Key points
- The Board provides some comments regarding inventive step of a second medical use claim, in cases wherein a clinical trial protocol has already been published.
- The Board: “Clinical trials are conventionally based on earlier preclinical studies, and the potential therapeutics tested in clinical trials are duly selected based on experimental data suggesting their success (see e.g. decision T 239/16, point 6.5 of the Reasons). ”
- “Thus, the board considers that 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. In the case in hand, the board holds that no such evidence to the contrary has been brought forward by the appellant.”
- “the board concludes that no evidence is on file calling into question that MG could be treated with eculizumab in humans, as proposed in the phase 2 clinical trial study disclosed in document D4. In view of the above considerations, the board holds that the subject-matter of claim 1 of the main request was obvious to the skilled person.”
- Note, there is recently also some case law suggesting that patent applications pertaining to second medical uses are already plausible if the skilled person has no doubt. (T0033/19, r.5).
T 0096/20 -
https://www.epo.org/law-practice/case-law-appeals/recent/t200096eu1.html
Reasons for the Decision
1. The appeal complies with Articles 106 to 108 and Rule 99 EPC and is admissible.
Inventive step (Article 56 EPC)
Main request and auxiliary request 1 - claim 1
Closest prior art and objective technical problem
2. Claimed is an inhibitor of human complement component C5 for use in treating MG in a human, wherein the inhibitor is an anti-C5 antibody (see section V.). One example of such compounds is eculizumab (see application page 8, line 11).
3. The examining division considered that the protocol of a safety and efficacy clinical trial of eculizumab in patients with refractory generalised MG disclosed in document D4 represented the closest prior art, and formulated the objective technical problem as "the provision of evidence-based medical application of an anti-C5 antibody in human [sic]".
source http://justpatentlaw.blogspot.com/2021/07/t-009620-clinical-trial-document-as.html
