United States: Otsuka's Orphan Drug Exclusivity Claims: FDA Rips Off The Band-Aid Early

Last Updated: May 20 2015
Article by Larissa C. Bergin

Sometimes you need to get in front of the issue early...

On April 20, 2015, FDA filed a brief in Opposition to Plaintiff's Motion for Temporary Restraining Order ("TRO") or Preliminary Injunction ("PI"), addressed how Otsuka Pharmaceutical Co., Ltd. Otsuka Pharmaceutical Development and Commercialization, Inc., and Otsuka America Pharmaceutical, Inc. (collectively "Otsuka") failed to meet the standard of review for a TRO or PI because Otsuka's claims are not ripe and are based on "speculation and assumptions." The complaint/TRO/PI concerns Otsuka's 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. FDA's argument about the speculative nature of Otsuka's allegations bled through FDA's analysis, honing in on how neither Otsuka's, nor the public's, interest have been affected because FDA has not taken any action. In fact, as of this writing, no generic form of Abilify® has been approved.

FDA's brief also spent a considerable amount of time attacking Otsuka's allegations of irreparable harm by emphasizing that any lost sales to generics (which, again, have not commenced) would be for a negligible period of time while the parties engage in an expedited briefing schedule. It also highlighted that, as of April 20, 2015, Otsuka should be recouping additional sales now that its agreement with Bristol-Myers Squibb, which received "50% of net sales" up to $2.7 million and a "declining tiered share of net sales above $2.7 million" under the terms of the agreement, expired. Last, it rebuffed Otsuka's argument that any alleged damages would be difficult to calculate.

But, prior to FDA's attack on Otsuka's allegedly premature filing, FDA tried to quickly dispel with the most interesting issues in this case within the "Factual Background" section of the brief: 1) whether FDA changed the scope of its approval during its correspondence with Otsuka and 2) whether Otsuka is entitled to exclusivity in all applications, even though it received orphan drug exclusivity in only one application.

Regarding the first issue, FDA argued that despite the various letters Otsuka received, the scope of the approval never changed, because "[t]he scope of FDA's approval for a particular indication for use, including the Tourette's Disorder indication, is reflected in Abilify's® labeling," and the labeling never changed during the course of the correspondence. Moreover, FDA also addressed allegations that the indication was expanded by an FDA project manager during e-mail correspondence, arguing that "the email was, at most, an informal communication that represents the judgment of that particular FDA employee at the time."

As to the second issue, FDA addressed this potential conundrum in a single paragraph. FDA simply stated that it "has made no final determination with respect to the issues raised in Otsuka's...letter and will only do so if, and when, it approves any generic versions of Abilify®." The brief then stated a few hypothetical situations in which FDA could approve a generic version of Abilify®, despite Otsuka's argument that it is impermissible under the Food, Drug, and Cosmetic Act (discussed in our prior blog). Specifically, FDA identified "other potentially important parts of the regulatory scheme" it would take into consideration, including:

  • "[T]he scope of permissible difference due to the difference in manufacturer exception to the same labeling requirement in the statute (21 U.S.C. 355(j)(2(A)(v))";
  • "[R]egulations (21 C.F.R. § 312.92(a)(1), 314.94(a)(8)(iv) and 314.127(a)(7)) and applicable case law, including whether a drug with information related to use of Abilify® for Tourette's Disorder in pediatric patients carved out would remain safe and effective for the remaining non-protected conditions of use"; and
  • "[T]he applicability to, and effect of, 21 U.S.C. 355(A)(o) on labeling that is protected by both Hatch-Waxman and orphan exclusivity." (emphasis in original)

The brief also stated that it would take into consideration the arguments of the defendant-intervenors.

While it is unclear how the FDA will make a decision, based on the suggestions listed above, it appears that the FDA has already come to the conclusion that it will find a way to approve generic versions of Abilify®. Only time will tell; we will keep you posted.

The content of this article is intended to provide a general guide to the subject matter. Specialist advice should be sought about your specific circumstances.

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