BioNTech SE & Anor v CureVac SE & Anor

BioNTech SE & Anor v CureVac SE & Anor

The patents are invalid for insufficiency because the technical contribution (improved expression from split poly(A) tails) is not plausibly disclosed or enabled across the scope of the claims, and is not in fact achieved by substantially all claimed mRNAs. The patents are also obvious over Thess, which motivates the skilled person to test constructs falling within the claims. The added matter attack fails as the claim features are individually and unambiguously disclosed in the application as filed.

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
21 October 2024
Procedural Posture
Patent Revocation and Validity Trial / First Instance Judgment
Outcome
Patents revoked for insufficiency and obviousness; added matter attack dismissed.
Legal Topics
Sufficiency, Plausibility, Obviousness, Added Matter, M RNA Technology, Biotechnology Patents
Intellectual Property Patents Sufficiency Plausibility Obviousness Added Matter M RNA Technology Biotechnology Patents

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 are plausible and sufficient across their scope
  2. 2 Whether the patents are obvious over Thess
  3. 3 Whether there is added matter in the granted claims

Ratio Decidendi

The patents are invalid for insufficiency because the technical contribution (improved expression from split poly(A) tails) is not plausibly disclosed or enabled across the scope of the claims, and is not in fact achieved by substantially all claimed mRNAs. The patents are also obvious over Thess, which motivates the skilled person to test constructs falling within the claims. The added matter attack fails as the claim features are individually and unambiguously disclosed in the application as filed.

Court Disposition

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

Orders

  • EP668 and EP755 declared invalid for insufficiency and obviousness.
  • Added matter ground dismissed.