GSK v Pfizer and BioNTech (Comirnaty): a UPC injunction for 35 countries that waits for a licence

What was decided

GSK’s European Patent 2 590 626 claims a liposome for delivering RNA into cells: a lipid bilayer around a watery core holding RNA that encodes an immunogen, in which one of the lipids has a pKa between 5.0 and 6.8. The pKa is the measure of how readily the lipid picks up a charge. The patent came to GSK with Novartis’s vaccines business in 2015, was filed in 2011 and runs to 2031. It had already survived an opposition at the European Patent Office, where it was revoked at first instance in 2018. A Board of Appeal set that aside in 2020, and the patent was maintained as granted after the opponent withdrew.

GSK sued thirty Pfizer and BioNTech companies at the Unified Patent Court (UPC) in The Hague over Comirnaty, the Covid-19 vaccine, and its variant versions. On 10 November 2026 the court (presiding judge Edger Brinkman) decided three things.

The patent is valid, apart from one claim. Pfizer and BioNTech were held to their five strongest attacks, two on novelty and three on inventive step, and all five failed. Only claim 13, which covers use of the liposome to raise a protective immune response, was revoked: the court found it not credible across its whole breadth, in particular for RNA that does not replicate itself. That revocation applies in the UPC countries.

Comirnaty infringes. The vaccine’s ionisable lipid, ALC-0315, measured at a pKa of about 6.75 to 6.8 by the method the patent prescribes. The court read the claimed range with the patent’s own stated measurement tolerance of 0.2, so the lipid fell inside it. On structure, electron-microscope images showed that a share of the vaccine’s particles, put at 7 to 24 per cent, have a water-filled compartment containing RNA and enclosed by a lipid bilayer. That was enough: not every particle has to match the claim.

The remedy covers most of Europe, but is deferred. These are the two parts that matter beyond this dispute, and each has its own section below.

How the order reaches countries outside the UPC

The injunction covers what the court calls the Relevant Territory: every European Patent Convention country where the patent is in force, except Ireland and the UK. The decision groups them as follows.

Group	Countries	Condition
UPC states	The 18 participating states	None
Other EU states	Cyprus, Czechia, Spain, Greece, Croatia, Hungary, Poland	Falls away if the national court revokes the patent there
Lugano Convention states	Iceland, Norway, Switzerland	Falls away if the national court revokes the patent there
Other European Patent Convention states	Albania, Liechtenstein, Monaco, North Macedonia, Serbia, San Marino, Turkey	None; the court found the patent valid as between the parties

The court reached the 17 countries outside its own territory in three steps.

1. Domicile. Twenty of the defendants are based in UPC states. Under the Brussels I Regulation a court at the defendant’s home can hear claims about that defendant’s acts anywhere, so for those companies the UPC could rule on infringement of every national part of the patent. Pfizer and BioNTech dropped their objection to this at the hearing.
2. Anchor defendants. The remaining companies, among them Pfizer’s Spanish, Polish, Czech, Hungarian, Croatian, Swiss and Norwegian subsidiaries and Pfizer Inc in New York, were joined to the case through the UPC-based companies. The court found that the two groups run Comirnaty as an “interdependent, integrated and centrally controlled” operation: one company holds the EU marketing authorisation, two make the vaccine, one makes the mRNA and the parents take the decisions. Each company’s acts could therefore be attributed to the others as joint infringers.
3. Validity left to the national courts. The UPC cannot revoke a Spanish or Swiss patent. Following the Court of Justice’s 2025 ruling in BSH v Electrolux and the UPC Court of Appeal’s test in Kodak v Fujifilm, it asked only whether there was a reasonable, non-negligible possibility that a national court would hold the patent invalid. It found none, noting that Pfizer and BioNTech had filed no revocation action in any of those countries, and granted the injunction on the condition that it lapses in a country if that country’s court revokes the patent.

GSK did not ask for the UK or Ireland. Those are the two countries where, according to JUVE Patent, Pfizer and BioNTech have brought revocation actions against the patent.

The background to this power, and the other cases on this site where a court has used it, are in the explainer on long-arm jurisdiction.

An injunction designed to produce a licence

GSK itself asked that the injunction should not bite straight away, and the court agreed. It becomes enforceable only when three things are true: the UPC’s decision is final, Pfizer and BioNTech have not taken a licence from GSK within three months of that point, and GSK has given formal notice. The defendants asked for six months and were refused, on the footing that the appeal period gives them time to negotiate as well.

The reasoning is unusually candid about what the case is for. GSK has no Covid-19 vaccine of its own, so the court treated it as a patentee that does not practise the invention and is “mainly after monetary compensation”. Taking Comirnaty off the market would be a major and hard-to-reverse step affecting third parties, and Comirnaty is BioNTech’s only product in the territory. But refusing an injunction altogether would leave GSK without an effective way to enforce its patent. Deferring enforcement was the balance.

The money orders are not deferred in the same way. Pfizer and BioNTech must:

• give GSK sales, price, quantity and profit information for the whole territory back to 1 January 2020, within three months;
• pay an interim award of €2 million towards damages, which will be assessed in separate proceedings;
• pay €1.75 million in agreed costs, plus court fees;
• face penalties of up to €100,000 a day for breach of the injunction once it is enforceable, capped at €50 million in total.

The court set the value of the case at €50 million.

The settlement next door

GSK’s parallel action against Moderna on the same patent was heard in the same week of September 2026, but no decision came. Moderna announced on 6 November that the two companies had settled their US and European litigation on 28 October: each granted the other patent licences in the field of infectious disease, and neither pays anything. The settlement covers Moderna’s Spikevax and mNEXSPIKE Covid-19 vaccines and its RSV vaccine mResvia. The companies asked the US court to dismiss GSK’s claims so that they cannot be refiled, and JUVE Patent reports that withdrawal requests were filed at the UPC.

The two outcomes belong together. A company with patents of its own to trade settled without payment before judgment. The companies that fought on received a judgment built around a three-month window to take a licence. Why disputes of this kind usually end that way, and what it does to dates, is covered in the explainer on settlements.

Timeline

Date	Event
July 2011	International application filed; the patent runs to 2031
2015	GSK acquires the patent with Novartis’s vaccines business; the European patent is granted
2018–2020	EPO opposition: revoked at first instance, set aside on appeal, maintained after the opponent withdrew
December 2020	Comirnaty first authorised in the EU
2025	GSK sues at the UPC in The Hague; Pfizer and BioNTech counterclaim for revocation
3 September 2026	Hearing in The Hague
28 October 2026	GSK and Moderna settle, with cross-licences and no payment
10 November 2026	Decision: patent upheld except claim 13, Comirnaty infringes, injunction for 35 countries, enforcement deferred

What it means if you are…

A parallel trader. Nothing changes for stock. Covid-19 vaccines are bought centrally, and the injunction cannot be enforced before the decision is final and a further three months have passed without a licence.

A generics or biosimilar launch planner. The reach is the lesson. Where the companies in a group work as one supply chain and at least one of them sits in a UPC state, a single UPC action can now produce an order for Spain, Poland, Czechia, Switzerland and Norway as well as the UPC area. The countries outside the UPC can no longer be assumed to follow their own timetable. The defence the court itself pointed to is a national revocation action: the order lapses in any EU or Lugano country where the national court revokes the patent, and none had been filed here. A company that expects to be sued across Europe has a reason to file those actions early.

A wholesaler or buyer. No effect on supply or price for now. If the decision becomes final and no licence follows, the position would change in 35 countries on the same day, but the terms of the order make a licence the far likelier outcome.

Status and what to watch

Pfizer and BioNTech can appeal to the UPC Court of Appeal. Watch for:

• whether an appeal is filed, and whether a licence is announced first;
• national revocation actions in Spain, Poland, Switzerland or the other countries outside the UPC, which would test the condition attached to the order;
• the revocation actions in the UK and Ireland;
• two further GSK patents asserted in The Hague, EP 4 226 941 and EP 4 066 856, where hearings were postponed pending EPO proceedings;
• the separate proceedings to assess damages.