Justice case law on inventive step. In the appeal decision, the Kalden CoA panel also assesses the next step, as in the first instance and in Nanostring , but appears to modify this approach by incorporating elements of older EPO case law. Historically, the concept of the reasonable expectation of success was introduced by earlier decisions of the EPO’s Boards of Appeal, such as T 2/83 and T 149/93, and further developed by numerous subsequent deci ‑ sions of the EPO. The concept was eventually adopt ‑ ed by the German courts, albeit in a modified way, ie, less focused on arriving at the claimed solution and its distinguishing effects over the starting point, and more on the next step the skilled person would perform. If there are multiple steps, the outcomes of previous steps can serve as incentives. In the Nanostring v 10x Genomics case (UPC CoA 335/2023) relating to provisional measures, the UPC CoA held that “problems that regularly arise” in the technical field at issue would not have prevented a skilled person from carrying out the relevant tests (page 33). This approach of the CoA is consistent with the notion that, in accordance with EPO and German practice, certainty of success is not required. However, in the Sanofi v Amgen case, reasonable expectation of success seems to be moving more in the direction of certainty for the therapeutic effect:“ A reasonable expectation of success implies the abil- ity of the skilled person to predict rationally, on the basis of scientific appraisal of the known facts before a research project was started, the successful con - clusion of that project within acceptable time limits ” (headnote 19). The Central Division Munich (UPC 1/2023) followed the Nanostring approach specifically in that “In the present case, the Defendant has not put forward any (technical) problems that the person skilled in the art would not have been able to overcome on the basis of their common general knowledge at the relevant
date. The uncertainties raised by the Defendant would not have prevented the skilled person from taking the obvious next step, ie, developing PCSK9/LDLR- inhibiting antibodies to treat hypercholesterolemia and related disorders, due to insufficient prospects of success (CoA in NanoString/10x Genomics , page 36, second paragraph). The UPC CoA set aside the first–instance revoca ‑ tion of Amgen’s patent and maintained the patent as granted. The CoA focused on the therapeutic effect described in the claim. To meet this requirement, the treatment must produce a noticeable improvement in patients’ medical condition – in other words, it must have a genuine therapeutic benefit. When assessing what the object of the invention is byestablishing what the invention adds to the state of the art, the CoA looks at the overall inventive concept rather than the individual distinguishing features of the claim. The CoA confirms the general rule, that a claimed solution must be considered obvious when the skilled person would take the next step prompted by the pointer or as a matter of routine, and arrive at the claimed invention and in expectation of finding an envisaged solution of his technical problem but finds that this is generally the case when the results of the next step were clearly predictable, or where there was a reasonable expectation of success (headnote 17). The CoA appears to suggest two alternative paths to obviousness: clear predictability or a reasonable expectation of success. However, the CoA in head ‑ note 19 defines the reasonable expectation of success as rational predictability:“ A reasonable expectation of success implies the ability of the skilled person to pre- dict rationally, on the basis of scientific appraisal of the known facts before a research project was started, the successful conclusion of that project within accept - able time limits ”. Applying this concept to the facts and specifically to the obviousness of the therapeutic effect defined by the CoA as “a noticeable improvement of the medi ‑ cal condition of the patient suffering from the disease mentioned in the claim”, the CoA concludes that the skilled person at any rate required, but failed to have a sufficient indication that the extracellular pathway
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