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PFIZER INC. v. SHALALA

No. 98-5151.

182 F.3d 975 (1999)

PFIZER INC., Appellant, v. Donna E. SHALALA, Secretary, U.S. Department of Health and Human Services, et al., Appellees.

United States Court of Appeals, District of Columbia Circuit.

Decided July 16, 1999.

Attorney(s) appearing for the Case

Bert W. Rein argued the cause for appellant. With him on the briefs were Andrew S. Krulwich, Bruce G. Joseph and Michael L. Sturm.

Drake Cutini, Attorney, U.S. Department of Justice, argued the cause for appellees. With him on the brief was Frank W. Hunger, Assistant Attorney General. Gerald C. Kell, Attorney, entered an appearance.

E. Anthony Figg argued the cause for appellee Mylan Pharmaceuticals, Inc. With him on the brief was Steven Lieberman.

David G. Adams was on the brief for appellee Penwest Pharmaceuticals Group. David M. Malone and Lawrence B. Bernard entered appearances.

David F. Weeda and David L. Durkin were on the brief for amicus curiae National Association of Pharmaceutical Manufacturers.

Before: EDWARDS, Chief Judge, GINSBURG, and TATEL, Circuit Judges.

Opinion for the Court filed by Circuit Judge GINSBURG.

GINSBURG, Circuit Judge:

Pfizer, Inc. manufactures and sells the pioneer drug Procardia XL®, which contains the active ingredient nifedipine, a calcium-blocker used to treat angina and hypertension. Procardia XL® uses a patented "osmotic pump" to control the extended release of nifedipine. Mylan Pharmaceuticals, Inc. filed an abbreviated new drug application (ANDA) with the Food and Drug Administration...

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