Civil Action No. 14–1923 BAH 03-11-2015 Ranbaxy Laboratories, Ltd, et al., Plaintiffs, v. Sylvia Mathews Burwell, Secretary, United States Department of Health and Human Services, et al., Defendants, v. Dr. Reddy's Laboratories, Inc., Endo Pharmaceuticals, Inc., Ivax Pharmaceuticals, Inc, Teva Pharmaceuticals USA, Inc. Defendant–Intervenors. John Kevin Dolan Crisham, Robert Anthony Gretch, Stephen S. Schwartz, Kirkland & Ellis LLP, New York, NY, Michael D. Shumsky, Kirkland & Ellis, LLP, Washington
(a) Definitions As used in this section, the term "pediatric studies" or "studies" means at least one clinical investigation (that, at the Secretary's discretion, may include pharmacokinetic studies) in pediatric age groups (including neonates in appropriate cases) in which a drug is anticipated to be used, and, at the discretion of the Secretary, may include preclinical studies. (b) Market exclusivity for new drugs (1) In general Except as provided in paragraph (2), if, prior to approval of an application