As discussed in our April 13, 2015 blog, Otsuka Pharmaceutical Co., Ltd. Otsuka Pharmaceutical Development and Commercialization, Inc., and Otsuka America Pharmaceutical, Inc. (collectively “Otsuka”) had until April 15, 2015 to file an amended complaint and a temporary restraining order (“TRO”) or preliminary injunction (“PI”) against FDA. The complaint/TRO/PI was to concern its claims that FDA could not approve generic versions of Otsuka’s Abilify® (aripiprazole) for any indication now that FDA has granted orphan drug exclusivity for the narrower indication of the treatment of pediatric patients with Tourette’s Disorder. Accordingly, today, Otsuka filed its Amended Complaint and a Motion for Temporary Restraining Order And/Or Preliminary Injunction and Request for Hearing (“Motion for TRO/PI”) challenging “FDA’s arbitrary, capricious, and unlawful denial and violation of Otsuka’s exclusivity rights” in violation of the Administrative Procedure Act (“APA”). Similar to its original Complaint, Otsuka challenges FDA’s authority to grant approval to generic forms of Abilify®.

Notably, Otsuka did not allege that FDA definitively concluded that generic forms of Abilify® could be approved. Indeed, Otsuka stated that “FDA has asserted repeatedly, including as recently as April 13 in a conference call with the Court, that it has not yet made a decision on Otsuka’s exclusivity rights and whether Otsuka’s pediatric orphan drug exclusivity bars the FDA from approving generic versions of Abilify.” In an effort to prevent any allegations that Otsuka’s claims are not ripe, it later stated that it “is not seeking preemptive judicial review of some non-final FDA decision.” (emphasis in original). With a patent expiration fast-approaching, Otsuka stated that it is looking to maintain the status quo until the FDA issues a final judicially-reviewable decision regarding Otsuka’s exclusivity rights.

Otsuka’s Motion for TRO/PI focused on the strict interpretation of the statutory language in the Food, Drug, and Cosmetic Act (“FD&C Act”) in addition to a review of the statute’s legislative history. Otsuka argued that Congress amended the FD&C Act to close the “loophole” identified by Bristol Myers Squibb (“BMS”), when BMS sought approval of its supplemental New Drug Application (“sNDA”) of its oral type 2 diabetes treatment, Glucophage® (metformin). This “loophole” allegedly provided total exclusivity of a given drug when the FDA granted three-year exclusivity under 21 U.S.C. §355(j)(5)(F), because generic manufacturers could not omit the pediatric labeling under the previous language of the FD&C Act. When the FDA approved BSM’s sNDA, Otsuka alleged that BMS had complete market exclusivity, because the existing law did not have a labeling carve out for pediatric applications. As a result, Congress drafted the revised legislation, permitting generic approval, despite the three-year exclusivity, by allowing the omission of pediatric labeling.

Under the Court’s April 14, 2015 Order, FDA and any defendant-intervenors have until April 20, 2015 to file their oppositions to Otsuka’s Motion for TRO/PI. The Court has not yet set a hearing date.