Modernatx Inc v Pfizer Limited & Ors

Modernatx Inc v Pfizer Limited & Ors

EP949 is valid and infringed: the prior art (UPenn, Karikó 2008) does not clearly and unambiguously disclose or render obvious the claimed mRNA with 100% N1-methyl-pseudouridine substitution, as the skilled person would not be motivated or have reasonable expectation of success to select and test m1Ψ absent hindsight. EP565 is invalid: it is obvious over WO674, which expressly teaches an mRNA/LNP vaccine for MERS-CoV spike protein, and the skilled team would be motivated to pursue this with reasonable expectation of success. EP565 also contains added matter, as the application as filed does not clearly and unambiguously disclose the combination of all physical features of the claims. None...

Parties
Claimant/defendant: MODERNATX, INC.; Defendant/claimant: PFIZER LIMITED; Defendant: PFIZER MANUFACTURING BELGIUM NV; Defendant/claimant: PFIZER INC.; Defendant: BIONTECH MANUFACTURING GMBH; Defendant/claimant: BIONTECH SE
Jurisdiction
England and Wales
Judgment Date
07 February 2024
Procedural Posture
Patent Revocation and Infringement / Final Judgment After Trial
Outcome
EP949: Valid and infringed. EP565: Invalid for obviousness and added matter. Proposed amendments to EP565 refused.
Legal Topics
Patent Validity, Obviousness, Novelty, Added Matter, Sufficiency, M RNA Technology, COVID 19 Vaccines

Case Brief

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Parties

MODERNATX, INC.

Claimant/defendant

PFIZER LIMITED

Defendant/claimant

PFIZER MANUFACTURING BELGIUM NV

Defendant

PFIZER INC.

Defendant/claimant

BIONTECH MANUFACTURING GMBH

Defendant

BIONTECH SE

Defendant/claimant

Procedural Posture

Patent Revocation and Infringement / Final Judgment After Trial

  1. 1 Whether EP949 is anticipated or obvious over prior art (UPenn, Karikó 2008)
  2. 2 Whether EP565 is anticipated or obvious over prior art (WO674, Pardi)
  3. 3 Whether EP565 contains added matter

Ratio Decidendi

EP949 is valid and infringed: the prior art (UPenn, Karikó 2008) does not clearly and unambiguously disclose or render obvious the claimed mRNA with 100% N1-methyl-pseudouridine substitution, as the skilled person would not be motivated or have reasonable expectation of success to select and test m1Ψ absent hindsight. EP565 is invalid: it is obvious over WO674, which expressly teaches an mRNA/LNP vaccine for MERS-CoV spike protein, and the skilled team would be motivated to pursue this with reasonable expectation of success. EP565 also contains added matter, as the application as filed does not clearly and unambiguously disclose the combination of all physical features of the claims. None...

Court Disposition

EP949: Valid and infringed. EP565: Invalid for obviousness and added matter. Proposed amendments to EP565 refused.

Orders

  • EP949 held valid and infringed by Pfizer/BioNTech's SARS-CoV-2 vaccines.
  • EP565 revoked for obviousness over WO674 and for added matter.