Patenting inventions relating to medical devices in Europe is quite complex. Careful drafting of medical device patents is needed to ensure sufficient protection for all aspects of the invention, without falling under excluded subject-matter at the European Patent Office (EPO).

In the field of medical devices, it is often desirable to not only protect the device itself, but to also protect other aspects relating to the medical device, such as:

• the methods or uses relating to the operation of the device,
• the methods of manufacturing the device, and/or
• computer programs relating to the operation of the medical device.

In this article, we focus on patenting methods or uses relating to the operation of medical devices.

Exclusions to patentability – Methods for treatment

At the EPO, it is not permitted to patent methods for treatment of the the human or animal body by surgery or therapy (according to Article 53(c) EPC). The exclusion also applies to diagnostic methods practised on the human or animal body. It is important to note that this exclusion applies to methods only, and does not apply to devices or apparatus. Consequently, device or apparatus claims usually steer clear of this exclusion, whereas method claims involving “surgical steps” are typically objected to at the EPO under this exclusion.

There is an exception to the above exclusion where it is permitted to protect a product for use in an excluded method for treatment. Such claims are known as “medical use claims”, and typically take the format “Substance X for use in the treatment of disease Y”.  As such, whilst it is not permitted to protect a method for treatment by surgery, protection may still be afforded for the medical use of a product.

Medical devices – Methods of operation and uses thereof

Methods relating to the operation of medical devices are often objected to for relating to methods of treatment by surgery. For example, the injection of a contrast agent into the heart or catheterisation of a patient are considered ‘surgical’ steps, and so, methods involving such steps are not permitted.

Careful drafting of method claims can help avoid any objections under the exclusion; for example, omitting from the method claim any steps which mention the interaction with the body (i.e. the surgical step), or drafting method claims which define steps that take place before or after the interaction with the body. (Although, it may still be useful to include surgical steps in the dependent claims if protection is sought outside Europe, where methods of treatment may be allowable.) If a surgical step is essential to the method, whether this is explicitly disclosed or implied, then it is likely that the method will not be permitted at the EPO.

Additionally, medical uses of medical devices may also face objection at the EPO. Whilst it possible to protect the medical use of a product using “a medical use claim”, this exception is limited to “substances or compositions”. The EPO does not consider traditional medical devices (e.g. a pacemaker or surgical tool) a “substance or composition”, and so it is not possible to gain protection for the medical use of a traditional medical device.

However, it may still be possible to protect a medical use for a substance or composition which is part of a medical device, or that is used with a medical device, providing that the substance or composition is an active agent. Thus, medical use claims may still provide some protection for the use or operation of medical devices where methods of treatment are excluded.

If you are interested in finding out more about patent protection for medical devices, please contact us to speak with one of our experienced attorneys.