Federal Court of Australia
FEDERAL COURT OF AUSTRALIA
Bristol-Myers Squibb Company v Apotex Pty Ltd (No 5) [2013] FCA 1114 Citation: Bristol-Myers Squibb Company v Apotex Pty Ltd (No 5) [2013] FCA 1114
Parties: BRISTOL-MYERS SQUIBB COMPANY and OTSUKA PHARMACEUTICAL CO., LTD v APOTEX PTY LTD (ACN 096 916 148)
File number: NSD 1116 of 2009
Judge: YATES J
Date of judgment: 30 October 2013
Catchwords: PATENTS – standard patent for improved form of anhydrous aripiprazole crystals having low hygroscopicity (Crystals B) – whether hygroscopicity is inherent property of given crystalline form of aripiprazole – whether disclosure of particular crystalline form of aripiprazole discloses its physicochemical properties including its hygroscopicity PATENTS – validity – novelty – inevitable result – whether person skilled in the art carrying out directions in prior art patent specification before priority date would inevitably have obtained anhydrous aripiprazole crystals having the characteristic low hygroscopicity of Crystals B – whether directions in prior art patent specification disclose the invention as claimed PATENTS – validity – novelty – whether disclosure of crystalline form of Crystals B in prior art publications discloses the invention as claimed – whether prior art publications should be treated as single source of information PATENTS – validity – false suggestion or misrepresentation – statements in complete specification and correspondence in course of prosecuting application for patent PATENTS – validity – inventive step – problem-solution approach – whether person skilled in the art would be directly led as a matter of course to take steps that would lead to the invention as claimed PATENTS – validity – manner of manufacture – whether working interrelationship between drug comprising Crystals B and commercial package carrying instructions for drug to be used to treat schizophrenia or its symptoms PATENTS – validity – clarity – whether requirement that compound exhibits a particular endothermic peak is unclear for failure to specify whether one or more other endothermic peaks may also be present on analysis – whether requirement of mean particle size unclear for failure of claim to expressly stipulate a particular method of measuring mean particle size or range of particle sizes in a given sample PATENTS – validity – fair basis – whether real and reasonably clear disclosure of Crystals B having certain particle size as part of invention PATENTS – infringement – threatened infringement –contributory infringement – authorisation PATENTS – standing to sue for infringement – whether first applicant is exclusive licensee of patent – right to manufacture aripiprazole under patent not conferred on licensee – consideration of meaning of "exclusive licensee"
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