Ivax Pharmaceuticals UK Ltd v Akzo Nobel NV

Ivax Pharmaceuticals UK Ltd v Akzo Nobel NV

The claimed invention was obvious to a skilled formulator who, faced with a monopoly on crystalline pure tibolone, would have considered formulating a polymorphous mixture and, through routine testing, arrived at the specified particle sizes to achieve bioequivalence with the marketed product. There was no technical...

Source-derived case information.

Parties
Claimant: Ivax Pharmaceuticals UK Limited; Claimant: Arrow Generics Limited; Defendant: Akzo Nobel NV
Jurisdiction
England and Wales
Judgment Date
22 May 2006
Procedural Posture
Patent Revocation/invalidity Proceedings / Judgment After Trial
Outcome
Patent revoked for lack of inventive step (obviousness).
Legal Topics
Obviousness, Inventive Step, Pharmaceutical Patents, Polymorphous Compounds, Bioequivalence
Intellectual Property Patent Law Obviousness Inventive Step Pharmaceutical Patents Polymorphous Compounds Bioequivalence

Source-derived case record

Summary, issues, holding and outcome

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Parties

Ivax Pharmaceuticals UK Limited

Claimant

Arrow Generics Limited

Claimant

Akzo Nobel NV

Defendant

Procedural Posture

Patent Revocation/invalidity Proceedings / Judgment After Trial

Legal Issues

  1. 1 Whether the patent for polymorphous tibolone with specified mean particle size involves an inventive step or is obvious to a person skilled in the art
  2. 2 Whether commercial and regulatory considerations are relevant to obviousness
  3. 3 Whether there was a technical prejudice against formulating polymorphous mixtures

Ratio Decidendi

The claimed invention was obvious to a skilled formulator who, faced with a monopoly on crystalline pure tibolone, would have considered formulating a polymorphous mixture and, through routine testing, arrived at the specified particle sizes to achieve bioequivalence with the marketed product. There was no technical prejudice strong enough to render this inventive.

Court Disposition

Patent revoked for lack of inventive step (obviousness).

Orders

  • Patent to be revoked in principle; precise terms of the order to be discussed if not agreed.