Veloxis Pharmaceuticals, Inc. v. FDA

Case Name: Veloxis Pharmaceuticals, Inc. v. FDA, Civ. No. 14-2126 (RBW), 2015 U.S. Dist. LEXIS 77559 (D.D.C. June 12, 2015) (Walton, J.) 

Drug Product and Patent(s)-in-Suit: Astagraf XL^® (tacrolimus); N/A

Nature of the Case and Issue(s) Presented: The issue before the Court was whether the FDA’s decision to delay final approval of a related drug application during the exclusivity period of the original application was proper. The drugs at issue are used as immunosuppressants to prevent organ rejection after transplantation. During the approval process, Veloxis obtained approval for Astagraf XL for use in patients receiving de novo kidney transplants. Veloxis was given three years exclusivity for use of the drug in this capacity. Plaintiff also sought approval of Envarsus XL for use in patient receiving de novo and conversion kidney transplants. The FDA refused to provide final approval of Envarsus XL because of the exclusivity given to Astgraf XL.

Veloxis asserted that Astagraf XL should not have been given the three-year exclusivity because the original NDA was filed before October 2008, which was the cutoff date in the QI Program Supplemental Funding Act of 2008. The original application for Astagraf XL was filed before October 2008, but had been withdrawn and a new application with new clinical information was submitted in 2012. The FDA argued that because the original application was withdrawn and a new application with new material was submitted after October 2008, the application was subject to the three-year exclusivity. Veloxis also asserted that the exclusivity should only bar those later-filed applications that rely upon the original application. Because Envarsus XL did not rely upon the studies and information in the Atagraf XL application, approval should not be withheld by the FDA. Lastly, Veloxis asserted that the conditions for approval were different between Envarsus XL and Astagraf XL, such that final approval should not be withheld. In particular, Envarsus XL conditions included both de novo and conversion kidney transplants while Astagraf XL included only de novo kidney transplants. The court found in favor of the FDA.

Why the FDA Prevailed: The court held that the FDA’s decision to withhold final approval of Envarsus XL was not arbitrary or capricious.  Firstly, the Court found that Astagraf XL was entitled to the three-year exclusivity because the application that ultimately was approved by the FDA was filed in 2012. Moreover, the new evidence submitted with the 2012 application was relied on and necessary to obtain the approval. As such, the fact that the original application was filed before October 2008 did not preclude the three-year exclusivity from applying to Astagraf XL. The court also found that a later-filed application does not need to rely upon the original application in order to fall within the scope of the exclusivity provision. After reviewing the relevant statutes, the court determined that the FDA may not approve a second-in-time application that shares “conditions of approval” with the first-in-time application. The court noted that Veloxis’s interpretation would provide a loophole for a second-in-time application to escape the exclusivity by relying on another application that was not the first-in-time application, which would be contrary to Congress’s intent to provide an incentive for the sponsor of the first-in-time application. 

The court rejected the position that the “conditions of approval” had to exactly match for the exclusivity to be triggered. The court noted that Veloxis had voluntarily refused to limit the conditions of approval for Envarsus XL to conversion kidney transplants, a condition that Astagraf XL was not approved for. Because the conditions of approval overlapped, the exclusivity applied and final approval had to be delayed.