Sandoz Ltd & Ors v TEVA UK Ltd [2022] EWHC 1831 (Pat) (15 July 2022)

Sandoz Ltd & Ors v TEVA UK Ltd [2022] EWHC 1831 (Pat) (15 July 2022)

The Court held that the skilled formulator, starting from Carreiro and applying the common general knowledge, would routinely test the dissolution rate of apixaban, identify any problem, and use obvious formulation techniques such as particle size reduction and excipient optimisation to achieve the claimed dissolution rate and particle size. The specific numerical limits in the claim were found to be arbitrary and not inventive. Therefore, claim 1 of the '021 patent (and the related claims and patents) was invalid for obviousness.

Citation
[2022] EWHC 1831 (Pat)
Parties
Claimant/part 20 Defendant in HP 2020 000048: Sandoz Limited; Claimant in HP 2021 000009: Teva Pharmaceutical Industries Limited; Defendant/part 20 Claimant in HP 2020 000048 & HP 2021 000009: Bristol-Myers Squibb Holdings Ireland Unlimited Company; Defendant/part 20 Claimant in HP 2020 000048 & HP 2021 000009: Pfizer Inc.; Part 20 Defendant in HP 2021 000009: Teva UK Limited
Jurisdiction
England and Wales
Judgment Date
15 July 2022
Procedural Posture
Patent Infringement and Validity Proceedings / High Court (patents Court) Judgment After Trial
Outcome
Claim 1 of EP(UK) 3 246 021 (and related claims/patents) held invalid for obviousness. Claimants succeed.
Legal Topics
Obviousness, Pharmaceutical Patents, Formulation Patents, Common General Knowledge, Biopharmaceutics Classification System (bcs), Dissolution Rate, Particle Size, Bioequivalence
Intellectual Property Patents Obviousness Pharmaceutical Patents Formulation Patents Common General Knowledge Biopharmaceutics Classification System (bcs) Dissolution Rate +2 more

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Parties

Sandoz Limited

Claimant/part 20 Defendant in HP 2020 000048

Teva Pharmaceutical Industries Limited

Claimant in HP 2021 000009

Bristol-Myers Squibb Holdings Ireland Unlimited Company

Defendant/part 20 Claimant in HP 2020 000048 & HP 2021 000009

Pfizer Inc.

Defendant/part 20 Claimant in HP 2020 000048 & HP 2021 000009

Teva UK Limited

Part 20 Defendant in HP 2021 000009

Procedural Posture

Patent Infringement and Validity Proceedings / High Court (patents Court) Judgment After Trial

Legal Issues

  1. 1 Whether claim 1 of EP(UK) 3 246 021 (the '021 patent) is invalid for obviousness over the prior art (Carreiro) and common general knowledge
  2. 2 Whether the claimed dissolution rate and particle size features are arbitrary or provide a technical contribution
  3. 3 Whether the patent discloses an inventive step over the common general knowledge and Carreiro

Ratio Decidendi

The Court held that the skilled formulator, starting from Carreiro and applying the common general knowledge, would routinely test the dissolution rate of apixaban, identify any problem, and use obvious formulation techniques such as particle size reduction and excipient optimisation to achieve the claimed dissolution rate and particle size. The specific numerical limits in the claim were found to be arbitrary and not inventive. Therefore, claim 1 of the '021 patent (and the related claims and patents) was invalid for obviousness.

Court Disposition

Claim 1 of EP(UK) 3 246 021 (and related claims/patents) held invalid for obviousness. Claimants succeed.

Orders

  • Patent claims in suit revoked for lack of inventive step.
  • Costs and further directions to be addressed separately.