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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