Mylan Pharmaceuticals, Inc. v. Sebelius
856 F. Supp. 2d 196
D.D.C.2012Background
- This pre-MMA Hatch-Waxman dispute concerns modafinil (Provigil) and the FDA’s grant of a 180-day exclusivity to Teva USA as the first ANDA filer for both listed patents ('516 and '346).
- Cephalon owned Provigil and sued the four early ANDA filers in 2003-2005 over the '516 patent, triggering a 30-month stay; Cephalon settled with Mylan, Barr, Ranbaxy, and Teva, paying them to delay entry.
- Cephalon later obtained the narrower '346 patent in 2007; Teva USA and Watson filed ANDAs with paragraph IV on that patent in 2007, while Mylan filed in 2011.
- Cephalon and Teva Ltd. merged (Cephalon acquired by Teva Ltd. in 2011), raising questions about adverseness and the continued viability of the paragraph IV framework for exclusivity.
- On April 4, 2012, FDA awarded Teva USA exclusive 180-day marketing rights beginning March 30, 2012 (the start of Cephalon’s authorized generic), and denied Mylan final approval pending Teva’s exclusivity period.
- Mylan challenged the FDA’s interpretation and sought a preliminary injunction to revoke Teva’s exclusivity and grant immediate final approval to Mylan.
Issues
| Issue | Plaintiff's Argument | Defendant's Argument | Held |
|---|---|---|---|
| Whether Teva USA’s 180-day exclusivity remains valid after Cephalon’s acquisition by Teva Ltd. | Mylan argues adverseness ended under common corporate control, rendering Teva USA ineligible. | FDA treated Teva USA as an eligible first filer despite corporate restructuring; the statute does not require ongoing adverseness. | FDA's exclusivity determination is reasonable; Mylan’s threshold likelihood of success on this claim is not established. |
| Whether Teva USA’s conduct constitutes abandonment of its ANDA under 21 C.F.R. § 314.107(c)(3). | FDA failed to disqualify Teva USA for not actively pursuing final approval, implying abandonment. | FDA properly found active pursuit after Teva’s March 30, 2012 letter; deference to agency’s interpretation applies. | FDA’s interpretation and application of the regulation were reasonable; abandonment claim fails. |
Key Cases Cited
- Chevron U.S.A., Inc. v. Natural Resources Defense Council, Inc., 467 U.S. 837 (1984) (agency interpretations of the FDCA receive deference when reasonable)
- Winter v. Natural Resources Defense Council, Inc., 555 U.S. 7 (2008) (four-factor test for preliminary injunctions with sliding-scale approach)
- Caraco Pharm. Labs., Ltd. v. Forest Labs., Ltd., 527 F.3d 1278 (Fed. Cir. 2008) (courts recognize covenants not to sue do not defeat exclusivity rights)
- Mova Pharm. Corp. v. Shalala, 140 F.3d 1060 (D.C. Cir. 1998) (paragraph IV certifications and exclusivity framework; litigation mechanics)
- Apotex, Inc. v. Cephalon, Inc., 449 F.3d 1249 (D.C. Cir. 2006) (pre-MMA forfeiture concerns and market entry dynamics)
- Apotex, Inc. v. Cephalon, Inc., 2012 U.S. Dist. LEXIS 43479 (E.D. Pa. 2012) (discussed in context of FDA’s post-settlement implications)
- Greater New Orleans Fair Housing Action Ctr. v. U.S. Dep’t of Housing and Urban Dev., 639 F.3d 1078 (D.C. Cir. 2011) (likelihood of success is a key consideration in preliminary injunctions)
- Mova Pharm. Corp. v. Shalala, 955 F. Supp. 128 (D.D.C. 1997) (earlier ruling on exclusivity and pre-MMA framework)