Personalised medicine

Personalised medicine is transforming healthcare by tailoring treatments to specific patient populations, often based on genetic or other biomarker features. But while the science is moving fast, the patent landscape presents ongoing challenges.

At HGF, we advise clients on securing protection for personalised therapies, companion diagnostics, and patient stratification methods. Key issues in this space include differing approaches to diagnostic claims and novelty, particularly the concept of inherency in US law, compared to EPO standards. These differences are crucial when claiming treatments of newly identifiable patient groups who may have previously received a treatment without a formal diagnosis.

Our team has significant in-house experience in both small and large molecule drug development, particularly in oncology. We also understand the complexities of collaboration between pharma companies and diagnostic partners, and the contractual and IP issues these arrangements raise.

Whether advising on freedom-to-operate, licensing, or securing robust protection for personalised medicine, HGF brings legal expertise, sector insight, and commercial awareness to help clients in this evolving field.

Latest updates

Strategic Deployment of Third Party Observations

This episode outlines the strategic use of European Patent Office (EPO) pre-grant Third Party Observations (TPOs) It explains how TPOs can be used to influence the outcome of competitor patent …

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Agritech Thymes: Rare UK Plant Variety Rights ruling provides guidance on the interpretation of “essentially derived varieties”

In this article, we examine a recent UK Plant Variety Right (PVR) case involving “Nadorcott” and “Tang Gold” mandarins. This judgement clarifies what constitutes an essentially derived variety (EDV) and …

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Agritech Thymes: Unlocking the Soil Microbiome: Driving Agritech Innovation in the UK

The UK offers an ideal platform for harnessing the untapped potential of soil and plant microorganisms. Although much of my professional experience has focused on the human microbiome, I have …

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Third party observations

Overview: Third Party Observations (TPOs) are a mechanism by which third parties can submit written observations in proceedings before the EPO. TPOs are often filed with the aim of persuading …

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EU Agrees on NGT Plant Regulation: What It Means for Patents and Licensing

The European Parliament and Council have reached a provisional agreement for plants developed using New Genomic Techniques (NGTs) – below we summarise the main points and set out the requirements …

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Agritech Thymes: The Bite of Implied Consent: Lessons from the Pink Lady Case

Can the supply of a plant variety without clear and defined restrictions on its use be an implicit consent to commercialise it? This case centres on the evidence required to …

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The Bite of Implied Consent: Lessons from the Pink Lady Case

A recent European Union court decision considers the issue of implied consent to commercialise a plant variety, and whether the evidence meets the threshold of “serious doubts” of the validity …

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How France's investment in digital health, AI, and bioinformatics is transforming the intellectual property (IP) landscape

In recent years, France has become a key player in digital health innovation, driven by strategic government investments under the France 2030 initiative and the French Tech 2030 program. These …

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Let's talk

If you would like to discuss how HGF could help you, contact one of our personalised medicine specialists.