GERMANY TRENDS AND DEVELOPMENTS Contributed by: Dr. Peter Klusmann, Gregor König, Dr. Dirk Schüßler-Langeheine and Dr. Lasse Christian Weinmann, Hoffmann Eitle
FCJ considered that results of clinical trials in the prior art were not required for a reasonable expectation of success. Instead, mere in vitro data were considered sufficient to motivate the skilled person to conduct the next step in the development if there was a reasonable expec - tation of success only for such next step, and the outcome of this step triggered the remaining steps all the way to the claimed invention. Recent developments and the testosterone ester case Following the above decisions (that were unfa - vourable for owners of pharmaceutical dos - ing and formulation patents), the FCJ has now provided (counter-)examples of cases in which medical use or composition claims were found to be inventive. In the Pemetrexed II case, which concerned a combination treatment involving pemetrexed, vitamin B12 and optionally folic acid, the FCJ held that there was no reasonable expectation of success in relation to using vitamin B12, inter alia because, firstly, it would have been necessary for the skilled person to deviate from the previous folic acid-based path of pre-clinical and clinical studies. Secondly, the skilled person would have had to return to an earlier development stage and perform studies for the claimed additional ingredient, vitamin B12, in animals and humans (see rec. 114-118). The FCJ was of the opinion that there was an imbalance between the incen - tive for deviating from the already promising path with only folic acid, on the one hand, and pur - suing the additional effort required for the folic acid/vitamin B12 combination (that would have led to the claimed invention), on the other hand. As a result, the FCJ decided that there was no reasonable expectation of success, so the claimed combination was inventive.
The FCJ decision in the Testosterone ester case seems to expand further on this approach. The claims concerned a composition containing a testosterone ester and a vehicle comprising castor oil in a concentration of 25-45 vol.% and a co-solvent. There were hints in the prior art that the claimed concentration of castor oil would result in an advantageous property of the composition (lower viscosity). At the same time, there was a risk of losing the composition’s long-term depot effect. The FCJ considered that the expected advantage provided only a weak incentive for the skilled person and that a dispro - portionate amount of effort— including clinical studies requiring considerable time and financial resources — would have been needed to iden - tify the effect on the required sustained release. The FCJ thus found that the claims involved an inventive step due to the lack of a reasonable expectation of success. This seems to be generally in line with the Sorafenib tosylate case, where the FCJ acknowl - edged an inventive step for a specific salt of sorafenib (the tosylate salt) in an oral dosage form. The FCJ found sorafenib tosylate as such to be obvious in view of the prior art (disclos - ing sorafenib as an orally effective compound with anti-cancer activity) since the skilled person would have found and identified the usefulness of the tosylate salt in a routine “preformula - tion screen”. The FCJ determined that the salt was inventive when claimed in “an oral dosage form.” This conclusion stemmed from a specific problem related to the salt’s usefulness in this context: both the free base of sorafenib and the tosylate salt exhibited very low solubility. The FCJ thus concluded that the measures routine - ly employed in a pre-formulation screen would not have worked, and it had not been obvious or predictable that non-routine measures would have resulted in a better outcome. While the pri -
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