Apotex Pty Ltd v Sanofi-Aventis [2009] FCAFC 134

Apotex Pty Ltd v Sanofi-Aventis [2009] FCAFC 134

All claims of the Patent were found invalid as lacking inventive step: the process of resolving enantiomers, forming their pharmaceutically acceptable salts, and making pharmaceutical compositions was well known and involved no invention as at the priority date. The d-enantiomer itself was anticipated by the prior art patents; although the specific salts were novel, their preparation was obvious. Pharmaceutical compositions and processes were similarly obvious. The Patent's subject matter was, however, a manner of manufacture. Consequently, the Patent was ordered to be revoked in full.

Jurisdiction
Australia
Judgment Date
29 September 2009
Procedural Posture
Appeals (consolidated) From a Single Judge of the Federal Court of Australia Regarding Patent Revocation and Cross Claims for Infringement / Judgment on Appeal (full Court)
Outcome
Patent revoked in full: All claims found invalid for lack of inventive step. All parties to submit proposed orders to give effect to the reasons by the stated date.
Legal Topics
['patent Validity' 'novelty' 'inventive Step' 'obviousness' 'selection Patents' 'manner of Manufacture' 'pharmaceutical Patents' 'enantiomers' 'chemical Patents' 'revocation']
['intellectual Property' 'patents'] ['patent Validity' 'novelty' 'inventive Step' 'obviousness' 'selection Patents' 'manner of Manufacture' 'pharmaceutical Patents' 'enantiomers' 'chemical Patents' 'revocation']

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Procedural Posture

Appeals (consolidated) From a Single Judge of the Federal Court of Australia Regarding Patent Revocation and Cross Claims for Infringement / Judgment on Appeal (full Court)

Legal Issues

  1. 1 ['Whether claims of Australian Patent No 597784 (clopidogrel, its salts, pharmaceutical compositions, and process for its preparation) are invalid for want of novelty, lack of inventive step, and/or not being a manner of manufacture; scope of prior art disclosure and anticipation; application of selection patent principles.']

Ratio Decidendi

All claims of the Patent were found invalid as lacking inventive step: the process of resolving enantiomers, forming their pharmaceutically acceptable salts, and making pharmaceutical compositions was well known and involved no invention as at the priority date. The d-enantiomer itself was anticipated by the prior art patents; although the specific salts were novel, their preparation was obvious. Pharmaceutical compositions and processes were similarly obvious. The Patent's subject matter was, however, a manner of manufacture. Consequently, the Patent was ordered to be revoked in full.

Court Disposition

Patent revoked in full: All claims found invalid for lack of inventive step. All parties to submit proposed orders to give effect to the reasons by the stated date.

Orders

  • ['Patent revoked in its entirety.' 'Parties to consult and submit jointly agreed proposed orders (including as to costs) by 6 October 2009, or, if unable to agree, each party to submit proposed orders by that date.']