Leo Pharma (a/s Leo Laboratories Ltd) v Sandoz Ltd [2009] EWHC 996 (Pat) (15 May 2009)

Leo Pharma (a/s Leo Laboratories Ltd) v Sandoz Ltd [2009] EWHC 996 (Pat) (15 May 2009)

The patent is not anticipated because neither the experimental nor the expert evidence establishes that carrying out Example 4 of WO 91/12807 inevitably produces calcipotriol monohydrate; the presence of seeds in Sandoz's experiments undermines inevitability, and the formation of monohydrate is not predictable in a seed-free environment. The patent is not obvious because, although polymorph screening and regulatory requirements were known, it was not obvious to conduct the necessary experiments or that such experiments would yield the monohydrate with superior properties. The skilled team would not have been motivated or expected to find the monohydrate without invention.

Citation
[2009] EWHC 996 (Pat)
Parties
Claimant: LEO PHARMA A/S; Claimant: LEO LABORATORIES LIMITED; Defendant: SANDOZ LIMITED
Jurisdiction
England and Wales
Judgment Date
15 May 2009
Procedural Posture
Patent Invalidity and Revocation Claim / First Instance Judgment
Outcome
Claim for revocation dismissed; patent held valid.
Legal Topics
Patent Validity, Novelty, Obviousness, Pharmaceutical Patents, Polymorphism, Hydrates, Regulatory Requirements
Intellectual Property Patents Patent Validity Novelty Obviousness Pharmaceutical Patents Polymorphism Hydrates +1 more

Case Brief

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Parties

LEO PHARMA A/S

Claimant

LEO LABORATORIES LIMITED

Claimant

SANDOZ LIMITED

Defendant

Procedural Posture

Patent Invalidity and Revocation Claim / First Instance Judgment

Legal Issues

  1. 1 Whether European Patent (UK) No. 0 679 154 is invalid for lack of novelty over WO 91/12807
  2. 2 Whether the patent is invalid for obviousness in light of WO 91/12807, the 834 application, and common general knowledge

Ratio Decidendi

The patent is not anticipated because neither the experimental nor the expert evidence establishes that carrying out Example 4 of WO 91/12807 inevitably produces calcipotriol monohydrate; the presence of seeds in Sandoz's experiments undermines inevitability, and the formation of monohydrate is not predictable in a seed-free environment. The patent is not obvious because, although polymorph screening and regulatory requirements were known, it was not obvious to conduct the necessary experiments or that such experiments would yield the monohydrate with superior properties. The skilled team would not have been motivated or expected to find the monohydrate without invention.

Court Disposition

Claim for revocation dismissed; patent held valid.

Orders

  • Patent EP (UK) No. 0 679 154 remains in force.
  • Counterclaim for revocation dismissed.