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

Agritech Thymes: A review of protection for gene edited plants

As we head into a new season, it’s a good time to revisit the current status of protection for Essentially Derived Varieties (EDVs) and plants derived from New Genomic Techniques …

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The Strawberry Patent Battle: Seeds, Speculation, and Jurisdiction

  This case, relating to infringement of a US plant patent, deals with the evidentiary burden required to show infringement of a plant patent in the US, as well as …

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The draft of The Genetic Technology (Precision Breeding) Regulations 2025 reveals practical details on how to obtain a Precision Bred Organism status

In a recent blog post we discussed the Precision Breeding Regulatory Framework developed by the Food Standards Agency (FSA). Further details on the application process for Precision Bred Organism confirmation …

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Regulation of NGT plants in Europe- Polish Presidency proposes an alternative solution to the Patent ban

In the latest development on the new proposed legislation for the regulation of NGT (gene-edited) plants in the EU, the Polish Presidency have proposed an amendment which removes the proposed …

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Can the Chancellor’s so-called “Europe’s Silicon Valley” really replicate the innovative activity of its namesake?

The Chancellor of the UK, Rachel Reeves, recently unveiled plans to deliver an Oxford-Cambridge growth corridor that promises to boost the UK economy by up to £78 billion by 2035.  …

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UPC on Doctrine of Equivalents

Plant-e Knowledge BV & anor v Arkyne Technologies SL UPC_CFI_239/2023 (Brinkman, Granata, Walker & Koke) – 22 November 2024 The Hague Local Division has handed down the first substantive UPC …

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The EPO Board of Appeal comments on the scope of the morality exclusion from patentability

The recent decision, T1553/22 of the Board of Appeal required the Board to consider the scope of the exclusions from patentability under Article 53(a) EPC. The invention in this case …

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Update on the Precision Breeding Act 2023: details emerge of the new simplified regulatory pathway for gene edited plant and animal derived food and feed products

The Genetic Technology (Precision Breeding) Act 2023 could come into force as early as spring 2025. It empowers the Food Standards Agency (FSA) to create a new simplified regulatory pathway …

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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.