106 F. Supp. 3d 196
D.D.C.2015Background
- Amarin challenges FDA's denial of five-year NCE exclusivity for Vascepa (icosapent ethyl) after Lovaza had EPA as a component; Vascepa’s active ingredient is a single molecule, EPA ester, whereas Lovaza is a multi-component mixture.
- FDA previously treated five-year exclusivity as applying to drugs with no active moiety previously approved; FDA adopted an 'active moiety' framework for mixtures in 2014, creating a three-part test for active moieties in mixtures.
- Lovaza was approved as a mixture with EPA as part of the entire omega-3 ethyl ester blend; Lovaza’s active ingredient was listed as the entire mixture in NDA approval.
- Vascepa was approved in 2012; Amarin sought five-year exclusivity based on its single-molecule EPA moiety distinct from Lovaza, but FDA denied, deeming EPA an active moiety already approved in Lovaza.
- FDA’s decision relied on a three-part framework distinguishing poorly characterized vs well-characterized mixtures, treating EPA as an active moiety shared with Lovaza, thus limiting Vascepa to three-year exclusivity.
- Court addresses whether FDA's statutory interpretation (active moiety vs active ingredient) and the framework are permissible under Chevron and the APA and whether the decision is arbitrary and capricious.
Issues
| Issue | Plaintiff's Argument | Defendant's Argument | Held |
|---|---|---|---|
| Is FDA’s 'active moiety' interpretation permissible under Chevron Step One? | Amarin: statute's 'active ingredient' means what Congress wrote; FDA cannot repurpose to 'active moiety'. | FDA: ambiguity allows reasonable interpretation; deference warranted under Chevron. | No; statute does not authorize the FDA’s interpretation. |
| Does FDA’s three-part framework for mixtures align with the exclusivity statute’s text? | Amarin: framework distorts statutory focus on 'active ingredient' that was approved; inconsistent with Lovaza approval. | FDA: can fill gaps with a framework to address naturally derived mixtures. | Framework does not harmonize with the statute; must be set aside. |
| Is FDA’s decision arbitrary and capricious under the APA? | Amarin: decision lacks reasoned explanation reconciling active ingredient vs active moiety; retroactivity concerns. | FDA: relied on expert framework; previous inconsistencies acknowledged; framework reasonable. | Yes; decision fails reasoned decisionmaking; vacate and remand. |
Key Cases Cited
- Abbott Laboratories v. Young, 920 F.2d 984 (D.C. Cir. 1990) (ambiguity of 'active ingredient' in different sections; not controlling here)
- Actavis Elizabeth LLC v. FDA, 625 F.3d 760 (D.C. Cir. 2010) (ambiguity of 'active ingredient' and FDA interpretation for prodrugs)
- Sorenson v. Sec’y of Treasury, 475 U.S. 851 (U.S. 1986) (identical words in same statute presumed same meaning)
- Powerex Corp. v. Reliant Energy Servs., Inc., 551 U.S. 224 (U.S. 2007) (Chevron step-two deferential standard)
- Util. Air Regulatory Grp. v. EPA, 134 S. Ct. 2427 (S. Ct. 2014) (presumption of consistent usage; context-based interpretation cautioned)
- City of Arlington v. FCC, 133 S. Ct. 1863 (S. Ct. 2013) (context matters; agency must give coherent justification)
- PGA Tour, Inc. v. Martin, 532 U.S. 661 (U.S. 2001) (statutory breadth and agency interpretation considerations)
- Serono Labs., Inc. v. Shalala, 158 F.3d 1313 (D.C. Cir. 1998) (sameness in context of drug approvals; regulatory interpretation)
- Abbott Laboratories v. Shalala, not included in list (D.C. Cir. 1990) (see Abbott Labs discussion above)