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TEVA PHARMACEUTICALS USA, INC. v. SEBELIUS

Nos. 09-5281, 09-5308.

595 F.3d 1303 (2010)

TEVA PHARMACEUTICALS USA, INC., Appellant v. Kathleen SEBELIUS, In her Official Capacity as Secretary of Health and Human Services, et al., Appellees.

United States Court of Appeals, District of Columbia Circuit.

Decided March 2, 2010.

Attorney(s) appearing for the Case

Michael D. Shumsky argued the cause for appellant. With him on the briefs were Jay P. Lefkowitz and Gregory L. Skidmore.

Carmen M. Shepard and Kate C. Beardsley were on the briefs for cross-appellant Apotex, Inc. in No. 09-5308.

Drake Cutini, Attorney, U.S. Department of Justice, argued the cause for appellees. With him on the brief were Eugene M. Thirolf Jr., Director, David S. Cade, Acting General Counsel, United States Food and Drug Administration, Michael M. Landa, Acting Associate General Counsel, and Eric M. Blumberg, Deputy Chief Counsel.

Carmen M. Shepard and Kate C. Beardsley were on the brief for amicus curiae Apotex, Inc. in support of appellees.

Dissenting opinion filed by Circuit Judge HENDERSON.

WILLIAMS, Senior Circuit Judge:

This is the latest installment in a long-running series of cases concerning an incentive that Congress established for companies to bring "generic" versions of branded drugs to market faster than they otherwise might. Teva Pharmaceuticals USA, Inc., a manufacturer of generics, has received tentative approval from the U.S. Food and Drug Administration to sell losartan potassium products—used primarily to treat hypertension. The...

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