Context: In a long-running patent infringement dispute between Pfizer, BioNTech and Moderna that began in September 2022, the the High Court of Justice for England & Wales (EWHC) granted Moderna a major win last July, finding that one of two patents it asserted was valid and infringed (EP3590949: July 2, 2024 judgment). In that same judgment, Mr Justice Meade found that the other patent (EP3718565) was invalid. All three companies appealed against that judgment, and while Mr Justice Meade granted Pfizer and BioNTech permission to file appeals in the England & Wales Court of Appeal (EWCA), Moderna was refused that right (September 25, 2024 judgment).
What’s new: In a two-day hearing last week, the EWCA heard Pfizer and BioNTech’s arguments as to why it should overturn the EWHC’s decision. The appellants argued that Moderna’s developments of mRNA technology were “obvious” and should therefore make the patent invalid, and that the judge made several crucial errors when ruling that the patent was not obvious, including an incorrect identification of the skilled person and “an unwarranted overemphasis” on the skilled person’s expectation of success.
Direct impact and wider ramifications: This case in the UK is part of a global fight between the COVID vaccine developers, who are also defending their patents in courts in the U.S., Germany, the Netherlands, and Belgium. The EWHC’s decision last July was a huge success for Moderna, but if Pfizer and BioNTech are successful in their invalidity appeal, this could significantly swing the pendulum in the appellants’ direction.
In a two-day hearing that started last Thursday, Pfizer and BioNTech made several arguments as to why the EWCA should overturn the EWHC’s validity findings:
- Novelty: Pfizer advanced three routes on novelty, and, as can be seen, despite having correctly identified the disclosure test for novelty, Pfizer and BioNTech claimed that Mr Justice Meade failed to apply that test appropriately to the facts, instead applying too strict a standard as to what was required to feature in the prior art for novelty to be destroyed.
- Obviousness: The judge made three errors that were “central” to his reasoning as to why the patent was not obvious. Had he not made any or all of the “errors”, Mr Justice Meade would have found that the patent was obvious:
- Skilled person: an incorrect identification of the skilled person and the associated finding that Prof Rosenecker was a more useful witness in helping the Judge to understand how the skilled person would think than Dr. Enright.
- Hindsight: a finding that Dr. Enright’s conclusions as to obviousness were given with hindsight, which was wrong and unfair.
- A fair or reasonable expectation of success: an “unwarranted overemphasis” on the skilled person’s expectation of success. The Judge “erred” in placing too much weight on the expectation of success, which should have afforded “considerably less weight, if any at all”.
In response to the appeal, Moderna argued that Mr Justice Meade’s approaches to obviousness and novelty were “entirely correct”.
In particular, counsel to Moderna noted during the hearing that the judge’s main task was to evaluate the patent in light of the evidence provided and arrive at a judicial determination as to whether it disclosed the combination of all the features in claim 3 either directly and unambiguously or by way of clear and unmistakable directions. “He rightly concluded that claim 3 was not anticipated,” they argued.
Moderna’s counsel also emphasized that the judge adopted the “right approach in law” in relation to obviousness:
He undertook a careful and detailed appraisal of the evidence, in the light of which he correctly identified EP949’s skilled person, correctly found that [the witness] Dr Enright’s approach was tainted by hindsight, and rightly concluded that the invention of claim 3 was not obvious. As the Judge explained in §415: “I must assess all these matters in the round. Doing so, I find that Pfizer/BioNTech’s obviousness case fails, and it is not a close call, either.” (emphasis added).
To get an appeal off the ground, Pfizer would have needed to identify a “fundamental error” in Mr Justice Meade’s approach, but no such error is articulated in their arguments, counsel alleged. “Instead, each aspect of PBNT’s appeal on obviousness goes to an alleged error of evaluation.”
The grounds of appeal go nowhere, as they are merely “complaints” about the judge’s impression of the witnesses, his findings in the light of their evidence, or the weight he gave to particular factors in the multi-factorial assessment of the statutory question, Moderna said.
“Moderna’s position is very simple [in relation to the skilled person],” counsel added, “the Judge followed the correct approach in law… undertook a textbook analysis of the materials in the case.”
And, Moderna added, the weight that the judge gave to the expectation of success in the overall assessment of the case was “a matter for the Judge” and a “non-starter” argument. Pfizer’s arguments claiming the contrary “have no substance” and “do not follow”, they said, adding:
“Just because, once someone has decided to do some work and has carried it out, the product of that work is useful, in no sense means it was obvious to undertake the work. Still less does it mean that it is obvious to do that work instead of taking forward an option in respect of which the prior art confers great promise, particularly in a field starved of promise for so long.”
This, Moderna concluded, is another “prime example” of how isolating and decontextualising particular elements of the global assessment is “dangerous and apt to mislead”.
Counsel
Pfizer is being represented Three New Square’s Tom Mitcheson KC and Alice Hart, as well as a team at Taylor Wessing LLP.
BioNTech is being represented by Michael Tappin KC and Michael Conway at 8 New Square, as well as a team at Powell Gilbert LLP: Tess Waldron, Dan Down, and Penny Gilbert.
Meanwhile, Moderna is being represented by Three New Square’s Andrew Waugh KC, Stuart Baran, Katherine Moggridge, and Richard Darby, as well as 11 South Square’s Piers Acland KC, and a team at Freshfields Bruckhaus Deringer LLP.
Global COVID patent infringement litigation
Pfizer and BioNTech’s case is one of an increasing number of COVID vaccine-related patent infringement disputes around the world. In October, Pfizer celebrated a major win in a dispute against CureVac, when the EWHC invalidated two of the latter’s patents. GlaxoSmithKline also joined the mRNA patent wars last April, suing Pfizer and BioNTech for infringing five of its COVID-19 vaccine patents (April 26, 2024 ip fray article). That dispute was concluded within 12 months, however, after GSK and Pfizer announced last month that they would be dismissing their case with prejudice (April 4, 2025 ip fray article).
Moderna’s Spikevax has also been targeted in several patent infringement suits. In February 2022, nucleic acid delivery company Genevant Sciences and clinical-stage biopharmaceutical company Arbutus Biopharma Corporation sued Moderna for allegedly infringing six U.S. patents in the District of Delaware (February 28, 2022 Genevant press release). The companies then expanded their enforcement campaign in March, filing suits in the Federal Court of Canada, the Tokyo District Court, Switzerland’s Federal Patent Court, and the Unified Patent Court (UPC) (March 4, 2025 ip fray article). Genevant and Arbutus are seeking monetary relief and injunctions against Moderna’s infringing vaccinations in every jurisdiction.
Moderna also celebrated a huge win in June in a separate case filed by Alnylam in the District of Delaware, when the United States Court of Appeals for the Federal Circuit upheld the district court’s findings that Moderna did not infringe its lipid nanoparticle (LNP) technology patents (June 6, 2025 ip fray article). The decision, which was precedential, concluded that Alnylam had acted as its own lexicographer in defining the term “branched alkyl” in its patent specifications, and this definition foreclosed Alnylam’s infringement allegations against Moderna.