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PUREPAC PHARMACEUTICAL CO. v. THOMPSON

No. CIV.A. 02-1657(ESH).

238 F.Supp.2d 191 (2002)

PUREPAC PHARMACEUTICAL CO. Plaintiff, v. Tommy G. THOMPSON, Secretary of Health & Human Services, and Lester M. Crawford, Jr., Deputy Commissioner of Food and Drugs, Defendants, and Apotex, Inc., and Torpharm, Inc., Intervenors-Defendants

United States District Court, District of Columbia.

December 16, 2002.

Attorney(s) appearing for the Case

Andrew M. Berdon, Frommer Lawrence & Haug, LLP, New York, NY, Joseph S. Hall, Mark C. Hansen, Richard H. Stern, Kellogg Huber Hansen Todd & Evans, PLLC, Washington, DC, for Plaintiff.

Andrew E. Clark, U.S. Dept. of Justice, Office of Consumer Litigation, Washington, DC, Peter Blumberg, U.S Attorney's Office, Civ. Div., Washington, DC, Arthur Y. Tsien, Olsson, Frank and Weeda, P.C., Washington, DC, Hugh L. Moore, William A. Rakoczy, Lord, Bissell and Brook, Chicago, IL, for Defendants.

Jeremy M. Jay, Leydig, Voit & Mayer, Washington, DC, Pamela J. Ruschau, Robert F. Green, Steven H. Sklar, Leydig, Voit & Mayer, Chicago, IL, for Amicus.

MEMORANDUM OPINION

HUVELLE, District Judge.

This case arises out of the Food and Drug Administration's ("FDA" or "the agency") denial of Abbreviated New Drug Applications for generic formulations of the drug gabapentin submitted by plaintiff Purepac Pharmaceutical Co. ("Purepac"). The agency denied plaintiff's ANDAs because those applications failed to include the proper certification (a "paragraph IV certification") regarding a method of use patent...

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