Substance, composition, or device? EPO addresses method of reaching a decision
Managing IP is part of the Delinian Group, Delinian Limited, 4 Bouverie Street, London, EC4Y 8AX, Registered in England & Wales, Company number 00954730
Copyright © Delinian Limited and its affiliated companies 2024

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

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

Sponsored by

inspicos-400px.png
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 ros bottom lb

More from across our site

We provide a rundown of Managing IP’s news and analysis from the week, and review what’s been happening elsewhere in IP
Law firms that pay close attention to their client relationships are more likely to win repeat work, according to a survey of nearly 29,000 in-house counsel
The EMEA research period is open until May 31
Practitioners analyse a survey on how law firms prove value to their clients and reflect on why the concept can be hard to pin down
The winner of Managing IP’s Life Achievement Award discusses 50 years in IP law and how even he can’t avoid imposter syndrome
Saya Choudhary of Singh & Singh explains how her team navigated nine years of litigation to secure record damages of $29 million and the lessons learned along the way
The full list of finalists has been revealed and the winners will be presented on June 20 at the Metropolitan Club in New York
A team of IP and media law specialists has joined from SKW Schwarz alongside a former counsel at Sky
The Irish government has delayed a planned referendum on whether Ireland should join the Unified Patent Court, prompting concern about when a vote may take place
With more than 250 winners recognised during the ceremony, there are many reasons to be positive about the health of the IP industry in EMEA
Gift this article