Arrow Generics Ltd & Ors v Norton Healthcare Ltd [2006] ScotCS CSOH_146 (15 September 2006)

Arrow Generics Ltd & Ors v Norton Healthcare Ltd [2006] ScotCS CSOH_146 (15 September 2006)

Claims 1-3 and 5 of the 035 patent are invalid for lack of novelty (anticipation) because the prior art (Declercq paper and GB1,177,845 patent) disclosed the monoclinic (Form I) tibolone of requisite crystalline purity and the method of preparation using acetone as solvent. The pharmaceutical composition claims are not saved by the inclusion of a carrier, as this was not inventive or novel. The attack based on obviousness fails, as the identification of polymorphism and the method of producing pure forms was not obvious to the skilled person at the priority date.

Citation
[2006] ScotCS CSOH_146
Parties
Petitioner: Arrow Generics Limited; Pursuer: Organon Laboratories Limited and Others; Defender/respondent: Norton Healthcare Limited
Jurisdiction
Scotland
Judgment Date
15 September 2006
Procedural Posture
Patent Revocation and Infringement Proceedings (consolidated) / First Instance Judgment (outer House, Court of Session)
Outcome
Claims 1-3 and 5 of EP 0 389 035 patent revoked for lack of novelty; attack based on obviousness rejected as immaterial.
Legal Topics
Patent Validity, Anticipation (lack of Novelty), Obviousness (inventive Step), Pharmaceutical Patents, Polymorphism, Chemical Purity
Intellectual Property Law Patent Law Patent Validity Anticipation (lack of Novelty) Obviousness (inventive Step) Pharmaceutical Patents Polymorphism Chemical Purity

Case Brief

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Parties

Arrow Generics Limited

Petitioner

Organon Laboratories Limited and Others

Pursuer

Norton Healthcare Limited

Defender/respondent

Procedural Posture

Patent Revocation and Infringement Proceedings (consolidated) / First Instance Judgment (outer House, Court of Session)

Legal Issues

  1. 1 Whether claims 1-3 and 5 of EP 0 389 035 patent (the 035 patent) are invalid for lack of novelty (anticipation) and/or obviousness
  2. 2 Whether the method of preparation claimed in claim 5 is anticipated by prior art
  3. 3 Whether the pharmaceutical composition claims are anticipated by prior disclosure of the compound in the prior art

Ratio Decidendi

Claims 1-3 and 5 of the 035 patent are invalid for lack of novelty (anticipation) because the prior art (Declercq paper and GB1,177,845 patent) disclosed the monoclinic (Form I) tibolone of requisite crystalline purity and the method of preparation using acetone as solvent. The pharmaceutical composition claims are not saved by the inclusion of a carrier, as this was not inventive or novel. The attack based on obviousness fails, as the identification of polymorphism and the method of producing pure forms was not obvious to the skilled person at the priority date.

Court Disposition

Claims 1-3 and 5 of EP 0 389 035 patent revoked for lack of novelty; attack based on obviousness rejected as immaterial.

Orders

  • Revocation of claims 1-3 and 5 of EP 0 389 035 patent
  • No order on obviousness as anticipation disposes of the claims