Biopharmaceuticals

The future of medicine is increasingly biological, personalised, and precise. Across fields such as cell and gene therapy, protein and nucleic acid drugs, and genomic medicine, companies are developing targeted, often curative treatments that redefine what’s possible in healthcare. At HGF, we work alongside these innovators to build robust IP strategies that protect cutting-edge technology and support commercial success in a competitive, highly regulated environment.c bv

Our Biotherapeutics team brings together deep experience across interrelated but technically distinct specialisms, including gene editing, personalised medicine, antibody and biologic therapeutics, nucleic acid therapeutics and advanced cell and gene therapies. We understand the legal and scientific nuances of each specialism, from evolving case law around diagnostics to the challenges of patenting functionally defined antibodies or CRISPR-based technologies.

The regulatory and IP landscapes in these sectors are constantly changing, with differences between EPO and USPTO approaches to novelty, written description and patentable subject-matter significantly affecting how claims are drafted, prosecuted, and enforced. Our attorneys work globally and collaboratively to ensure our clients’ portfolios reflect both the latest developments and long-term strategic goals.

Whether supporting spin-outs, universities, biotech, or multinational pharmaceutical companies, we combine legal accuracy with first-hand knowledge of R&D pipelines, due diligence, and licensing in this space.

Latest updates

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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Agritech Thymes: Arusha Protocol Enters into Force

Since being introduced in July 2015, the Arusha protocol for the protection of novel plant varieties in Africa has finally entered into force on the 24th of November 2024, after …

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Let's talk

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