Legal Opinion
Mead Johnson Pharmaceutical Group, Mead Johnson & Company v. Otis R. Bowen, Secretary of H.H.S.
Court of Appeals for the D.C. Circuit
Decided February 12, 1988No. 87-5099PublishedCited by 44 opinions
1Opinion of the Court
Opinion for the Court filed by Circuit Judge HARRY T. EDWARDS.
HARRY T. EDWARDS, Circuit Judge:
Mead Johnson Pharmaceutical Group (“Mead”) appeals from a judgment of the District Court, 655 F.Supp. 53, upholding the Food and Drug Administration’s (“FDA”) denial of a citizen petition filed by Mead. At issue is whether Mead is entitled to a ten-year period of nonpatent exclusivity for its drug “Desyrel” under the Drug Price Competition and Patent Term Restoration Act. The answer to that question turns solely on whether Mead’s New Drug Application (“NDA”) for Desyrel was “approved” by the FDA…
2Cases cited5 opinions
- Chevron U. S. A. Inc. v. Natural Resources Defense Council, Inc.Supreme Court of the United States · 1984
- Immigration & Naturalization Service v. Cardoza-FonsecaSupreme Court of the United States · 1987
- National Labor Relations Board v. United Food & Commercial Workers Union, Local 23Supreme Court of the United States · 1987
- Norwich Eaton Pharmaceuticals, Inc. v. BowenCourt of Appeals for the Sixth Circuit · 1987
- Mead Johnson Pharmaceutical Group v. BowenDistrict Court, District of Columbia · 1986
3Cited by44 opinions
- Serono Labs Inc v. Ferring Pharm. Inc.Court of Appeals for the D.C. Circuit · 1998
- Mylan Pharmaceuticals, Inc. v. ShalalaDistrict Court, District of Columbia · 2000
- Mylan Laboratories, Inc. v. Tommy G. Thompson, Secretary, United States Department of Health and Human ServicesCourt of Appeals for the D.C. Circuit · 2005
- Bristol-Myers Squibb Co. v. ShalalaDistrict Court, District of Columbia · 1996
- Robert Simpson v. Federal Mine Safety and Health Review CommissionCourt of Appeals for the D.C. Circuit · 1988
39 more not listed; retrieve them via the Exa API.