Leo Pharma (a/s Leo Laboratories Ltd) v Sandoz Ltd [2009] EWCA Civ 1188 (17 November 2009)

Leo Pharma (a/s Leo Laboratories Ltd) v Sandoz Ltd [2009] EWCA Civ 1188 (17 November 2009)

The Court of Appeal held that Sandoz failed to prove anticipation because the evidence did not establish that the monohydrate would inevitably result from following example 4 of the acne use patent, given the unpredictability of crystallisation and the influence of impurities. The obviousness attacks failed because full or limited polymorph screening was not standard or mandatory practice in the vitamin D analogue field, and the formation of the monohydrate was not predictable or obvious to the skilled team. The trial judge's findings were supported by ample evidence and contained no error of principle.

Citation
[2009] EWCA Civ 1188
Parties
Claimant/respondent: Leo Pharma A/S; Claimant/respondent: Leo Laboratories Limited; Appellant/defendant: Sandoz Limited
Jurisdiction
England and Wales
Judgment Date
17 November 2009
Procedural Posture
Patent Appeal / Appeal From High Court (patents Court) to Court of Appeal
Outcome
Appeal dismissed
Legal Topics
Patent Validity, Obviousness, Anticipation, Pharmaceutical Patents, Patent Infringement

Case Brief

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Parties

Leo Pharma A/S

Claimant/respondent

Leo Laboratories Limited

Claimant/respondent

Sandoz Limited

Appellant/defendant

Procedural Posture

Patent Appeal / Appeal From High Court (patents Court) to Court of Appeal

  1. 1 Whether Leo's EP (UK) No. 0 679 154 is invalid for anticipation or obviousness over prior art, specifically example 4 of the acne use patent and common general knowledge

Ratio Decidendi

The Court of Appeal held that Sandoz failed to prove anticipation because the evidence did not establish that the monohydrate would inevitably result from following example 4 of the acne use patent, given the unpredictability of crystallisation and the influence of impurities. The obviousness attacks failed because full or limited polymorph screening was not standard or mandatory practice in the vitamin D analogue field, and the formation of the monohydrate was not predictable or obvious to the skilled team. The trial judge's findings were supported by ample evidence and contained no error of principle.

Court Disposition

Appeal dismissed

Orders

  • Patent held valid
  • No order for revocation or amendment