T 0752/19 - Pharmaceutical composition comprising a computer program

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."
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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.

2. Main request - Inventive step (Article 56 EPC)

2.1 The appellant did not contest that the second medical use of ticagrelor and acetylsalicylic acid for the treatment of Acute Coronary Syndrome or myocardial infarction was already known at the priority date of the application at hand, e.g. from D3, which the appellant considered to be the closest prior art. The board agrees that D3 is a suitable starting point to assess inventive step.

2.2 The subject-matter of claim 1 of the main request differs from D3 in that it further includes an interactive computer program. This computer program presents to the patient, according to a question schedule, a set of questions specific to ticagrelor, collects their answers, generates patient-specific feedback based on the answers and provides this feedback to the patient.

2.3 The appellant argued that, according to the established case law of the boards of appeal, in order to answer the question as to whether an intrinsically non-technical distinguishing feature, such as the computer program according to claim 1, contributes to the technical character of the invention, the distinguishing feature was not to be considered in isolation. Instead, it was the overall technical effect brought about by the distinguishing feature which had to be assessed, i.e. if it contributes to the technical character of the claim by interacting with the technical features of the claim to solve a technical problem (see Case Law of the Boards of Appeal of the European Patent Office, Ninth Edition, July 2019, I.D.9.1.3(c)). 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.

2.4 To answer this question, the board asked the appellant whether the computer program according to claim 1 interacted with any biological target, which the appellant answered in the negative. Thus, it is not disputed that the computer program according to claim 1 does not interact with the technical features of claim 1 at the level of a biological target. Instead, the appellant argued that the alleged interaction of the computer program with the combination of ticagrelor and acetylsalicylic acid lay in an enhanced likelihood of a patient complying with a prescribed treatment regimen with the combination of ticagrelor and acetylsalicylic acid and consequently in an enhanced therapeutic effect. Referring in particular to T 970/12, the appellant argued that the provision of a new pharmaceutical formulation comprising a known active ingredient but exhibiting good patient compliance was recognised as a technical effect by the boards of appeal. However, the computer program according to claim 1 is neither a pharmaceutical formulation nor an active ingredient in a pharmaceutical formulation, while the pharmaceutical formulation in the case at hand, i.e. the combination of ticagrelor and acetylsalicylic acid, is not new. The appellant did not contest these observations. In T 970/12, the board had defined the objective technical problem as "the provision of alternative inhalation formulations of hypertonic saline solutions exhibiting good patient compliance [emphasis by the board]". In the case at hand, since the pharmaceutical formulation in question, namely the combination of ticagrelor and acetylsalicylic acid, is not new, it cannot be argued that the effect of the distinguishing feature lies in the provision of an alternative formulation exhibiting good patient compliance.

2.5 In this regard, the appellant argued that patient compliance was not an intrinsic property of a pharmaceutical composition, unlike physical properties such as pH, viscosity, solubility, etc., which can be objectively measured by studying the composition in isolation. Instead, it was an effect which could only be measured after a pharmaceutical composition had been administered to a population of test subjects. Thus, it was obvious that the board in T 970/12 meant by "good patient compliance" an improved compliance when the formulation was administered to a population of subjects, not any objective and intrinsic physical property of the formulation. In the case at hand, the computer program of claim 1 led to improved patient compliance as demonstrated by the clinical studies presented in D4 and D5.

The board does not agree with the appellant's theory. To the contrary, 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. For example in T 970/12, the board traced such an unbroken technical chain starting from "the addition of hyaluronic acid or a salt of ester thereof with a low molecular weight or an intermediate weight at a concentration of between 0.01% and 1%, instead of quinine sulfate" to an inhalation formulation, which led to "better local tolerability, with a reduction in the inflammatory component affecting the mucosa of the airways", which in turn led to "a lower risk of discontinuance of the treatment", ending thus in "good patient compliance" (see point 2.3.1 of the Reasons).

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. In the case at hand, the possible final technical effect of improved patient compliance brought about by a computer program generating and presenting patient-specific feedback is conditional on the patient's mental activities and thus cannot be used to establish an overall technical effect. This is analogous to the information provided on a package insert, which would also not produce any technical effect in an unbroken technical chain. In fact, D6, an extract from a textbook on therapeutics, which was cited in the contested decision and also discussed by the appellant, lists several such techniques involving a broken technical chain, such as labelling prescriptions with clear directions, encouraging the use of stickers or calendars to remind patients to take medications, providing feedback to patients, establishing a positive relationship with them or rewarding them for taking medications. While the board does not dispute that such techniques may have the effect of improved patient compliance, such an effect is conditional on the patient's mental activities and thus does not contribute to the technical character of the invention.

2.6 Another argument brought forward by the appellant was that a CE marking was a secondary indicator of technical character. The interactive support tool of D4, which corresponds to the computer program according to claim 1, was subsequently approved as a medical device (see D4, page 93, "Contributions") in accordance with EU regulations. In order to be registered as a medical device, the computer program had to achieve the performance intended by the manufacturer and solve technical problems. Therefore, a CE marking was in essence the acknowledgement of the achievement of a technical effect. However, regulatory approval of a device has no relevance to the assessment of its patentability in accordance with the EPC.

2.7 Therefore, the distinguishing features of claim 1 of the main request do not have any overall technical effect, thus do not solve any objective technical problem and do not involve an inventive step (Article 56 EPC).