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
Summary, issues, holding and outcome
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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
Legal Issues
- 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
Full Case Text
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