ModernaTX v. Pfizer: Pledge Rejection and Patent Infringement Explained for Pharma Attorneys
- Sarvesh Saxena, Attorney
- Jul 8, 2024
- 4 min read
Introduction
The recent judgment in ModernaTX, Inc. v. Pfizer Limited and BioNTech SE provides significant insights into patent infringement, public pledge, binding contracts and intellectual property management, particularly for general counsels in the pharmaceutical industry. This case revolves around the alleged infringement of Moderna's European Patents (EP949 and EP565) by Pfizer/BioNTech’s SARS-CoV-2 vaccines. The case was decided in the High Court of Justice, Business and Property Courts of England and Wales, Patents Court.
Neutral Citation Numbers:
[2024] EWHC 1648 (Pat) and [2024] EWHC 1695 (Pat), Case Number: HP-2022-000022 and HP-2022-000027
Key Issues and Findings
1. Patent Infringement:
Claims by Moderna: Moderna alleged that Pfizer/BioNTech’s vaccine infringed two UK patents, EP949 and EP565, related to mRNA technology.
Pfizer/BioNTech's Defence: Sought revocation of these patents and argued that their actions were protected under Moderna's public statement made in 2020, known as "the Pledge."
"Beyond Moderna’s vaccine, there are other COVID-19 vaccines in development that may use Moderna-patented technologies. We feel a special obligation under the current circumstances to use our resources to bring this pandemic to an end as quickly as possible. Accordingly, while the pandemic continues, Moderna will not enforce our COVID-19 related patents against those making vaccines intended to combat the pandemic. Further, to eliminate any perceived IP barriers to vaccine development during the pandemic period, upon request we are also willing to license our intellectual property for COVID-19 vaccines to others for the post pandemic period. " - Extract from 2020 Moderna Pledge.
2. The Pledge:
Initial Statement: On 8 October 2020, Moderna publicly pledged not to enforce its COVID-19-related patents against those making vaccines to combat the pandemic.
Update to the Pledge: In March 2022, Moderna updated this statement, indicating that it would enforce patents outside the 92 low- and middle-income countries (AMC 92).
3. Consent and Contract:
Pfizer/BioNTech's Argument: The Pledge created a binding unilateral contract under Massachusetts law or a Federal Law Waiver under US federal law, preventing Moderna from enforcing its patents during the pandemic.
Moderna's Counter: Argued that the Pledge did not constitute legal consent to patent use and had been effectively revoked by the March 2022 update.
"In non-AMC 92 countries, vaccine supply is no longer a barrier to access. In these countries, the Company expects those using Moderna-patented technologies will respect the Company’s intellectual property. Moderna remains willing to license its technology for COVID-19 vaccines to manufacturers in these countries on commercially reasonable terms." - Extract from Moderna Updated Pledge
Key Cases Cited in Judgment
1. United Wire v Screen Repair Services [2001] RPC 24:
Discussed the necessity for consent to be contractual to be valid. It clarified that merely selling a product does not mean the patentee consents to subsequent infringing acts by the purchaser.
The judgment emphasised that for consent to be valid, it must be explicitly given and clearly defined within the contractual framework.
The decision highlighted the importance of clearly delineating the scope and limits of any consent provided to avoid ambiguity in its application to potential infringements.
2. Costa v Dissociadid Ltd [2022] EWHC 1934 (IPEC):
Explored the idea of a “bare licence” formed by conduct, which can terminate only after a reasonable period following notice of revocation.
It was determined that no contract conferring “consent” existed in the Moderna case, hence no requirement for reasonable notice of revocation.
Judgment
1. Patent Validity and Infringement:
Court's Focus: The court concentrated on whether the Pledge constituted consent to the alleged infringements rather than the technical validity of the patents.
Ruling: The court ruled that the Pledge did not provide Pfizer/BioNTech with an enduring defence against patent infringement claims. Moderna was entitled to enforce its patents post-March 2022.
2. Interpretation of the Pledge:
Objective Statement: The court interpreted the Pledge as an objective statement meant to encourage vaccine development during the pandemic but found it did not create irrevocable consent or a binding contract.
The judge refused Pfizer/BioNTech's argument because Moderna's Pledge lacked the specificity and clear intent required for a binding contract. The March 2022 update revoked any implied consent, clarifying Moderna's intent to enforce its patents outside specified countries.
The Pledge was interpreted as an encouragement for vaccine development, not a legal commitment. There was no mutual intention to create legal relations, making the Pledge non-binding.
Effect of Update: Moderna’s update in March 2022 effectively revoked any implied consent, limiting non-enforcement to vaccines for use in AMC 92 countries.
3. Outcome:
- EP949: Valid and infringed by Pfizer/BioNTech.
- EP565: Found to be obvious over prior art (WO674) and invalid for added matter, but not anticipated by WO674.
Lessons for Intellectual Property Counsels in the Pharmaceutical Industry
1. Clarity in Public Statements:
Ensure that public pledges or statements regarding patent enforcement are clear and legally binding, with specific terms to avoid ambiguity.
2. Understanding Legal Implications:
Recognise that public statements may not always constitute binding legal agreements unless explicitly stated and mutually accepted as such.
3. Regular Review and Updates:
Continuously review and update public statements and pledges to reflect the current legal stance and ensure stakeholders are informed.
4. Expert Witness Preparation:
Hire robust and credible expert witnesses for litigation to ensure that your case is presented competently supporting your claim.
By integrating these lessons, Intellectual Property Counsels can better navigate complex patent litigation, safeguard their organisations' intellectual property rights, and ensure fair outcomes in disputes.
For a deeper dive into the judgment and its implications, refer to the detailed court documents and legal analyses.
Sources : Judgment Summary
LEGAL ANALYSIS BY: Sarvesh Saxena, Barrister, Bar of England & Wales. Authorised to conduct unreserved legal services. No Rights of Audience.
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Legal Disclaimer:
This article is for general informational purposes only and is not legal advice. It may not reflect the latest legal developments and is not guaranteed to be accurate or complete. No attorney-client relationship is created by this article. Readers should seek professional legal advice from a qualified attorney in their jurisdiction before making any legal decisions. The author disclaims all liability for actions taken based on this article's content.
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