Rivaroxaban (Xarelto): one dosing patent, two Europes

What was decided

Rivaroxaban’s compound patent and its UK SPC expired on 1 April 2024. Bayer still held European Patent (UK) 1 845 961, which claims a rapid-release rivaroxaban tablet given no more than once a day for at least five days, in other words the once-daily regimen that most patients actually take. If valid, it would have kept once-daily generics off the UK market until January 2026 while leaving twice-daily use open.

Six generic companies sued to revoke it. On 12 April 2024 His Honour Judge Hacon found the patent obvious: given two conference posters (the Harder and Kubitza posters), the skilled team would have included a 30 mg once-daily arm in a Phase II trial. The Court of Appeal (Lord Justice Arnold, with Lady Justices Nicola Davies and Falk) dismissed Bayer’s appeal on 24 May 2024 and refused Bayer’s attempt to add a new ground.

The judgment also records how the same patent fared elsewhere: the European Patent Office’s Technical Board of Appeal had upheld it in 2021, and first-instance courts in Australia, Belgium, the Netherlands (twice), Norway and Sweden had found it inventive, as had the German Federal Patent Court in a preliminary opinion; France and South Africa had found it obvious. The English court regarded those decisions as of little help because they rested on different evidence.

Timeline

Date	Event
October 2021	EPO Technical Board of Appeal upholds the dosing patent
1 April 2024	UK compound patent and SPC expire
12 April 2024	High Court revokes the dosing patent for obviousness
24 May 2024	Court of Appeal dismisses Bayer’s appeal
2024	Courts in Germany, Sweden and the Netherlands maintain the patent; France and South Africa do not
1 September 2025	High Court ([2025] EWHC 2201 (Pat)) strikes out Sandoz’s claim to Bayer’s profits under the cross-undertaking; compensation is limited to the generics’ own losses, indicated at about £3.9m on the conventional measure
January 2026	Dosing patent reaches the end of its 20-year term (to be confirmed)

What it means if you are…

A parallel trader. For about twenty months the same once-daily product was generic in the UK and France but patent-protected in Germany, Sweden and the Netherlands. That is the kind of asymmetry parallel trade is built on, and it cuts both ways: a generic bought in a country where the patent fell cannot be sold in one where it stands. The dosing patent has now run out everywhere, so this particular split has closed, but the pattern repeats with every secondary patent.

A generics or launch planner. The compound SPC date was never the launch date; the dosing patent was. Secondary patents, dosing regimens, formulations and uses, decide real launch dates far more often than compound patents do, and they are litigated country by country with different results. Plan on the register entry for each country and on the local court’s record, not on the European Patent Office’s view.

A wholesaler or buyer. The UK had a once-daily generic from spring 2024; price followed. Note too the sequel: the generics were kept off the market by an interim injunction while the court finished its judgment, and in September 2025 the court held that what Bayer owes them for that period is their own lost profit, not Bayer’s gain. Launches at risk carry a bill one way or the other, and the bill is measured by the loser’s loss.

Status and what to watch

The UK position is final. The remaining question is the amount payable under the cross-undertaking, now to be assessed as the generics’ lost profits; Sandoz may appeal the refusal of an account of Bayer’s profits.