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OTSUKA PHARMACEUTICAL CO., LTD. v. PRICE

No. 16-5229.

869 F.3d 987 (2017)

OTSUKA PHARMACEUTICAL CO., LTD., et al., Appellants v. Thomas PRICE, Secretary, U.S. Department of Health and Human Services, et al., Appellees.

United States Court of Appeals, District of Columbia Circuit.

Decided August 29, 2017.

Attorney(s) appearing for the Case

Thomas G. Saunders argued the cause for appellants. With him on the briefs were Seth P. Waxman and Robbie Manhas , Washington, DC.

Henry C. Whitaker , Attorney, U.S. Department of Justice, argued the cause for federal appellees. With him on the brief were Benjamin C. Mizer , Principal Deputy Assistant Attorney General, and Scott R. McIntosh , Attorney.

William M. Jay , Washington, DC, argued the cause for intervenors-appellees Alkermes, Inc., et al. With him on the brief were Brian T. Burgess , Andrew Kim , Sarah K. Frederick , and Christopher T. Holding , Boston, MA.

Before: Brown and Srinivasan, Circuit Judges, and Williams, Senior Circuit Judge.

The Food, Drug, and Cosmetic Act affords periods of "marketing exclusivity" to pioneering drug products. When a drug earns a period of exclusivity, the Food and Drug Administration must withhold approval of certain competing drugs if various conditions are satisfied. But how does the FDA determine if a new drug bears a...

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