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CHAPTER XI
ANTITRUST ISSUES INVOLVING INTELLECTUAL
PROPERTY
B. Antitrust Issues Arising During the Grant of the Intellectual
Property Right
1. Securing Patents as an Antitrust Violation
The Federal Trade Commission (FTC) has taken several actions
following its issuance of a policy statement in September 2023 alleging
that many pharmaceutical companies have improperly or inaccurately
listed patents in the Food and Drug Administration’s (FDA's) Orange
Book, which lists approved drug products and their therapeutic
equivalence evaluations.1
On November 7, 2023, the FTC challenged more than one hundred
patents held by manufacturers of brand-name asthma inhalers, epinephrine
autoinjectors, and other drug products as “improperly or inaccurately
listed” in the Orange Book, stating that improper listings can delay the
entry of lower-cost generic drugs into the market, keeping drug prices
artificially high and stifling competition 2 The FTC’s notice letters stated
that it “opted to use the FDA’s regulatory dispute process to address the
improper listings,” but it “retain[ed] the right to take any further action the
public interest may require, including investigating this conduct as an
unfair method of competition under Section 5 of the FTC Act.”3 In
1. “FTC Issues Policy Statement on Brand Pharmaceutical Manufacturers’
Improper Listing of Patents in the Food and Drug Administration’s
‘Orange Book’” (Sep. 14 2023), available at https://www.ftc.gov/news-
events/news/press-releases/2023/09/ftc-issues-policy-statement-brand-
pharmaceutical-manufacturers-improper-listing-patents-food-drug.
2. “FTC Challenges More Than 100 Patents as Improperly Listed in the
FDA’s Orange Book” (Nov. 7, 2023), available at
https://www.ftc.gov/news-events/news/press-releases/2023/11/ftc-
challenges-more-100-patents-improperly-listed-fdas-orange-book.
3. “Warning Letters by Press Release” (Nov. 7, 2023), available at
https://www.ftc.gov/legal-library/browse/warning-letters/81927.
