Pharmacia Italia S.P.A v Mayne Pharma Pty Ltd [2005] FCA 1078

Pharmacia Italia S.P.A v Mayne Pharma Pty Ltd [2005] FCA 1078

The exclusionary integer 'which has not been reconstituted from a lyophilizate' in Claim 1 is to be construed in light of the patent specification and common general knowledge as referring to reconstitution of lyophilized preparations in vials immediately prior to administration, not to the use of bulk lyophilizate in manufacturing. The addition of a minor amount of sodium hydroxide after pH adjustment with hydrochloric acid does not constitute a material variation so as to avoid infringement. Accordingly, the respondents' product infringes the relevant patent claims.

Parties
First Applicant: Pharmacia Italia S.P.A; Second Applicant: Pfizer (Perth) Pty Limited; First Respondent: Mayne Pharma Pty Ltd; Second Respondent: F H Faulding & Co Ltd; Third Respondent: Faulding Healthcare Pty Ltd
Jurisdiction
Australia
Judgment Date
05 August 2005
Procedural Posture
Patent Infringement Proceedings / First Instance—judgment on Liability and Construction of Patent Claims
Outcome
Applicants succeed on the issue of infringement; liability orders to be settled.
Legal Topics
Infringement of Patent Claims, Construction of Patent Claims, Principles of Purposive Construction, Process and Product Claims, Australian Letters Patent 598197
Intellectual Property Patents Infringement of Patent Claims Construction of Patent Claims Principles of Purposive Construction Process and Product Claims Australian Letters Patent 598197

Case Brief

Summary, issues, holding and outcome

More case intelligence is available

Unlock the full research layer for this judgment.

Full judgment text Downloadable case file Legal principles 3 Authorities cited 36 Party arguments 2
Sign in to unlock

Parties

Pharmacia Italia S.P.A

First Applicant

Pfizer (Perth) Pty Limited

Second Applicant

Mayne Pharma Pty Ltd

First Respondent

F H Faulding & Co Ltd

Second Respondent

Faulding Healthcare Pty Ltd

Third Respondent

Procedural Posture

Patent Infringement Proceedings / First Instance—judgment on Liability and Construction of Patent Claims

Legal Issues

  1. 1 Proper construction of exclusionary integer 'which has not been reconstituted from a lyophilizate' in Claim 1 of Patent 598197
  2. 2 Whether respondents' product infringes Claim 1 despite use of bulk lyophilizate
  3. 3 Whether minor addition of sodium hydroxide to adjust pH precludes infringement under integer (6)(ii)

Ratio Decidendi

The exclusionary integer 'which has not been reconstituted from a lyophilizate' in Claim 1 is to be construed in light of the patent specification and common general knowledge as referring to reconstitution of lyophilized preparations in vials immediately prior to administration, not to the use of bulk lyophilizate in manufacturing. The addition of a minor amount of sodium hydroxide after pH adjustment with hydrochloric acid does not constitute a material variation so as to avoid infringement. Accordingly, the respondents' product infringes the relevant patent claims.

Court Disposition

Applicants succeed on the issue of infringement; liability orders to be settled.

Orders

  • Parties to prepare short minutes of final orders on liability in accordance with the reasons and to include any other orders or directions as appropriate for further disposition of the matter.