Aripiprazole – Australia

Aripiprazole – Australia

On Aug 24, 2016, the Full Court of the Federal Court of Australia handed down a decision [Otsuka Pharmaceutical Co., Ltd v Generic Health Pty Ltd (No 2) [2016] FCAFC 111] in which it upheld Justice Yates’ findings that Otsuka’s patent relating to aripiprazole, a drug used in the treatment of schizophrenia, is invalid for want of novelty and inventive step.
The patent that was at stake in this case was AU2005201772, titled “Substituted carbostyril derivatives as 5-HT1A receptor subtype agonists” (“the 722 Patent”). The 772 patent essentially claimed the use of aripiprazole to create a medicament which would be used to treat disorders of the central nervous system which are associated with the 5-HT1A receptor. 
The decision represents a blow for pharmaceutical giants Otsuka (the patentee) and Bristol-Myers Squibb (the Australian licensee of the product). Subject to any application for special leave to appeal to the High Court of Australia, generic pharmaceutical companies could now seek to list on the Pharmaceutical Benefits Scheme and enter the market with a generic aripiprazole product, which will lead to an automatic 16% price cut for aripiprazole.
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