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England and Wales decisions
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The High Court held that an SPC export-waiver notification can be valid before an export-country marketing authorisation is granted, so long as the MA number is supplied once publicly available.
Formycon AG & Anor v Regeneron Pharmaceuticals Inc & Anor [2025] EWHC 2527 (Pat) (08 October 2025)
Patents Court trial on aflibercept formulation patents, addressing infringement by equivalence, priority, added matter, obviousness and insufficiency.
Patent trial on aflibercept formulations: the court rejected infringement by equivalence, upheld the ‘691 patent as amended, and invalidated ‘306 for added matter.
Samsung demonstrated an objective need for expedition due to the ongoing commercial uncertainty and chilling effect caused by Alexion's assertion of patent rights, which may inhibit uptake of Samsung's biosimilar. The court found this justified some degree of expedition, balanced against the court's calendar and parties' availability, and ordered the trial expedited to a date no earlier than mid-February 2025.
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Sandoz AG & Ors v Biogen MA Inc [2024] EWHC 2567 (Pat) (11 October 2024)
High Court patent trial on a JCV antibody assay for PML risk assessment, addressing validity, infringement, claim construction, and Arrow-type relief.
Samsung Bioepis UK Ltd v Alexion Pharmaceuticals, Inc [2024] EWHC 1407 (Pat) (06 June 2024)
The Patents Court granted Samsung’s application to expedite a patent trial, finding objectively ascertainable commercial urgency from a likely chilling effect on biosimilar uptake.
The Patents Court refused Pfizer’s request for Arrow declarations about bevacizumab combinations, holding that no UK patent rights remained and foreign spin-off value was insufficient.
Pfizer Ltd v F. Hoffmann-La Roche AG & Anor [2019] EWHC 1520 (Pat) (20 June 2019)
The Patents Court refused Pfizer’s request for Arrow declarations over bevacizumab patent families, holding the declarations would not serve a sufficient useful purpose.
Patents Court decision on adalimumab dosage-regimen patents, priority title and declaratory relief in a biosimilars dispute.
Fujifilm Kyowa Kirin Biologics Co, Ltd & Ors v Abbvie Biotechnology Ltd & Anor [2016] EWHC 3383 (Ch) (29 December 2016)
The High Court refused AbbVie’s bid to stop patent-clearing Arrow declaration claims over adalimumab, finding a real prospect that declarations would serve a useful purpose.
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