Alphapharm Pty Ltd v H Lundbeck A/S [2008] FCA 559

Alphapharm Pty Ltd v H Lundbeck A/S [2008] FCA 559

The claim to the (+)-enantiomer (escitalopram) was held to be for the isolated enantiomer, not for the enantiomer present as part of a racemate; thus, prior art for citalopram racemate did not anticipate the claims. On the evidence, neither the product nor the method claims were obvious at the priority date, applying the 'matter of routine' test. The statutory requirements for extension of the patent term were not met because Cipramil, the racemate, contained (+)-citalopram and was already listed on the ARTG; thus Lundbeck's application for an extension was out of time and the extension was invalid. For protected information under TG Act s 25A, since Cipramil already contained...

Parties
Applicant/cross Respondent/second Respondent: Alphapharm Pty Ltd; Respondent/first Cross Claimant/applicant: H Lundbeck A/S; Second Cross Claimant/applicant: Lundbeck Australia Pty Ltd; First Respondent: Secretary of the Department of Health and Ageing of the Commonwealth of Australia; Applicant: Arrow Pharmaceuticals Pty Ltd; First Respondent: Commissioner of Patents
Jurisdiction
Australia
Judgment Date
24 April 2008
Procedural Posture
Federal Court Multiple Related Proceedings (patent, Revocation, Regulatory) / Post Trial Judgment (reasons With Orders Reserved for Subsequent Hearing)
Outcome
Patent upheld except for claim 5; orders deferred for further submissions. Extension of time for the patent held invalid. Lundbeck's 'protected information' claim under TG Act s 25A dismissed. Partial infringement found before 27 May 2004, but exempted after that date due to regulatory exception.
Legal Topics
Patent Validity, Obviousness, Novelty, Extension of Patent Term, Protected Information Under Therapeutic Goods Act, Patent Infringement, Pharmaceutical Regulation, Expert Evidence
Intellectual Property Patent Law Administrative Law Patent Validity Obviousness Novelty Extension of Patent Term Protected Information Under Therapeutic Goods Act +3 more

Case Brief

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Parties

Alphapharm Pty Ltd

Applicant/cross Respondent/second Respondent

H Lundbeck A/S

Respondent/first Cross Claimant/applicant

Lundbeck Australia Pty Ltd

Second Cross Claimant/applicant

Secretary of the Department of Health and Ageing of the Commonwealth of Australia

First Respondent

Arrow Pharmaceuticals Pty Ltd

Applicant

Commissioner of Patents

First Respondent

Procedural Posture

Federal Court Multiple Related Proceedings (patent, Revocation, Regulatory) / Post Trial Judgment (reasons With Orders Reserved for Subsequent Hearing)

Legal Issues

  1. 1 Whether Australian Patent No 623144 (Escitalopram Patent) is invalid for lack of novelty, obviousness, lack of utility, clarity, fair basis, or manner of manufacture
  2. 2 Whether claims to the (+)-enantiomer of citalopram are anticipated by prior art (including the citalopram racemate)
  3. 3 Whether the patent's claims are obvious in light of common general knowledge and the law as at the priority date

Ratio Decidendi

The claim to the (+)-enantiomer (escitalopram) was held to be for the isolated enantiomer, not for the enantiomer present as part of a racemate; thus, prior art for citalopram racemate did not anticipate the claims. On the evidence, neither the product nor the method claims were obvious at the priority date, applying the 'matter of routine' test. The statutory requirements for extension of the patent term were not met because Cipramil, the racemate, contained (+)-citalopram and was already listed on the ARTG; thus Lundbeck's application for an extension was out of time and the extension was invalid. For protected information under TG Act s 25A, since Cipramil already contained...

Court Disposition

Patent upheld except for claim 5; orders deferred for further submissions. Extension of time for the patent held invalid. Lundbeck's 'protected information' claim under TG Act s 25A dismissed. Partial infringement found before 27 May 2004, but exempted after that date due to regulatory exception.

Orders

  • All proceedings stood over to 9 May 2008 for making of final orders, including costs.
  • Parties to attempt to agree on orders; if agreed, supply them by 5 May 2008; if not, file proposed orders and submissions by 5 May 2008.