Substance, composition, or device? EPO addresses method of reaching a decision

Managing IP is part of Legal Benchmarking Limited, 1-2 Paris Gardens, London, SE1 8ND

Copyright © Legal Benchmarking Limited and its affiliated companies 2025

Accessibility | Terms of Use | Privacy Policy | Modern Slavery Statement

Substance, composition, or device? EPO addresses method of reaching a decision

Sponsored by

inspicos-400px recrop.jpg
Patent Health Care Pharmaceuticals Innovation concept. Copy rights patented certified medicine.

While concrete definitions are still lacking, Peter Koefoed of Inspicos says patent applicants seeking protection for second medical uses of products could now find it easier to build their case

Under Article 53(c) of the European Patent Convention (EPC), methods of therapy or surgery for humans and animals are exempted from patentability, as are diagnostic methods carried out on the human or animal body. At the same time, Article 53(c) specifies that this exemption does not apply to products – in particular, substances and compositions – for use in these methods.

Moreover, Article 54(5), by legal fiction, acknowledges novelty of any "substance or composition" for use in such exempted methods that are themselves novel. It can be derived from the wording of the latter provisions that they only apply to a subset of the products mentioned in Article53(c): substances and compositions.

Board of appeal case law has previously sought to establish criteria for determining whether a product is a substance or composition and not a device. These criteria are laid down in the Guidelines for Examination, G-VI, 6.1.1, which states that a product qualifies as a substance or composition if it is the active agent or ingredient in the specific medical use and if the therapeutic effect can be ascribed to its chemical properties (see G 5/83 and T 1758/15).

In decision T 1252/20 (relating to peptides used in cancer treatment by mechanically blocking blood vessels), of February 6 2024, the board saw no basis in the EPC for considering the mode of action of the claimed substance or composition to determine compliance with Article 54(5). The board pointed out that the exempted methods in Article 53(c) are not merely medical methods but also surgery and diagnostic methods. Moreover, the precise mode of action of a product is not always known. The board hence concluded that it is only relevant to consider whether the claimed product is a substance or composition but not to consider its mode of action.

T 1252/20 does not offer a concrete definition of a substance or composition. Nevertheless, applicants may face fewer obstacles when seeking protection at the EPO for second medical uses of products in cases where the claimed product at face value does not have device-like features.

more from across site and SHARED ros bottom lb

More from across our site

A $110 million US verdict against Apple and an appellate order staying a $39 million trademark infringement finding against Amazon were also among the top talking points
Attorneys are watching how AI affects trademark registrations and whether a SCOTUS ruling from last year will have broader free speech implications
Patent lawyers explain why they will be keeping an eye on the implications of a pharma case and on changes at the USPTO in the second half of 2025
The insensitive reaction to a UK politician crying on TV proves we have a long way to go before we can say we are tackling workplace wellbeing
Adrian Percer says he was impressed by the firm’s work on billion-dollar cases as well as its culture
In our latest interview with women IP leaders, Catherine Bonner at Murgitroyd discusses technology, training, and teaching
Developments included an update in the VAR dispute between Ballinno and UEFA, the latest CMS updates, and a swathe of market moves
The LMG Life Sciences Americas Awards is thrilled to present the 2025 shortlist
A new order has brought the total security awarded to a Canadian tech company to $45 million, the highest-ever by an Indian court in an IP case
Andrew Blattman reflects on how IP practices have changed and shares his hopes for increased AI use and better performance on the stock market
Gift this article