What’s at Stake in the Precedex ® Use Code Litigation?
The U.S. Food and Drug Administration’s (FDA) August 18, 2014, decision 1 to accept section viii certifications for generic versions of Precedex ®, despite overlap between the labeled uses for these generic versions and the patent use code assigned to Precedex ®, has significant implications for generic and brand drug manufacturers, and calls into question the FDA’s administration of patent safeguards in the 1984 Hatch Waxman Act 2 (Hatch Waxman).
The dispute centers on the FDA’s use code system, which until now has largely served Hatch Waxman’s purpose of ensuring that patent disputes are resolved by the courts, before FDA grants approval to an abbreviated new drug application (ANDA). As the FDA stated in a 2003 Federal Register notice, “[a] fundamental assumption of the Hatch-Waxman Amendments is that the courts are the appropriate mechanism for the resolution of disputes about the scope and validity of patents.” 3 Under the FDA’s use code system, the innovator drug company proposes a use code to the FDA whenever one of its patents covers a use for which its drug is approved, and this use code serves as the basis for determining whether a label carve-out or “skinny labeling” can be employed to avoid the patent.
While an ANDA is supposed to include the same label as the innovator drug, an ANDA can in some instances exclude uses from a label that are protected by patent or regulatory exclusivity. When this happens, the ANDA no longer must include a patent certification, but will instead include a section viii statement that the drug will not be marketed for the patented use. The FDA reviews the use code to determine whether the section viii certification is appropriate. If the label includes information covered by the use code, the FDA will reject the section viii statement and require an appropriate patent certification.
However, that arguably is not what happened for Precedex ®, a dexmedetomine hydrochloride injection marketed by Hospira, Inc. (Hospira). Precedex ® is approved for two indications, intensive care unit sedation and surgical procedure sedation. Hospira’s patent use code refers to sedation in an intensive care setting, but the FDA acknowledges that surgical procedure sedation can also occur in an intensive care setting. 4 Nevertheless, the FDA approved an ANDA label from Mylan Institutional LLC (Mylan) that carved out the first indication, and accepted Mylan’s section viii statement, because Hospira’s patent use code was limited to an intensive care setting and, according to FDA, Mylan’s labeling omitted any “express references to the protected use.” In other words, Mylan’s label did not state that the surgical procedure sedation could occur in an intensive care setting.
In the Citizen Petition response 5 that preceded Mylan’s approval, the FDA admitted that there was potential overlap between the use code and the uses described in Mylan’s label, but argued that its precedent allowed for a section viii certification in this context. According to the FDA, it “previously has determined that it can approve 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 are omitted from the labeling.”
Hospira immediately filed suit against the FDA in response to the Mylan approval, 6 and on August 19, 2014, the United States District Court for the District of Maryland granted a temporary restraining order against the FDA, ruling that the FDA likely had violated its own precedent when it accepted Mylan’s paragraph viii statement. 7 Even if the FDA had previously accepted section viii statements in comparable situations, the FDA still was breaking with a policy it had articulated in the Federal Register, recently cited in the Supreme Court’s Caraco Pharm. Labs., Ltd. v. Novo Nordisk A/S decision, that the FDA would not approve an ANDA with labeling that overlapped the use code submitted by the innovator. 8 According to the Maryland District Court, the FDA could not change this policy without employing formal rulemaking procedures required by the Administrative Procedures Act.
Because the Maryland decision was issued in the context of a temporary restraining order, the Court will have the opportunity to revisit its decision after the factual record is more fully developed. However, the FDA appears to have backtracked on a policy it instituted to safeguard Hatch Waxman’s intellectual property protections, and we will see how the Court eventually responds.
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1 FDA’s August 18, 2014 Letter Decision in Docket No. FDA-2014-N-0087 (FDA Precedex ® Decision).
2 Public Law 98-417 (Drug Price Competition and Patent Term Restoration Act of 1984).
3 68 Fed. Reg. 36682–36683 (2003).
4 See FDA Precedex ® Decision.
5 Id.
6 Hospira, Inc. v. Sylvia Mathews Burwell, et al., Case No. GJH-14-02662 (D. Md.).
7 Hospira, Inc. v. Sylvia Mathews Burwell, et al., Case No. GJH-14-02662 (D. Md.) (August 19, 2014, Memorandum Opinion).
8 As the Supreme Court stated in its Caraco Pharm. Labs., Ltd. v. Novo Nordisk A/S, 132 S. Ct. 1670 (2012), “the FDA will not approve such an ANDA if the generic’s proposed carve-out label overlaps at all with the brand’s use code.” Citing 68 Fed. Reg. 36682–36683 (2003).
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