Patient compliance and the broken technical chain fallacy (T 0752/19)

A recent interesting case from the EPO Boards of Appeal (T 0752/19) straddled the technical fields of pharmaceuticals and computer-implemented methods. The case considered whether an overall technical effect could be found in a known drug combo for use in the treatment in combination with a computer program for improving patient compliance. The computer program itself was considered to have enough technical character to require an EU marketing authorisation as a medical device, but was not found to have an overall technical effect permitting patentability at the EPO. 

Legal Background

According to the established case law of the EPO, an invention must have "technical character". In the case of a product, an invention must possess tangible ("technical") features. In the case of a method, an invention must require the use of tangible means (Case law of the Boards of Appeal, A.1.1). A computer program or the mere use of a computer program per se is not considered to possess technical features, and therefore is not considered an invention. 

An invention may possess both technical and non-technical features, e.g. the use of a computer program in conjunction with a technical effect or result. However, according to the Comvik approach (T 641/00), novelty and inventive step can only be based on technical features (Case law of the Boards of Appeal, D.9.1), although the overall technical effect of the claim should be considered in this assessment. 

A computer program for improving patient compliance

The decision in T 0752/19 concerned a patent application (EP2666113) relating to a computer program for improving patient compliance with a known drug combo for the treatment of heart disease. The claim of the main request specified the drug combo and a computer program comprising instructions to a) ask a patient a set of questions about the drug, 2) collect the answers, 3) generate patient specific feedback and 4) provide this feedback to the patient. An app using the program has been used in the clinic. The Examining Division found that the computer program lacked technical character. Given that the computer program was also the only feature distinguishing the claim from the prior art, the Examination Division rejected the application for lacking inventive step (Article 56 EPC). 

In search of an overall technical effect

In an assessment of inventive step, a distinguishing non-technical feature of a claim should not be considered in isolation. Instead, it is the overall technical effect brought about by the distinguishing feature which has to be assessed. On appeal, the Board therefore considered whether the computer program of the claim interacted with the technical features of the claim i.e. the drug combo and its use to treat disease, to bring about an overall technical effect.

Mental act

The applicant argued that the interaction between the computer program and the drug combo lay in the effect of the program in improving patient compliance with the treatment, and the resulting improved therapeutic effect. The question then became whether "improved patient compliance" was a technical effect. The applicant cited a previous case that had found inventive step for a new pharmaceutical formulation of a known drug on the basis of the technical effect of improved patient compliance (T 970/12). The applicant argued that "patient compliance" was not an intrinsic physical property of a pharmaceutical composition that can be objectively measured like pH, viscosity or solubility. As such, the applicant argued, what the board in T 970/12 meant by "good patient compliance" was a technical effect that involved administration of the formulation to patients.

The Board of Appeal did not agree with the applicant's reasoning. The applicant, it seems, had fallen into the "broken technical chain fallacy" (IPKat). It has been established by a previous Board of Appeal that any effect reliant on a user's reaction (i.e. mental activity) breaks the technical chain of events, and can therefore not be used to establish an overall technical effect (T 1670/07). In a case where a new formulation of a known drug has fewer side effects, the technical effect arises directly from the physical properties of the formulation that objectively increase the likelihood that patients will comply with the prescribed dosage regime. However, in the case in question, the drug combo itself was not new, and the computer program did not interact with the drug combo itself. The effect of the computer program in improving patient compliance was instead the result of a broken technical chain. The chain of technical events was broken by the step in which feedback was given to the patient. Importantly, this step was necessarily reliant on the patient's mental activities. 

The Board of Appeal outlined some other "non-technical" techniques that would improve patient compliance but would also be considered to be breaks in the technical chain. These included "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". As summarised by the Board:

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.

The applicant had also argued that the fact that the computer program was an EU approved medical device was evidence of technical character, given the technical hurdles for regulatory approval. The Board of Appeal gave this argument short-shift, noting that "regulatory approval of a device has no relevance to the assessment of its patentability in accordance with the EPC" (r. 2.6).

The Board of Appeal therefore concluded that the distinguishing features of claim 1 of the main request did not have any overall technical effect and thus did not involve an inventive step. The appeal was therefore dismissed. 

Final thoughts

The definition of what actually constitutes a "technical feature" is not provided in the EPC. The definition of technical effect has instead been left open so as to permit developments in the understanding of technical character by society at large (G 1/19, r. 76). To this Kat it is a curious situation where a product that must obtain regulatory approval is not thought of as "technical" enough for patent protection. A parallel may also be drawn here with the refusal of the EPO to recognise the second medical use of medical devices as patentable (IPKat). With burgeoning use of algorithms and apps in medical care, innovators will have to consider their IP strategy with care.