916 F. Supp. 2d 76
D.D.C.2013Background
- ViroPharma sued FDA in the D.D.C. challenging FDA’s approval of three vancomycin generic ANDAs on April 9, 2012.
- Plaintiff asserts two claims: a statutory exclusivity claim under the QI Act for three-year exclusivity; and a bioequivalence claim based on in vitro testing.
- FDA denied ViroPharma three-year exclusivity by interpreting 21 U.S.C. § 355(v)(3)(B) to exclude labeling changes that refine existing, not create new, conditions of use.
- ViroPharma previously lost a motion for preliminary relief; the court now addresses merits via summary judgment, applying APA standards and reviewing the administrative record.
- The court previously found labeling changes refined and added detail to the already approved conditions of use, not creating a new condition of use.
- Evidence shows Genzyme studies were not essential to the labeling change approval, and PREA pediatric studies were not triggered.
Issues
| Issue | Plaintiff's Argument | Defendant's Argument | Held |
|---|---|---|---|
| Does FDA's §355(v)(3)(B) interpretation deny exclusivity as a reasonable reading? | ViroPharma argues labeling changes create a new condition of use and thus merit exclusivity. | FDA's reading reflects refinement of already approved conditions of use and is within its discretion. | Yes; FDA interpretation reasonable and exclusivity denied. |
| Was FDA within discretion to approve ANDAs based on in vitro bioequivalence? | In vivo testing is the default requirement for bioequivalence. | Bioequivalence can be determined case-by-case; in vitro testing appropriate here. | Yes; FDA acted within its discretion and approval stands. |
| Were Genzyme data essential to the FDA's labeling-change approval and does PREA apply? | Genzyme data supported exclusivity; PREA would apply if new dosing/indication. | Genzyme data were not essential to approval; PREA did not apply. | Not essential; PREA not triggered. |
Key Cases Cited
- Serono Labs. v. Shalala, 158 F.3d 1313 (D.C. Cir. 1998) (deference to agency scientific determinations in technical matters)
- National Cable & Telecomms. Ass’n v. Brand X Internet Servs., 545 U.S. 967 (S. Ct. 2005) (Chevron step two: agency interpretations upheld if reasonable)
- Schering Corp. v. FDA, 51 F.3d 390 (3d Cir. 1995) (agency expertise in scientific regulatory decisions)
- AstraZeneca Pharms. LP v. FDA, 872 F. Supp. 2d 60 (D.D.C. 2012) (3-year exclusivity not triggered solely by labeling changes)
- Belbacha v. Bush, 520 F.3d 452 (D.C. Cir. 2008) (law-of-the-case and preliminary relief considerations)
- Kuzinich v. Cnty. of Santa Clara, 689 F.2d 1345 (9th Cir. 1982) (limits on when a prior ruling governs later decisions)