9.21.12 Animal testing and human clinical trials

In T 1493/09 the board found that the skilled person seeking to solve the problem formulated (provision of a broadly effective vaccine against HPV, especially providing broad protection against cervical cancer) would have considered not only formulations for immediate use in human clinical trials but also additional animal testing. It took the view that its assessment according to the problem and solution approach applied for the same reasons to claim 1 of auxiliary request 1 (directed to the second medical use of the vaccine composition and including the therapeutic effect "prevention or treatment of a disorder related to HPV infection" as an explicit feature), and concluded accordingly that it too lacked inventive step. See also T 237/15.

In T 237/15 the invention aimed to provide suitable dosages and dosing schedules of histone deacetylase inhibitors, especially suberoylanilide hydroxamic acid (SAHA), and to develop preferably oral formulations. The technical problem was the provision of a treatment regimen for human patients based on oral administration of SAHA. The board found the skilled person, in the knowledge (disclosed in D2) that SAHA was bioavailable when given orally in animal studies and having been given the information that SAHA achieved effective treatment in humans when introduced directly into the blood stream, would expect an effective treatment also for oral administration in human patients. The determination of the optimum dosage regimen required to achieve the therapeutic effect in the (human) patient was a matter of routine experimentation for the skilled person. The board held such routine tests did not require inventive skill and could consequently not establish an inventive step. See also in this Chapter I.D.9.21.7 "Enhanced effect".