Bayer Pharma Aktiengesellschaft v Generic Health Pty Ltd (No 2) [2013] FCA 279

Bayer Pharma Aktiengesellschaft v Generic Health Pty Ltd (No 2) [2013] FCA 279

The Court found that the skilled addressee, at the priority date, would not have as a matter of routine or with an expectation of success created a rapidly dissolving (as specified) formulation of drospirenone and ethinylestradiol as claimed. The claimed invention was held not to be obvious, was a manner of manufacture, and was fairly based on the specification. The construction of '3mg' was determined consistently with industry variance, and the applicants established infringement by the respondents' products. Therefore, claims 3 and 11 are valid and infringed.

Jurisdiction
Australia
Judgment Date
04 April 2013
Procedural Posture
Patent Infringement and Revocation Proceeding / Judgment After Trial
Outcome
Claims 3 and 11 of the patent are valid; infringement established against the respondents. Orders to be made on terms.
Legal Topics
['patent Infringement' 'inventive Step / Obviousness' 'manner of Manufacture' 'fair Basing' 'pharmaceutical Patents' 'bioavailability' 'dissolution Rate Requirements']
['intellectual Property' 'patents'] ['patent Infringement' 'inventive Step / Obviousness' 'manner of Manufacture' 'fair Basing' 'pharmaceutical Patents' 'bioavailability' 'dissolution Rate Requirements']

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Procedural Posture

Patent Infringement and Revocation Proceeding / Judgment After Trial

Legal Issues

  1. 1 ['Whether claims 3 and 11 of Australian Patent No 780330 lack an inventive step (are obvious) under the Patents Act 1990 (Cth)' 'Whether the invention claimed is not a manner of manufacture' 'Whether the claims are not fairly based on the description in the specification' 'Whether the respondents have infringed claims 3 and 11 of the patent']

Ratio Decidendi

The Court found that the skilled addressee, at the priority date, would not have as a matter of routine or with an expectation of success created a rapidly dissolving (as specified) formulation of drospirenone and ethinylestradiol as claimed. The claimed invention was held not to be obvious, was a manner of manufacture, and was fairly based on the specification. The construction of '3mg' was determined consistently with industry variance, and the applicants established infringement by the respondents' products. Therefore, claims 3 and 11 are valid and infringed.

Court Disposition

Claims 3 and 11 of the patent are valid; infringement established against the respondents. Orders to be made on terms.

Orders

  • ['Parties to file and serve proposed orders reflecting these reasons within seven days of the date of the orders.' 'Proceeding to be listed on a date not less than seven days thereafter, to be determined in consultation with parties.']