{"id":40072,"date":"2026-11-10T10:00:00","date_gmt":"2026-11-10T15:00:00","guid":{"rendered":"https:\/\/www.drugpatentwatch.com\/blog\/?p=40072"},"modified":"2026-11-01T19:41:48","modified_gmt":"2026-11-02T00:41:48","slug":"your-device-patent-buys-four-years-not-forty-what-happens-when-the-delivery-mechanism-becomes-prior-art","status":"publish","type":"post","link":"https:\/\/www.drugpatentwatch.com\/blog\/your-device-patent-buys-four-years-not-forty-what-happens-when-the-delivery-mechanism-becomes-prior-art\/","title":{"rendered":"Your Device Patent Buys Four Years, Not Forty: What Happens When the Delivery Mechanism Becomes Prior Art"},"content":{"rendered":"\n
\"\"<\/figure>\n\n\n\n

Device patents extended market protection for brand-name asthma and COPD inhalers by a median of 5.5 years beyond the last non-device patent, according to a 2023 study in Chest. [1] The interquartile range of that result runs from 0.0 to 10.5 years. [1] The spread is the point. Some device patents add a decade. A quarter or more of the studied records add nothing.<\/p>\n\n\n\n

This article asks why the spread is so wide. We follow four documented cases: the ProAir HFA inhaler, the Lantus SoloStar pen, the EpiPen auto-injector and the FTC’s Orange Book campaign. We add one original calculation of the ProAir HFA patent clock and one original framework that sorts device patents into four tests. Each test can cut the paper term of a device patent to a fraction of its nominal 20 years.<\/p>\n\n\n\n

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

A device patent adds real protection only if it passes four tests. The patent must be listed correctly. Its claims must survive the prior art. A generic maker must be unable to design around it. And FDA must require the generic product to match the brand device. Published data put the paper extension from device patents at 5.5 years for inhalers [1] and 7.5 years across all drug products with tertiary patents. [2] Three documented cases below show that the paper figure and the effective figure can differ by years.<\/p>\n\n\n\n

The Six Findings That Matter<\/strong><\/h3>\n\n\n\n
    \n
  1. Delivery-device patents were 1,751 of 3,241 Orange Book patents (54.0%) on 331 small-molecule products that had at least one tertiary patent. [2]<\/li>\n\n\n\n
  2. Of those 1,751 device patents, 1,047 (59.8%) had claims that did not mention the active ingredient. [2]<\/li>\n\n\n\n
  3. Tertiary patents added a median of 7.5 years (interquartile range 2.8 to 13.9 years) on the 180 products where they extended protection. [2]<\/li>\n\n\n\n
  4. On December 20, 2024, the Federal Circuit held that patents claiming only device components of an approved product do not meet the Orange Book listing requirement. [3]<\/li>\n\n\n\n
  5. The Federal Circuit affirmed four PTAB decisions on December 29, 2021 that found the challenged claims of three Sanofi SoloStar pen patents obvious over earlier pen designs. [4]<\/li>\n\n\n\n
  6. Analysis: all nine ProAir HFA patents on our list that expire after September 12, 2023 have device titles, and the last of them expires about 8.3 years after the last formulation patent. [5] [6]<\/li>\n<\/ol>\n\n\n\n

    What Is a Device Patent in the Orange Book?<\/strong><\/h2>\n\n\n\n

    A device patent is a patent whose claims cover the delivery hardware of a drug product, not the drug molecule or the formulation. In this article, a drug-device combination product means a drug product that includes a delivery device such as an inhaler, a pen or an auto-injector.<\/p>\n\n\n\n

    Definition: Primary, Secondary and Tertiary Patents<\/strong><\/h3>\n\n\n\n

    The authors of a 2026 JAMA Health Forum study sort Orange Book patents into three groups. Primary patents cover the active ingredient. Secondary patents cover formulations and methods of use. Tertiary patents cover delivery devices. [2] This is a published research taxonomy, not an FDA classification. We use “device patent” and “tertiary patent” as synonyms.<\/p>\n\n\n\n

    What Does a Patent Need to Be Listed in the Orange Book?<\/strong><\/h3>\n\n\n\n

    A patent must “claim the drug” or claim a method of using the drug under 21 U.S.C. 355(b)(1)(A)(viii). [3] In Teva v. Amneal, the Federal Circuit read “claims the drug” narrowly. The court wrote that “to qualify for listing, a patent must claim at least what made the product approvable as a drug in the first place,” which is the active ingredient. [3] It also wrote that “patents claiming just the device components of the product approved in an NDA do not meet the listing requirement.” [3]<\/p>\n\n\n\n

    What Is a 30-Month Stay and Why Does Listing Matter?<\/strong><\/h3>\n\n\n\n

    A listed patent can trigger a “statutory stay that generally blocks the introduction of competing drug products for 30 months,” as the FTC described it in November 2023. [7] The stay is the commercial reason brand companies list patents. An unlisted patent does not trigger the stay. The brand company can still sue for infringement, but it loses the automatic delay. This is why the listing test comes first in our framework below.<\/p>\n\n\n\n

    How Long Does a Device Patent Last?<\/strong><\/h2>\n\n\n\n

    A US utility patent ends 20 years from the filing date of the application, or from the earliest application whose benefit it claims. [8] A device patent filed late in a product’s life therefore expires late. That is the source of its paper value.<\/p>\n\n\n\n

    Why Does a Late Filing Create a Late Expiration?<\/strong><\/h3>\n\n\n\n

    Take the ProAir HFA inhaler. FDA approved it on October 29, 2004 under NDA 021457. [3] Teva listed US Patent 8,132,712, titled “Metered-dose inhaler,” with an expiration of September 7, 2028. [6] [5] If no term adjustment applies, a 2028 expiration implies a filing date near September 2008. That is about four years after approval. This is our inference from the 20-year rule, not a reported filing date.<\/p>\n\n\n\n

    The inference shows how device patents work. A formulation patent filed before approval expires before the device patents filed after it. The device patents fill the time after the formulation patents run out.<\/p>\n\n\n\n

    Term Adjustment, Term Extension and Terminal Disclaimers<\/strong><\/h4>\n\n\n\n

    Three rules can move the 20-year date. Patent term adjustment can add days for USPTO delay. Patent term extension can add time for premarket regulatory review. A terminal disclaimer can shorten a patent to the date of an earlier patent. [8] We use the expiration dates that the sources report and do not recompute them.<\/p>\n\n\n\n

    What Does the Data Say About Added Protection From Device Patents?<\/strong><\/h3>\n\n\n\n

    Two peer-reviewed studies measure the paper extension. They agree on direction and differ on size.<\/p>\n\n\n\n

    The Chest Study of Inhaler Device Patents<\/strong><\/h4>\n\n\n\n

    The 2023 Chest study identified brand-name asthma and COPD inhalers approved from 1986 to 2020 in the Orange Book. [1] It found 53 approved brand-name inhalers. Of these, 39 had at least one device patent. [1] The study counted 137 distinct device patents, which was 49% of all patents listed on those inhalers. [1] Of the 137, 77% did not mention active ingredients or their molecular structures. [1]<\/p>\n\n\n\n

    \n

    “Device patents extended market protection by a median of 5.5 years (IQR 0.0-10.5 years) beyond the last-to-expire nondevice patent.” (Chest, 2023) [1]<\/p>\n<\/blockquote>\n\n\n\n

    Analysis: 39 of 53 is 73.6%. A 5.5-year median equals 27.5% of a nominal 20-year term. These are our calculations from the reported figures.<\/p>\n\n\n\n

    The JAMA Health Forum Study of Tertiary Patents<\/strong><\/h4>\n\n\n\n

    A 2026 study in JAMA Health Forum covered FDA-approved small-molecule drugs from 1986 to 2023. [2] It found 331 products with at least one tertiary patent and 3,241 patents listed on them. [2] Of those patents, 137 (4.2%) were primary, 1,353 (41.7%) were secondary and 1,751 (54.0%) were tertiary. [2] Median expected patent protection across the products was 17.6 years. [2] For 180 products (54.4%), tertiary patents extended protection beyond the other patents, by a median of 7.5 years. [2]<\/p>\n\n\n\n

    Read the 54.4% figure with care. It means tertiary patents extended protection on 180 of 331 products. On the other 151 products, calculated from the same figures, they did not extend it.<\/p>\n\n\n\n

    Methodology: How We Built the ProAir HFA Patent Clock<\/strong><\/h2>\n\n\n\n

    What Data Did We Analyze?<\/strong><\/h3>\n\n\n\n

    We used three inputs. The first is the Federal Circuit opinion in Teva v. Amneal, which names the product, the NDA, the approval date and five patents. [3] The second is a Teva press release of June 20, 2014 that gives exact expiration dates for four ProAir HFA patents. [6] The third is a GreyB Pharsight table of 14 US patents for ProAir HFA with titles and month-level expiration dates. [5]<\/p>\n\n\n\n

    The DrugPatentWatch record for ProAir HFA confirms the NDA number, the October 29, 2004 approval date and one Paragraph IV ANDA submission dated 2012-05-18 for the 0.09 mg base per actuation strength. [9] Patent-level fields on that page sit behind a subscription. We therefore took patent dates from the court opinion, the company press release and the GreyB table. DrugPatentWatch is useful for tracking this kind of record by drug. We do not use it as proof of the dates below.<\/p>\n\n\n\n

    How Did We Select and Classify Records?<\/strong><\/h3>\n\n\n\n

    We included every patent in the GreyB table. We matched records by patent number, so no patent counts twice. We classified a patent as a device patent when its title names a device or a device component, such as “dose counter” or “metered-dose inhaler.” We classified a patent as a formulation patent when its title names an aerosol formulation. We did not read the claims. Title-based classification is a limit of this analysis.<\/p>\n\n\n\n

    How Did We Calculate the Numbers?<\/strong><\/h3>\n\n\n\n

    We calculated years as elapsed days divided by 365.25. The “paper gap” is the time from the last-expiring formulation patent to the expiration of each device patent. GreyB gives month-level dates, so figures that rely on it carry an error of about one month.<\/p>\n\n\n\n

    What Are the Limits?<\/strong><\/h3>\n\n\n\n

    Four limits apply. We did not verify the current Orange Book status of every patent. We did not read claims. GreyB is a secondary source. And expiration dates can change with terminal disclaimers or legal events. [5]<\/p>\n\n\n\n

    Data Finding: The ProAir HFA Patent Timeline<\/strong><\/h2>\n\n\n\n

    Nine of the 14 patents on our list expire after September 12, 2023, the date the last formulation patent expired. All nine have device titles. [5] [6]<\/p>\n\n\n\n

    Patent<\/th>Title (as reported)<\/th>Expiration<\/th>Years after approval<\/th>Type (analysis)<\/th>Source<\/th><\/tr><\/thead>
    US 5,605,674<\/td>Medicinal aerosol formulations<\/td>Feb 2014<\/td>9.3<\/td>Formulation<\/td>[5]<\/td><\/tr>
    US 7,566,445 and US 8,834,849<\/td>Medicinal aerosols and methods of delivery thereof<\/td>Jun 2017<\/td>12.6<\/td>Formulation<\/td>[5]<\/td><\/tr>
    US 6,446,627<\/td>Inhaler dose counter<\/td>Dec 18, 2017<\/td>13.1<\/td>Device<\/td>[6] [5]<\/td><\/tr>
    US 7,105,152<\/td>Suspension aerosol formulations<\/td>Sep 12, 2023<\/td>18.9<\/td>Formulation<\/td>[6] [5]<\/td><\/tr>
    US 8,132,712<\/td>Metered-dose inhaler<\/td>Sep 7, 2028<\/td>23.9<\/td>Device<\/td>[6] [5]<\/td><\/tr>
    Seven dose counter patents (US 9,463,289; 9,808,587; 10,022,509; 10,022,510; 10,086,156; 10,695,512; 11,395,889)<\/td>Dose counter titles<\/td>May 2031<\/td>about 26.5<\/td>Device<\/td>[5]<\/td><\/tr>
    US 10,561,808<\/td>Dose counter for inhaler having an anti-reverse rotation actuator<\/td>Jan 2032<\/td>about 27.2<\/td>Device<\/td>[5]<\/td><\/tr><\/tbody><\/table><\/figure>\n\n\n\n

    Formulation Patents Versus Dose-Counter Patents<\/strong><\/h3>\n\n\n\n

    The last formulation patent on the list expires 18.9 years after approval. The last device patent expires about 27.2 years after approval. [5] The paper gap between them is about 8.3 years for the January 2032 patent, about 7.7 years for the May 2031 group and 5.0 years for US 8,132,712. This is our calculation.<\/p>\n\n\n\n

    The Federal Circuit case concerned five of these patents: US 8,132,712, 9,463,289, 9,808,587, 10,561,808 and 11,395,889. [3] Four other dose-counter patents on the GreyB list were not part of that case. We did not check their Orange Book status.<\/p>\n\n\n\n

    What the Dose-Counter Lineage Shows<\/strong><\/h4>\n\n\n\n

    US 6,446,627 is titled “Inhaler dose counter” and expired on December 18, 2017. [6] [5] Eight later patents on the list also claim dose counters, and they expire between May 2031 and January 2032. [5] Four of them name an “anti-reverse rotation actuator” in the title. [5] We have not compared the claims. The titles suggest where the claimed difference sits. A later dose-counter patent must claim something that the earlier dose-counter art does not teach or suggest. The earlier counter is the starting point for any validity challenge against the later ones.<\/p>\n\n\n\n

    What Happens When the Delivery Mechanism Becomes Prior Art?<\/strong><\/h2>\n\n\n\n

    When a device is sold, published or patented, its design becomes part of the prior art against later device claims. A later patent survives only if its claims differ from that design in a way that is not obvious. The sponsor’s own launch, its own published applications and every competitor device all count.<\/p>\n\n\n\n

    How Does a Commercial Launch Create Prior Art?<\/strong><\/h3>\n\n\n\n

    A sale can bar a later patent. In Helsinn v. Teva, decided January 22, 2019, the Supreme Court held that “a commercial sale to a third party who is required to keep the invention confidential may place the invention ‘on sale.'” [10] The sale does not need to reveal the design to the public. For a device sponsor, this means the date of the first commercial sale of a device is a deadline for any claim to that device.<\/p>\n\n\n\n

    Does the Sponsor’s Own Earlier Device Count Against Its Later Patent?<\/strong><\/h3>\n\n\n\n

    Yes, unless the disclosure falls inside the grace period. Under the America Invents Act, a disclosure by the inventor does not count as prior art if it was made one year or less before the effective filing date of the claimed invention. [11] The exception covers only the inventor’s own work or work obtained from the inventor. [11] An earlier device that went public more than one year before the filing date is not excepted.<\/p>\n\n\n\n

    The One-Year Grace Period<\/strong><\/h4>\n\n\n\n

    The grace period is a narrow window. MPEP 2153.01 applies it to applications examined under the first-inventor-to-file rules. [11] A device team that ships a prototype design in year one and files an improvement in year three has no grace period for the shipped design.<\/p>\n\n\n\n

    The 18-Month Publication Rule<\/strong><\/h4>\n\n\n\n

    The USPTO publishes most applications promptly after 18 months from the earliest filing date for which benefit is sought. [12] A sponsor’s first device application therefore becomes public prior art about a year and a half after filing. Analysis: any later application that does not claim benefit of that first filing is measured against that publication.<\/p>\n\n\n\n

    When Is a Device Improvement Obvious?<\/strong><\/h3>\n\n\n\n

    An improvement is obvious when it only rearranges known parts. In KSR v. Teleflex, decided April 30, 2007, the Supreme Court said that a combination of familiar elements by known methods “is likely to be obvious when it does no more than yield predictable results.” [13] The Court found that the Federal Circuit had treated obviousness “in a narrow, rigid manner that is inconsistent with \u00a7103 and this Court’s precedents.” [13] Pen, inhaler and auto-injector parts are mechanical and well documented. That makes KSR a practical tool for challengers.<\/p>\n\n\n\n

    A Taxonomy of Prior Art Sources for Device Claims<\/strong><\/h3>\n\n\n\n

    This is an original classification, not an industry standard. It sorts the prior art that a device claim faces into four sources.<\/p>\n\n\n\n

      \n
    • Source A, own product: the sponsor’s marketed device, including confidential sales under Helsinn. [10]<\/li>\n\n\n\n
    • Source B, own publications: the sponsor’s published applications and patents, which the USPTO publishes at 18 months. [12]<\/li>\n\n\n\n
    • Source C, adjacent devices: devices from other drug programs that use the same mechanism, such as a pen from another injectable.<\/li>\n\n\n\n
    • Source D, patent literature: expired and abandoned device patents, such as an older dose counter patent in the same field.<\/li>\n<\/ul>\n\n\n\n

      The SoloStar case below shows Source D at work. The ProAir HFA lineage shows where Source A and Source B apply.<\/p>\n\n\n\n

      Case Study: Sanofi Lantus SoloStar Pen Patents Versus Mylan<\/strong><\/h2>\n\n\n\n

      Mylan challenged Sanofi’s Lantus SoloStar pen patents at the PTAB, and Sanofi lost on most claims. Mylan announced the results on May 29, 2020. [14]<\/p>\n\n\n\n

      What Did the PTAB Decide?<\/strong><\/h3>\n\n\n\n

      The PTAB held all challenged claims of US 8,603,044, US 8,992,486 and US 9,526,844 unpatentable. [14] For US 9,604,008, it held three claims unpatentable and two patentable. [14] Mylan already held a covenant not to sue from Sanofi on the ‘008 patent. [14] The Board had also invalidated the single challenged claim of US 8,679,069 in the previous month. [14] Mylan’s chief executive Heather Bresch said the decision was “likely the final defeat of Sanofi’s attempts to prevent generic competition.” [14] That is a company statement, not a court finding.<\/p>\n\n\n\n

      What Did the Federal Circuit Say?<\/strong><\/h3>\n\n\n\n

      On December 29, 2021, the Federal Circuit affirmed four final written decisions in a nonprecedential per curiam opinion. [4] The decisions covered claims of US 8,679,069, 8,603,044 and 8,992,486 and rested on the Steenfeldt-Jensen reference, US 6,235,004. [4] The Board had also found the claims obvious over a second reference, Burroughs, which the court did not address. [4]<\/p>\n\n\n\n

      The Threaded Driver Tube<\/strong><\/h4>\n\n\n\n

      The Board found it obvious to give the fifth embodiment of Steenfeldt-Jensen an internally threaded driver tube, based on a nut member in the first embodiment that engages the piston rod. [4]<\/p>\n\n\n\n

      The Radial Stop<\/strong><\/h4>\n\n\n\n

      For claims 30 and 32 of the ‘486 patent, the Board found it obvious to replace outer hooks and longitudinal slots in the fifth embodiment with protruding teeth from the third embodiment. [4] The court found that “these two elements were interchangeable” and described the change as “a rearrangement of old elements, each performing the same function it had been known to perform.” [4]<\/p>\n\n\n\n

      Timeline: From Petition to Affirmance<\/strong><\/h3>\n\n\n\n
      Event<\/th>Date<\/th>Detail<\/th>Source<\/th><\/tr><\/thead>
      IPR petitions<\/td>2018 and 2019<\/td>IPR2018-01670, -01676, -01678 and IPR2019-00979 are the four decisions on appeal<\/td>[4]<\/td><\/tr>
      PTAB decision on US 8,679,069<\/td>April 2020<\/td>Sole challenged claim invalidated<\/td>[14]<\/td><\/tr>
      PTAB decisions on ‘044, ‘486, ‘844, ‘008<\/td>May 2020<\/td>All challenged claims of ‘044, ‘486 and ‘844 unpatentable; 3 of 5 claims of ‘008 unpatentable<\/td>[14]<\/td><\/tr>
      Federal Circuit affirmance<\/td>Dec 29, 2021<\/td>About 19 months after the May 2020 decisions<\/td>[4]<\/td><\/tr><\/tbody><\/table><\/figure>\n\n\n\n

      What This Means for Pen and Auto-Injector Patents<\/strong><\/h3>\n\n\n\n

      The shared specification in the SoloStar family describes a pen-type injector that lets a user set and administer a dose. [4] The prior art that defeated the claims was an earlier pen patent. A pen sponsor should assume that every earlier pen patent is prior art to its improvements and that a challenger will combine its parts.<\/p>\n\n\n\n

      Case Study: Teva v. Amneal and the ProAir HFA Delisting<\/strong><\/h2>\n\n\n\n

      Teva v. Amneal removed five dose-counter patents from the Orange Book for ProAir HFA. The Federal Circuit decided it on December 20, 2024. [3]<\/p>\n\n\n\n

      What Did the Court Hold?<\/strong><\/h3>\n\n\n\n

      The panel of Judges Prost, Taranto and Hughes held that a patent “claims the drug” only when it “particularly points out and distinctly claims the drug as the invention.” [3] The court rejected Teva’s argument that infringement by the NDA product is enough. The opinion states that the fact “that an NDA could infringe a patent does not mean that the patent ‘claims’ the underlying drug.” [3] The five patents are directed to the inhaler, with claims on an improved dose counter and a canister. They recite no active ingredient. [15]<\/p>\n\n\n\n

      Litigation Clock for Teva v. Amneal<\/strong><\/h3>\n\n\n\n
      Event<\/th>Date<\/th>Elapsed since prior event<\/th>Source<\/th><\/tr><\/thead>
      D.N.J. orders delisting of five patents (No. 2:23-cv-20964)<\/td>Jun 10, 2024<\/td>Not applicable<\/td>[3]<\/td><\/tr>
      Federal Circuit affirms<\/td>Dec 20, 2024<\/td>193 days<\/td>[3]<\/td><\/tr>
      Federal Circuit stays its ruling at Teva’s request<\/td>Jan 22, 2025<\/td>33 days<\/td>[16]<\/td><\/tr>
      Rehearing en banc denied<\/td>Mar 3, 2025<\/td>40 days<\/td>[16]<\/td><\/tr>
      Original certiorari deadline<\/td>Jun 2, 2025<\/td>91 days<\/td>[17]<\/td><\/tr>
      Extension requested to<\/td>Aug 1, 2025<\/td>60 days<\/td>[17]<\/td><\/tr><\/tbody><\/table><\/figure>\n\n\n\n

      From the district court order to the denial of rehearing, 266 days passed. During that time the patents stayed in the Orange Book. Teva’s suit against Amneal triggered a 30-month stay on Amneal’s ANDA. [16] The delisting fight therefore ran while the stay it targeted was in force.<\/p>\n\n\n\n

      Did the Supreme Court Take the Case?<\/strong><\/h3>\n\n\n\n

      The sources we reviewed show an application to extend Teva’s time to petition for certiorari to August 1, 2025. [17] Another source states that Teva petitioned. [18] None of the sources we reviewed reports the outcome. Readers who need the current status should check Supreme Court docket 24A1149.<\/p>\n\n\n\n

      The FTC Orange Book Campaign: Three Rounds of Device-Patent Challenges<\/strong><\/h2>\n\n\n\n

      The FTC challenged device patent listings in three rounds between November 2023 and May 2025. The rounds overlap, so the patent counts must not be added together. [19]<\/p>\n\n\n\n

      How Many Patents Did the FTC Challenge?<\/strong><\/h3>\n\n\n\n
      Round<\/th>Date<\/th>Scale reported<\/th>Products or areas<\/th>Source<\/th><\/tr><\/thead>
      1<\/td>Nov 7, 2023<\/td>More than 100 patents; 10 companies<\/td>Asthma inhalers, epinephrine auto-injectors, Restasis multidose bottles<\/td>[7]<\/td><\/tr>
      2<\/td>Apr 30, 2024<\/td>About 300 listings; 10 companies; 20 products<\/td>Diabetes, weight loss, asthma, COPD<\/td>[19] [20]<\/td><\/tr>
      3<\/td>May 21, 2025<\/td>More than 200 patents; 17 products<\/td>Asthma, diabetes, COPD<\/td>[18]<\/td><\/tr><\/tbody><\/table><\/figure>\n\n\n\n

      The November 2023 letters named AbbVie, AstraZeneca, Boehringer Ingelheim, Impax Laboratories, Kaleo, Mylan Specialty and subsidiaries of GlaxoSmithKline and Teva. [7] FTC Chair Lina Khan said: “Wrongfully listed patents can significantly drive up the prices Americans must pay for medicines.” [7] Companies had 30 days to remove a listing or recertify it. [21]<\/p>\n\n\n\n

      Who Delisted and Who Did Not?<\/strong><\/h3>\n\n\n\n

      As of August 2024, White & Case recorded voluntary delistings by GlaxoSmithKline for Anoro Ellipta, Trelegy Ellipta, Arnuity Ellipta and Ventolin HFA. [20] Glaxo Group delisted patents for Advair HFA, Flovent HFA, Incruse Ellipta and Breo Ellipta. [20] Kaleo delisted patents for AUVI-Q and its naloxone product. [20] Those companies still kept several targeted patents. [20] Boehringer Ingelheim did not delist. [20] The May 2025 letters went to companies that had not delisted patents challenged earlier. [18]<\/p>\n\n\n\n

      Case Study: EpiPen and the Gap Between a Settlement Date and a Launch Date<\/strong><\/h2>\n\n\n\n

      For EpiPen, FDA timing, not the patent, set the real entry date. On April 26, 2012, Mylan and Pfizer announced a settlement with Teva that allowed Teva to launch a generic epinephrine auto-injector on June 22, 2015, or earlier in some circumstances, subject to FDA approval. [22] The suit was brought by Meridian Medical Technologies, a Pfizer subsidiary that makes the EpiPen Auto-Injector. [22] The press release does not name the patents.<\/p>\n\n\n\n

      What Happened After the Settlement Date?<\/strong><\/h3>\n\n\n\n

      Teva received a complete response letter from FDA in February 2016 that cited “certain major deficiencies.” [23] FDA approved Teva’s generic on August 16, 2018. [23] Analysis: that date is 3.2 years after the June 22, 2015 settlement entry date, and the settlement date itself came 3.2 years after the 2012 announcement. The sources we reviewed do not say what the deficiencies were. We make no claim that they concerned the device.<\/p>\n\n\n\n

      What Does FDA Require of a Generic Drug-Device Product?<\/strong><\/h3>\n\n\n\n

      FDA’s January 2017 draft guidance, docket FDA-2016-D-4412, describes how an ANDA applicant should compare the user interface of its generic with that of the reference product. [24] An FDA workshop presentation by a Teva regulatory director describes the current method. The applicant compares labeling, task analysis and physical device parts. [25] It sorts differences into “no design difference,” “minor difference” and “other difference.” [25] An “other difference” can require a comparative use human factors study. [25]<\/p>\n\n\n\n

      Why This Matters to Device Patent Value<\/strong><\/h4>\n\n\n\n

      The FDA comparison rule works in two directions. It makes a generic copy the brand device closely, which can bring the copy into the brand’s patent claims. It also lets a generic maker accept a minor difference without a study. Both effects shape the design-around test in our framework.<\/p>\n\n\n\n

      Case Data Point: Spiriva HandiHaler and Revenue Exposure<\/strong><\/h2>\n\n\n\n

      Lupin announced on August 16, 2023 the launch of a generic equivalent of Spiriva HandiHaler (tiotropium bromide inhalation powder, 18 mcg per capsule) from Boehringer Ingelheim. [26] Lupin reported that the reference product had estimated annual US sales of USD 1,264 million (IQVIA MAT March 2023). [26] The press release does not discuss patents. We include the figure as a measure of what is at stake in a capsule-inhaler launch.<\/p>\n\n\n\n

      The Four-Test Framework: Listing, Validity, Design-Around and Substitution<\/strong><\/h2>\n\n\n\n

      This framework is our own. It is not an industry or regulatory classification. It turns the case law above into four questions that a device patent must answer.<\/p>\n\n\n\n

      Test 1: Is the Device Patent Listable?<\/strong><\/h3>\n\n\n\n

      The patent must claim at least the active ingredient or a method of using it. [3] A device patent that fails this test cannot support the automatic 30-month stay. It can still support an infringement suit.<\/p>\n\n\n\n

      Test 2: Do the Claims Survive the Prior Art?<\/strong><\/h3>\n\n\n\n

      The claims must differ from Sources A to D in our taxonomy in a non-obvious way. The SoloStar patents failed this test on a combination of parts from earlier pen embodiments. [4]<\/p>\n\n\n\n

      Test 3: Can a Generic Maker Design Around the Claims?<\/strong><\/h3>\n\n\n\n

      Device claims are often narrow, because they recite mechanical parts. A generic maker can change a part and stay outside the claim. FDA’s comparison rules allow minor design differences. [25] Whether a design-around works is a case-by-case question that a court decides.<\/p>\n\n\n\n

      Test 4: Does FDA Require the Generic to Match the Device?<\/strong><\/h3>\n\n\n\n

      If FDA requires the generic to match the brand user interface, the generic has less room to design around. If FDA accepts differences, the patent covers less. The 2017 draft guidance sets the method for this comparison. [24]<\/p>\n\n\n\n

      How the Tests Interact<\/strong><\/h4>\n\n\n\n

      The tests are not independent. Failing Test 1 removes the stay but leaves Tests 2 to 4 for the court. Failing Test 2 removes the patent. Passing Tests 1 and 2 and failing Test 3 leaves a valid patent that no generic infringes. A device patent has full effect only when it passes all four.<\/p>\n\n\n\n

      Scenario Analysis: How Many Years Does the ProAir HFA Device Patent Gap Really Add?<\/strong><\/h2>\n\n\n\n

      The scenarios below use the ProAir HFA paper gap of about 8.3 years as the base. They are illustrations built on stated assumptions. They are not forecasts and they carry no probabilities, because no public source supplies probabilities for these outcomes.<\/p>\n\n\n\n

      Scenario<\/th>Assumption<\/th>Effective years added after Sep 12, 2023<\/th><\/tr><\/thead>
      A. All four tests pass<\/td>Patent is listed, valid, not designed around, and FDA requires a matching device<\/td>Up to about 8.3 (the paper gap)<\/td><\/tr>
      B. Listing test fails<\/td>Patent leaves the Orange Book, so no automatic stay; suit still possible<\/td>0 to 8.3; the automatic stay of up to 2.5 years is lost<\/td><\/tr>
      C. Design-around reaches market in year 4<\/td>A generic with a different dose counter launches four years after Sep 12, 2023<\/td>4.0<\/td><\/tr>
      D. Claims held obvious<\/td>A court or the PTAB finds the claims unpatentable over earlier dose counters<\/td>0<\/td><\/tr><\/tbody><\/table><\/figure>\n\n\n\n

      Where Does the Four-Year Figure Come From?<\/strong><\/h3>\n\n\n\n

      The headline figure of four years is shorthand for scenario C. It is a scenario value. No study measures it. The published medians are 5.5 years for inhalers [1] and 7.5 years across tertiary patents. [2] Both are paper figures. Scenario C shows how an effective figure can fall below them when a competitor designs around a single part.<\/p>\n\n\n\n

      What This Means for Brand Manufacturers<\/strong><\/h2>\n\n\n\n

      Brand teams should treat a device patent as a narrow right with four exposure points. Four actions follow from the cases above.<\/p>\n\n\n\n

        \n
      • Check each listing against the Teva v. Amneal rule before the next patent certification. [3]<\/li>\n\n\n\n
      • File device improvements within the one-year grace period of any public disclosure or sale. [11]<\/li>\n\n\n\n
      • Map your own earlier devices and published applications as prior art against each new filing. [12]<\/li>\n\n\n\n
      • Expect combination-of-parts challenges against mechanical claims. [13] [4]<\/li>\n<\/ul>\n\n\n\n

        What This Means for Generic Entry and ANDA Filers<\/strong><\/h2>\n\n\n\n

        Generic teams gain leverage from the same four tests. A listing that fails Test 1 can be attacked by a counterclaim. That is the route Amneal used. [3] A claim that fails Test 2 can be attacked at the PTAB. That is the route Mylan used. [14] A device with a minor difference can reach FDA without a human factors study. [25] The cost of each route is time. The delisting case took 266 days from district court order to the end of rehearing. [3] [16]<\/p>\n\n\n\n

        What Happens Next: Forecast and Open Questions<\/strong><\/h2>\n\n\n\n

        This section is analysis. The facts above are confirmed. The items below are open.<\/p>\n\n\n\n

        Will the FTC Continue the Campaign?<\/strong><\/h3>\n\n\n\n

        The FTC sent a third round of letters on May 21, 2025, which shows the campaign continued after the change in administration. [18] Whether it sends a fourth round is not documented in the sources we reviewed.<\/p>\n\n\n\n

        Will the Teva v. Amneal Rule Stand?<\/strong><\/h3>\n\n\n\n

        The Federal Circuit denied rehearing en banc on March 3, 2025. [16] The outcome of any certiorari petition is not in the sources we reviewed. [17] Until that outcome is known, brand companies cannot rely on the narrow rule changing.<\/p>\n\n\n\n

        Key Takeaways<\/strong><\/h2>\n\n\n\n
          \n
        • Device patents were 54.0% of the Orange Book patents on the 331 products with tertiary patents in a 2026 study, and 59.8% of them did not mention the active ingredient. [2]<\/li>\n\n\n\n
        • The published paper extension is a median of 5.5 years for inhalers and 7.5 years for tertiary patents overall. [1] [2]<\/li>\n\n\n\n
        • The lower quartile for inhalers is 0.0 years. [1]<\/li>\n\n\n\n
        • A patent that claims only device components cannot be listed in the Orange Book under the December 20, 2024 Federal Circuit holding. [3]<\/li>\n\n\n\n
        • Three Sanofi SoloStar patents fell to obviousness over earlier pen designs, and the Federal Circuit affirmed on December 29, 2021. [4]<\/li>\n\n\n\n
        • ProAir HFA has a paper gap of about 8.3 years between its last formulation patent and its last device patent (analysis). [5] [6]<\/li>\n\n\n\n
        • The EpiPen settlement date and the FDA approval date of Teva’s generic were 3.2 years apart (analysis). [22] [23]<\/li>\n\n\n\n
        • The four-year figure in the headline is a scenario value, not a measured statistic.<\/li>\n<\/ul>\n\n\n\n

          FAQ<\/strong><\/h2>\n\n\n\n

          Can a Device Patent Be Listed in the Orange Book?<\/strong><\/h3>\n\n\n\n

          Only if it claims at least the active ingredient. The Federal Circuit held on December 20, 2024 that patents claiming just device components do not meet the listing requirement. [3]<\/p>\n\n\n\n

          Does a Device Patent Trigger a 30-Month Stay?<\/strong><\/h3>\n\n\n\n

          A listed device patent can. A properly delisted one cannot. The FTC describes the stay as one that “generally blocks the introduction of competing drug products for 30 months.” [7]<\/p>\n\n\n\n

          How Long Does a Device Patent Last?<\/strong><\/h3>\n\n\n\n

          Twenty years from the filing date, with possible adjustments. [8] The calendar date of expiration depends on when the application was filed, not on when the drug was approved.<\/p>\n\n\n\n

          Can My Own Earlier Product Block My Later Device Patent?<\/strong><\/h3>\n\n\n\n

          Yes. A disclosure by the inventor is excepted only if made one year or less before the effective filing date. [11] An earlier sale or publication outside that window is prior art.<\/p>\n\n\n\n

          Does a Confidential Sale Count as Prior Art?<\/strong><\/h3>\n\n\n\n

          Yes. The Supreme Court held in Helsinn that a commercial sale to a third party who must keep the invention confidential may place the invention on sale. [10]<\/p>\n\n\n\n

          What Is a Tertiary Patent?<\/strong><\/h3>\n\n\n\n

          It is a patent on a delivery device. Researchers use the term for patents listed in the Orange Book that are not primary (active ingredient) or secondary (formulation or use). [2]<\/p>\n\n\n\n

          How Many Device Patents Has the FTC Challenged?<\/strong><\/h3>\n\n\n\n

          The FTC challenged more than 100 patents in November 2023 [7], about 300 listings in April 2024 [19] and more than 200 patents in May 2025. [18] The rounds overlap, so the figures are not additive. [19]<\/p>\n\n\n\n

          Why Did the Generic EpiPen Reach Market Years After the Settlement Date?<\/strong><\/h3>\n\n\n\n

          The settlement allowed launch on June 22, 2015 subject to FDA approval. [22] FDA issued a complete response letter in February 2016 and approved the product on August 16, 2018. [23]<\/p>\n\n\n\n

          What Must a Generic Show About Its Device?<\/strong><\/h3>\n\n\n\n

          It must compare its user interface with the reference product under FDA’s draft guidance, and a difference in an external critical design attribute can require a comparative use human factors study. [24] [25]<\/p>\n\n\n\n

          How Can I Check the Patents and Challenges on a Drug-Device Product?<\/strong><\/h3>\n\n\n\n

          Use the FDA Orange Book for listing data and a tracker such as DrugPatentWatch for patents, Paragraph IV filings and litigation by drug. The DrugPatentWatch ProAir HFA record, for example, shows the NDA number, the approval date and an ANDA Paragraph IV submission date. [9] Confirm patent dates against the primary documents.<\/p>\n\n\n\n

          References<\/strong><\/h2>\n\n\n\n
            \n
          1. Patenting strategies on inhaler delivery devices. (2023). Chest, 164<\/em>(2), 450-460. https:\/\/pubmed.ncbi.nlm.nih.gov\/36842533\/<\/li>\n\n\n\n
          2. Teng, T. W., Tu, S. S., Mooney, H., Bendicksen, L., Gabriele, S. M., Wouters, O. J., & Feldman, W. B. (2026). Tertiary patents on drugs approved by the FDA. JAMA Health Forum, 7<\/em>(1), e255909. https:\/\/researchonline.lse.ac.uk\/id\/eprint\/136989<\/li>\n\n\n\n
          3. U.S. Court of Appeals for the Federal Circuit. (2024, December 20). Teva Branded Pharmaceutical Products R&D, Inc. v. Amneal Pharmaceuticals of New York, LLC<\/em> (No. 2024-1936). https:\/\/cafc.uscourts.gov\/opinions-orders\/24-1936.OPINION.12-20-2024_2439730.pdf<\/li>\n\n\n\n
          4. U.S. Court of Appeals for the Federal Circuit. (2021, December 29). Sanofi-Aventis Deutschland GmbH v. Mylan Pharmaceuticals Inc.<\/em> (Nos. 2020-1871 et al.; nonprecedential). https:\/\/www.cafc.uscourts.gov\/opinions-orders\/20-1871.OPINION.12-29-2021_1886444.pdf<\/li>\n\n\n\n
          5. GreyB. (n.d.). ProAir HFA patent expiration [Database page]. Pharsight. https:\/\/pharsight.greyb.com\/drug\/proair-hfa-patent-expiration<\/li>\n\n\n\n
          6. Teva Pharmaceutical Industries Ltd. (2014, June 20). Teva reaches settlement in ProAir HFA patent case [Press release]. https:\/\/www.tevausa.com\/news-and-media\/press-releases\/teva-reaches-settlement-in-proair-hfa-patent-case\/<\/li>\n\n\n\n
          7. Federal Trade Commission. (2023, November 7). FTC challenges more than 100 patents as improperly listed in FDA’s Orange Book [Press release]. https:\/\/www.ftc.gov\/news-events\/news\/press-releases\/2023\/11\/ftc-challenges-more-100-patents-improperly-listed-fdas-orange-book<\/li>\n\n\n\n
          8. U.S. Patent and Trademark Office. (n.d.). MPEP 2701: Patent term. https:\/\/www.uspto.gov\/web\/offices\/pac\/mpep\/s2701.html<\/li>\n\n\n\n
          9. DrugPatentWatch. (2026, November 1). PROAIR HFA [Drug record page]. https:\/\/www.drugpatentwatch.com\/p\/alphasignals\/tradename\/PROAIR+HFA<\/li>\n\n\n\n
          10. Helsinn Healthcare S.A. v. Teva Pharmaceuticals USA, Inc., 586 U.S. ___ (2019). https:\/\/www.supremecourt.gov\/opinions\/18pdf\/586us1r10_fcgk.pdf<\/li>\n\n\n\n
          11. U.S. Patent and Trademark Office. (2024). MPEP 2153.01: Prior art exception under AIA 35 U.S.C. 102(b)(1)(A) to AIA 35 U.S.C. 102(a)(1) (R-01.2024). Summarized at https:\/\/www.clfip.com\/ip\/blog\/mpep\/2153-1\/<\/li>\n\n\n\n
          12. U.S. Patent and Trademark Office. (2022). MPEP 1120: Eighteen-month publication of patent applications (R-07.2022). https:\/\/www.uspto.gov\/web\/offices\/pac\/mpep\/s1120.html<\/li>\n\n\n\n
          13. KSR International Co. v. Teleflex Inc., 550 U.S. 398 (2007). https:\/\/www.law.cornell.edu\/supct\/html\/04-1350.ZS.html<\/li>\n\n\n\n
          14. Mylan N.V. (2020, May 29). [News release on PTAB final written decisions concerning Sanofi’s Lantus SoloSTAR device patents]. https:\/\/investor.mylan.com\/node\/29246<\/li>\n\n\n\n
          15. Duane Morris LLP. (2025). Federal Circuit affirms delisting patents claiming device components of drug product without active ingredient. https:\/\/www.duanemorris.com\/alerts\/federal_circuit_affirms_delisting_patents_claiming_device_components_drug_product_without_0125.html<\/li>\n\n\n\n
          16. Haynes Boone. (2025, March 13). Teva v. Amneal: Reshaping generic drug rights. https:\/\/www.haynesboone.com\/news\/publications\/teva-v-amneal-reshaping-generic-drug-rights<\/li>\n\n\n\n
          17. Supreme Court of the United States. (2025, May 22). Application No. 24A1149: Application to extend the time to file a petition for a writ of certiorari (Teva Branded Pharmaceutical Products R&D, Inc. v. Amneal Pharmaceuticals of New York, LLC). https:\/\/www.supremecourt.gov\/DocketPDF\/24\/24A1149\/359510\/20250522170811156_ProAir%20-%20SCt%20Extension%20Request_EFILE.pdf<\/li>\n\n\n\n
          18. McDermott Will & Emery. (2025). FTC revives Orange Book listing challenges. https:\/\/www.mcdermottlaw.com\/?p=320171<\/li>\n\n\n\n
          19. Hogan Lovells. (2024). FTC disputes new slate of Orange Book patents for weight loss, diabetes, asthma and COPD drugs. https:\/\/www.hlc.com\/en\/publications\/ftc-disputes-new-slate-of-orange-book-patents-for-weight-loss-diabetes-asthma-and-copd-drugs<\/li>\n\n\n\n
          20. White & Case LLP. (2024). The current status of FTC’s Orange Book listings challenge: A mixed bag. https:\/\/www.whitecase.com\/insight-our-thinking\/current-status-ftcs-orange-book-listings-challenge-mixed-bag<\/li>\n\n\n\n
          21. Cooley LLP. (2023, November 21). Following recent policy statement, FTC disputes 100+ patent listings in FDA Orange Book. https:\/\/www.cooley.com\/news\/insight\/2023\/2023-11-21-following-recent-policy-statement-ftc-disputes-100-patent-listings-in-fda-orange-book<\/li>\n\n\n\n
          22. Pharmaceutical Processing World. (2012, April 26). Mylan and Pfizer announce epinephrine auto-injector settlement agreement with Teva. https:\/\/www.pharmaceuticalprocessingworld.com\/mylan-and-pfizer-announce-epinephrine-auto-injector-settlement-agreement-with-teva\/<\/li>\n\n\n\n
          23. Healthcare Dive. (2018, August 16). [Dive Brief on FDA approval of Teva’s generic EpiPen]. https:\/\/www.healthcaredive.com\/news\/teva-epipen-generic-mylan-fda-approval\/530301\/<\/li>\n\n\n\n
          24. U.S. Food and Drug Administration. (2017, January). Comparative analyses and related comparative use human factors studies for a drug-device combination product submitted in an ANDA: Draft guidance for industry (Docket No. FDA-2016-D-4412). https:\/\/www.fda.gov\/regulatory-information\/search-fda-guidance-documents\/comparative-analyses-and-related-comparative-use-human-factors-studies-drug-device-combination<\/li>\n\n\n\n
          25. Wood, B. (2024). Comparative use human factors studies: Challenges and recommendations [Presentation slides]. FY 2024 Generic Drug Science and Research Initiatives Public Workshop, U.S. Food and Drug Administration. https:\/\/www.fda.gov\/media\/187997\/download<\/li>\n\n\n\n
          26. Lupin Limited. (2023, August 16). Lupin launches tiotropium dry powder for inhaler for the treatment of COPD in the United States [Press release]. BioSpace. https:\/\/www.biospace.com\/lupin-launches-tiotropium-dry-powder-for-inhaler-for-the-treatment-of-copd-in-the-united-states<\/li>\n<\/ol>\n","protected":false},"excerpt":{"rendered":"

            Device patents extended market protection for brand-name asthma and COPD inhalers by a median of 5.5 years beyond the last […]<\/p>\n","protected":false},"author":1,"featured_media":40073,"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-40072","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\/40072","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=40072"}],"version-history":[{"count":1,"href":"https:\/\/www.drugpatentwatch.com\/blog\/wp-json\/wp\/v2\/posts\/40072\/revisions"}],"predecessor-version":[{"id":40074,"href":"https:\/\/www.drugpatentwatch.com\/blog\/wp-json\/wp\/v2\/posts\/40072\/revisions\/40074"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/www.drugpatentwatch.com\/blog\/wp-json\/wp\/v2\/media\/40073"}],"wp:attachment":[{"href":"https:\/\/www.drugpatentwatch.com\/blog\/wp-json\/wp\/v2\/media?parent=40072"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/www.drugpatentwatch.com\/blog\/wp-json\/wp\/v2\/categories?post=40072"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/www.drugpatentwatch.com\/blog\/wp-json\/wp\/v2\/tags?post=40072"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}