Case Name: Hospira, Inc. v. Burwell, Civ. No. 14-02662-GJH, U.S. Dist. LEXIS 123972 (D. Md. Sept. 5, 2014) (Hazel, J.)
Drug Product and Patent(s)-in-Suit: Precedex® (dexmedetomidine hydrochloride); U.S. Patent No. 6,716,867 (“the ’867 patent”)
Nature of the Case and Issue(s) Presented: Precedex is commonly used as a sedative. Specifically, the FDA has approved Precedex for two uses: (i) sedation of initially intubated and mechanically ventilated patients during treatment in an intensive care setting (“ICU Sedation”); and (ii) sedation of non-intubated patients prior to and/or during surgical and other procedures (“Procedural Sedation”). Precedex’s FDA-approved label lists these two separate uses, and also indicates that these separate uses call for different dosages, provide different warnings regarding withdrawal, and describe different adverse event information. The ’867 patent is the only unexpired patent that currently covers Precedex. In particular, the ’867 patent is a method patent that covers ICU Sedation.
In 2009, Sandoz submitted an ANDA, which included a paragraph IV certification against the ’867 patent, seeking approval to market and sell its generic product. Hospira sued Sandoz, and after three years of litigation, the parties reached a settlement agreement permitting Sandoz to market its generic product in the US no later than Dec. 26, 2014.
Unlike Sandoz, Mylan and Par submitted ANDAs to the FDA seeking to market their generic versions of Precedex pursuant to a section viii statement, carving out all mentions of the ICU Sedation indication that was still protected by the ‘867 patent. On Mar. 4, 2013, the FDA tentatively approved Mylan’s ANDA with its proposed carve-out labelling. Hospira sought to amend the ’867 patent use code from “Intensive Care Unit Sedation” to “Intensive Care Unit Sedation, including sedation of non-intubated patients prior to and/or during surgical and other procedures.” Hospira admitted that its amendment was meant to clarify without expanding the original use code. Hospira also requested that the FDA not approve any ANDAs containing section viii statements relating to generic Precedex. The FDA concluded that Mylan’s generic label appropriately carved out ICU Sedation, and was safe and effective for the remaining Procedural Sedation indication. Hospira sued and sought a temporary restraining order and/or preliminary injunction seeking to stay the FDA’s decision. All of the Defendants filed cross motions for summary judgment in relation to the temporary restraining order and/or preliminary injunction sought by Hospira. The court granted defendants’ motions and denied plaintiff’s motion.
Why the FDA Prevailed: Count I of Hospira’s complaint alleged that the FDA had violated 21 U.S.C. § 355(j)(2)(A)(viii) when it approved Mylan and Par’s ANDAs. Hospira argued that the authorization was arbitrary and capricious because the FDA ignored the clear statutory language of section viii when it approved generic drugs that had carve-out labels that overlapped with the branded drug’s use code. Applying the Chevron factors, the court found that the statute did not address what constitutes “overlap” between an NDA holder’s “use code” and an ANDA sponsor’s “carved-out” label. The court also determined that Hospira failed to identify any legislative history in support of its proposed construction, nor had it pointed to another statutory provision which, when read in tandem with section viii, compelled Hospira’s construction of the statute. Therefore, the court moved on to step two of its Chevron analysis: whether the FDA’s action was based on a permissible construction of the statute.
Hospira’s main argument was that the Supreme Court’s Caraco decision prevented the FDA from approving an ANDA with a section viii statement if there was any overlap between methods of using the drug reflected in (i) the carved-out labelling proposed in the ANDA and (ii) the use code in the Orange Book. The court disregarded this argument for three reasons: first, the FDA had been consistent in how it had interpreted section viii; second, Hospira’s reading of Caraco would turn the holding of that case on its head; and third, there was no overlap between the ANDA’s carved-out labels and the Precedex use code. In fact, the court found that the FDA had consistently determined that it could approve section viii ANDAs for broad, general indications that may partially overlap with a protected method of use, so long as any express references to the protected use was omitted from the labelling. The FDA determined that the ANDAs’ proposed carve-out did not provide any reference to the lone protected method of use, ICU Sedation, on the proposed label, regardless of the fact that some physician might potentially use the generic product in the ICU at some point in the future. The court also pointed to the FDA’s determination that it had not acknowledged “overlap in fact” between the proposed labelling and the protected use, as Hospira asserted, but only the possibility of use, which was very different. The court noted that so long as the label carve-out was appropriate, it was not obliged to consider how a product might be used by a physician, beyond the approved labelling.
Finally, the court dismissed Hospira’s second count, which alleged that the FDA had violated the Administrative Procedure Act when it engaged in making a new rule without adhering to the notice and comment rulemaking requirements of the Act. The FDA had an established history of approving section viii ANDAs for broad, general indications even though they may, as in this case, partially overlap with a protected method of use where all express references to the protected use were appropriately carved out of the proposed labelling. The court pointed to the FDA’s similar handling of carve-out labelling related to generic versions of repaglinide, tramadol, and oxandrolone as evidence of adhering to past practice. Because the FDA was simply following past practice, the court concluded that it had not engaged in making a new rule.
