GERMANY TRENDS AND DEVELOPMENTS Contributed by: Dr. Peter Klusmann, Gregor König, Dr. Dirk Schüßler-Langeheine and Dr. Lasse Christian Weinmann, Hoffmann Eitle
or art was found to have justified an increased likelihood of success that there must be some form of sorafenib suitable for oral administra- tion, this did not provide a sufficient guarantee that the tosylate salt would belong to “the group of the investigated substances” (the sorafenib forms to be tested for oral administration suit- ability). In other words, it was not “obvious to try” testing the suitability of the tosylate since there was no reasonable expectation of success to justify considering this compound as a possible candidate. In the Mirabegron case, the FCJ acknowledged an inventive step for a second medical use of mirabegron in the treatment of overactive blad - der. In the prior art, mirabegron had been known to be a selective β3-adrenoceptor agonist and had been suggested for use in, eg, prevent - ing obesity and hyperglycaemia. It has also been known that an active ingredient having β3-adrenoceptor agonist properties can cause alleviation of the symptoms associated with an overactive bladder. The FCJ found the definition of the technical problem crucial, dismissing the lower court’s definition (“finding new fields of use or indications for mirabegron”) as containing ele - ments of the solution. The FCJ confirmed its ear - lier case law (eg, FCJ X ZR 41/13 – “Quetiapin”) that the technical problem must be formulated in such a general and neutral manner that the question of what suggestions the skilled person obtained from the prior art in this respect only arises when assessing obviousness. Regardless of the starting point in the prior art (ie, on the one hand, the effect of β3-adrenoceptor agonists on overactive bladder symptoms or, on the other hand, the use of mirabegron for the treatment of other diseases), the FCJ saw the problem as “providing an effective remedy for the treatment of an overactive bladder”. The claimed solution was not obvious. The FCJ reasoned that while it
may have seemed possible in the prior art that mirabegron could have the properties necessary for preventing and treating overactive bladder, there was no sufficient expectation of success in this regard, especially given the complexity shown in tests with other substances. Although many β3-adrenoceptor agonists were known in the art, this also could not establish a sufficient expectation of success, for it was known that not every one of these substances is equally suit - able for the treatment of bladder dysfunctions and that a high β3-adrenoceptor selectivity was a necessary, but not a sufficient condition in this respect. The claimed second medical use was thus found to be non-obvious. A patent-friendly trend? While the recent FCJ case law seems promis - ing for patent owners, this may not necessar - ily be a new trend in the sense of a departure from the previous case law. Rather, the FCJ has further supplemented its existing case law with individual cases in which applying the previously developed criteria has resulted in a finding of inventive step. In particular, the FCJ’s reasoning in the Pem - etrexed II, Testosterone ester and Mirabegron cases provides concrete examples of situations in which the balancing of the criteria for a rea - sonable expectation of success, including, eg, the incentives and the required effort, led to a favourable outcome for the patentees. Patent owners may look for similar arguments for their own cases. It may be helpful, for instance, to demonstrate that the skilled person needed to deviate from a previous path and/or that a con - siderable and unnecessary effort for the skilled person outweighs a small incentive.
107 CHAMBERS.COM
Powered by FlippingBook