Sandoz Limited & Anor. v Bristol-Myers Squibb Holdings Ireland Unlimited Company & Anor.

Sandoz Limited & Anor. v Bristol-Myers Squibb Holdings Ireland Unlimited Company & Anor.

The patents are invalid for obviousness over Carreiro because the skilled formulator, using common general knowledge, would have targeted the claimed dissolution rate and particle size as routine steps in developing an apixaban tablet. The features claimed are within the normal range and do not involve an inventive step. The proposed amendments do not cure the invalidity.

Parties
Claimant/part 20 Defendant: Sandoz Limited; Claimant/part 20 Defendant: Teva Pharmaceutical Industries Limited; Claimant/part 20 Defendant: Teva UK Limited; Defendant/part 20 Claimant: Bristol-Myers Squibb Holdings Ireland Unlimited Company; Defendant/part 20 Claimant: Pfizer Inc.
Jurisdiction
England and Wales
Judgment Date
15 July 2022
Procedural Posture
Patent Revocation and Amendment Proceedings / Judgment After Trial
Outcome
Patents declared invalid for obviousness; proposed amendments allowed but do not cure invalidity.
Legal Topics
Obviousness, Pharmaceutical Patents, Formulation Patents, Common General Knowledge, Patent Amendment, Technical Contribution
Intellectual Property Patents Obviousness Pharmaceutical Patents Formulation Patents Common General Knowledge Patent Amendment Technical Contribution

Case Brief

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Parties

Sandoz Limited

Claimant/part 20 Defendant

Teva Pharmaceutical Industries Limited

Claimant/part 20 Defendant

Teva UK Limited

Claimant/part 20 Defendant

Bristol-Myers Squibb Holdings Ireland Unlimited Company

Defendant/part 20 Claimant

Pfizer Inc.

Defendant/part 20 Claimant

Procedural Posture

Patent Revocation and Amendment Proceedings / Judgment After Trial

Legal Issues

  1. 1 Whether the patents relating to apixaban formulations are invalid for obviousness over the Carreiro prior art
  2. 2 Whether the proposed amendments to the patents cure any invalidity
  3. 3 Whether the claimed particle size and dissolution rate features are inventive or arbitrary

Ratio Decidendi

The patents are invalid for obviousness over Carreiro because the skilled formulator, using common general knowledge, would have targeted the claimed dissolution rate and particle size as routine steps in developing an apixaban tablet. The features claimed are within the normal range and do not involve an inventive step. The proposed amendments do not cure the invalidity.

Court Disposition

Patents declared invalid for obviousness; proposed amendments allowed but do not cure invalidity.

Orders

  • All the patents are invalid for obviousness over Carreiro.
  • The proposed amendments to the patents are formally allowable but do not cure the invalidity.