BERLEX LABORATORIES, INC., Plaintiff,
v.
FOOD AND DRUG ADMINISTRATION, et al., Defendants.
United States District Court, District of Columbia.https://leagle.com/images/logo.png
October 7, 1996.
October 7, 1996.
Attorney(s) appearing for the Case
James R. Phelps, Robert A. Dormer, A. Wes Siegner, Jr., Hyman, Phelps & McNamara, P.C., Washington, DC, for Plaintiff.
Drake Cutini, Office of Consumer Litigation, U.S. Department of Justice, Washington, DC, for Defendants.
Allen R. Snyder, Robert P. Brady, Douglas A. Fellman, Gregory G. Garre, Hogan & Hartson, Washington, DC, William C. Brashares, William A. Davis, Michael B. Bressman, Mintz, Levin, Cohn, Ferris, Glovsky and Popeo, P.C., Washington, DC, Michael J. Astrue, Elan Z. Ezickson, Biogen, Inc., Cambridge, MA, for Intervenors.
United States District Court, District of Columbia.
MEMORANDUM OPINION
ROBERTSON, District Judge.
Plaintiff Berlex Laboratories, Inc. ("Berlex") manufactures Betaseron, a biological drug classified as an interferon beta product.1 On July 23, 1993, the Food and Drug Administration approved Betaseron for the treatment of multiple sclerosis. Because it was the first interferon beta product approved for the treatment of MS, Betaseron was also given market exclusivity for seven...
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