Aripiprazole – USA

Aripiprazole – USA

On Jul 20, 2017, Federal circuit affirmed the decision of lower court to toss the patent suit in Abilify (Aripiprazole) ANDA case. The patent in suit was US 8,759,350 expiring on March 02, 2027. US’350 patent claims pharmaceutical composition comprising Aripiprazole & Serotonin reuptake inhibitor such as citalopram or escitalopram.

The parties to the suit stipulated non-infringement of US’350 patent previously. Otsuka appealed the decision in various cases and this is now consolidated with main Zydus appeal (16-1962). Oral argument was heard on Jul. 10, 2017.

During oral argument Otsuka said that pharmaceutical composition means separate dosage forms containing Aripiprazole & serotonin reuptake inhibitor. While defendants argued that claims when interpreted means single dosage form where Aripirazole & serotonin reuptake inhibitor in same dosage form as correctly decided by district court previously.

Federal circuit finally affirmed the district court’s decision of non-infringement via Rule 36 judgment.

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