BioNTech SE & Anor v CureVac SE & Anor [2024] EWHC 2538 (Pat) (08 October 2024)

BioNTech SE & Anor v CureVac SE & Anor [2024] EWHC 2538 (Pat) (08 October 2024)

The patents do not disclose the technical contribution alleged by CureVac; the skilled person would not understand the patents to teach that a split poly(A) tail improves protein expression beyond the known effects of poly(A) tail length. The effect is not plausible or achieved across the scope of the claims, as the experiments do not support a general improvement and the common general knowledge teaches a plateau and masking effect. The patents are also obvious over the prior art (Thess). The added matter attack fails.

Citation
[2024] EWHC 2538 (Pat)
Parties
Claimant: BioNTech SE; Claimant: Pfizer Inc.; Defendant/part 20 Claimant: CureVac SE; Part 20 Defendant: BioNTech Manufacturing GmbH; Part 20 Defendant: Pfizer Limited
Jurisdiction
England and Wales
Judgment Date
08 October 2024
Procedural Posture
Patent Revocation and Validity Trial / First Instance Judgment
Outcome
Patents EP668 and EP755 revoked for insufficiency and obviousness; added matter attack dismissed.
Legal Topics
Patent Validity, Sufficiency, Obviousness, Added Matter, Common General Knowledge, M RNA Technology
Intellectual Property Patents Patent Validity Sufficiency Obviousness Added Matter Common General Knowledge M RNA Technology

Case Brief

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Parties

BioNTech SE

Claimant

Pfizer Inc.

Claimant

CureVac SE

Defendant/part 20 Claimant

BioNTech Manufacturing GmbH

Part 20 Defendant

Pfizer Limited

Part 20 Defendant

Procedural Posture

Patent Revocation and Validity Trial / First Instance Judgment

Legal Issues

  1. 1 Whether the patents EP668 and EP755 disclose a technical contribution as alleged by CureVac
  2. 2 Whether the technical contribution is plausible across the scope of the claims
  3. 3 Whether the technical contribution is in fact achieved across the scope of the claims

Ratio Decidendi

The patents do not disclose the technical contribution alleged by CureVac; the skilled person would not understand the patents to teach that a split poly(A) tail improves protein expression beyond the known effects of poly(A) tail length. The effect is not plausible or achieved across the scope of the claims, as the experiments do not support a general improvement and the common general knowledge teaches a plateau and masking effect. The patents are also obvious over the prior art (Thess). The added matter attack fails.

Court Disposition

Patents EP668 and EP755 revoked for insufficiency and obviousness; added matter attack dismissed.

Orders

  • EP668 and EP755 are revoked.
  • CureVac's conditional application to amend the patents is dismissed as moot.