The Modern v Pfizer-Biontech COVID-19 vaccine dispute: a brief explanation

Modern’s patent infringement claim against Pfizer and BioNTech about its COVID-19 vaccine technology has been widely reported. After filing lawsuits in August 2022 in the US and Germany, Modern has now launched related proceedings[1] in the UK Patents Court. In response, Pfizer and BioNTech have issued separate UK claims[2] that Modern’s patents are invalid and should therefore be revoked.

This article discusses the issues in the UK proceedings, although it is to be expected that similar arguments will arise in the US lawsuit.

Background

Modern made headlines in October 2020 when it issued a ‘patent pledge’ which stated that it would not enforce its COVID-19 related patents against those making vaccines intended to combat the pandemic ‘while the pandemic continues’. In March 2022, Modern issued a revised version of the pledge that limited it to companies manufacturing in or for 92 low- and middle-income countries, thus signalling its intention to enforce its rights in higher-income territories such as the USA and Europe.

Unusually for a patent infringement case, Modern is not requesting a court order to prevent Pfizer and BioNTech from selling its vaccine. Instead, it has requested ‘payment of appropriate compensation… in lieu of an injunction’ together with a damages payment for sales of Pfizer’s competing product which, given the global sales of the product, could be a huge sum.

The differing technologies

The patent cases concern Pfizer and BioNTech’s Cominarty® COVID-19 vaccine which was authorised before Modern’s Spikevax® in both the UK and the USA. Both vaccines work by using messenger rn (mrn) to create an immune response against the virus that causes COVID-19. They are the first vaccines to be authorised using this new mrn technology.

Most traditional vaccines work by introducing weakened or inactivated viruses or virus proteins to the body, triggering the immune system to respond. In contrast, mrn vaccines work by providing the ‘code’ for cells to make copies of viral proteins – or fragments of those proteins – triggering an equivalent immune response.

A significant advantage of this approach is that, because no potentially infectious material is introduced to the body, the vaccine is safer. In addition, the mrn degrades naturally so no additional or potentially toxic chemicals are needed to inactivate the vaccine. The technology can also be used to manufacture and modify vaccines more quickly than conventional techniques.

In addition to vaccines, mrn technology shows significant promise as a therapy for other diseases such as cancer as it can be used to deliver tailored proteins directly into cells.

What are coronaviruses?

Coronaviruses are named for the crown-like protrusions or ‘spikes’ on their surface. These spike proteins mediate entry of the virus into host cells, which is necessary for the virus to replicate.

There are four main types of coronavirus. SARS-CoV-2, the virus which causes COVID-19, is a new member of the group of ‘beta’ coronaviruses which includes the viruses that cause Middle East respiratory syndrome (MERS) and severe acute respiratory syndrome (SARS).

mrn technology: Modern’s infringement claim

Modern is asserting its patent rights in respect of three elements of the Cominarty® vaccine:

• Use of lipid nanoparticles to encapsulate mrn

The vaccine mrn must be delivered inside cells for protein synthesis to occur. One way of achieving this is to encapsulate the mrn strands in tiny bubbles of fat, known as lipid nanoparticles. This is the method used for Cominarty®.

Modern has asserted that the formulation of the lipid nanoparticles used in Cominarty®, in particular the types and ratios of lipids used, infringes its patent rights.

• Replacement of uracil with N1-methylpseudouridine in the vaccine mrn

Early attempts to deliver mrn into cells were limited by the inherent instability of mrn and concern about allergic reactions to it. In the mid-2000s, it was discovered that modifying uracil, one of the four building blocks of rn, to create an analogue called pseudouridine significantly improved the stability and safety of mrn.  

Modern has claimed that the mrn in Cominarty® contains N1-methylpseudouridine in place of the uracil building blocks. In turn, Pfizer and BioNTech’s case is that this technique to stabilise mrn was well known and therefore obvious to do at the relevant time, particularly in light of the work of Katalin Karikó, an eminent mrn research scientist who is now at BioNTech.

• Use of mrn which codes for the SARS-CoV-2 spike (S) protein

Cominarty® contains mrn strands which code for the entire spike protein of the COVID-19 virus. Modern is asserting that this infringes its patent rights which cover (in part) a ‘betacoronavirus mrn vaccine’ encoding the coronavirus spike protein.

Pfizer and BioNTech’s position is that, given the previous work on MERS and SARS, the spike protein was well known to be a primary target for vaccine development for a betacoronavirus.

The patents asserted by Modern in the US and UK proceedings claim these elements either individually or in combination. There are three US patents asserted in the US infringement claim. For the UK proceedings, the relevant patents are EP (UK) 3590949 (concerning the replacement of uracil in mrn) and EP (UK) 3718565 (concerning a betacoronavirus mrn vaccine encoding the spike protein, formulated in a lipid nanoparticle comprising four types of lipid molecule).

Implications for mrn technology

As Modern’s patents relate to the fundamental principles of mrn technology, they are likely to apply to future developments in mrn vaccines and therapeutics. This is a rapidly developing area of medicine, with mrn vaccines currently in development for conditions such as influenza, rabies and respiratory syncytial virus (RSV).

An analysis of the market for mrn technology published last year revealed that more than 30 biopharma companies were working on mrn vaccines and/or therapeutics last year. If the patents are upheld, they could provide a lucrative future revenue stream for Modern. With such high stakes, these claims are likely to be fiercely fought.

Modern is also facing claims relating to mrn technology from Alnylam Pharmaceuticals, Arbutus Biopharma and Genevant Sciences. CureVac, a German pharmaceutical company, has also launched proceedings against Pfizer and BioNTech for alleged infringement of four of its patents relating to lipid nanoparticle technology.

[1] Case No. HP-2022-000022

[2] Case No. HP-2022-000027