Journal

Clinical trial disclosures and patentability at the EPO – Part 1

Clinical trial disclosures can play a pivotal role in shaping the patent landscape. Whilst such public disclosures can showcase a company’s innovative developments, they can also place new information, including new data, into the public domain that may present challenges to overcome for demonstrating novelty and inventive step for later patent claims. The timing and content of these disclosures are crucial considerations for pharmaceutical and biotech companies seeking to protect their intellectual property.

Companies are faced with important strategic decisions around filing patents early in the development process, possibly before clinical trial results are available, versus filing later with clinical trial results and delaying publication of trial outcomes to prevent prior art from interfering with patent claims. Such decisions have been brought to the fore in view of an increased focus from regulatory authorities on transparency and therefore public disclosures. Understanding the legal issues and, in particular, the rapidly developing case law at the EPO, are key for decision making.

In the first part of this two-part article, we discuss the changes regarding the publication of information relating to clinical trials at the European Medicines Agency (‘EMA’) and patent filing strategy considerations as a result. We then review decisions of the EPO Boards of Appeal where the novelty of therapeutic use claims or product claims was assessed in view of clinical trial related disclosures. See:

• Balancing transparency and innovation: regulatory clinical trial disclosures and strategic approaches to patent filings at the EPO
• Clinical trial disclosures and their impact on novelty at the EPO

In the second part to be published in the April issue of the CIPA Journal, we will discuss decisions of the EPO Boards of Appeal where inventive step of therapeutic use claims or product claims was assessed in view of clinical trial prior art. We will also consider whether product codes in clinical trial prior art documents affect the status of such documents as relevant prior art against patent claims, particularly in the context of inventive step.

Nadège Beynon and Sophie Skidmore. See below the author details for both articles in the March 2025 issue.

Authors’ notes and acknowledgements

Authors: Nadège Beynon (Fellow) is a Senior Associate Patent Attorney and Sophie Skidmore (Student) is a Trainee Patent Attorney at CMS Cameron McKenna Nabarro Olswang LLP. Gabriela Staber is a Partner (attorney-at-law specialising in intellectual property and life sciences law) at CMS Reich-Rohrwig Hainz Rechtsanwälte GmbH, Austria.

Acknowledgements: the Authors would like to express their sincere gratitude to Jane Evenson and Jane Hollywood (both Partners at CMS Cameron McKenna Nabarro Olswang LLP) and Sarah Klaczynska (Senior Director Intellectual Property at BioNTech UK Limited) for their invaluable input and thorough review of this article. Their expertise and insightful feedback were instrumental in shaping the final article. We are truly appreciative of their time and support in making this publication possible.

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