Bristol-Myers Squibb Company v Apotex Pty Ltd [2015] FCAFC 2

Bristol-Myers Squibb Company v Apotex Pty Ltd [2015] FCAFC 2

The patent claims crystalline aripiprazole having certain characteristics, including low hygroscopicity achieved by specific processing steps, not merely a particular crystalline form. Prior art did not clearly disclose or teach all essential characteristics of Crystals B, notably low hygroscopicity, nor the processes to achieve it, and thus did not anticipate the patent. The invention involved an inventive step, as the skilled person would not be directly led by prior art to take the required steps to produce Crystals B and its low hygroscopicity. BMS was not an exclusive licensee for purposes of the Patents Act as Otsuka retained exclusive manufacturing rights. False suggestion failed...

Parties
Appellant / First Respondent: Bristol-Myers Squibb Company; Appellant / Second Respondent: Otsuka Pharmaceutical Co Ltd; Respondent / Appellant: Apotex Pty Ltd ACN 096 916 148
Jurisdiction
Australia
Judgment Date
23 January 2015
Procedural Posture
Appeal / Final Judgment
Outcome
Appeals dismissed
Legal Topics
Patent Construction, Novelty (lack of Novelty), Inventive Step (obviousness), Exclusive Licence, False Suggestion, Patent Infringement, Standing to Sue
Intellectual Property Patents Patent Construction Novelty (lack of Novelty) Inventive Step (obviousness) Exclusive Licence False Suggestion Patent Infringement +1 more

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Parties

Bristol-Myers Squibb Company

Appellant / First Respondent

Otsuka Pharmaceutical Co Ltd

Appellant / Second Respondent

Apotex Pty Ltd ACN 096 916 148

Respondent / Appellant

Procedural Posture

Appeal / Final Judgment

Legal Issues

  1. 1 Proper construction of the patent claims and specification particularly claim 12
  2. 2 Whether prior art anticipates the invention under novelty law
  3. 3 Whether the invention claimed involves an inventive step or is obvious

Ratio Decidendi

The patent claims crystalline aripiprazole having certain characteristics, including low hygroscopicity achieved by specific processing steps, not merely a particular crystalline form. Prior art did not clearly disclose or teach all essential characteristics of Crystals B, notably low hygroscopicity, nor the processes to achieve it, and thus did not anticipate the patent. The invention involved an inventive step, as the skilled person would not be directly led by prior art to take the required steps to produce Crystals B and its low hygroscopicity. BMS was not an exclusive licensee for purposes of the Patents Act as Otsuka retained exclusive manufacturing rights. False suggestion failed...

Court Disposition

Appeals dismissed

Orders

  • The appeal in NSD 2526 of 2013 be dismissed.
  • The appellants pay the respondent's costs of the appeal in NSD 2526 of 2013.