European Patent Office Opens Up Protection Of Medical Technology

Businesses developing methods of medical treatment or diagnosis have new opportunities to protect their technology after a recent decision by the Board of Appeal of the European Patent Office.

A recent decision issued by the European Patent Office (T1252/20) changes the interpretation of which known products can be protected by claims to their use in new methods of treatment by surgery or therapy or in diagnostic methods. This decision is a welcome development, and if followed allows a broader range of products to be considered patentable in Europe.

Under European law, methods of treatment by surgery or therapy and diagnostic methods practised on the human or animal body are excluded from patent protection. This exclusion does not apply to “substances or compositions” for use in these methods. Therefore, claims to a known substance or composition for a new use in a method of treatment or diagnosis are allowed.

This case relates to the use of self-assembling peptides in the treatment of various diseases. The peptides are administered into a blood vessel, where they aggregate to form a solid hydrogel. The blood vessel is blocked by the hydrogel, inducing death of the tissue supplied by the vessel. This is useful in the treatment of a number of conditions including cancer. The peptides themselves, and their ability to form hydrogels were already known, but the use to block blood vessels was new. The application was refused as the claims were not considered to be novel, as the peptide solution was not considered to be a “substance or composition” eligible for a second medical use.

Under previous case law, a ”substance or composition” was only considered to be eligible for a so-called “second medical use” claim if it had a therapeutic effect due to its chemical properties. For example, a filler composition, injected between target tissue and sensitive body tissue to reduce the side effects of radiation was not considered to have a therapeutic effect, and so was not deemed to be patentable (T1758/15). Therefore, the case law imposed restrictions on the types of substances or compositions which could be protected by medical use claims based on their mode of action. If the substance or composition itself did not have a therapeutic effect, it was seen to be a “device”, and so the exception did not apply.

In the present case, the Board considered that the peptide solution must be considered a “substance or composition” and not a device. The solution as administered had not yet formed the plug for blocking the blood vessel, bringing about the therapeutic effect. A device was defined by the Board as having a set shape to carry out its function. The composition was a shapeless liquid mixture of chemical entities so could not be considered a “device”. Although the solution would transform into a solid hydrogel, the Board felt there was no reason why the peptide solution defined in the claim should be defined as a device.

The Board noted that the exception applies to the use of a substance or composition not only in a method of treatment but also methods of surgery and diagnosis. Therefore, it should not be interpreted narrowly so as to only apply to substances or compositions where the mode of action is due to a chemical effect or the chemical nature of the composition or substance. The Board stated that there is no legal basis for using the mode of action to determine if the exception applies. Provided that the invention relates to the use of a known substance in new therapies, then it deserves protection. There is no additional legal requirement based on the mechanism of action. The claims were therefore found to be allowable.

This decision, if followed, provides a sensible and more generous approach, opening the possibility of obtaining protection for compositions, such as fillers which have been previously considered unpatentable by the EPO. These products may also now be eligible for SPC protection.

If you would like to discuss the implications of this decision for your business in more detail, please contact the author, Deborah Hart (dhart@beckgreener.com) or Ben Muir (bmuir@beckgreener.com), the Head of our Life Sciences team.