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OTSUKA PHARMACEUTICAL CO., LTD. v. BURWELL

Civil Action No. 15-cv-1688 (KBJ).

302 F.Supp.3d 375 (2016)

OTSUKA PHARMACEUTICAL CO., LTD., et al., Plaintiffs, v. Sylvia Mathews BURWELL, in her official capacity as Secretary of the United States Department of Health and Human Services, et al., Defendants, and Alkermes, Inc., et al., Intervenor-Defendants.

United States District Court, District of Columbia.

Signed July 28, 2016.

Attorney(s) appearing for the Case

Maggie T. Grace , Ralph Sargent Tyler, III , Venable LLP, Baltimore, MD, Seth Paul Waxman , Wilmer Cutler Pickering Hale & Dorr LLP, Hockessin, DE, for Plaintiffs.

Roger Joseph Gural , Andrew E. Clark , US Department of Justice, Consumer Protection Branch, Washington, DC, for Defendants.

Christopher T. Holding , Sarah K. Frederick , Goodwin Procter LLP, Boston, MA, William M. Jay , Goodwin Procter, LLP, Washington, DC, for Intervenor-Defendants.

MEMORANDUM OPINION

To incentivize the development and marketing of safe, effective, and affordable drug products, the Federal Food, Drug, and Cosmetic Act ("FDCA"), 21 U.S.C. § 321 et seq., provides a variety of benefits for drug manufacturers, including prescribed periods...

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