Pfizer Inc & Anor v Modernatx Inc

For the purposes of Patents Act 1977, consent to acts that would otherwise infringe a patent may be given informally and need not be contractual. A patentee’s statement that it will not enforce patents may therefore amount to consent, but consent remains capable of withdrawal unless supported by an irrevocable contractual obligation.

Foreign law may establish facts relevant to consent, including a contract governed by foreign law. The English court must nevertheless apply the UK statutory concept of consent. A temporary forbearance to sue for patent infringement is not, without more, an irrevocable waiver of patent rights under US federal law.

Modernatx, Inc alleged that Pfizer and BioNTech’s COVID-19 vaccine infringed two UK patents. Pfizer and BioNTech relied on Moderna’s public statement of 8 October 2020, under which Moderna said that, while the pandemic continued, it would not enforce its COVID-19-related patents against those making vaccines intended to combat the pandemic.

The parties disputed the objective meaning and duration of that statement, the effect of Moderna’s March 2022 update, and whether the statement created either a unilateral contract governed by Massachusetts law or a waiver under US federal law. The court also considered whether those foreign-law matters could establish consent under section 60 of the Patents Act 1977.

1. Consent and foreign law. The question whether the patentee consented to otherwise infringing acts was governed by section 60 of the Patents Act 1977. Foreign law could establish relevant facts, including an irrevocable foreign-law contract, but could not displace the UK statutory concept of consent. The court therefore considered the asserted Massachusetts contract and US federal-law waiver.
2. Construction of the Pledge. Objectively construed, the Pledge applied to persons already making vaccines intended to combat the pandemic, including Pfizer/BioNTech. The expression pandemic period was worldwide rather than country-specific, but the Pledge gave no objectively certain means of determining when that period ended. The forward-looking-statements wording meant that Moderna reserved the ability to change its position and stated that the relevant statements were neither promises nor guarantees.
3. March 2022 Statement. The March 2022 Statement withdrew the non-enforcement assurance outside the AMC 92 countries while retaining a commitment for vaccines manufactured solely for use in those countries. It therefore revoked the relevant consent from 7 March 2022.
4. Unilateral contract. Under Massachusetts law, a unilateral contract requires offer, acceptance and consideration. The forward-looking-statements wording objectively manifested no intention to make a contractual offer. Alternatively, although manufacture of the vaccines with knowledge of the Pledge raised a presumption of acceptance, Pfizer/BioNTech’s conduct was inherently ambiguous and showed no assent to the Pledge. The same reasoning defeated consideration. No unilateral contract was formed.
5. US federal-law waiver. A temporary forbearance to sue was more naturally characterised as an implied licence or estoppel requiring reliance than as an irrevocable federal-law waiver. The Pledge was not such a waiver. Even if it had been, it was retracted by the March 2022 Statement before material reliance.
6. Disposition. Pfizer/BioNTech had non-contractual consent between 8 October 2020 and 7 March 2022. The consent was thereafter revoked. The pleaded unilateral-contract and federal-law-waiver cases failed.