Key points
- "Claim 1 of the main request reads as follows: "Ticagrelor for use in a treatment of Acute Coronary Syndrome or myocardial infarction, in combination with acetyl salicylic acid and a computer program product comprising instructions causing a computer to perform a method comprising the steps - providing a patient with a set of questions according to a question schedule, ... providing said feedback information to the patient"
- The Board: "The subject-matter of claim 1 of the main request differs from D3 in that it further includes an interactive computer program."
- As a comment, apparently, a second medical use claim can validly recite a computer program.
- Note that a second medical use claim directed to a medical device is not permitted.
- I acknowledge that the claim at issue is of the kit-of-parts type second medical use claim. "In T 9/81 [25.01.1983] the board held that combined preparations, the individual components of which represented known therapeutic agents, might be protected in a formulation corresponding to Art. 54(5) EPC 1973 (now Art. 54(4) EPC) even when claimed as a kit-of-parts, [provided that] those components formed a functional unity (true combination [)] through a purpose-directed application. " CLBA 9th ed. I.C.7.1.3. (note, these claims were a kind of second-medical use claims avant la lettre (G 1/83 being issued 05.12.1984). However, the Board therein required that " the individual components of which represented known therapeutic agents".
- The Board, on inventive step: " It thus has to be assessed whether the computer program according to claim 1 interacts with the technical features of claim 1, namely the combination of ticagrelor and acetylsalicylic acid, to bring about an overall technical effect."
- "improved patient compliance could be recognised as the overall technical effect of the distinguishing features of claim 1 only if it were shown to arise objectively in an unbroken technical chain from the intrinsic properties of the claimed pharmaceutical formulation. In general, in a pharmaceutical formulation exhibiting improved patient compliance, the intrinsic properties of the improved pharmaceutical formulation either lead to fewer side effects or make the administration of the pharmaceutical formulation into the patient's body easier, thus objectively lowering the risk of discontinuation or interruption of the therapy regimen."
- "In the case at hand, the pharmaceutical composition is indeed not new. Since the computer program of claim 1 does not interact with the intrinsic properties of the pharmaceutical composition, it can be ruled out that it leads to an overall technical effect in terms of improved patient compliance. Any improved patient compliance in the case at hand, as apparently demonstrated by D4 or D5, is instead the result of a "broken technical chain" (see T 1670/07, point 11 of the Reasons), namely an alleged chain of technical effects starting with information provided to a patient which is then broken by the patient's mental activities."
EPO T 0752/19
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/2022/08/t-075219-pharmaceutical-composition.html
