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England and Wales decisions
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The High Court dismissed Leon’s appeal against refusal of an SPC for drospirenone, holding that earlier combination-product MAs counted as the first authorisation under Article 3(d).
Regeneron Pharmaceuticals, Inc & Anor v Alvotech HF & Anor [2025] EWHC 3050 (Pat) (24 November 2025)
The High Court held that an SPC manufacturing-waiver notification can be valid before an export-country marketing authorisation is granted, so long as the MA number is supplied when publicly available.
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.
Both sides face irreparable harm if the injunction is granted or refused; uncertainties exist in quantifying damages for either party. The status quo, as defined by who is currently on the market, should be preserved pending the imminent appeal. An interim injunction restraining all respondents from marketing generic dapagliflozin is appropriate.
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Dr Reddy's Laboratories (UK) Ltd v Boehringer Ingelheim International GmbH [2025] EWHC 2834 (Pat) (05 November 2025)
The High Court granted an interim injunction restraining Dr Reddy's from launching generic empagliflozin pending trial, finding damages inadequate and preserving the status quo.
The Court of Appeal refused AstraZeneca’s bid for injunctions pending a Supreme Court challenge, but granted a 14-day injunction to preserve the status quo.
Astrazeneca AB & Anor v Glenmark Pharmaceuticals Europe Ltd [2025] EWHC 1339 (Pat) (28 May 2025)
The Patents Court refused AstraZeneca an interim injunction pending appeal over generic dapagliflozin, finding irreparable harm and status quo arguments balanced on both sides.
Damages would not be an adequate remedy for either party due to market unpredictability, risk of further generic entry, and inability to quantify harm. Preservation of the status quo and DR's failure to clear the way for its generic launch justify granting the interim injunction sought by BI.
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Astrazeneca AB & Anor v Glenmark Pharmaceuticals Europe Ltd [2025] EWCA Civ 480 (16 April 2025)
The Court of Appeal granted AstraZeneca an interim injunction to stop Glenmark marketing a dapagliflozin product until the form of order hearing.
The Court of Appeal allowed AstraZeneca’s appeal and granted an interim injunction restraining Glenmark’s dapagliflozin launch until the form of order hearing.
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