Actavis Elizabeth LLC v. United States Food & Drug Administration
393 U.S. App. D.C. 188
| D.C. Cir. | 2010Background
- Actavis challenged FDA's five-year exclusivity grant to Vyvanse (lisdexamfetamine dimesylate) after Vyvanse received FDA approval in 2007.
- Hatch-Waxman exclusivity provisions govern five-year and three-year periods for pioneer drugs and their derivatives.
- FDA treated lisdexamfetamine as a separate active moiety due to its amide bond, granting it five-year exclusivity as a new chemical entity.
- Actavis argued lisdexamfetamine contains a previously approved active moiety, so it could not qualify for five-year exclusivity.
- Salts and esters are excluded from active moiety; lisdexamfetamine is a prodrug that converts to dextroamphetamine in the body.
- District court granted summary judgment for FDA and Shire; the DC Circuit affirmed the decision on review.
Issues
| Issue | Plaintiff's Argument | Defendant's Argument | Held |
|---|---|---|---|
| Is FDA's five-year exclusivity interpretation reasonable? | Actavis asserts exclusivity should align with the plain meaning of 'active ingredient'. | FDA's interpretation, treating certain prodrugs as separate active moieties, is consistent with regulations. | Reasonable interpretation; agency deference preserved. |
| Does lisdexamfetamine qualify as an active moiety for five-year exclusivity? | Lisdexamfetamine contains a previously approved active moiety via dextroamphetamine. | Lisdexamfetamine is a prodrug with its own active moiety under the FDA's covalent-bond approach. | Lisdexamfetamine qualifies as a separate active moiety; five-year exclusivity granted. |
| Does the agency's interpretation conflict with the statutory structure and history of Hatch-Waxman? | Interpretation upsets the incentive scheme and allows minor variations to obtain five years. | Agency balance and policy justify the distinction between five- and three-year exclusivity. | Agency interpretation consistent with statutory structure and purpose. |
Key Cases Cited
- Mistick PBT v. Chao, 440 F.3d 503 (D.C. Cir. 2006) (deference to agency interpretations of its regulations)
- Thomas Jefferson Univ. v. Shalala, 512 U.S. 504 (Sup. Ct. 1994) (agency deference to regulatory interpretation)
- Abbott Labs. v. Young, 920 F.2d 984 (D.C. Cir. 1990) (ambiguity in 'active ingredient' interpretation under Hatch-Waxman)
- National Cable & Telecomm. Ass'n v. Brand X Internet Servs., 545 U.S. 967 (S. Ct. 2005) (deference to agency interpretations when not plainly erroneous)
- Serono Labs., Inc. v. Shalala, 158 F.3d 1313 (D.C. Cir. 1998) (judicial deference to agency scientific expertise)