F.T.C. v. ABBVIE INC.

No. 18-2621, No. 18-2748, No. 18-2758.

976 F.3d 327 (2020)

FEDERAL TRADE COMMISSION, Appellant v. ABBVIE INC.; Abbott Laboratories; Unimed Pharmaceuticals, LLC; Besins Healthcare, Inc.; *Teva Pharmaceuticals USA, Inc. (*Dismissed Pursuant to Court's 3/12/19 Order.) Federal Trade Commission v. Abbvie Inc.; Abbott Laboratories; Unimed Pharmaceuticals, LLC; Besins Healthcare, Inc.; *Teva Pharmaceuticals USA, Inc. Abbvie Inc.; Abbott Laboratories; Unimed Pharmaceuticals, LLC, Appellants (*Dismissed Pursuant to Court's 3/12/19 Order.) Federal Trade Commission v. Abbvie Inc.; Abbott Laboratories; Unimed Pharmaceuticals, LLC; Besins Healthcare, Inc.; *Teva Pharmaceuticals USA, Inc. Besins Healthcare, Inc., Appellant (*Dismissed Pursuant to Court's 3/12/19 Order.)

United States Court of Appeals, Third Circuit.

Filed: September 30, 2020.


Attorney(s) appearing for the Case

Mark S. Hegedus , Federal Trade Commission, MS-582, 600 Pennsylvania Avenue, N.W., Washington, DC 20580, Matthew M. Hoffman [Argued], Joel R. Marcus , Federal Trade Commission, 600 Pennsylvania Avenue, N.W., Washington, DC 20580, Attorneys for Federal Trade Commission.

Brittany Amadi , Catherine M.A. Carroll , Leon B. Greenfield , Seth P. Waxman [Argued], WilmerHale, 1875 Pennsylvania Avenue, N.W., Washington, DC 20006, Elaine J. Goldenberg , Munger Tolles & Olson, 601 Massachusetts Avenue, N.W., Suite 500e, Washington, DC 20001, Adam R. Lawton , Stuart N. Senator , Jeffrey I. Weinberger , Munger Tolles & Olson, 350 South Grand Avenue, 50th Floor, Los Angeles, CA 90071, William F. Lee , WilmerHale, 60 State Street, Boston, MA 02109, Paul H. Saint-Antoine , John S. Yi , Faegre Drinker Biddle & Reath, One Logan Square, Suite 2000, Philadelphia, PA 19103, Attorneys for AbbVie Inc, Abbott Laboratories, and Unimed Pharmaceuticals LLC.

Melinda F. Levitt , Gregory E. Neppl [Argued], Foley & Lardner, 3000 K Street, N.W., Suite 600, Washington, DC 20007, Paul H. Saint-Antoine , John S. Yi , Faegre Drinker Biddle & Reath, One Logan Square, Suite 2000, Philadelphia, PA 19103, Attorneys for Besins Healthcare, Inc.

William A. Rivera , AARP Foundation Litigation, B4-230, 601 E Street, N.W., Washington, DC 20049, Attorney for Amici AARP and AARP Foundation.

Ilana H. Eisenstein , DLA Piper, 1650 Market Street, One Liberty Place, Suite 5000, Philadelphia, PA 19103, Attorney for Amicus Chamber of Commerce of the United States of America.

Bradford J. Badke , Sidley Austin, 787 Seventh Avenue, New York, NY 10019, Attorney for Amicus Amgen Inc.

Andrew D. Lazerow , Covington & Burling, 850 10th Street, N.W., One City Center, Washington, DC 20001, Attorney for Amicus Pharmaceutical Research and Manufacturers of America.

Richard M. Brunell , Hilliard & Shadowen, 1135 West 6th Street, Suite 125, Austin, TX 78703, Attorney for Amici American Antitrust Institute, Public Citizen Inc, and Public Knowledge.

Before: HARDIMAN, PORTER and PHIPPS, Circuit Judges.


OPINION OF THE COURT

TABLE OF CONTENTS

I. FACTUAL BACKGROUND...338

A. FDA Approval under the Hatch-Waxman Act...338

B. Patent disputes under the Hatch-Waxman Act...339

C. Therapeutic equivalence ratings...340

D. Hypogonadism and testosterone replacement therapies...340...

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