Otsuka Pharm. Co., Ltd. v. Torrent Pharms. Ltd., Inc.

Case Name: Otsuka Pharm. Co., Ltd. v. Torrent Pharms. Ltd., Inc., Civ. No. 14-1078 (JBS/KMW), 2015 U.S. Dist. LEXIS 50082 (D.N.J. Apr. 16, 2015) (Simandle, C.J.) 

Drug Product and Patent(s)-in-Suit: Abilify^® (aripiprazole); U.S. Patent No. 8,759,350 ("the '350 patent")

Nature of the Case and Issue(s) Presented: 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 ’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. 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 ’350 patent. Claim 1 describes “[a] pharmaceutical composition comprising (a) aripiprazole in combination with (b) at least one serotonin reuptake inhibitor selected from citalopram, escitalopram and salts thereof.” 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 ’350 patent. The court agreed and denied Otsuka’s motion.

Why Defendant Prevailed: Otsuka failed to demonstrate it was likely to succeed on its claims of direct or induced infringement. The court construed the language of Claim 1, on its face, to describe “a single dosage form, or ‘pharmaceutical composition,’ containing at least two ingredients: (a) aripiprazole and (b) at least one of citalopram, escitalopram and salt thereof.” This construction was bolstered by the dependent claims, which contemplated the combined weight of the “total composition,” and the specification, which “uniformly treat[ed] the claimed invention as a single ‘combination’ dosage.” Thus, defendants’ proposed products, containing only aripiprazole, could not directly infringe the claim.

Further, defendants’ labels did not contain any instruction to or encourage infringement of the claim. 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. By actively “carving out” this indication, defendants appeared to negate any inference that they intended to induce infringement. Otsuka pointed to references to antidepressants in the warnings for the generic products as evidence that defendants induce infringement of the patent. But the court held that these warnings were not instructions to combine the generic product with an antidepressant. And even if they were, the court reasoned, incidental references in these sections of a label were not sufficient to constitute instruction or encouragement. Otsuka’s argument ignored the context in which the statements appeared. 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. In addition, the record showed that the generic drugs, and Abilify, were substantially used in a tablet containing only the active ingredient aripiprazole.

The court also called into question the validity of the ’350 patent in light of prior art to Migaly. Otsuka did not contest that Migaly taught the same elements as the ’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 disagreed and found that, although it contained substantial extraneous material, the provisional application was “squarely” directed to a pharmaceutical combination of antipsychotics and antidepressants, including those described in Claim 1 of the ’350 patent. Otsuka also argued that a person of ordinary skill in the art would not arrive at the combination of aripiprazole and either citalopram or escitalopram because those ingredients appeared among many other antipsychotics and antidepressants, which could “result in many 1000s of different, indeterminate” combinations of drugs. Otsuka’s argument was undercut by its own expert, however, who stated that he “immediately envisioned a combination of aripiprazole with either citalopram or escitalopram” after reviewing Migaly.

Next, Otsuka did not show it would suffer immediate and irreparable harm in the absence of an injunction. Otsuka did not present evidence showing that the damages it claimed, loss of market share, sales, and price erosion, were unquantifiable. Indeed, Otsuka’s damages expert was able to estimate these damages in terms of percentage losses. Otsuka was also unable to show a “causal nexus” between the harm alleged and the infringement. Abilify only contains aripiprazole as its active ingredient, like defendants’ generic drugs. But the ’350 patent claims a combination of aripiprazole and either citalopram or escitalopram. Thus, Otsuka’s alleged harm is not the result of patent infringement, but rather is the result of lawful competition. Finally, Otsuka’s delay in moving for injunctive relief suggested a lack of urgency. For these reasons, Otsuka failed to prove the immediate and irreparable harm necessary for injunctive relief.

Moreover, the potential harm to defendants cautioned against injunctive relief. Defendants had taken affirmative steps towards entering the market, including investing in materials, manufacturing facilities, and supply pipelines. An injunction would “seriously erode” these efforts. Further, the delay of an injunction would cause the defendants to lose the advantage of early entry into the market. In light of this potential harm, the balance of hardships favored the defendants.

Finally, the court determined that the public interest was best served by denying injunctive relief. The public’s interest in rewarding innovation had already been adequately served. Otsuka benefited from its market exclusivity for many years, generating over $100 billion in revenue over the previous eight years. Now, the public has a strong interest in lower prices and increased competition in the marketplace.