Vedolizumab: four biosimilar developers ask the Patents Court to clear the way for Entyvio biosimilars

What is in dispute

Entyvio is Takeda’s gut-selective antibody for ulcerative colitis and Crohn’s disease, said in the proceedings to be Takeda’s most important product. The antibody itself is no longer protected. The original patents trace back to a United States filing of 1996; the UK register shows the humanised antibody patent expired in 2017 and the later Takeda and Genentech antibody patent in 2021, with its UK supplementary protection certificate recorded as not in force. The Dutch certificate on the same patent expired in 2026. What stands between a biosimilar and the UK market is a cluster of follow-on patents, all filed on 2 May 2012 with an earliest priority of 2 May 2011, which run to 2032.

Four of those patents are in issue. Two are dosing patents. EP (UK) 3 329 965 claims the intravenous regimen: 300 mg at weeks 0, 2 and 6, then 300 mg every 4 or 8 weeks. EP (UK) 3 311 834 claims a subcutaneous regimen with an intravenous induction phase followed by 108 mg under the skin every 2 weeks. Two are formulation patents. EP (UK) 2 704 798 claims a 300 mg formulation reconstituted from a freeze-dried powder, and EP (UK) 4 403 579, a divisional of the subcutaneous patent granted in December 2025, claims stable liquid formulations, with one claim directed to subcutaneous use. Two divisional applications, one from each dosing family, are still pending at the EPO. A pending application cannot be litigated, so the claimants ask instead for Arrow declarations: declarations that their own products were obvious at the priority date, which would make any patent later granted on those applications unenforceable against them. The explainer on clearing the path describes the mechanism.

Fresenius Kabi, through its Swiss and UK companies, served the first claim on 24 February 2026; Advanz served the second 3 days later. Accord sued on 19 May 2026 and Samsung Bioepis on 15 July 2026. In each action the claimant seeks revocation of some or all of the four patents, declarations of non-infringement, Arrow relief, or a combination. Each product is different and confidential, so the infringement questions may differ from claimant to claimant even though the validity questions overlap. The four actions are case managed and will be tried together. Trade reporting says a fifth developer, Celltrion, filed its own claim in August 2026; that has not been confirmed from a primary source.

The one judgment so far, handed down on 31 July 2026 after a joint case-management conference on 24 July, decides nothing about the patents. The court accepted the claimants’ undertaking to use best endeavours to align their invalidity cases by 10 September 2026 and declined, for now, to force a consolidated pleading or shared leading counsel. The main contest was over confidentiality. Advanz’s intravenous and subcutaneous formulations are secret until its regulatory filings are published, which the judgment expects around the second quarter of 2027. Takeda’s two in-house lawyers in the confidentiality club were already barred from drafting claims on pending applications. The court extended that bar to post-grant amendments and auxiliary requests in any proceedings, at the EPO or abroad, finding a real risk that the information would colour that work and no material prejudice to Takeda, which can nominate other people for it. The judgment refers to a possible appeal by Millennium on the point.

The same patents are under attack elsewhere. The judgment records six oppositions at the EPO against the intravenous dosing patent, with Takeda preparing dozens of auxiliary requests, and refers to the patents being under opposition or attack at the EPO, in the UK, the Netherlands and France. No Unified Patent Court action was found. On the regulatory side, Fresenius Kabi announced on 31 July 2026 that the EMA and the FDA had accepted Polpharma’s PB016 for review, and the judgment notes that Advanz’s formulations were accepted by the FDA in June 2026. No biosimilar vedolizumab is yet approved in the UK or the EU.

Timeline

Date	Event
2 May 2011	Earliest priority date of the dosing and formulation patents
2 May 2012	Filing date shared by all four patents and both pending applications
12 July 2017	First formulation patent (EP 798) takes effect in the UK
19 March 2025	Intravenous dosing patent (EP 965) takes effect in the UK
10 December 2025	Liquid formulation divisional (EP 579) takes effect in the UK
24 February 2026	Fresenius Kabi serves the first claim
27 February 2026	Advanz serves the second claim
11 March 2026	Subcutaneous dosing patent (EP 834) takes effect in the UK
8 April 2026	Trial of the Fresenius and Advanz actions fixed for a window from 6 April 2027
19 May 2026	Accord commences the third action
15 July 2026	Samsung Bioepis commences the fourth action
24 July 2026	Joint case-management conference
31 July 2026	Procedural judgment: Samsung joins the trial; extended prosecution bar imposed; EMA and FDA accept PB016 for review
10 September 2026	Claimants’ date for aligning their invalidity cases
6 April 2027	Start of the 5-day window for a 15-day trial

What it means if you are…

A parallel trader. Nothing here opens the UK to imported vedolizumab, biosimilar or otherwise. Entyvio itself can be parallel imported as it always could, subject to a UK licence; the dispute is about whether a different product may be sold at all. If a biosimilar launches in the UK after the trial, its stock is UK stock: the EU position depends on the EPO oppositions and the national cases, and a UK ruling binds no one abroad. The autumn 2026 watch list notes that the UK now tends to open first and that a UK opening no longer signals an EU one. Vedolizumab is likely to follow that pattern.

A biosimilar developer or generic launch planner. The four claimants have spent 2026 doing what the UK system rewards: suing early enough for a judgment before launch, and asking for Arrow declarations to neutralise the divisionals that a revocation cannot reach. The 10 September 2026 alignment date and the 15-day estimate show the scale of the validity case. The confidentiality ruling matters to anyone planning to join: a developer who discloses its formulation to the court can expect the originator’s claim drafters to be walled off from it, in every forum, until the regulator publishes it. The patents run to 2032, so a loss at trial, or an injunction pending appeal, would cost years rather than months. The explainer on biosimilars in Europe sets out how the UK and EU clocks differ for an antibody like this.

A wholesaler or buyer. Do not plan on a UK biosimilar vedolizumab before the second half of 2027 at the earliest, and treat any earlier date as conditional. A trial starting in April 2027 will take 3 weeks, judgment usually follows within months, and an appeal is possible either way. No biosimilar has a UK or EU licence yet; the first EU application was accepted for review only in July 2026. A tender that assumes biosimilar supply in 2027 should say what happens if the court finds for Takeda.

Status and what to watch

Pending. The trial is listed to start in a window from 6 April 2027 and nothing on validity or infringement has been decided. Three things could change the picture before then. The EPO opposition division’s decision on the intravenous dosing patent, the one with six opponents, would be the first ruling anywhere on the core dosing claim, though a UK court decides UK validity for itself. A settlement with any one claimant would, on the pattern of denosumab and aflibercept, tend to set a licensed date for the others. And any appeal on the prosecution bar could disturb the trial timetable. Whether Celltrion is a fifth claimant, who the Dutch and French claimants are and where those cases stand, and the identity of the EPO opponents are all unverified from primary sources at the date of this note. The position in each country, with the patent and SPC references, is in MPA Search.

This note is a summary for commercial readers and is not legal advice.