Exclusion of methods of surgical or therapeutic treatment and diagnostic methods

Methods for treatment of the human or animal body by surgery or therapy and diagnostic methods practised on the human or animal body are not patentable. The exclusion is laid down in Article 53(c) of the European Patent Convention and Article L. 611-16 of the French Intellectual Property Code. It does not apply to products, in particular substances or compositions, for use in any of these methods, which remain patentable under the ordinary conditions of patentability.

Rationale and scope of the exclusion

The exclusion seeks to preserve the freedom of medical practitioners, who must be able to choose the most appropriate treatment without being hampered by a monopoly. It covers surgical methods, understood as physical interventions on the body requiring medical expertise, therapeutic methods, which aim to cure, alleviate or prevent a disease or malfunction, and diagnostic methods, provided that all the technical steps leading to the diagnosis are practised on the human or animal body. By contrast, purely cosmetic treatment methods and methods carried out on samples taken from the body fall outside the exclusion.

Protection of products and therapeutic applications

Medical devices, substances and compositions used in the excluded methods are patentable like any other product. The European Patent Convention and the French Intellectual Property Code also provide an exception to the novelty principle so as to allow the protection of the first medical use of a known substance and of any second medical use of a substance already used in medicine, novelty then arising from the specific use claimed. Since the revision of the Convention, these inventions are claimed in the form of a product for a specified use, which has replaced the Swiss-type claim previously used.

Litigation issues

The exclusion is frequently relied on in invalidity actions against process claims which, although drafted in technical terms, include a step of treating the body, such as administering a substance or positioning an instrument. The characterisation depends on the interpretation of the claims and on whether there is a therapeutic or surgical interaction with the body. Conversely, product claims for therapeutic use raise difficulties in proving infringement where the product is marketed for an unprotected indication but prescribed for the patented one.

Key points

Methods of surgical or therapeutic treatment and diagnostic methods practised on the human or animal body are not patentable, so as to preserve the freedom of medical practitioners. The products, devices and substances used in those methods are patentable, and the first and second medical uses of a known substance are protected by a claim to a product for that use. When drafting, it should be checked that no claimed step constitutes an act performed on the body and, when defending a patent, the proof of infringement of use claims should be anticipated.

---

This glossary entry is general in scope and does not constitute legal advice.

Dhenne Avocats litigates patent disputes before the Paris Judicial Court, the Paris Court of Appeal and the Unified Patent Court. When the question arises in a real case, the right moment is almost always before proceedings are issued.

Patent litigation · Unified Patent Court · UPC case law · Tell us about your situation