{"id":39455,"date":"2026-08-19T09:56:00","date_gmt":"2026-08-19T13:56:00","guid":{"rendered":"https:\/\/www.drugpatentwatch.com\/blog\/?p=39455"},"modified":"2026-08-16T20:15:52","modified_gmt":"2026-08-17T00:15:52","slug":"why-your-regulatory-team-needs-to-think-like-drug-patent-litigators","status":"publish","type":"post","link":"https:\/\/www.drugpatentwatch.com\/blog\/why-your-regulatory-team-needs-to-think-like-drug-patent-litigators\/","title":{"rendered":"Why Your Regulatory Team Needs to Think Like Drug Patent Litigators"},"content":{"rendered":"\n
\"\"<\/figure>\n\n\n\n

On November 7, 2023, the Federal Trade Commission sent warning letters to ten pharmaceutical manufacturers over more than 100 patents listed in the FDA’s Orange Book.[1]<\/sup> Those listings were not filed by outside litigation counsel. They were filed months or years earlier by regulatory affairs staff completing FDA Form 3542, the routine post-approval patent disclosure every NDA holder submits within 30 days of approval.[2]<\/sup> By the time the FTC’s third round of warning letters went out in May 2025, the agency had disputed more than 600 patent listings across three rounds, and the U.S. Court of Appeals for the Federal Circuit had already ordered one company to delist patents outright.[3][4]<\/sup> A form filed by a regulatory affairs analyst had become a live piece of antitrust and patent litigation.<\/p>\n\n\n\n

That is the pattern this article documents. Across Orange Book listings, label carve-outs, biosimilar patent-dance elections, REMS design, and citizen petitions, the decisions FDA-facing teams make routinely now determine the shape, timing, and cost of patent litigation years later. Regulatory affairs and IP litigation used to run on separate tracks inside most companies. The cases below show what happens when they do not talk to each other, and what changes when they do.<\/p>\n\n\n\n

The Short Answer<\/strong><\/h2>\n\n\n\n

A regulatory filing is a legal act with litigation consequences attached by statute. Listing a patent in the Orange Book triggers an automatic 30-month stay against generic entry if the listing survives challenge, or an antitrust exposure if it does not.[5]<\/sup> Writing a label carve-out under Section viii determines whether a generic manufacturer induces infringement of a method-of-use patent it never touched.[6]<\/sup> Choosing whether to participate in the BPCIA’s information exchange, known as the patent dance, sets the entire scope and timing of a biosimilar’s later infringement suit.[7]<\/sup> None of these are IP litigation decisions in form. All of them are IP litigation decisions in effect.<\/p>\n\n\n\n

The Five Findings That Matter<\/strong><\/h2>\n\n\n\n
    \n
  • The FTC has disputed more than 600 Orange Book patent listings across three enforcement rounds since September 2023, and several hundred have been removed or corrected in response.[1][3][8]<\/sup><\/li>\n\n\n\n
  • A generic label carve-out written under 21 CFR 314.94(a)(12) produced a $235.51 million jury verdict against Teva in GSK v. Teva, a case that ran from 2014 to a February 2026 settlement, nearly nine years after trial.[9][10]<\/sup><\/li>\n\n\n\n
  • The FDA denied 92 percent of section 505(q) citizen petitions filed against competing drug applications between 2011 and 2015, according to a peer-reviewed empirical study, yet each petition still consumes up to 150 statutory review days.[11][12]<\/sup><\/li>\n\n\n\n
  • A REMS-based sample-access dispute over Actelion’s Tracleer ran from a 2012 declaratory judgment filing to a $65 million class settlement granted preliminary approval on March 13, 2026, a span of roughly 14 years.[13][14]<\/sup><\/li>\n\n\n\n
  • The Federal Circuit’s December 20, 2024 ruling in Teva v. Amneal held that a patent must claim the drug’s active ingredient to qualify for Orange Book listing, invalidating a listing strategy regulatory teams across the industry had used for device-combination products for nearly two decades.[4][15]<\/sup><\/li>\n<\/ul>\n\n\n\n

    What the Data Shows: Five Regulatory Decisions, Five Litigation Mechanisms<\/strong><\/h2>\n\n\n\n

    Five recurring regulatory decision points carry statutory litigation consequences: what to list in the Orange Book, how to word a label carve-out, whether to join a biosimilar patent dance, how restrictively to design a REMS, and whether to file a citizen petition. Methodology note: the cases below were selected because each produced a final court ruling, a Supreme Court decision, a completed settlement, or a published federal agency report, not because they represent every dispute in the category. Settlement amounts and dates are drawn from court filings, agency press releases, or SEC disclosures cited inline.<\/p>\n\n\n\n

    Regulatory decision<\/th>Regulatory vehicle<\/th>Litigation mechanism<\/th>Documented case<\/th>Outcome<\/th><\/tr>
    Which patents to list in the Orange Book<\/td>FDA Form 3542, 21 CFR 314.53<\/td>FTC Section 5 challenge; Federal Circuit delisting order<\/td>Teva v. Amneal (ProAir HFA)<\/td>Delisting of five device patents affirmed Dec. 20, 2024[4]<\/sup><\/td><\/tr>
    How to word a generic label carve-out<\/td>Section viii statement, 21 CFR 314.94(a)(12)<\/td>Induced infringement under 35 U.S.C. \u00a7 271(b)<\/td>GSK v. Teva (Coreg)<\/td>$235.51M verdict, cert. denied 2023, settled Feb. 2026[9][10][16]<\/sup><\/td><\/tr>
    Whether to join the BPCIA patent dance<\/td>42 U.S.C. \u00a7 262(l) information exchange<\/td>Reference sponsor infringement suit; scope-of-litigation dispute<\/td>Sandoz v. Amgen (filgrastim biosimilar)<\/td>Unanimous SCOTUS ruling, June 12, 2017: opt-out lawful, no federal injunction[7][17]<\/sup><\/td><\/tr>
    How restrictively to design a REMS distribution program<\/td>REMS with ETASU, 21 U.S.C. \u00a7 355-1<\/td>Antitrust monopolization claim<\/td>Actelion (Tracleer) sample-access litigation<\/td>$65M class settlement, preliminary approval March 13, 2026[13][14]<\/sup><\/td><\/tr>
    Whether and when to file a citizen petition against a rival’s application<\/td>505(q) citizen petition, 21 CFR 10.30<\/td>FDA denial, statutory delay, potential FTC referral<\/td>Industry-wide pattern (Carrier & Minniti; Feldman)<\/td>92% denial rate 2011-2015; up to $1.9B estimated societal cost from four studied petitions[11][18]<\/sup><\/td><\/tr><\/tbody><\/table><\/figure>\n\n\n\n

    The Orange Book Listing Decision Is a Litigation Decision<\/strong><\/h2>\n\n\n\n

    How Orange Book Patent Listings Work<\/strong><\/h3>\n\n\n\n

    Under 21 CFR 314.53, an NDA holder must submit patent information within 30 days of approval on FDA Form 3542, and within 30 days of issuance for any patent that issues later.[2][19]<\/sup> To qualify for listing, a patent must claim the drug substance, the drug product formulation, or an approved method of use, and the form requires the applicant to certify the listing is accurate.[2][19]<\/sup><\/p>\n\n\n\n

    What the Listing Buys the Brand<\/strong><\/h4>\n\n\n\n

    A properly listed patent gives the brand manufacturer an automatic 30-month stay of FDA approval the moment it sues a generic filer over a Paragraph IV certification, without needing to win a preliminary injunction motion.[5]<\/sup> That stay is the single most valuable procedural tool the Hatch-Waxman Act gives brand manufacturers, and it exists because of a regulatory filing, not a court order.<\/p>\n\n\n\n

    What an Improper Listing Now Costs<\/strong><\/h4>\n\n\n\n

    The same filing that triggers the stay can trigger a Section 5 unfair-methods-of-competition claim if the FTC or a court later finds it improper, an outcome the agency has pursued aggressively since 2023.[1][20]<\/sup><\/p>\n\n\n\n

    The FTC’s 2023-2025 Patent Listing Crackdown: Three Rounds<\/strong><\/h3>\n\n\n\n

    Round One: November 7, 2023<\/strong><\/h4>\n\n\n\n

    The FTC sent warning letters to ten manufacturers challenging more than 100 patents covering roughly 17 branded products, mostly asthma inhalers and epinephrine autoinjectors, arguing the listings covered device components rather than the approved drug itself.[1][21]<\/sup> Recipients included GSK, Teva, Kaleo, and Impax Labs.[22]<\/sup> Several manufacturers delisted 14 patents across six NDAs in response.[20]<\/sup><\/p>\n\n\n\n

    Round Two: April 30, 2024<\/strong><\/h4>\n\n\n\n

    The FTC expanded its dispute to more than 300 additional patents across 20 branded products, including injectable diabetes and weight-loss devices and additional inhalers.[1][23]<\/sup> This time, none of the manufacturers delisted patents. All recertified their listings as accurate, betting the agency’s theory would not survive judicial scrutiny.[23]<\/sup><\/p>\n\n\n\n

    Round Three: May 21, 2025<\/strong><\/h4>\n\n\n\n

    Under new FTC leadership, the agency issued a third round of warning letters to five companies covering more than 200 patent listings across 17 products.[3][24]<\/sup> This round explicitly invoked the Federal Circuit’s December 2024 ruling in Teva v. Amneal as legal support for the agency’s position, marking the first time a federal appellate decision, not just an FTC policy statement, backed the delisting theory.[3]<\/sup><\/p>\n\n\n\n

    Teva v. Amneal: When a Court Overrules a Regulatory Listing Choice<\/strong><\/h3>\n\n\n\n

    Teva had listed nine patents covering its ProAir HFA albuterol inhaler in the Orange Book. Amneal filed an ANDA with a Paragraph IV certification against those patents in 2023, and Teva sued for infringement of six of them, triggering an automatic 30-month stay.[15][25]<\/sup> Amneal counterclaimed that five of the patents, which covered the inhaler’s dose counter and canister but never mentioned the active ingredient albuterol sulfate, did not belong in the Orange Book at all.[15][25]<\/sup><\/p>\n\n\n\n

    The district court agreed and ordered Teva to delist the patents.[15]<\/sup> On December 20, 2024, the Federal Circuit affirmed, holding that a patent must claim at least the active ingredient of the approved drug to be eligible for Orange Book listing, and that patents claiming only device components do not meet that bar no matter how central the device is to the approved product.[4][25][26]<\/sup> The ruling did not just resolve one dispute over one inhaler. It invalidated a listing approach that regulatory affairs teams across the device-combination sector, inhalers, autoinjectors, prefilled syringes, had used for years, and it gave the FTC a judicial holding to cite instead of only its own policy statement.[3][8]<\/sup><\/p>\n\n\n\n

    What This Means for Regulatory Affairs Teams<\/strong><\/h3>\n\n\n\n

    Every patent going onto Form 3542 should be evaluated against the same active-ingredient test a federal court would now apply, not just against whether the patent’s claims could plausibly be infringed by the approved product. Teams tracking listing disputes and delisting rulings in near real time, whether through internal counsel or a monitoring platform such as DrugPatentWatch, catch exposure before a Paragraph IV notice letter forces the question in litigation rather than in an internal review.<\/p>\n\n\n\n

    Skinny Labels: When an FDA-Approved Carve-Out Becomes an Infringement Verdict<\/strong><\/h2>\n\n\n\n

    Section viii Statements Under 21 CFR 314.94(a)(12)<\/strong><\/h3>\n\n\n\n

    When a generic manufacturer wants to launch before every indication on a reference label is off-patent, it can file a Section viii statement asserting that it is not seeking approval for the indications still covered by an unexpired method-of-use patent, and carve those indications out of its own label.[27]<\/sup> The strategy exists precisely so generics do not have to wait for every last method-of-use patent to expire before launching on the indications that are already open. It is a regulatory tool, built into the FDA’s own labeling review process, not a patent litigation maneuver.<\/p>\n\n\n\n

    GSK v. Teva: The Coreg Timeline<\/strong><\/h3>\n\n\n\n

    2007: Teva Launches With a Carved-Out Label<\/strong><\/h4>\n\n\n\n

    Teva launched generic carvedilol in 2007 for hypertension and post-myocardial-infarction left ventricular dysfunction, carving out GSK’s method-of-use patent covering congestive heart failure treatment.[28][29]<\/sup><\/p>\n\n\n\n

    2011: FDA Requires a Full Label<\/strong><\/h4>\n\n\n\n

    The FDA directed Teva to revise its label to match GSK’s full label, including the congestive heart failure indication, once the compound patent had expired and only the reissued method-of-use patent remained.[29]<\/sup> Teva’s carve-out, in other words, ended not by Teva’s choice but by regulatory instruction.<\/p>\n\n\n\n

    2017: Jury Verdict, $235.51 Million<\/strong><\/h4>\n\n\n\n

    GSK sued in 2014, arguing that even during the skinny-label period, Teva’s marketing materials and press releases described its generic as equivalent to Coreg in ways that induced doctors to prescribe it for the carved-out indication. A Delaware jury agreed and awarded GSK $235.51 million in lost profits and royalties.[9][28]<\/sup><\/p>\n\n\n\n

    2020-2023: Reversal, Rehearing, Reinstatement, Certiorari Denied<\/strong><\/h4>\n\n\n\n

    The district court granted Teva judgment as a matter of law, finding no evidence any doctor was actually induced by Teva’s label. The Federal Circuit reversed and reinstated the verdict in October 2020, then granted a rare panel rehearing in February 2021 after amicus pressure from generic-industry stakeholders, only to reach the same result again in August 2021.[29][30][31]<\/sup> Even the U.S. Solicitor General urged the Supreme Court to grant certiorari, warning of consequences for the entire skinny-label pathway.[32]<\/sup> The Court denied review on May 15, 2023, with only Justice Kavanaugh voting to hear the case, and GSK and Teva filed a joint stipulation resolving the case in February 2026.[16][32][33]<\/sup><\/p>\n\n\n\n

    What This Means for Labeling and Regulatory Submission Decisions<\/strong><\/h3>\n\n\n\n

    GSK v. Teva did not hold that skinny labels are unlawful. Courts decided since 2021 have continued to find no inducement where a generic’s label and marketing genuinely stayed within the carved-out indications.[34]<\/sup> What the case settled is narrower and more consequential for regulatory teams specifically: a label that technically omits an indication provides no protection if marketing materials, press releases, or even the retained portions of the label point back toward the excluded use.[34]<\/sup> Regulatory affairs and commercial teams reviewing label language and promotional claims side by side, rather than in sequence, is now the practical difference between a valid carve-out and an eight-figure verdict.<\/p>\n\n\n\n

    The BPCIA Patent Dance: A Regulatory Election With Permanent Litigation Consequences<\/strong><\/h2>\n\n\n\n

    How the Patent Dance Works<\/strong><\/h3>\n\n\n\n

    The Biologics Price Competition and Innovation Act, enacted in 2010, gives a biosimilar applicant the option to exchange its abbreviated Biologics License Application and manufacturing information with the reference product sponsor within 20 days of FDA accepting the application for review, a process nicknamed the patent dance.[35][36]<\/sup> Participating narrows and negotiates the list of patents that will actually be litigated. Declining leaves the reference sponsor free to sue on whatever patents it chooses once the biosimilar launches or gives notice.[35][36]<\/sup><\/p>\n\n\n\n

    Sandoz v. Amgen: Opting Out and the 2017 Supreme Court Ruling<\/strong><\/h3>\n\n\n\n

    Sandoz refused to give Amgen a copy of its abbreviated application for a filgrastim biosimilar and gave its 180-day notice of commercial marketing before FDA had even approved the product.[17][37]<\/sup> Amgen sued to force compliance. On June 12, 2017, the Supreme Court ruled unanimously that the patent dance is not enforceable by federal injunction and that the 180-day notice can be given before FDA approval, not only after.[17][38]<\/sup> The Court left open, and remanded, the separate question of whether a reference sponsor could pursue a state-law claim over the refusal to exchange information.[37][39]<\/sup><\/p>\n\n\n\n

    Patent Dance vs. Opt-Out: A Comparison<\/strong><\/h3>\n\n\n\n
    Factor<\/th>Full patent dance participation<\/th>Opt-out (Sandoz approach)<\/th><\/tr>
    Confidential manufacturing data disclosed to reference sponsor<\/td>Yes<\/td>No<\/td><\/tr>
    Scope of eventual litigation<\/td>Negotiated, narrowed patent list<\/td>Reference sponsor’s unilateral choice, potentially broader<\/td><\/tr>
    Federal injunction available to force compliance<\/td>N\/A, applicant participated<\/td>No, per Sandoz v. Amgen[17]<\/sup><\/td><\/tr>
    180-day notice of commercial marketing timing<\/td>Can follow the negotiated exchange<\/td>May be given before FDA licensure[17]<\/sup><\/td><\/tr><\/tbody><\/table><\/figure>\n\n\n\n

    REMS Design as an Antitrust Exposure Point<\/strong><\/h2>\n\n\n\n

    Restricted Distribution and the Sample-Access Problem<\/strong><\/h3>\n\n\n\n

    A Risk Evaluation and Mitigation Strategy with Elements to Assure Safe Use, an ETASU REMS, can restrict which pharmacies or distributors handle a drug.[40]<\/sup> For decades, that same restriction was also used, according to multiple antitrust complaints, to deny generic manufacturers the samples they need to run bioequivalence testing, since a company cannot file an ANDA without enough of the reference product to test against.[40][41]<\/sup><\/p>\n\n\n\n

    Actelion, Tracleer, and the $65 Million Settlement<\/strong><\/h3>\n\n\n\n

    Generic manufacturers including Mylan, Apotex, and Watson sought samples of Actelion’s pulmonary arterial hypertension drug Tracleer to prepare Paragraph IV challenges starting around 2009.[41]<\/sup> Rather than wait to be sued, Actelion filed a 2012 declaratory judgment action against Apotex and Roxane, asking a federal court to confirm it had no legal duty to supply samples under its REMS.[42][43]<\/sup> The FTC filed an amicus brief warning that upholding Actelion’s position would let any manufacturer with a REMS block generic entry indefinitely.[42][44]<\/sup> That case settled without a precedential ruling, but purchaser class actions continued for over a decade. A federal judge in Maryland denied Actelion’s motion to dismiss and certified a purchaser class in 2024, and the case settled for $65 million two weeks before a scheduled 25-day jury trial, with the court granting preliminary approval on March 13, 2026.[13][14]<\/sup><\/p>\n\n\n\n

    The CREATES Act of 2019<\/strong><\/h3>\n\n\n\n

    Congress responded to years of REMS-based sample disputes with the Creating and Restoring Equal Access to Equivalent Samples Act, signed into law on December 20, 2019 as part of the Further Consolidated Appropriations Act.[45][46]<\/sup> The law creates a private right of action letting a generic or biosimilar developer sue for an injunction and damages if a brand manufacturer will not sell samples on commercially reasonable terms, and it clarifies that providing samples for testing does not itself violate a REMS.[46][47]<\/sup> It also lets the FDA approve a generic’s own, different safety protocol instead of forcing a single shared REMS with the brand, removing another point where a brand’s regulatory design choices could be used to stall a competitor.[46][48]<\/sup><\/p>\n\n\n\n

    Citizen Petitions: A Regulatory Tool the FDA Treats as a Litigation Risk<\/strong><\/h2>\n\n\n\n

    The Section 505(q) 150-Day Clock<\/strong><\/h3>\n\n\n\n

    A citizen petition asking the FDA to delay or deny a pending generic, 505(b)(2), or biosimilar application is governed by section 505(q) of the FD&C Act, which requires FDA to take final action within 150 days and bars the agency from granting an extension for that purpose.[49][50]<\/sup> Congress added this provision in 2007 specifically because petitions were being filed late in the review cycle to run out the clock on generic approval.[51]<\/sup><\/p>\n\n\n\n

    \n

    “Delaying generic entry of a drug, even by a few months, can be worth hundreds of millions of dollars of additional revenue, a cost ultimately borne by consumers and government agencies in the form of high drug prices.” [52]<\/sup><\/p>\n<\/blockquote>\n\n\n\n

    What the Data Shows About Petition Outcomes<\/strong><\/h3>\n\n\n\n

    An empirical study of 505(q) petitions filed between 2011 and 2015 found the FDA denied 92 percent of them, and a separate study of petitions filed against generic competitors between 2001 and 2010 found an 81 percent denial rate.[11][53]<\/sup> The FDA’s own annual reports to Congress confirm the agency has met its 150-day statutory deadline in nearly every reporting year since the guidance took effect, which means the delay a petition buys is capped by statute even when the petition itself has no scientific merit.[54][55]<\/sup><\/p>\n\n\n\n

    The Financial Stakes of Eleventh-Hour Petitions<\/strong><\/h3>\n\n\n\n

    Analyzing four citizen petitions identified as the likely final obstacle to a specific generic’s launch, one study estimated the combined cost to society at $1.9 billion, or roughly $3.6 million per day of delay, with about $782 million of that borne by government insurance programs.[18]<\/sup> The FDA’s final guidance on 505(q), issued in September 2019, now lets the agency flag on the public docket when it determines a petition’s primary purpose was delay, and refer that determination to the FTC.[49][56]<\/sup><\/p>\n\n\n\n

    What Happens When Regulatory and Legal Do Not Coordinate<\/strong><\/h2>\n\n\n\n

    Every case above shares a structure. A regulatory filing gets made on its own internal timeline, driven by an approval deadline or a labeling requirement, without a parallel assessment of how a court or the FTC would read that filing years later. The Orange Book listing goes in because the patent could plausibly cover some feature of the approved product, not because someone checked whether it claims the active ingredient. The label carve-out goes out because it satisfies the FDA’s Section viii requirements, not because someone cross-checked it against the marketing deck. The REMS gets built to satisfy a Risk Management Plan requirement, not because someone modeled how a restricted distributor list looks to a generic company that cannot get a sample.<\/p>\n\n\n\n

    None of these regulatory choices were made carelessly. Each satisfied the immediate regulatory requirement it was built for. The gap is that the requirement being satisfied and the litigation exposure being created are governed by different statutes, reviewed by different courts, and, in most companies, owned by different departments that do not routinely share drafts before filing.<\/p>\n\n\n\n

    Building a Coordinated Regulatory-Litigation Function<\/strong><\/h2>\n\n\n\n

    Checkpoint One: Test Every Orange Book Candidate Against the Active-Ingredient Rule<\/strong><\/h3>\n\n\n\n

    Before a patent goes on Form 3542, confirm its claims actually recite the drug substance, the approved formulation, or an approved method of use, the same test the Federal Circuit applied in Teva v. Amneal.[4]<\/sup> A patent that only covers a device component, a manufacturing process, or an intermediate is a listing risk, not a listing asset.<\/p>\n\n\n\n

    Checkpoint Two: Route Label Carve-Out Language Through Both Regulatory and Commercial Review<\/strong><\/h3>\n\n\n\n

    A Section viii statement that is legally sound on its face can still fail in litigation if marketing materials describe the generic as equivalent to the full reference product. GSK v. Teva turned on exactly that gap.[34]<\/sup> Commercial claims and label language need a shared review step, not sequential sign-offs.<\/p>\n\n\n\n

    Checkpoint Three: Decide the Patent Dance Election Before the 20-Day Clock Starts<\/strong><\/h3>\n\n\n\n

    Whether to participate in the BPCIA information exchange has to be decided with litigation strategy in the room, since Sandoz v. Amgen confirmed there is no way to be forced back into the exchange once an applicant opts out.[17]<\/sup> That decision permanently shapes who controls the scope of the eventual infringement suit.<\/p>\n\n\n\n

    Checkpoint Four: Model REMS Distribution Terms Against CREATES Act Exposure<\/strong><\/h3>\n\n\n\n

    Since the CREATES Act took effect in December 2019, a REMS distribution plan that a generic developer could plausibly frame as commercially unreasonable is a litigation target with a statutory private right of action attached, not just a safety document.[45]<\/sup> Building sample-access terms with that exposure in view, rather than discovering it in a demand letter, is now the lower-cost path.<\/p>\n\n\n\n

    Frequently Asked Questions<\/strong><\/h2>\n\n\n\n

    What is the Orange Book patent-listing dispute process, and who can trigger it?<\/strong>
    Any person, including a competitor or the FTC, can notify the FDA that they dispute the accuracy or relevance of a listed patent under the agency’s administrative dispute process. The FDA will only correct the listing if the NDA holder agrees to amend it, but the dispute becomes part of the public record and can support a later antitrust or delisting claim.[57]<\/sup><\/p>\n\n\n\n

    Can regulatory affairs staff face personal liability for an inaccurate Orange Book listing?<\/strong>
    Form 3542 requires a signed declaration of accuracy, and federal declarations to a government agency generally implicate the general false-statements statute, 18 U.S.C. \u00a7 1001, if knowingly false. In practice, enforcement to date has targeted the company through FTC antitrust actions and delisting orders rather than individual signers.[2][20]<\/sup><\/p>\n\n\n\n

    What is a skinny label, and does the FDA still allow section viii carve-outs after GSK v. Teva?<\/strong>
    A skinny label is a generic label that omits, or carves out, an indication still covered by an unexpired method-of-use patent under 21 CFR 314.94(a)(12). The FDA still permits the pathway. GSK v. Teva did not eliminate it, but it confirmed that marketing and promotional conduct can still support induced-infringement liability even where the label itself is properly carved out.[27][34]<\/sup><\/p>\n\n\n\n

    What is the BPCIA patent dance, and is a biosimilar applicant required to participate?<\/strong>
    It is the information exchange process under 42 U.S.C. \u00a7 262(l) in which a biosimilar applicant may share its application and manufacturing data with the reference sponsor to negotiate which patents will be litigated. Participation is optional. Sandoz v. Amgen confirmed a reference sponsor cannot obtain a federal injunction forcing an applicant to participate.[17][35]<\/sup><\/p>\n\n\n\n

    How does a REMS program affect generic entry?<\/strong>
    A REMS with restricted distribution can be structured in a way that makes it difficult for a generic developer to obtain the samples needed for bioequivalence testing, delaying or blocking an ANDA filing. Multiple antitrust suits, including the Actelion Tracleer litigation, have challenged this use of REMS.[13][41]<\/sup><\/p>\n\n\n\n

    What did the CREATES Act change for generic and biosimilar sample access?<\/strong>
    Signed into law December 20, 2019, it created a private right of action allowing a generic or biosimilar developer to sue for an injunction and damages if a brand will not sell samples on commercially reasonable terms, and it clarified that providing samples for testing does not violate a REMS.[45][46]<\/sup><\/p>\n\n\n\n

    How often does the FDA deny citizen petitions filed against competing drug applications?<\/strong>
    An empirical study found the FDA denied 92 percent of section 505(q) petitions filed between 2011 and 2015, and a separate study found an 81 percent denial rate for generic-related petitions filed between 2001 and 2010.[11][53]<\/sup><\/p>\n\n\n\n

    What is the 30-month stay, and how does an Orange Book listing decision trigger it?<\/strong>
    When a generic files an ANDA with a Paragraph IV certification against a listed patent and the brand sues within 45 days, FDA approval of the ANDA is automatically stayed for up to 30 months without the brand needing to win a preliminary injunction motion. The stay only exists because the patent was listed in the Orange Book in the first place.[5]<\/sup><\/p>\n\n\n\n

    Did the Federal Circuit’s Teva v. Amneal ruling apply beyond inhaler patents?<\/strong>
    The court’s holding, that a patent must claim at least the active ingredient to be Orange Book eligible, applies to any drug-device combination product, not only inhalers. The FTC cited the ruling as legal support for its May 2025 warning letters covering autoinjectors and other device-combination drugs.[3][4]<\/sup><\/p>\n\n\n\n

    What should a regulatory affairs team do differently to reduce litigation exposure?<\/strong>
    Test Orange Book candidates against the active-ingredient standard before filing, route label carve-out language through commercial review before it goes to market, decide BPCIA patent-dance participation with litigation strategy input before the 20-day clock starts, and model REMS distribution terms against CREATES Act exposure before finalizing a Risk Management Plan.[4][17][34][45]<\/sup><\/p>\n\n\n\n

    Key Takeaways<\/strong><\/h2>\n\n\n\n
      \n
    • The FTC has disputed more than 600 Orange Book patent listings across three warning-letter rounds since November 2023, and the Federal Circuit’s December 2024 ruling in Teva v. Amneal gave the agency its first judicial backing for the delisting theory.[1][3][4]<\/sup><\/li>\n\n\n\n
    • A properly filed Section viii label carve-out is still lawful, but GSK v. Teva shows that marketing and promotional language reviewed separately from the label can turn a compliant regulatory filing into a nine-figure infringement verdict.[9][34]<\/sup><\/li>\n\n\n\n
    • The decision to join or decline the BPCIA patent dance is effectively permanent once the statutory window closes, and it determines who controls the scope of the resulting infringement litigation.[17]<\/sup><\/li>\n\n\n\n
    • REMS distribution design has carried real antitrust exposure since well before the CREATES Act, and continues to, as the $65 million Actelion Tracleer settlement approved in March 2026 shows.[13][45]<\/sup><\/li>\n\n\n\n
    • Citizen petitions filed against competing applications are denied roughly nine times out of ten, but the 150-day statutory review window means even a doomed petition buys real delay, at an estimated cost of hundreds of millions of dollars per case in some documented instances.[11][18]<\/sup><\/li>\n<\/ul>\n\n\n\n
      \n\n\n\n

      References<\/strong><\/h3>\n\n\n\n

      [1] American Action Forum. (2024, May 15). Primer: FTC scrutinizes Orange Book listings.<\/em> https:\/\/www.americanactionforum.org\/insight\/primer-ftc-scrutinizes-orange-book-listings\/
      [2] U.S. Food and Drug Administration. Instructions for filling out Form FDA 3542.<\/em> https:\/\/www.fda.gov\/media\/102047\/download
      [3] Federal Trade Commission. (2025, May 21). FTC renews challenge of more than 200 improper patent listings.<\/em> https:\/\/www.ftc.gov\/news-events\/news\/press-releases\/2025\/05\/ftc-renews-challenge-more-200-improper-patent-listings
      [4] Teva Branded Pharm. Prods. R&D, Inc. v. Amneal Pharms. of N.Y., LLC, No. 24-1936 (Fed. Cir. Dec. 20, 2024). https:\/\/law.justia.com\/cases\/federal\/appellate-courts\/cafc\/24-1936\/24-1936-2024-12-20.html
      [5] Congressional Research Service. (2026, January 21). Patent listing in FDA’s Orange Book.<\/em> https:\/\/www.congress.gov\/crs-product\/IF12644
      [6] Cooley LLP. (2021, August 17). GSK v. Teva: Federal Circuit opinion after rehearing confirms induced infringement liability despite skinny label.<\/em> https:\/\/www.cooley.com\/news\/insight\/2021\/2021-08-17-gsk-v-teva-federal-circuit-opinion-rehearing-induced-infringement-liability-skinny-label
      [7] Sandoz Inc. v. Amgen Inc., 137 S. Ct. 1664 (2017), summarized in National Law Review, Sandoz v. Amgen: Biosimilars at the U.S. Supreme Court.<\/em> https:\/\/natlawreview.com\/article\/sandoz-v-amgen-biosimilars-us-supreme-court
      [8] Crowell & Moring LLP. (2024). The FTC strikes out: Drug manufacturers refuse to play ball and delist Orange Book patents in response to FTC warning letters.<\/em> https:\/\/www.crowell.com\/en\/insights\/client-alerts\/the-ftc-strikes-out-drug-manufacturers-refuse-to-play-ball-and-delist-orange-book-patents-in-response-to-ftc-warning-letters
      [9] GSK plc. (2024). Form 20-F for fiscal year 2023.<\/em> U.S. Securities and Exchange Commission. https:\/\/www.sec.gov\/Archives\/edgar\/data\/1131399\/000113139924000007\/gsk-20231231.htm
      [10] Kansteiner, F. (2026, February 11). GSK, Teva quietly settle Coreg ‘skinny label’ dispute after long legal back-and-forth.<\/em> Fierce Pharma. https:\/\/www.fiercepharma.com\/pharma\/gsk-teva-quietly-settle-coreg-skinny-label-dispute-after-more-decade-legal-back-and-forth
      [11] Carrier, M. A., & Minniti, C. J. (2016). Citizen petitions: Long, late-filed, and at-last denied. American University Law Review, 66,<\/em> 305-333, discussed in California Lawyers Association, Empirical evidence of drug companies using citizen petitions to hold off competition.<\/em> https:\/\/calawyers.org\/publications\/antitrust-unfair-competition-law\/competition-winter-2017-18-vol-27-no-1-empirical-evidence-of-drug-companies-using-citizen-petitions-to-hold-off-competition\/
      [12] U.S. Food and Drug Administration. Sixteenth annual report on delays in approvals of applications related to citizen petitions and petitions for stay of agency action, FY 2023.<\/em> https:\/\/www.fda.gov\/media\/184951\/download
      [13] Cohen Milstein. Tracleer antitrust litigation, Mayor of Baltimore v. Actelion Pharmaceuticals Ltd.<\/em> https:\/\/www.cohenmilstein.com\/case-study\/baltimore-v-actelion-pharmaceuticals-ltd\/
      [14] Citeline. (2026, March). Actelion settles Tracleer antitrust case for $65m ahead of trial.<\/em> https:\/\/insights.citeline.com\/generics-bulletin\/legalandip\/actelion-settles-tracleer-antitrust-case-for-65m-ahead-of-trial-LL32F3D4HZAONELCSKHK4RN3PM\/
      [15] Cooley LLP. (2025, January 2). Teva v. Amneal ruling interprets Orange Book listing statute, affirms delisting of device patents.<\/em> https:\/\/www.cooley.com\/news\/insight\/2025\/2025-01-02-teva-v-amneal-ruling-interprets-orange-book-listing-statute-affirms-delisting-of-device-patents
      [16] A&O Shearman. (2023, June 8). SCOTUS denies cert in skinny label appeal from the Federal Circuit.<\/em> https:\/\/www.aoshearman.com\/en\/insights\/ao-shearman-on-life-sciences\/scotus-denies-cert-in-skinny-label-appeal-from-the-federal-circuit
      [17] Finnegan LLP. (2017, June 14). Sandoz v. Amgen Supreme Court decision.<\/em> https:\/\/www.finnegan.com\/en\/insights\/ip-updates\/sandoz-v-amgen-supreme-court-decision.html
      [18] Feldman, R. (2020). The burden on society from eleventh-hour “citizen petitions” filed to slow generic drugs. Maryland Law Review Online, 79,<\/em> 1. https:\/\/papers.ssrn.com\/sol3\/papers.cfm?abstract_id=3404301
      [19] WSGR. FDA’s proposed rules to address inaccurate Orange Book use codes.<\/em> https:\/\/www.wsgr.com\/a\/web\/148\/orange-book.pdf
      [20] Cooley LLP. (2023, November 21). Following recent policy statement, FTC ‘disputes’ 100+ patent listings in FDA Orange Book.<\/em> https:\/\/www.cooley.com\/news\/insight\/2023\/2023-11-21-following-recent-policy-statement-ftc-disputes-100-patent-listings-in-fda-orange-book
      [21] Mayer Brown LLP. (2024). US FTC continues aggressive scrutiny of pharmaceutical patents listed in the Orange Book.<\/em> https:\/\/www.mayerbrown.com\/en\/insights\/publications\/2024\/05\/us-ftc-continues-aggressive-scrutiny-of-pharmaceutical-patents-listed-in-the-orange-book
      [22] Federal Trade Commission. (2023, November 7). FTC challenges more than 100 patents as improperly listed in the FDA’s Orange Book.<\/em> https:\/\/www.ftc.gov\/legal-library\/browse\/warning-letters\/81927
      [23] Crowell & Moring LLP. (2024). Throwing the (Orange) Book at pharmaceutical manufacturers.<\/em> https:\/\/www.crowell.com\/en\/insights\/client-alerts\/throwing-the-orange-book-at-pharmaceutical-manufacturers-ftc-challenges-over-100-drug-product-patents-listed-in-fda-publication
      [24] McDermott Will & Emery. (2025, June 3). FTC revives Orange Book listing challenges.<\/em> https:\/\/www.mcdermottlaw.com\/insights\/ftc-revives-orange-book-listing-challenges\/
      [25] Patently-O. (2024, December 20). Orange Book device patent listings: Understanding Teva v. Amneal.<\/em> https:\/\/patentlyo.com\/patent\/2024\/12\/orange-listings-understanding.html
      [26] National Law Review. (2024, December 24). Federal Circuit decides case involving Orange Book listing of device patents.<\/em> https:\/\/natlawreview.com\/article\/federal-circuit-decides-case-involving-orange-book-listing-device-patents
      [27] Biosimilars Law Bulletin. (2021, February 17). Uncertain future for skinny labels as Federal Circuit panel agrees to rehearing.<\/em> https:\/\/www.biosimilarsip.com\/2021\/02\/17\/uncertain-future-for-skinny-labels-as-federal-circuit-panel-agrees-to-rehearing\/
      [28] Marshall, Gerstein & Borun LLP. (2020, October 2). GSK v. Teva: Federal Circuit reinstates $236 million verdict.<\/em> https:\/\/www.marshallip.com\/insights\/federal-circuit-reinstates-236-million-verdict-for-induced-infringement-in-gsk-v-teva\/
      [29] Dechert LLP. (2021, March 3). Chief Judge leads Federal Circuit in reconsidering its appetite for skinny labels.<\/em> https:\/\/www.dechert.com\/knowledge\/onpoint\/2021\/3\/chief-judge-leads-federal-circuit-in-reconsidering-its-appetite-.html
      [30] GlaxoSmithKline LLC v. Teva Pharms. USA, Inc., No. 18-1976 (Fed. Cir. Aug. 5, 2021). https:\/\/www.cafc.uscourts.gov\/opinions-orders\/18-1976.opinion.8-5-2021_1814836.pdf
      [31] Foley Hoag LLP. The fate of the skinny label: Teva Pharmaceuticals USA, Inc. v. GlaxoSmithKline LLC.<\/em> https:\/\/foleyhoag.com\/news-and-insights\/publications\/alerts-and-updates\/2023\/may\/the-fate-of-the-skinny-label-teva-pharmaceuticals-usa-inc-v-glaxosmithkline-llc\/
      [32] Haug Partners LLP. (2024, September 26). Teva Pharm. USA, Inc. v. GlaxoSmithKline LLC: Supreme Court refuses to review “skinny label” patent case.<\/em> https:\/\/haugpartners.com\/article\/teva-pharm-usa-inc-v-glaxosmithkline-llc-supreme-court-refuses-to-review-skinny-label-patent-case\/
      [33] pharmaphorum. SCOTUS won’t hear ‘skinny label’ lawsuit.<\/em> https:\/\/pharmaphorum.com\/news\/scotus-wont-hear-skinny-label-lawsuit
      [34] IPWatchdog. (2024, July 25). Call off Chicken Little: The sky is not falling for skinny labeling after GSK v. Teva.<\/em> https:\/\/ipwatchdog.com\/2024\/07\/25\/call-off-chicken-little-sky-not-falling-skinny-labeling-gsk-v-teva\/
      [35] Food and Drug Law Institute. Case note: Sandoz v. Amgen.<\/em> https:\/\/www.fdli.org\/2017\/08\/case-note-sandoz-v-amgen\/
      [36] Venable LLP. (2017, April 27). Supreme Court hears oral argument in Sandoz Inc. v. Amgen Inc.<\/em> https:\/\/www.venable.com\/insights\/publications\/2017\/04\/supreme-court-hears-oral-argument-in-sandoz
      [37] Patent Docs. (2017, June 12). Sandoz Inc. v. Amgen Inc. (2017).<\/em> https:\/\/www.patentdocs.org\/2017\/06\/sandoz-inc-v-amgen-inc-2017.html
      [38] Mintz. (2017, June 14). Amgen v. Sandoz: The Supreme Court’s first biosimilars ruling.<\/em> https:\/\/www.mintz.com\/insights-center\/viewpoints\/2017-06-14-amgen-v-sandoz-supreme-courts-first-biosimilars-ruling
      [39] Leydig, Voit & Mayer, Ltd. Sandoz v. Amgen: A landmark ruling, but state law claims still undecided.<\/em> https:\/\/www.leydig.com\/publications\/sandoz-v-amgen-a-landmark-ruling-but-state-law-claims-still-undecided\/
      [40] Federal Trade Commission. (2013, March). FTC amicus brief: Improper use of restricted drug distribution programs may impede generic competition.<\/em> https:\/\/www.ftc.gov\/news-events\/news\/press-releases\/2013\/03\/ftc-amicus-brief-improper-use-restricted-drug-distribution-programs-may-impede-generic-competition
      [41] The FDA Law Blog. (2014, April 4). Another REMS antitrust lawsuit: Mylan sues Celgene over Thalomid and Revlimid to obtain drug product samples.<\/em> https:\/\/www.thefdalawblog.com\/2014\/04\/another-rems-antitrust-lawsuit-mylan-sues-celgene-over-thalomid-and-revlimid-to-obtain-drug-product\/
      [42] Medical Malpractice Lawyers. Maryland class action lawsuit contends pharmaceutical company unlawfully barred generic version of its drug.<\/em> https:\/\/medicalmalpracticelawyers.com\/maryland-class-action-lawsuit-contends-pharmaceutical-company-unlawfully-barred-generic-version-of-its-drug\/
      [43] ClassAction.org. (2018, November 26). Class action claims Actelion inflated prices of bosentan by blocking generic alternatives.<\/em> https:\/\/www.classaction.org\/news\/class-action-claims-actelion-inflated-prices-of-bosentan-by-blocking-generic-alternatives
      [44] Federal Trade Commission. FTC amicus brief filed in Actelion Pharms Ltd. v. Apotex Inc., No. 1:12-cv-05743.<\/em> https:\/\/www.ftc.gov\/news-events\/news\/press-releases\/2013\/03\/ftc-amicus-brief-improper-use-restricted-drug-distribution-programs-may-impede-generic-competition
      [45] Covington & Burling LLP. (2020, January 13). CREATES Act becomes law.<\/em> https:\/\/www.cov.com\/-\/media\/files\/corporate\/publications\/2020\/01\/creates_act_becomes_law.pdf
      [46] Congress.gov. H.R.965, CREATES Act of 2019, 116th Congress.<\/em> https:\/\/www.congress.gov\/bill\/116th-congress\/house-bill\/965\/text
      [47] Congress.gov. S.340, CREATES Act of 2019, 116th Congress.<\/em> https:\/\/www.congress.gov\/bill\/116th-congress\/senate-bill\/340\/text
      [48] EveryCRSReport.com. (2019, March 12). The CREATES Act of 2019 and lowering drug prices: Legal background and overview.<\/em> https:\/\/www.everycrsreport.com\/reports\/LSB10272.html
      [49] Wilson Sonsini Goodrich & Rosati. FDA issues final guidance on citizen petitions and stay of action petitions subject to FDCA Section 505(q).<\/em> https:\/\/www.wsgr.com\/en\/insights\/fda-issues-final-guidance-on-citizen-petitions-and-stay-of-action-petitions-subject-to-fdca-section-505q.html
      [50] U.S. Food and Drug Administration. Thirteenth annual report on delays in approvals of applications related to citizen petitions and petitions for stay of agency action.<\/em> https:\/\/www.fda.gov\/media\/151706\/download
      [51] Congress.gov. (2026, January 21). Patent listing in FDA’s Orange Book<\/em> (background on 2007 amendments). https:\/\/www.congress.gov\/crs-product\/IF12644
      [52] Stanford Law School. Empirical evidence of drug pricing games: A citizen’s pathway gone astray.<\/em> https:\/\/law.stanford.edu\/?p=222934
      [53] University of Maryland Carey School of Law. The burden on society from eleventh-hour “citizen petitions” filed to slow generic drugs<\/em> (endnotes). https:\/\/digitalcommons.law.umaryland.edu\/cgi\/viewcontent.cgi?article=1061&context=endnotes
      [54] U.S. Food and Drug Administration. Twelfth annual report on delays in approvals of applications related to citizen petitions and petitions for stay of agency action.<\/em> https:\/\/www.fda.gov\/media\/143518\/download
      [55] U.S. Food and Drug Administration. Fourteenth annual report on delays in approvals of applications related to citizen petitions and petitions for stay of agency action.<\/em> https:\/\/www.fda.gov\/media\/166169\/download
      [56] U.S. Food and Drug Administration. FDA brief: FDA issues final guidance to address gaming use of citizen petitions.<\/em> https:\/\/www.fda.gov\/news-events\/fda-brief\/fda-brief-fda-issues-final-guidance-address-gaming-use-citizen-petitions
      [57] Congress.gov. Patent listing in FDA’s Orange Book<\/em> (patent listing dispute process). https:\/\/www.congress.gov\/crs-product\/IF12644<\/p>\n","protected":false},"excerpt":{"rendered":"

      On November 7, 2023, the Federal Trade Commission sent warning letters to ten pharmaceutical manufacturers over more than 100 patents […]<\/p>\n","protected":false},"author":1,"featured_media":39456,"comment_status":"open","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"_lmt_disableupdate":"","_lmt_disable":"","site-sidebar-layout":"default","site-content-layout":"","ast-site-content-layout":"default","site-content-style":"default","site-sidebar-style":"default","ast-global-header-display":"","ast-banner-title-visibility":"","ast-main-header-display":"","ast-hfb-above-header-display":"","ast-hfb-below-header-display":"","ast-hfb-mobile-header-display":"","site-post-title":"","ast-breadcrumbs-content":"","ast-featured-img":"","footer-sml-layout":"","ast-disable-related-posts":"","theme-transparent-header-meta":"","adv-header-id-meta":"","stick-header-meta":"","header-above-stick-meta":"","header-main-stick-meta":"","header-below-stick-meta":"","astra-migrate-meta-layouts":"default","ast-page-background-enabled":"default","ast-page-background-meta":{"desktop":{"background-color":"var(--ast-global-color-4)","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""},"tablet":{"background-color":"","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""},"mobile":{"background-color":"","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""}},"ast-content-background-meta":{"desktop":{"background-color":"var(--ast-global-color-5)","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""},"tablet":{"background-color":"var(--ast-global-color-5)","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""},"mobile":{"background-color":"var(--ast-global-color-5)","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""}},"footnotes":""},"categories":[10],"tags":[],"class_list":["post-39455","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-insights"],"modified_by":"DrugPatentWatch","_links":{"self":[{"href":"https:\/\/www.drugpatentwatch.com\/blog\/wp-json\/wp\/v2\/posts\/39455","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/www.drugpatentwatch.com\/blog\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/www.drugpatentwatch.com\/blog\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/www.drugpatentwatch.com\/blog\/wp-json\/wp\/v2\/users\/1"}],"replies":[{"embeddable":true,"href":"https:\/\/www.drugpatentwatch.com\/blog\/wp-json\/wp\/v2\/comments?post=39455"}],"version-history":[{"count":1,"href":"https:\/\/www.drugpatentwatch.com\/blog\/wp-json\/wp\/v2\/posts\/39455\/revisions"}],"predecessor-version":[{"id":39457,"href":"https:\/\/www.drugpatentwatch.com\/blog\/wp-json\/wp\/v2\/posts\/39455\/revisions\/39457"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/www.drugpatentwatch.com\/blog\/wp-json\/wp\/v2\/media\/39456"}],"wp:attachment":[{"href":"https:\/\/www.drugpatentwatch.com\/blog\/wp-json\/wp\/v2\/media?parent=39455"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/www.drugpatentwatch.com\/blog\/wp-json\/wp\/v2\/categories?post=39455"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/www.drugpatentwatch.com\/blog\/wp-json\/wp\/v2\/tags?post=39455"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}