Modernatx Inc v Pfizer Limited & Ors
[2024] EWHC 1695 (Pat)
Pfizer Limited v GlaxoSmithKline Biological SA & Anor
7 October 2024
[2024] EWHC 2523 (Pat)
High Court
Pfizer's RSV vaccine was challenged by GSK who held patents on a similar technology. The judge decided that GSK's patents were based on ideas that were already known, making them invalid. Pfizer's vaccine doesn't infringe on these invalid patents, and the judge officially declared that the main parts of Pfizer's vaccine were already obvious to experts at the time, allowing Pfizer to sell their vaccine.
Key Facts
- •The case concerns two GSK patents (EP258 and EP710) for an RSV vaccine using a stabilized prefusion F protein.
- •Pfizer challenged the patents' validity and sought to clear the way for their RSV vaccine.
- •Key issues included the composition of the skilled team, their common general knowledge (CGK), claim construction, infringement, priority, novelty, and obviousness.
- •GSK's case relied heavily on secondary evidence of non-obviousness, which was largely developed during cross-examination.
- •Disputes centered on the level of expertise needed in the skilled team (specifically, the need for a structural biologist) and the scope of the CGK.
Legal Principles
Obviousness assessment using the Pozzoli/Generics v Lundbeck framework.
Actavis v ICOS [2019] UKSC 15
Infringement by equivalence assessment using the Actavis v Lilly framework.
Actavis v Lilly [2017] UKSC 48
Priority entitlement considering legal and equitable title, with focus on substantive rights.
KCI Licensing v Smith & Nephew [2010] EWHC 1487 (Pat)
Sufficiency requiring clear and complete disclosure enabling performance without undue burden.
Eli Lilly and Company v Human Genome Sciences Inc [2008] EWHC 1903 (Pat)
AgrEvo principle: technical contribution must justify the scope of the claim.
Generics v Yeda [2013] EWCA Civ 925
Plausibility requires some reason for supposing the claimed technical effect is true.
Fibrogen v. Akebia [2021] EWCA Civ 1279
Arrow declaration considering justice to both parties, usefulness, and special reasons.
Fujifilm Kyowa Kirin Biologics Co Ltd v AbbVie Biotechnology Ltd [2017] EWHC 395 (Pat)
Outcomes
Both EP258 and EP710 patents are invalid for obviousness.
The court found that the prior art (Jardetzky Abstract and Slides, Yin 2006, ASV Abstract) clearly suggested the claimed inventions and the CGK would have enabled a skilled team to arrive at the inventions without undue burden. Secondary evidence presented by GSK was deemed incomplete and insufficient to overcome the strong prima facie case for obviousness.
The patents are not insufficient.
The court found that the specification provided sufficient directions to enable the inventions to be performed without undue burden, despite Pfizer's arguments about the uncertainty surrounding the term "stabilized."
The patents are not invalid under AgrEvo principles.
The court determined that the claims were restricted to subject matter that made good the technical contribution, thus not exceeding the technical contribution of the patents.
The allegation of lack of plausibility is rejected.
The court found that the specification rendered plausible the use of PreF antigens with or without an adjuvant for preventing or treating RSV-associated diseases.
Pfizer's RSVPreF product does not infringe either patent.
The court's construction of the term "polypeptide" led to the conclusion that Pfizer's product, due to its structure, did not meet the claims' requirements for a single polypeptide. The court also found that the RSVPreF product did not achieve stabilization in substantially the same way as the patented inventions, even when considering the doctrine of equivalents.
The Arrow Declaration is granted.
The court found that it was obvious at the priority date to make the RSV antigen described and use it as claimed. The declaration was deemed to serve a useful purpose due to the commercial uncertainty surrounding GSK's divisional applications and the potential impact on Pfizer's ability to supply its vaccine in the UK.