CABINET CHAILLOT

Appeal decision T0096/20

Inventive step

"1. An inhibitor of human complement component C5 for use in treating myasthenia gravis (MG) in a human, wherein the inhibitor is an anti-C5 antibody." One example of such compounds is eculizumab
Actual therapies for treatment of MG in humans, such as therapies with immunosuppressants including prednisone, methotrexate, cyclosporine and cyclophosphamide, disclosed in document D4 (page 1), represent the closest prior art.
The claimed subject-matter differs from the known MG therapies in humans in that the therapeutic is an inhibitor of human complement component C5, wherein the inhibitor is an anti-C5 antibody ("C5 antibody").
The application does not attribute a particular technical effect to the claimed therapeutic in the claimed use, which goes beyond the technical effect of the known MG therapies. The objective technical problem can thus be formulated as the provision of an alternative treatment of MG in humans. This has not been contested by the appellant.
Document D4 discloses a protocol of a safety and efficacy clinical trial of eculizumab in patients with refractory generalised MG. The results of this clinical trial are not disclosed. Thus, document D4 proposes the antibody eculizumab (an inhibitory C5 antibody) as an alternative therapeutic for refractory generalised MG in humans.
The announcement of a detailed safety and efficacy clinical trial protocol for a particular therapeutic and disease provided the skilled person with a reasonable expectation of the success of this particular therapeutic, unless there was evidence to the contrary in the state of the art.
No inventive step.

Decision here

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