There are three EPO medical exclusions to patentability: methods for treatment of the human or animal body by surgery or therapy, and diagnostic methods practised on the human or animal body. Practitioners do not need to be present for the exclusions to apply and, for the surgery and therapy exclusions, treatment of some kind is also required. There are different approaches that the EPO adopts to dealing with the surgery and therapy exclusions - where only a single surgical or therapeutic step is required to fall within the exclusion - versus the need to have present all of the steps identified by the EPO as being intrinsic to any diagnosis. As a brief summary:
When deciding whether a claim relates to surgery, the EPO will factor in the required medical expertise, degree of invasiveness, and health risk. Minor interventions that have no substantial health risks and low risk routine techniques carried out on uncritical body parts - such as tattooing – will not be excluded.
Excluded therapies need to be curative or prophylactic: “to cure, alleviate, remove or lessen the symptoms of, or prevent or reduce the possibility of contracting any disorder or malfunction of the human or animal body”.
For a claim to be interpreted as an excluded diagnostic method, the EPO requires that it has all of the following features: an examination phase, a comparison with standard data, the finding of a significant deviation, and a decision phase.
Although the exclusions are far-reaching, they are not blanket bans of all medical methods and there often remains scope to obtain beneficial protection.
Maximising protection for your Healthcare innovations
Getting your application into shape for a later European filing needs to begin at the drafting stage, as some subtle differences to the language used in the claims and description can be enough to get you across the line in Europe.
The main considerations here are the exclusions and interplay with EPO’s strict added matter requirements. Even the addition of a couple of sentences to the description explaining why your claimed subject matter does not fall within the scope of the EPO exclusions can help. Good, clear drawings can also be useful to provide you with fallbacks that might be needed during EPO prosecution.
Also make sure you have included all relevant categories of independent claim, as the EPO will allow multiple claim categories in the same application as long as they all share the same inventive concept. There may also be some claim categories which you might not consider for the US but could be allowed in Europe, so don’t miss out on protecting all aspects of your invention.
Consideration also need to be given to claim scope for infringement. Firstly, consider who is going to be the end user. For many home care innovations, such as in the diabetes space, the end user is the patient and therefore the potential infringer, which is something best avoided if possible. Also, make sure your IP supports the commercial reality of your product. Consider for example the Gillette sales model for point of care diagnostics, for example small scale, lab on chip diagnostics. Here, the machine is likely to be the clever bit, but having a patent on the disposable cartridge will be important commercially as that’s the part that’s going to be sold in higher volumes.
Finally, get an opinion from a European attorney, either at the drafting stage or prior to PCT filing. They can help you to navigate the exclusions and the EPO’s added matter requirements, and ensure you have the relevant fallback positions in the description and/or claims that you can rely on later if needed.
If you'd like our help with any Healthcare issues that you are facing or have any questions on this topic, please get in touch.