By Jeffrey H. Brochin, J.D.
The FDA’s determination that approval of Brixadi® Monthly was subject to a 3-year right of exclusivity belonging to Indivior, Inc.’s Sublocade®, ruled arbitrary and capricious.
A federal district court in Washington has granted summary judgment in favor of Braeburn, Inc., manufacturer of the injectable buprenorphine drug Brixadi® Monthly, for the treatment of opioid use disorder (OUD). Although the company’s weekly injectable depot of the drug had received FDA approval, the agency denied approval for the monthly version on the grounds that Braeburn’s competitor, Invidior, Inc., was entitled to a 3-year exclusivity for their competing OUD drug, Sublocade®. However, the FDA’s reasoning in defining one innovation as circumscribed by the patient population, but not applying the same definitional limit for the other, was inconsistent, and therefore arbitrary and capricious (Braeburn, Inc. v. FDA, July 19, 2019, Howell, B.).
Statutory and Regulatory environment. In 1984, Congress passed the Drug Price Competition and Patent Term Restoration Act of 1984 (Hatch-Waxman Amendments), which introduced two streamlined paths for the sponsor of a new drug to seek FDA approval. Pursuant to § 505(b)(2) of the Food, Drug, and Cosmetic Act (FDC ACT), as amended, a new-drug sponsor may rely on investigations that were not conducted by or for the applicant and for which the applicant has not obtained a right of use from the person by or for whom the investigations were conducted. However, that type of application must still meet the remaining requirements codified in § 355(b)(1) and must certify that marketing the new drug would not infringe certain patent protections.
In order to avoid "free riding" by a new drug sponsor on a competitor’s safety and efficacy investigations, the Hatch-Waxman Amendments also established conditions under which new drugs are entitled to a period of market exclusivity. Blending streamlined paths for a new-drug sponsor to obtain FDA approval with exclusivity protections was designed to balance the need to make available more low cost generic drugs by establishing a generic approval procedure with new incentives for drug development in the form of exclusivity and patent term extensions.
Three-year exclusivity. The court noted that at the crux of the instant case was the three-year exclusivity term granted to the party who conducted the clinical drug investigations, thereby barring the new drug applicant from obtaining FDA approval until the expiration of that period of exclusivity running from the date of the approval of the prior application. In July 2017, Braeburn applied to the FDA for approval of Brixadi® and, on December 21, 2018, received tentative approval for both Brixadi® Weekly and Monthly. However, although Braeburn was notified that Brixadi® Weekly could receive final approval, Brixadi® Monthly was not eligible for final approval until November 30, 2020, upon expiration of Indivior’s three-year right to exclusivity, under 21 U.S.C. § 355(c)(3)(E)(iii), and the instant lawsuit followed in April 2019.
‘Conditions of approval’ ambiguous term. Braeburn contended that the FDA’s exclusivity determination was premised on an interpretation of the FDC Act that was contrary to the statute. The parties agreed that the term "conditions of approval" was undefined in the FDC Act and that no FDA implementing regulation clarified the meaning of that term and therefore it was ambiguous. Both the FDA’s and Braeburn’s interpretation of "the conditions of approval" started from roughly the same place, but each understood the phrase to refer to a different subset of circumstances.
Exclusivity and innovative features. As the FDA’s decision letter articulated, the agency interpreted "the conditions of approval" bar clause to limit exclusivity to instances in which a follow-on drug product shared the innovation supported by the first product’s new clinical investigations: a follow-on drug product could not be approved within three years of the first product’s approval if the latter product incorporated the first’s innovative features. However, the court disapproved of the FDA’s failure to explain how it arrived at that statutory construction, noting that merely describing a feature as an "innovation" risked making it an empty label in the absence of a standard by which "innovation" could be determined.
Accordingly, the court found that the agency’s action in disapproving Braeburn’s application for Brixadi® Monthly was arbitrary and capricious and their decision letter based on Invidior’s 3-year exclusivity was vacated.
For the foregoing reasons, the court granted Braeburn’s motion for summary judgment and remanded the matter back to the FDA for it to reconsider, "with deliberate speed," Braeburn’s application for final approval of Brixadi® Monthly.
The case is No. 1:19-cv-00982-BAH.
Attorneys: Brian Burgess (Goodwin Procter LLP) for Braeburn Inc. Roger Joseph Gural, U.S. Department of Justice, for U.S. Food and Drug Administration.
Companies: Braeburn Inc.; U.S. Food and Drug Administration
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