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Computer implemented invention refused due to “broken technical chain”


Summary

The Board of Appeal (BoA) rejected the application in the field of pharmaceuticals and computer implemented inventions. The application aims to help patients maintain the correct dose of medication by interacting with a computer program. The application was originally rejected by the Examining Division and the applicant subsequently appealed. But the BoA supported the original decision citing a “broken technical chain” as one of the reasons for the denial.

The application

A common problem in the field of medication administration is that patients may not follow prescription instructions leading to overdosage, underdosage, missed days and overall low effectiveness of medication. The application aims to overcome this issue despite a kit of parts containing the drug and a computer program that can be run on a mobile phone. The program asks the patient questions tailored to the medication taken. Common questions centered on food and beverage consumption, mood, sleep, use of recreational medications, stress levels, current medication adherence, blood pressure and body weight. The questions were mixed on multiple choice, yes/no, Likert scale and visual analogue scale. Based on patient responses the program will provide feedback including recommendations to improve dose adherence as well as a visual illustration of past, present and future health predictions to help motivate the patient. Clinical trials have shown that the applicant’s program has been successful in improving patient compliance for the combination of ticagrelor and acetyl salicylic acid in the treatment of acute coronary syndrome. The applicant also earned CE certification in their program.

The law

Article 52 (2) of the EPC contains a list of excluded inventions, including computer programs. There is a caveat to this that computer programs are not included as such means that if the computer program has a technical nature beyond the “normal” physical interaction between the program (software) and the computer (hardware) then it is patentable. The word technical nature is never positively defined in EPO and is intended as such, to prevent future technologies, which are currently not being developed, from being included in patentability. However, the EPO clarified that the computer programs themselves have no technical nature.

The arguments

The drugs ticagrelor and acetyl salicylic acid and their effects are known to the date of priority. Therefore, the only distinguishing part of the application is the computer program. According to the established law in the case of appellate boards, to answer the question of whether an intrinsically nontechnical distinction, such as a computer program, contributes to the technical nature of the invention, the distinctive feature must not considered alone. Instead, it should be examined in light of its interaction with the technical aspects of the application, namely ticagrelor and acetyl salicylic acid.

The applicant relied on T970/12 in connection with the application for the new drug formulation which also resulted in improved patient compliance. In T970/12 the patent was granted and so the applicant argued that their application would be based on the same rationale of the improved therapeutic effect due to the improved compliance. But the EPO points out that there are significant differences between T970/12 and the applicant’s case, in particular that T9702/12 relates to the new drug formulation (which is considered a technical subject) and has nothing to do with programs. computer. The T970 / 12 has an “unbreakable technical chain” based on the technical impact of the new formulation with little impact. In the present case, however, the board says that any improvement in patient compliance is the result of a “broken technical chain” that is conditional on the patient’s mental activities. The same techniques that result from a broken technical chain are already known in art for improving patient compliance. This includes marking prescriptions with clear direction, encouraging the use of stickers or calendars to remind patients to take medications, providing feedback to patients, establishing positive relationships. with them or reward them for taking medications. While EPO recognizes that all of the above are good techniques for improving patient compliance, none of the techniques have become an invention.

The broken technical chain of reasoning originates at Point 11 of T 1670/07 where an alleged chain of technical effects that begins with information provided to a patient is then broken by the patient’s mental activities.

The applicant also argued that CE certification is an endorsement of technical effect but the EPO disagrees stating that CE certification has nothing to do with patentability.



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