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Patenting Medical Devices at the European Patent Office

Patenting Medical Devices at the European Patent Office

European News 08/09/2021

It has been well understood for many years that European patent law excludes patent protection for methods of treatment of the human or animal body by surgery or therapy. This exclusion also applies to diagnostic methods practised on the human or animal body. However the EPC explicitly mentions that this exclusion does not apply to products for use in such methods.

The examination practice of the EPO and the Boards of Appeal has been that claims to medical devices or computer programs which correspond to a method of treatment are not objected to because only method claims fall under this exclusion. The interpretation is that the exclusion does not apply to products or apparatus even if some features of the apparatus were functionally defined in relation to a body of a patient. The main texts of the EPO – the Case Law of the Boards of Appeal and the Guidelines for Examination – both contain relevant sections which are unequivocal on this issue.

In a recent decision of one of the Technical Boards of Appeal T 944/15 a computer program claim was objected to on this treatment method ground.

In this case the patent application was originally refused on the grounds of being a method of therapy. The decision to refuse was then appealed. During the appeal proceedings the Board of Appeal had a massive fourteen different requests to consider and ultimately dismissed all of these requests to uphold the decision to refuse the patent application.

Of particular interest was the fourth auxiliary request directed to a computer program claim. The appellant argued that such a computer program claim could not possibly be excluded from patentability as a method for treatment, because it was a computer program and not a method claim. Interestingly the EPO Guidelines for Examination provide explicit support for this very argument.

Surprisingly however the Board of Appeal took the complete opposite view. Because computer programs are not explicitly mentioned in the relevant EPC article, and are not sufficiently explained in the travaux préparatoires of the EPC, the Board of Appeal decided that computer programs related to treatment do fall within this method of treatment exclusion. The Board justified this interpretation by explaining that a computer program is only defined by what the programmed method does when run. Because the computer program is a thing that is defined by what it does, and has no other use than the execution of the programmed method, then the program is only the necessary description of the method in a manner that can be understood by a computer. From the perspective of legislative intent, the Board considered that if protection were provided for the computer program, then de facto protection would also be provided for the method of treatment, because running the program is using the method.

The Board of Appeal therefore decided that the computer program should be excluded just as the method of treatment is excluded, so that a medical practitioner would not be hindered by patent protection.

It is interesting to note that the EPO has not changed the Guidelines for Examination following this Board of Appeal decision. This is all the more significant because the Board explicitly expressed its disagreement with the relevant section of the Guidelines. It therefore remains to be seen whether the EPO will follow this decision T 944/15. So far there has been no change to the existing examination practice and the EPO has not started to raise objections to computer program claims on method of treatment grounds.

This is welcome news for MedTech innovators. European patent law is already more restrictive than in other jurisdictions, such as the US, when it comes to the exclusion of claims for methods of treatment by surgery or therapy. The fact that the EPO has not made any change of practice with regard to computer program claims is good news for inventors. Applicants for European patents may continue to pursue patent protection for medical devices and apparatus without objections being raised on grounds related to methods of treatment.

We will continue to monitor developments related to patenting medical devices at the EPO. Any conflicting interpretations of the EPC to confusingly apply the method of treatment exclusion to devices or products or apparatus is unwelcome for inventors and business users.