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FTC v. AbbVie Inc.

United States Court of Appeals for the Third Circuit

January 15, 2020, Argued; September 30, 2020, Filed

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

Opinion

OPINION OF THE COURT

HARDIMAN, Circuit Judge.

TABLE OF CONTENTS

I. FACTUAL BACKGROUND

A. FDA Approval under the Hatch-Waxman Act

B. Patent disputes under the Hatch-Waxman Act

C. Therapeutic equivalence ratings

D. Hypogonadism and testosterone

replacement therapies

E. AndroGel

F. The '894 patent's prosecution history

G. AndroGel's competitors

H. The lawsuits against Teva and Perrigo

I. The settlements with Perrigo and Teva

J. Teva and Perrigo's generic versions of AndroGel

II. PROCEDURAL HISTORY

III. JURISDICTION

IV. LIABILITY

A. The District Court erred by rejecting the

reverse-payment theory

B. The District Court erred in concluding AbbVie and

Besins's litigation against Teva was a sham; it did

not err in concluding the Perrigo litigation was a

C. The District Court did not err in concluding

AbbVie and Besins had monopoly power [*3]  in the

relevant market

V. REMEDIES

A. The District Court erred in ordering disgorgement

B. The District Court did not abuse its discretion in

denying injunctive relief

C. Remand on the reverse-payment theory is not

futile

This appeal involves a patented drug called AndroGel. A blockbuster testosterone replacement therapy that generated billions of dollars in sales, AndroGel caught the attention of the Federal Trade Commission. The FTC sued the owners of an AndroGel patent—AbbVie, Inc., Abbott Laboratories, Unimed Pharmaceuticals LLC, and Besins Healthcare, Inc.—under Section 13(b) of the Federal Trade Commission Act in the United States District Court for the Eastern District of Pennsylvania. The FTC alleged that Defendants filed sham patent infringement suits against Teva Pharmaceuticals USA, Inc. and Perrigo Company, and that AbbVie, Abbott, and Unimed entered into an anticompetitive reverse-payment agreement with Teva. The FTC accused Defendants of trying to monopolize and restrain trade over AndroGel.

The District Court dismissed the FTC's claims to the extent they relied on a reverse-payment theory but found Defendants liable for monopolization on the sham-litigation theory. The Court ordered Defendants [*4]  to disgorge $448 million in ill-gotten profits but denied the FTC's request for an injunction. The parties cross-appeal.

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2020 U.S. App. LEXIS 31048 *; __ F.3d __; 2020 WL 5807873

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.)

Prior History:  [*1] On Appeal from the United States District Court for the Eastern District of Pennsylvania. (D.C. No. 2-14-cv-05151). District Judge: Honorable Harvey Bartle, III.

FTC v. AbbVie Inc., 329 F. Supp. 3d 98, 2018 U.S. Dist. LEXIS 109628 (E.D. Pa., June 29, 2018)FTC v. AbbVie Inc., 2017 U.S. Dist. LEXIS 149824 (E.D. Pa., Sept. 15, 2017)FTC v. AbbVie Inc., 107 F. Supp. 3d 428, 2015 U.S. Dist. LEXIS 59115 (E.D. Pa., May 6, 2015)

CORE TERMS

patent, settlement, infringement, patentee, sham, isopropyl, injunction, gel, lawsuit, disgorgement, antitrust, baseless, anticompetitive, enhancers, injectables, penetration, reverse-payment, tangentiality, brand-name, myristate, monopoly, acid, testosterone, palmitate, notice, competitors, estoppel, equitable, expiration, restitution

Antitrust & Trade Law, Consumer Protection, Deceptive Labeling & Packaging, Federal Food, Drug & Cosmetic Act, Business & Corporate Compliance, Infringement Actions, Defenses, Experimental Use & Testing, Governments, Agriculture & Food, Federal Food & Drugs Act, Infringing Acts, Offers to Sell & Sales, Patent Law, Marking, Statute of Limitations, Inequitable Conduct, Anticompetitive Conduct, Regulated Practices, Trade Practices & Unfair Competition, Federal Trade Commission Act, Exemptions & Immunities, Noerr-Pennington Doctrine, Sham Exception, Monopolies & Monopolization, Actual Monopolization, Monopoly Power, Sherman Act, Scope, Monopolization Offenses, Governments, Courts, Authority to Adjudicate, Jurisdiction & Review, Subject Matter Jurisdiction, Appeals, Civil Procedure, Federal Questions, Well Pleaded Complaint Rule, Jurisdiction Over Actions, Exclusive Jurisdiction, Judicial Precedent, Appeals, Standards of Review, De Novo Review, Private Actions, Standing, Requirements, Remedies, Damages, Infringer's Profits, Exclusive Rights, Manufacture, Sale & Use, Attempts to Monopolize, Elements, Per Se Rule & Rule of Reason, Per Se Rule Tests, Manifestly Anticompetitive Effects, Defenses, Demurrers & Objections, Motions to Dismiss, Failure to State Claim, Pleadings, Complaints, Requirements for Complaint, Sherman Act, Right to Petition Immunity, Constitutional Law, Bill of Rights, Fundamental Freedoms, Freedom to Petition, Scope, Parker State Action Doctrine, Bad Faith Enforcement, Statute of Limitations, Tolling of Statute of Limitations, Stay, Summary Judgment Review, Standards of Review, Doctrine of Equivalents, Elements, Equivalence, Ordinary Skill, Functional & Structural Limitations, Equivalence Limits, Prosecution History Estoppel, Abandonment & Amendment, Fact & Law Issues, Prosecution Related Arguments & Remarks, Estoppel & Laches, Contracts Law, Types of Contracts, Settlement Agreements, Trials, Bench Trials, Clearly Erroneous Review, Questions of Fact & Law, Reviewability of Lower Court Decisions, Preservation for Review, Claims, Anticompetitive & Predatory Practices, Predatory Pricing, Price Fixing & Restraints of Trade, Exclusive & Reciprocal Dealing, Exclusive Dealing, Market Definition, Relevant Market, Product Market Definition, Legislation, Interpretation, Deceptive & Unfair Trade Practices, Federal Trade Commission Act, US Federal Trade Commission, State Regulation, False Advertising, Injunctions, Securities Law, Securities Exchange Act of 1934 Actions, Insider Trading, Disgorgement of Profits, Civil Liability Considerations, Equitable Relief, Magnuson-Moss Warranty Act, Remedies, Preliminary Considerations, Equity, Relief, Freedom of Speech, Clayton Act, Appellate Briefs