UPC finds Comirnaty infringes GSK’s RNA-delivery patent—but delays the injunction

The story

The Unified Patent Court has found that Pfizer and BioNTech’s Comirnaty COVID-19 vaccine infringes a GSK patent on lipid structures used to deliver RNA into cells. The November 10 decision is a significant first-instance victory for GSK, but it does not order an immediate vaccine withdrawal. The court deliberately postponed enforcement of the injunction until the UPC judgment is final and Pfizer and BioNTech have had a further three months to reach a license.

The dispute concerns European Patent EP 2 590 626, titled “Liposomes with lipids having an advantageous pKa-value for RNA delivery.” Its asserted claims cover liposomes with an ionizable lipid bilayer, an aqueous RNA-containing core and specified pKa characteristics. Those chemical properties help a particle protect RNA and release it after entering a cell. The patent therefore concerns a delivery system used by an mRNA vaccine—not ownership of messenger RNA, COVID-19 vaccination or Comirnaty as a whole.

The Hague Local Division held claims 1, 2, 3, 6, 10 and 12 valid between the parties and infringed by Comirnaty. It revoked claim 13. A central question was how strictly to read the claimed pKa range of 5.0 to 6.8. The judges read the claims with the description, which disclosed measurement imprecision of plus or minus 0.2 pKa units, and rejected a rigid numerical boundary. They also found that different portions of the range were entitled to two priority dates in 2010.

That reasoning matters beyond this vaccine. In chemistry and biotechnology patents, a decimal boundary can decide whether a product falls inside a claim and whether earlier technical literature destroys novelty. The court’s approach makes the specification and the disclosed measurement method essential to claim scope. It does not establish that every stated numerical range is flexible; it ties the result to this patent’s text, method and evidence.

The remedy is broad on paper. The court prohibited infringement across European Patent Convention countries where the patent is valid, except Ireland and the United Kingdom, and treated the Pfizer-BioNTech group’s integrated development, manufacturing and sales structure as joint infringement. For non-UPC countries, enforcement is additionally conditioned on national courts not finding the patent invalid. Ireland and the UK remain outside the injunction because parallel national cases are proceeding there.

The practical position is narrower. GSK itself requested delayed enforceability, and the court agreed. The injunction becomes enforceable only after a final, irrevocable UPC decision, only if the parties have not signed a license within three months after that decision, and only after GSK files the required enforcement notice. The judges said an immediate removal could have a major impact on the companies and third parties relying on the vaccine, while GSK—described as a non-implementing patent owner in this market—could be compensated financially.

Other consequences arrive sooner. Pfizer and BioNTech were declared jointly and severally liable for damages and ordered to pay a €2 million interim award. They must also provide sales, distribution, pricing and profit information dating from January 2020, and pay €1.75 million toward GSK’s costs. Those information, payment and cost orders are immediately enforceable if GSK gives the prescribed notice; the ultimate damages total will be determined separately.

The decision can be appealed within two months. BioNTech’s November 3 securities filing, published before the ruling, said the companies believed they had strong defenses and intended to defend the litigation vigorously. An appeal would keep the injunction from becoming final while the Court of Appeal reviews validity, infringement, territorial reach and remedy. The delayed structure therefore converts the next phase into a race between appellate review and commercial licensing, not an imminent stop-sale.

INNOVOX analysis: the most consequential feature is the court’s separation of legal entitlement from immediate market disruption. GSK obtained a finding of infringement, damages leverage and a future injunction across a multinational operating network. Pfizer and BioNTech retained continuity of supply and time to challenge the result or buy freedom to operate. That balance may become a template in health-technology cases where a conventional immediate injunction would place patients and public systems inside a private patent dispute.

What to watch now is whether the Court of Appeal accepts the Hague division’s treatment of pKa measurement uncertainty and partial priority. The outcome will influence how narrowly companies can design around quantitative biotechnology claims. Equally important will be any license: its scope, geography and treatment of future vaccine variants could reveal whether the judgment becomes a durable boundary for RNA-delivery technology or mainly a bargaining point in an already crowded mRNA patent landscape.

INNOVOX analysis

The judgment turns a delivery-system patent into immediate financial leverage without forcing an abrupt vaccine withdrawal. That split remedy is the important precedent: the UPC recognized infringement across an integrated multinational supply chain, yet used delayed enforceability to protect patients and give the companies time to appeal or license the technology.

What to watch

Watch for an appeal within the court’s two-month window, any stay or variation of the immediately enforceable financial and information orders, and licensing talks between GSK and Pfizer/BioNTech. Challenges in non-UPC EPC states and parallel proceedings in Ireland and the UK could also narrow the ruling’s practical reach.