Patent judgments highlight ramifications of Covid vaccine pledges

The High Court in England and Wales recently handed down two decisions in the patent battle between Moderna and Pfizer/BioNTech in respect of Pfizer/BioNTech’s Covid-19 vaccine Cominarty. This is a high profile action, with parallel proceedings in other jurisdictions including Ireland, Germany, the Netherlands and the US, and before the EPO.

One judgment related to Moderna’s pledge not to enforce Covid-19 patents against those seeking to develop vaccines to help bring the pandemic to an end (the pledge decision), and the other considered issues relating to the enforcement and validity of Moderna’s Covid-19 vaccine patents (the patent decision). 

In the patent decision, the court considered Pfizer/BioNTech’s liability for infringement of two patents owned by Moderna, both of which pre-date the Covid pandemic by several years.

While Pfizer/BioNTech admitted infringing the first patent in issue, European Patent (UK) No. 3 718 565 (EP565), which concerns a betacoronavirus mRNA vaccine encoding a spike protein which is formulated into a lipid nanoparticle (Covid-19 is a betacoronavirus), the court found the patent to be invalid on the grounds of obviousness and added matter.

However, the court dismissed Pfizer/BioNTech invalidity arguments in respect of the second patent in issue, European Patent (UK) No. 3 590 949 (EP949) which concerns the nucleotides used to make mRNA vaccines such as Comirnaty. Pfizer/BioNTech admitted infringing this patent.

On the basis of Pfizer/BioNTech’s admissions, Pfizer/BioNTech were found to have infringed a valid Moderna patent, and therefore, subject to appeal, will have to pay Moderna damages for in respect of its sales of Comirnaty in the UK. However, issues arose as to whether Pfizer/BioNTech’s had a valid defence to infringement. These were considered in the pledge decision, which is the first decision in the world to consider the scope of Moderna’s Covid-19 vaccine pledge.

Pfizer/BioNTech argued that if any of the patents were found valid and infringed, it could rely upon Moderna’s pledge - a public statement on 8 October 2020 to the effect that, while the pandemic continued, it would not enforce its patents against those making Covid-19 vaccines.

Pfizer/BioNTech said Moderna’s statement amounted to ‘consent’ to acts that would otherwise amount to patent infringement under section 60 of the UK Patents Act 1977. They also said that the pledge amounted to an offer, which they accepted by conduct, resulting in a  unilateral contract under Massachusetts law which prevented Moderna from enforcing the patents against them until the pandemic ended. Finally, they said that the pledge amounted to a partial waiver of Moderna’s patent rights under US Federal law.

Pfizer/BioNTech failed on the unilateral contract and Federal law waiver issues, but the court  found that the pledge did amount to consent to Pfizer/BioNTech’s actions under section 60 of the Patents Act 1977. The judge explained that, on an objective reading, Moderna failed in its argument that the pledge did not confer consent to companies such as Pfizer/BioNTech that were already making Covid-19 vaccines prior to the date of pledge.  

However, a further issue related to the duration over which the pledge would operate. Moderna argued that even if the pledge did confer consent upon Pfizer/BioNTech, it was withdrawn by a subsequent public statement made in March 2022, which it said made clear that the non-enforcement would only apply to low and middle income countries. In contrast, Pfizer/BioNTech argued that the pledge remained until 5 May 2023, the date on which the WHO Emergency Committee declared that Covid-19 no longer constituted a public health emergency.

The judge dismissed Pfizer/BioNTech’s arguments, instead finding that the relevant time period was 8 October 2020 until 7 March 2022, when Moderna’s second statement effectively withdrew the original pledge.

If this decision is upheld on appeal, Pfizer/BioNTech will therefore be liable to pay damages – to be determined at a further trial - in respect of sales of Comirnaty in the UK after 7 March 2022. Moderna have not claimed injunctive relief and therefore Pfizer/BioNTech will be able to continue selling Comirnaty in the UK.

Ian Turner of Pinsent Masons said: “While the precise scenario is highly unlikely to arise again, patent holders should take heed of the potential ramifications of statements seeking good PR. Only make comments about not enforcing patents against competitors if you wish to stick to your word, at least for the UK. However, for those wishing to use such technology, this decision indicates that Pfizer/BioNTech should have continued to keep their position under review, and should have identified the risk that a license may be required as soon as Moderna modified their pledge, if not before. It was always going to be difficult to argue that a patentee was unable to withdraw an informally provided ‘consent’ such as Moderna’s pledge.”

The global nature of the Covid pandemic inevitably means that patent disputes in relation to the technology are not limited to just one jurisdiction. Karen Gallagher of Pinsent Masons said “While the first instance UK decisions are overall favourable to Moderna, they are only one part of a wider, global battle between these Covid vaccine manufacturers. Attention will now turn to proceedings in other jurisdictions which are part of the vaccine supply chain, including Germany, Ireland, Belgium and the US.” 

Proceedings were issued in Ireland last year, but then paused, potentially pending the results of the UK litigation.

“Assuming the Irish proceedings are now revived, there is a risk for Pfizer/BioNTech that the Irish Courts will come to the same conclusions as their counterparts in the UK, due to the similarity in patent law and legal approach between the two jurisdictions,” said Gallagher.

While the UK rulings are only a partial win for Moderna, “they bring into focus the importance of foundational mRNA technology that is critical for a class of therapeutics with great promise more widely. For example, Moderna recently obtained approval from the US Food and Drug Administration for a mRNA vaccine against respiratory syncytial virus which can protect older adults from lower respiratory tract disease”, said Turner.