Listed, Stayed, Delayed: Brand-Name Drug Manufacturer’s Strategic Patent Listings and the Breakdown of the Hatch-Waxman Act

[1]

I. Background on the Orange Book

A.    Origin and Role of the Orange Book

On October 31, 1980, the FDA’s released its first edition of the Approved Drug Products with Therapeutic Equivalence Evaluations (playfully named the “Orange Book”), which identifies drugs that are approved based on safety and effectiveness.[2] This database is monitored by the FDA and provides a list of patents and the market exclusivities that protect brand-name drugs.[3] The Orange Book plays a central role in balancing pharmaceutical innovation and competition, yet its structure has increasingly become a tool for delaying generic entry rather than facilitating it.

The Hatch-Waxman Act was passed in 1984 and created a framework to make it easier for generics to come to market, focusing on balancing the incentivization of drug innovation with the demand for more affordable therapeutics.[4] Following the Hatch-Waxman Act, the Orange Book became the database for all the patents protecting the corresponding drugs.[5] Brand-name drug manufacturers self-report their patents along with their New Drug Application (“NDA”).[6] At the time generic drug manufacturers submit their Abbreviated New Drug Application (“ANDA”), they must make a certification about the state of the brand-name’s patent in the Orange Book.[7] There are four different types of certifications that can be made.[8] A Paragraph IV certification asserts that a listed patent in the Orange Book is invalid or will not be infringed upon by the generic drug, triggering patent litigation and an automatic 30-month stay of FDA approval.[9] 

B.    The FDA’s Role in Reviewing Submissions

The brand-name drug manufacturer submitting the NDA is responsible for submitting the requisite patent information.[10] The FDA does not police the patent listings provided by the NDAs.[11] The FDA justifies their lack of policing on the grounds that it lacks both the legal authority and expertise in patent law, as well as the necessary resources.[12] The FDA’s lack of oversight in the patent review process creates incentives for brand-name manufactures to game the system by claiming more or incorrectly claiming the patents. A brand-name manufacturer is only incentivized to list as many patents as possible because any challenge from a generic with a Paragraph IV certification, triggers the 30-month stay, which prohibits the FDA from approving any ANDAs with that active ingredient for 30 months or until the litigation has resolved.[13] The consequences for mislabeling a patent are minimal.[14] The only check on this system is patent infringement litigation, as third-party neutrals will become involved to determine the validity of the claimed patents. More recently, the Federal Trade Commission has begun challenging the validity of patent listings, urging delisting.[15] 

C.    Delisting Submissions

The original adoption of the Hatch-Waxman Act had no private right of action for competitors to delist an allegedly improperly listed Orange Book patent.[16] In 2003, Congress amended the Food, Drug, & Cosmetic Act through the Medicare Prescription Drug, Improvement, and Modernization Act to create a limited statutory counterclaim.[17] This counterclaim permits ANDA applicants to seek a correction or deletion of patent information submitted by NDA holders if an NDA holder brings a patent infringement suit against the ANDA applicant.[18] The counterclaim is limited to the grounds that the listing was improper for the drug that the application was approved for or the approved method of using the drug.[19] The Supreme Court verified the scope of this counterclaim in Caraco Pharm. Lab’y, LTD v. Novo Nordisk, holding that an ANDA applicant is permitted to properly challenge an overbroad use code that inaccurately describes the approved method of use.[20] This counterclaim delisting order is critical because it could make the difference between the FDA’s required 30-month stay of approval or immediate approval of the ANDA, restoring competition.[21] 

II. Controversies and Litigation Involving the Orange Book

A.    Hatch-Waxman Litigation

Filing an ANDA is an artificial act of patent infringement.[22] A brand-name manufacturer can initiate the patent litigation process as soon as it receives the Paragraph IV notice letter.[23] If the suit is filed within 45 days of receiving the letter, the FDA will stay approval of the ANDA for up to 30 months pending the outcome of the suit.[24]

This automatic stay operates independently of the merits of the infringement claim, effectively allowing brand-name manufacturers a regulatory injunction without any preliminary showing of likelihood of success.[25] Once the blockage to the ANDA is removed by either the stay expiring, the generic winning the infringement suit, or the parties settle, the ANDA applicant may request a full approval from the FDA.[26]  If no suit is initiated, the FDA may approve the ANDA at its discretion.[27] 

Generic drugmakers expose themselves to liability if they file a Paragraph IV certification, which is why the Act provides a 180-day exclusivity period for the first generic manufacturer to challenge a brand-name manufacturers’ patent.[28] During that period, the FDA may not approve any other ANDA for a relevant product.[29]  While this framework was intended to encourage timely patent challenges, it also heightens the consequences of improper Orange Book listings.[30] When patents that do not statutorily qualify for listing are present in the Orange Book and trigger Paragraph IV certifications, brand-name manufacturers can delay competition through litigation, even where infringement claims are weak.[31] 

B.    Improper Listings

a.     In re Lantus Direct Purchaser Antitrust Litig.

Previously, there has been evidence that some brand-name manufacturers were exploiting the framework of the Act to prevent or delay generics entering the market by improperly listing patents in the Orange Book.[32] When a brand-name manufacturer improperly lists patents in the Orange Book, it can block potential competition because generic manufacturers must file a Paragraph IV certification, which is an act of infringement, and triggers a 30-month stay.[33] In 2020, the court in In re Lantus held that improperly listing a patent in the Orange Book can support antitrust claims because there are unfair methods being used to block competition in the market.[34] 

The court’s decision in Lantus was significant because it recognized that Orange Book manipulation can cause competitive harm independent of patent validity.[35] Even where patents are later found invalid or not infringed, the temporary exclusion of generic drug manufacturers from the market may still constitute anticompetitive conduct under antitrust law.[36] By allowing these antitrust claims to proceed, the court implicitly acknowledged the structural weakness of relying solely on Hatch-Waxman litigation to police Orange Book validity. Despite this, antitrust litigation remains costly, fact-intensive, and offers limited deterrence against future conduct because it works retrospectively.[37] 

b.    Role of the FTC

The Federal Trade Commission (“FTC”) has also played a role in policing incorrectly listed device patents. The key role of the FTC is to promote competition and to protect consumers.[38] It is the FTC’s position that improperly listing patents in the Orange Book constitutes unfair competition because the only method to challenge them is through patent litigation, which is expensive. Improper listings also disincentivize generics to innovate.[39] 

In 2022, the FTC filed an amicus brief regarding Jazz Pharms v. Avadel CNS Pharms. The brief first explains how improper patent listings is an illegal way for brand-name manufacturers to take control of the market and harm competition.[40] The brief describes that Jazz improperly listed a patent because it claimed a distribution process for the drug, which is not included in the method-of-use class.[41] The FTC further emphasized that the FDA’s refusal to review patent listings has contributed to the high number of improper listings, which has put the burden on private litigants to challenge the validity of these patents.[42] In 2023, the FTC announced that it would use its full legal authority to take actions against companies that have improperly listed patents in the Orange Book, stating these improper listings may violate Section 5 of the FTC Act.[43] 

c.     Teva Branded Pharm. Prods. R&D, Inc. v. Amneal Pharms.

In 2024, the court in Teva held that Teva incorrectly listed 5 patents that claimed the asthma inhaler delivery device and did not claim the API and thus were improperly listed in the Orange Book.[44] The court held that Teva had to delist the improper patents, highlighting that device patents, even if closely associated with a drug patent, cannot be used to trigger Hatch-Waxman litigation unless the patent claims the drug or an approved method of use.[45] 

In May 2025, the FDA sent out warning letters to different pharmaceutical companies making up over 200 improperly listed patents in the Orange Book.[46] October 2025 marked the first ever monetary resolution to an antitrust claim on over-inclusive filings in the Orange Book when Teva reached a 35-million-dollar settlement.[47] These developments reflect the growing recognition that abuse of the Orange Book is widespread; despite this, they highlight the retroactive nature of the current enforcement mechanisms.

C.    Litigation and Enforcement as Inadequate Safeguards

Collectively, this line of cases demonstrates that improper Orange Book listings are not random and are structurally encouraged. Hatch-Waxman litigation relies on generic manufacturers to assume significant financial and legal risks just to correct the public record.[48] Antitrust and FTC enforcement, while important, remain retrospective and do not prevent improper listings from triggering the 30-month stays at the root of the competition issue.[49] This systemic delay is the central flaw of the Orange Book framework: competitive harm occurs at the moment of listing, while remedies come years later, if at all.[50] Absent a screening mechanism where brand-name drug manufacturers list the patents, there remains strong incentives to over-list patents, knowing that even temporary delays in generic entry can have substantial financial gains.[51] 

References

[1] Photo by David Trinks, A Close Up of Many Orange Pills on a White Surface, Unsplash (June 6, 2022), https://unsplash.com/photos/a-close-up-of-many-orange-pills-on-a-white-surface-L7OtUEnYTyI.

[2] See Crystal Canterbury, Katelyn Nguyen,  Andrew Coogan, Freshly Squeezed: Orange Book History and Key Updates at 45, Food  Drug Law Institute, https://www.fdli.org/2025/05/freshly-squeezed-orange-book-history-and-key-updates-at-45/ (last visited Dec. 22, 2025).

[3] See id.

[4] See Patent Use Codes for Pharmaceutical Products: A Comprehensive Analysis for Strategic Advantage, DrugPatentWatch (Aug. 3, 2025),  https://www.drugpatentwatch.com/blog/patent-use-codes-for-pharmaceutical-products-a-comprehensive-analysis/?srsltid=AfmBOopvjPk3FcDtKc5T2YFSRE4PqEOiUvzllzByQ0sgz7Su7GJ0o-NG.  

[5] See Christina D. Brown-Marshall & Dexter Whitley, Hatch-Waxman 101, Fish & Richardson (Apr. 15, 2024), https://www.fr.com/insights/thought-leadership/blogs/hatch-waxman-101-3/. (including patents for drugs and methods of using drugs, covering active ingredients, drug formulas, and drug compositions).

[6] See id.

[7] See id.

[8] See 21 U.S.C. § 355(j)(2)(A)(vii)(I-III) (outlining Paragraph I certification means there is no patent in Orange Book, Paragraph II certifications means there is expired patent in Orange Book, and Paragraph III means patent is still valid, but generic will not bring drug to market until expiration).

[9] See 21 U.S.C. § 355(j)(2)(A)(vii)(IV); see also Brown-Marshall & Whitley, supra note 5.

[10] See David B. Gornish, To Be Listable in the FDA’s “Orange Book,” Patents Must Recite the API in Claims, Eckert Seamans (Dec. 30, 2024), https://www.eckertseamans.com/legal-updates/to-be-listable-in-the-fdas-orange-book-patents-must-recite-the-api-in-claims.

[11] See Patent Use Codes for Pharmaceutical Products: A Comprehensive Analysis for Strategic Advantage, supra note 4.

[12] See id.

[13] See id.

[14] See id.

[15] See FTC Renews Challenge of More Than 200 Improper Patent Listings, FTC (May 21, 2025),  https://www.ftc.gov/news-events/news/press-releases/2025/05/ftc-renews-challenge-more-200-improper-patent-listings.

[16] See Mylan Pharm., Inc. v. Thompson, 268 F.3d 1323, 1333 (Fed. Cir. 2001).

[17]  See 21 U.S.C. § 355(j)(5)(C)(ii)(I); see also Kurt R. Karst, A First? Orange Book Patent Delisting Counterclaim Denied in Litigation over Acetaminophen Injection, Hyman, Phelphs  McNamara PC (June 11, 2014), https://www.thefdalawblog.com/2014/06/a-first-orange-book-patent-delisting-counterclaim-denied-in-litigation-over-acetaminophen-injection/.

[18] See Karst, supra note 17.

[19] See 21 U.S.C. § 355(j)(5)(C)(ii)(I).

[20] See Caraco Pharm. Lab’y, LTD, 566 U.S. at 425–26.

[21] See Teva Branded Pharm. Prods R&D, Inc, 124 F.4th at 906.

[22] See 35 U.S.C. § 271(e)(2); see also Brown-Marshall & Whitley, supra note 5.

[23] See Brown-Marshall & Whitley, supra note 5.

[24] See 21 U.S.C. § 355(j)(5)(B)(iii); see also Brown-Marshall & Whitley, supra note 5.

[25]  See Brown-Marshall & Whitley, supra note 5.

[26] See Brown-Marshall & Whitley, supra note 5.

[27] See id.

[28] See id.

[29] See id.

[30] See id.

[31] See id.

[32] See Caraco Pharm. Lab’y, LTD, 566 U.S. at 408.

[33] See Brown-Marshall & Whitley, supra note 5.

[34] See In re Lantus Direct Purchaser Antitrust Litig., 950 F.3d 1, 3, 15 (1st Cir. 2020).

[35]  See generally id.

[36] See Listing a Liability: The Orange Book’s New Antitrust Frontier, Haug Partners (Nov. 21, 2025), https://haugpartners.com/article/listing-a-liability-the-orange-books-new-antitrust-frontier/.

[37] See id.

[38] See FTC Renews Challenge of More Than 200 Improper Patent Listings, supra note 15.

[39] See Listing a Liability: The Orange Book’s New Antitrust Frontier, supra note 36.

[40] See Federal Trade Commission, Brief of Amicus Curiae in Jazz Pharm., Inc. v. Avadel CNS Pharms., LLC, No. 1:21-cv-00691-GBW (D. Del. Nov. 10, 2022), at 11.

[41] See id. at 19.

[42]  See Barbara T. Sicalides, Michael J. Hartman, & Julian Weiss, FTC Issues Policy Statement Confirming Its Position That Improperly Listing Patents in the Orange Book May Be Considered a Violation of the FTC Act, Troutman Pepper Locke (Oct. 5, 2023), https://www.troutman.com/insights/ftc-issues-policy-statement-confirming-its-position-that-improperly-listing-patents-in-the-orange-book-may-be-considered-a-violation-of-the-ftc-act/ 

[43] See Matthew S. Murphy & Ross E. Blau, No Voluntary Delistings or Disputes in the FDA’s Orange Book Update, Axinn (Nov. 13, 2023), https://www.axinn.com/en/insights/axinn-viewpoints/no-voluntary-delistings-or-disputes-in-fdas-orange-book-update?id=102isb4; https://www.whitecase.com/insight-our-thinking/current-status-ftcs-orange-book-listings-challenge-mixed-bag 

[44] See Teva Branded Pharm. Prods R&D, Inc. v. Amneal Pharms., 124 F.4th 898, 908 (Fed. Cir. 2024).

[45]  See id. at 922.

[46] See FTC Renews Challenge of More Than 200 Improper Patent Listings, supra note 15.

[47] See Listing a Liability: The Orange Book’s New Antitrust Frontier, supra note 39.

[48] See Brown-Marshall & Whitley, supra note 5.

[49] See FTC Renews Challenge of More Than 200 Improper Patent Listings, supra note 15.

[50]  See id.

[51] See generally Caraco, 566 U.S. at 408