Viropharma Incorporated v. Hamburg
898 F. Supp. 2d 1
D.D.C.2012Background
- ViroPharma sued FDA challenging the April 9, 2012 approval of three vancomycin generic ANDAs.
- Two claims: (i) statutory exclusivity under 21 U.S.C. § 355(j)(5)(F)(iv) for an Old Antibiotic (via the QI Act) and (ii) bioequivalence testing methodology for vancomycin (in vitro vs in vivo).
- FDA denied exclusivity based on § 355(v)(3)(B) limitations and concluded the sNDA did not show a significant new use; FDA also approved in vitro-based bioequivalence rather than in vivo data.
- Vancocin is an Old Antibiotic; FDAMA repealed Section 507, but QI Act later granted limited exclusivity for Old Antibiotics under certain conditions.
- FDA relied on its regulatory interpretation that exclusivity for Old Antibiotics covers significant new uses, not mere labeling refinements.
- For bioequivalence, FDA concluded it could rely on in vitro dissolution data and/or waiver in vivo testing under 21 C.F.R. § 320.22(e); ViroPharma challenged this interpretation.
Issues
| Issue | Plaintiff's Argument | Defendant's Argument | Held |
|---|---|---|---|
| Whether FDA erred in denying exclusivity under § 355(v)(3)(B). | ViroPharma argues § 355(v)(3)(B) applies to labeling changes and new uses, supporting exclusivity for Vancocin. | FDA reasons exclusivity limited to significant new use not merely refinements; sNDA labeling changes did not meet 'condition of use' prior to enactment. | Not likely to succeed; FDA's Chevron-deferential interpretation reasonable. |
| Whether FDA properly approved vancomycin ANDAs with in vitro bioequivalence without in vivo testing. | Regulations default to in vivo bioequivalence unless waived; in vivo is required absent waiver. | FDA has discretion under 21 C.F.R. § 320.24 to require in vivo, in vitro, or both; waiver under § 320.22(e) is appropriate here. | Not likely to succeed; FDA's in vitro approach and waiver decision were permissible. |
Key Cases Cited
- Winter v. NRDC, 555 U.S. 7 (Supreme Court 2008) (four-factor preliminary injunction test)
- Mayo Foundation for Med. Educ. & Research v. United States, 131 S. Ct. 704 (S. Ct. 2011) (Chevron step-one requirement and deference framework)
- Serono Labs., Inc. v. Shalala, 158 F.3d 1313 (D.C. Cir. 1998) (Chevron deference and agency interpretations in bioequivalence cases)
- Mylan Labs., Inc. v. Thompson, 389 F.3d 1272 (D.C. Cir. 2004) (FDA expertise and deference in regulatory determinations)
- Bristol-Myers Squibb Co. v. Shalala, 923 F. Supp. 212 (D.D.C. 1996) (deference to FDA bioequivalence determinations)
- National Cable & Telecomm. Ass’n v. Brand X Internet Servs., 545 U.S. 967 (Supreme Court 2005) (Chevron framework and agency statutory interpretation)