Key points
- Claim 1 is, arguably, a second medical use claim and reads: “"1. A pharmaceutical combination for use in the prevention, alleviation or/and treatment of epileptic seizures, which comprises a separate dosage form comprising (a) a first composition comprising lacosamide and (b) a second composition comprising levetiracetam, wherein the compositions (a) and (b) are provided in distinct preparations (separate dosage forms), which are administered simultaneously and/or subsequently, wherein said separate dosage forms are co-presented in separate packaging, or are separately packaged and available for sale independently of one another, but are co-marketed or co-promoted for simultaneous and/or subsequent administration."
- “D2 discloses a pharmaceutical combination for use in the treatment of epileptic seizures which comprises a separate dosage form comprising (a) a first composition comprising LCM and (b) a second composition comprising LVT, where the compositions (a) and (b) are provided in distinct preparations, i.e. packaged separately, and administered simultaneously and/or subsequently.”
- “Regarding the feature in claim 1 that the actives are available for sale independently of one another but are co-marketed or co-promoted for simultaneous and/or subsequent administration, the board notes the following. The effective treatment of epileptic seizures according to both claim 1 and D2 is achieved by the simultaneous and/or subsequent administration of the separate dosage forms of LCM and LVT. The fact that these dosage forms are available for sale independently of one another but co-marketed or co-promoted for simultaneous or subsequent administration does not render the therapeutic treatment in claim 1 different from that in D2. In both cases, the therapeutic effect is the same, it is achieved on patients having the same physiologic and pathologic state, using the same combination of active ingredients, administered by the same route and with the same dosage regime. In other words, claim 1 and D2 relate to an identical clinical situation which is treated with the same therapeutic measures. Therefore, claim 1 does not define a new specific use within the meaning of Article 54(5) EPC.”
- As a comment, one may ask if “re co-marketed or co-promoted for simultaneous and/or subsequent administration” is a technical feature at all.
EPO - T 2056/17 -
Link to the decision after the jump, as well as an extract of the decision text.
source http://justpatentlaw.blogspot.com/2022/02/t-205617-co-marketing-as-2nd-medical-use.html
