The inferential wording pursuant to the auxiliary requests 1 to 9, which was alternatively defended by the defendant also proves to be invalid on account of lack of inventive step. 1. Patent claim 1 pursuant to auxiliary request 1 differs from patent claim 1 pursuant to main request in that pemetrexed disodium is now administered pursuant to how vitamin B12 or vitamin B12 derivative is administered. However, this additional feature cannot establish the basis of the use of an inventive step as the subject matter of the dispute. The person skilled in the art knew from the studies pursuant to NIK8, NIK16 and HLNK31 that there is a strong correlation between homocysteine level and the serious side effects of pemetrexed treatment (cf. loc. cit in respectively entire Abstract; cf. also HLNK2 p. 106 right column line 17 to 12 from end). With this knowledge, there was no need for inventive activity to lower the homocysteine level before the start of treatment by administering vitamins such as vitamin B12 (see NIK9 and others p. 1276S Abstract last sentence). Rather, the person skilled in the art will consider this measure within the framework of the usual optimisation in medicament development. It can therefore be attributed to their routine work. 2. For the same reason, the additional features in the respective patent claim 1 of auxiliary requests 2 and 3 cannot establish the basis of an inventive step. When used under patent claim 1 pursuant to auxiliary request 2, it is claimed the additional administration of a folic acid binding protein binding agent that, inter alia, is selected from folic acid, is opposite to the use under patent claim 1 of auxiliary request 1. In patent claim 1 of auxiliary request 3, the order of administration has also been determined in such a way that pemetrexed disodium is also applied after administration of the folic acid binding protein binding agent. These features also result in an anticipated way from the NIK8, NIK16 and HLNK31 studies and the expert knowledge of the person skilled in the art in the treatment of elevated homocysteine levels. 3. In patent claim 1 under auxiliary request 4, the order of administration is specified in such a way that vitamin B12 is administered first, followed by the folic acid binding protein binding agent and then pemetrexed disodium. The determination of the order of
The inferential wording pursuant to the auxiliary requests 1 to 9, which was alternatively defended by the defendant also proves to be invalid on account of lack of inventive step. 1. Patent claim 1 pursuant to auxiliary request 1 differs from patent claim 1 pursuant to main request in that pemetrexed disodium is now administered pursuant to how vitamin B12 or vitamin B12 derivative is administered. However, this additional feature cannot establish the basis of the use of an inventive step as the subject matter of the dispute. The person skilled in the art knew from the studies pursuant to NIK8, NIK16 and HLNK31 that there is a strong correlation between homocysteine level and the serious side effects of pemetrexed treatment (cf. loc. cit in respectively entire Abstract; cf. also HLNK2 p. 106 right column line 17 to 12 from end). With this knowledge, there was no need for inventive activity to lower the homocysteine level before the start of treatment by administering vitamins such as vitamin B12 (see NIK9 and others p. 1276S Abstract last sentence). Rather, the person skilled in the art will consider this measure within the framework of the usual optimisation in medicament development. It can therefore be attributed to their routine work. 2. For the same reason, the additional features in the respective patent claim 1 of auxiliary requests 2 and 3 cannot establish the basis of an inventive step. When used under patent claim 1 pursuant to auxiliary request 2, it is claimed the additional administration of a folic acid binding protein binding agent that, inter alia, is selected from folic acid, is opposite to the use under patent claim 1 of auxiliary request 1. In patent claim 1 of auxiliary request 3, the order of administration has also been determined in such a way that pemetrexed disodium is also applied after administration of the folic acid binding protein binding agent. These features also result in an anticipated way from the NIK8, NIK16 and HLNK31 studies and the expert knowledge of the person skilled in the art in the treatment of elevated homocysteine levels. 3. In patent claim 1 under auxiliary request 4, the order of administration is specified in such a way that vitamin B12 is administered first, followed by the folic acid binding protein binding agent and then pemetrexed disodium. The determination of the order of