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Otsuka did not contest that Migaly taught the same elements as the вЂ™350 patent, but argued that Migaly could not claim priority to its provisional application, due to differences between the provisional application and the final patent. The court also called into question the validity of the вЂ™350 patent in light of prior art to Migaly. In addition, the record showed that the generic drugs, and Abilify, were substantially used in a tablet containing only the active ingredient aripiprazole.

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This rationale held true even though the warnings disclosed the a potential benefit when taken with antidepressants, a decreased risk of suicidality in patients age 65 and older, because in its full context the statement was warning of an increased risk of suicidality in children and young adults. OtsukaвЂ™s argument ignored the context in which the statements appeared. And even if they were, the court reasoned, incidental references in these sections of a label were not sufficient to constitute instruction or encouragement. But the court held that these warnings were not instructions to combine the generic product with an antidepressant. Otsuka pointed to references to antidepressants in the warnings for the generic products as evidence that defendants induce infringement of the patent. By actively вЂњcarving outвЂќ this indication, defendants appeared to negate any inference that they intended to induce infringement. When they created their labels, defendants specifically omitted any indication that the generic drug could be used to treat major depressive disorders, and thus did not promote the use of the aripiprazole product with an antidepressant, which could include citalopram or escitalopram. The court construed the language of Claim 1, on its face, to describe вЂњa single dosage form, or вЂpharmaceutical composition,вЂ™ containing at least two ingredients: (a) aripiprazole and (b) at least one of citalopram, escitalopram and salt thereof.вЂќ This construction was bolstered by the dependent claims, which contemplated the combined weight of the вЂњtotal composition,вЂќ and the specification, which вЂњuniformly treat the claimed invention as a single вЂcombinationвЂ™ dosage.вЂќ Thus, defendantsвЂ™ proposed products, containing only aripiprazole, could not directly infringe the claim.ДЇurther, defendantsвЂ™ labels did not contain any instruction to or encourage infringement of the claim. Why Defendant Prevailed:В Otsuka failed to demonstrate it was likely to succeed on its claims of direct or induced infringement. The court agreed and denied OtsukaвЂ™s motion. Claim 1 describes вЂњ pharmaceutical composition comprising (a) aripiprazole in combination with (b) at least one serotonin reuptake inhibitor selected from citalopram, escitalopram and salts thereof.вЂќ Defendants argued that because their products and Abilify only contain aripiprazole, not in combination with citalopram, escitalopram and salts thereof, they could not infringe or induce infringement of the вЂ™350 patent. Ahead of that expiration, Otsuka brought this lawsuit, and filed a motion for preliminary injunction and temporary restraining order seeking to enjoin defendant drug manufacturers from marketing aripiprazole, arguing that the generic products will infringe Claim 1 of the вЂ™350 patent. Otsuka enjoyed a lengthy exclusivity period to market Abilify, but that exclusivity was set to expire on April 20, 2015, the expiration date of the original compound patent covering Abilify. Nature of the Case and Issue(s) Presented:В Otsuka manufactures and markets Abilify to treat a variety of mental health disorders and owns a family of patents related to the drug, including the вЂ™350 patent. 16, 2015) (Simandle, C.J.)Дrug Product and Patent(s)-in-Suit:В Abilify В® (aripiprazole) U.S.

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