A patent application targeting a computer program to improve patient compliance fails

A recent decision of the European Patent Office Boards of Appeal has concluded that a medicine and computer program combination was not patentable. The computer program served to improve patient compliance with taking a known drug combination for the treatment of heart disease. The application failed the EPO’s “technical effect” test.

Intellectual Property Enabler Stockholm AB filed a European Patent application claiming the drug combination together with the computer program in 2012. The computer program helps patients to improve behaviour by asking a series of questions and generating patient-specific feedback to aid compliance with treatment.

The problem of technical effect

To be patentable in the EPO system, an invention must involve an “inventive step” that is not obvious to a person skilled in the relevant field, having regard to earlier developments. In the EPO’s analysis an inventive step must have “technical character” – it must solve a technical problem using technical means. Computer programs on their own are excluded from patentability, although they can contribute to an invention in conjunction with a technical effect or result.

In this case, the claimed invention involved non-technical, as well as technical aspects:

  • The technical aspect, namely the implementation into a computer of a questionnaire which generates patient-specific feedback, was found to be included in prior art and therefore not new.
  • The non-technical aspect, the effect of patients being encouraged to be more compliant, was found by the EPO to be a cognitive effect taking place in the mind of the user.

The applicant argued on appeal that the overall technical effect brought about by the computer program and drug combination should be considered when assessing the technical character of the invention, and that good patient compliance is a technical effect.

This was not successful. Improved compliance could only be recognised as a technical effect if it arose “objectively in an unbroken technical chain” from the properties of the pharmaceutical formulation. In this case the technical chain was broken by the patient’s mental activities. Compliance was dependent on the choices made by patients and their ability to interact with the computer program. The EPO compared the program to other non-technical aspects that would improve patient compliance such as labeling prescriptions with clear directions, encouraging the use of calendars to take medications and providing feedback to patients. None of these would have a technical effect for patenting purposes.

The applicant’s argument that the computer program had been CE-marked as a medical device and should therefore be regarded as having a technical effect was also dismissed. Regulatory approval was found to have no relevance for assessing technical effect in a patent application.

Impact on strategy

Developers of algorithms and apps for use in promoting patient compliance need to be aware that combinations of computer programs and known drugs are unlikely to be patentable within the EPO framework. Innovators in this area may need to consider alternative IP strategies, including protection of trade secrets and confidentiality in the development stage, as well as reliance on copyright for the software aspects of their technology.

 

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