Key points
- Claim 1 is directed to: " 1. [vortioxetine] for use in the long-term treatment of depression or anxiety in a patient who has previously received medication for the treatment of said disease which medication was ceased due to weight gain related adverse events, wherein long-term treatment refers to a treatment period above 12 weeks."
- The question is whether the feature in italics can provide for novelty, i.e. whether it specifies a valid second medical use under Art. 54(5) EPC. More in particular, whether the feature defines a patient group.
- The Board: " The indication that the previous treatment was stopped due to weight gain related adverse events establishes the fact that the group of patients under consideration is known to develop weight gain related side-effects when administered medication active in the treatment of depression or anxiety. The development of certain side-effects reflects a certain physiological and/or pathological status of the patients concerned. The development of these side-effects during treatment for depression or anxiety creates a link between the patients, their physiological and/or pathological status, and the therapeutic treatment. The patient group under consideration is thus a technical feature of the claims."
- As to inventive step, D7 " describes weight gain as a common adverse effect of psychotropic drugs (abstract). In the concluding passages, it states that medication should be switched to another drug if weight increase due to a psychotropic drug cannot be stopped or reversed by measures relating to proper nutrition and eating habits, physical exercise and behaviour modification "
- " The difference between the subject-matter of claims 1 and 3 as granted and the disclosure of document (7) is the use of vortioxetine as the switch drug."
- " In view of the disclosure of document (7) []and the objective technical problem, it is clear that the person skilled in the art would have avoided the administration of any psychotropic drug for which long-term weight gain related side-effects had not been excluded. They would also have avoided any treatment potentially worsening the overall physiological condition of the patient, or, when leading to non-compliance, worsening the underlying psychiatric condition and potentially leading to relapse, hospitalisation or even fatal consequences. "
- " In summary, the person skilled in the art would have needed to count on success or, put differently, have a strong expectation of success. Any treatment undertaken with a mere hope to succeed, in the present case a treatment where short-term side-effects had been excluded but nothing was known on long-term side-effects, would not have been envisaged by the person skilled in the art."
- " Consequently, since no information on long-term weight gain related side-effects was known for vortioxetine, the person skilled in the art would not have considered vortioxetine for solving the technical problem stated above, and thus would not have arrived at the claimed subject-matter."
EPO T 2344/19
The link to the decision is provided after the jump, as well as (an extract of) the text of the decision.
source http://justpatentlaw.blogspot.com/2022/07/t-234419-weight-gain-related-adverse.html
