Case Name: Sanofi-Aventis U.S. LLC v. Food and Drug Administration, Civ. No. 10-01255-ABJ, 2012 U.S. Dist. LEXIS 14873 (D.D.C. Feb. 7, 2012) (Jackson, J.). (Biosimilars/Citizens Petition - Agency deference resulted in a finding that FDA acted reasonably in denying Sanofi's citizen petition and approving Sandoz's ANDA generic enoxaparin/Lovenox).
Drug Product and Patent(s)-in-Suit: Lovenox® (enoxaparin); No Patent Asserted
Nature of the Case and Issue(s) Presented: The issue here concerns whether the Food and Drug Administration ("FDA") exceeded its statutory authority under the Federal Food, Drug, and Cosmetic Act ("FDCA") and unlawfully departed from agency precedent when it approved a generic version of Sanofi's Lovenox anti-coagulant drug. On February 19, 2003, Sanofi filed a citizen petition with the FDA urging it to withhold approval of any ANDA for generic enoxaparin until enoxaparin could be adequately characterized or the ANDA applicant could establish that its manufacturing process was identical to Sanofi's. The FDA eventually rejected Sanofi's citizen petition, instead adopting a five-pronged analysis designed to evaluate different aspects of the active ingredient's equivalence in relation to the Sanofi branded formulation. Sandoz filed an ANDA for generic enoxaparin while the FDA considered Sanofi's citizen petition. The FDA approved Sandoz's ANDA on July 23, 2010, the same day it rejected Sanofi's citizen petition. On July 26, 2010, Sanofi filed a three-count suit against the FDA, in addition to motions seeking a temporary restraining order and a preliminary injunction compelling the FDA to withdraw its approval of the Sandoz ANDA. The court denied the requests for a temporary restraining order and preliminary injunction. Sandoz filed a motion to intervene as an additional defendant on July 28, 2010, which was granted. The parties filed cross motions for summary judgment concerning the following issues: (i) the FDA was not within its statutory authority when it called for Sandoz to submit immunogenicity test data in conjunction with its ANDA; (ii) the FDA unlawfully departed from agency precedent by approving a generic before the active ingredient had been fully characterized; and (iii) the FDA unreasonably found that the active ingredient in Sandoz's generic was the same as the active ingredient in Lovenox. The court ruled in the FDA's and Sandoz's favor on all three issues.
Why FDA and Sandoz Prevailed: The FDA and Sandoz prevailed because Sanofi failed to establish that the FDA had exceeded its statutory authority under the FDCA. In particular, Sanofi alleged that it was improper for the FDA to require Sandoz to submit immunogenicity data in support of its ANDA for generic enoxaparin. The court found that the FDA's actions were subject to Chevronreview. Chevron requires the court to apply a two-part analysis when reviewing an agency's interpretation of a statute: First, analyzing whether Congress has directly spoken to the precise question at issue; and second, if the statute is silent or ambiguous, the court must then determine whether the agency's proffered interpretation is based on a permissible construction of the statute. The court found that the FDCA does not address specifically the issue of whether the FDA could require immunogenicity data as part of an ANDA because immunogenicity data was not one of the eight categories of information that Congress listed in FDCA sections 355(j)(2)(A)(i)-(viii). The court then analyzed the statutory text both in light of the entire statutory scheme and the statute's purpose, and found it to be ambiguous, and therefore, incapable of being resolved at the first step of the Chevron review.
Looking to the second step of its Chevron review, the court found that FDA's interpretation of FDCA section 355(b)(1)(D) was based on a permissible construction of the statute. The court found that the FDA's request for immunogenicity studies in conjunction with its review of Sandoz's ANDA was made to alleviate its concerns regarding the purity of generic enoxaparin, and that this conduct fell within the "full description" described in FDCA section 355(b)(1)(D). The court also noted that the careful scientific review of Sandoz's ANDA, for which approval took nearly five years, further evidenced the high degree of deference that should be afforded to the FDA.
Next, the court quickly dispensed with the notion that the FDA had departed from agency precedent when it approved an ANDA for a drug that had not been characterized fully, as Sanofi argued. Sanofi raised a nearly identical argument in its previously-filed preliminary-injunction motion, which the court had rejected. Although it was true that the FDA had refused to grant three previous ANDAs on the basis that the active ingredients had not been properly characterized, the court found that the FDA had provided legitimate reasons why those drugs should be treated differently than enoxaparin. Noting that its review of such an agency determination is "highly deferential," and that the FDA's arguments satisfied the minimal standard of rationality, the court rejected Sanofi's argument.
Last, the court held that the FDA's evaluation of the relevant scientific data concerning the active ingredient was within the FDA's area of expertise. The court found that the five-pronged analysis the FDA developed to determine whether generic enoxaparin was the same as branded Lovenox was a reasonable way to determine active ingredient equivalence. In the absence of any established method to definitively characterize the composition of enoxaparin, the court found that the FDA's thorough, and well-reasoned five-pronged approach was reasonable, and that Sandoz's generic had satisfied each prong of the FDA's five-pronged approach. Accordingly, the court afforded the FDA heightened deference in that regard, and granted the defendants' cross-motions for summary judgment.
