{"id":40078,"date":"2026-11-12T09:23:00","date_gmt":"2026-11-12T14:23:00","guid":{"rendered":"https:\/\/www.drugpatentwatch.com\/blog\/?p=40078"},"modified":"2026-11-02T07:52:58","modified_gmt":"2026-11-02T12:52:58","slug":"method-of-use-patents-only-work-if-nobody-reads-the-label-carefully","status":"publish","type":"post","link":"https:\/\/www.drugpatentwatch.com\/blog\/method-of-use-patents-only-work-if-nobody-reads-the-label-carefully\/","title":{"rendered":"Method-of-Use Patents Only Work If Nobody Reads the Label Carefully"},"content":{"rendered":"\n
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In March 2020, Hikma issued a press release that cited Vascepa sales of about $919 million for the 12 months to February 2020. The Federal Circuit later noted that the cardiovascular indication made up more than 75 percent of Vascepa sales [2]. Hikma then launched an AB-rated generic icosapent ethyl product with a label that did not list that indication. On June 4, 2026, the Supreme Court held 9-0 that Amarin did not state a valid claim that Hikma induced doctors to use the product for the cardiovascular indication [1].<\/p>\n\n\n\n

That outcome shows how a method-of-use patent really works. The patent covers a way to use a drug. The Orange Book and the FDA label describe that use in words. Every reader of those words can try to avoid the patent: the FDA reviewer, the generic regulatory team, the pharmacist, the prescriber and the judge. The patent holds only when those readers do not separate the patented use from the unpatented uses. This article explains where that happens, where it does not, and what the 2026 decision changes.<\/p>\n\n\n\n

The Short Answer: Does a Method-of-Use Patent Still Block a Skinny-Label Generic?<\/strong><\/h2>\n\n\n\n

It can, but only in narrow cases. A method-of-use patent no longer blocks a skinny-label generic just because the generic is sold, rated AB, or called a “generic version” of the brand. After Hikma v. Amarin, a brand must show that the generic maker took affirmative steps that encouraged the patented use [1][3].<\/p>\n\n\n\n

    \n
  • A generic label that copies the brand label except for the carved-out use is required by statute [3].<\/li>\n\n\n\n
  • Calling a product a “generic equivalent” is “normal industry practice” and does not by itself show inducement [1].<\/li>\n\n\n\n
  • A label or a marketing statement that tells prescribers to use the product for the patented use can still create liability [1][10].<\/li>\n\n\n\n
  • The ruling decided a pleading question. It did not decide how courts will treat these facts at trial [4].<\/li>\n<\/ul>\n\n\n\n

    The Five Findings That Matter<\/strong><\/h2>\n\n\n\n

    Each finding below can be quoted alone. Findings that rely on our own arithmetic are marked “calculated.”<\/p>\n\n\n\n

      \n
    1. The Supreme Court decided Hikma v. Amarin on June 4, 2026, by a unanimous vote, with Justice Jackson writing the opinion. It reversed the Federal Circuit’s 2024 ruling [1].<\/li>\n\n\n\n
    2. More than 75 percent of Vascepa sales came from the cardiovascular indication that Hikma carved out. On the $919 million of 12-month sales that Hikma cited, that is at least $689 million of sales tied to the carved-out use (calculated from [2]).<\/li>\n\n\n\n
    3. In GSK v. Teva, a jury awarded GSK about $235 million [12]. Teva had about $74 million in sales in the relevant period, so the judgment was about 3.2 times those sales (calculated from [7]).<\/li>\n\n\n\n
    4. Estimates of how often a first generic carves out a patented use range from “nearly half” of eligible drugs [7] to 43 percent in one 2021 to 2023 sample of 21 brand drugs [6].<\/li>\n\n\n\n
    5. Only 21 of 290 first-time generic approvals, or 7.2 percent, were in that 21-drug sample (calculated from [6]). One drug moves the yearly rate by 11 to 20 percentage points. A single-year skinny-label rate from that sample is a weak basis for a forecast.<\/li>\n<\/ol>\n\n\n\n

      What Is a Method-of-Use Patent, and What Does the Label Have to Do With It?<\/strong><\/h2>\n\n\n\n

      A method-of-use patent claims a way to use a drug, such as a way to treat a disease in a defined group of patients. It does not claim the molecule. The FDA approves a drug for specific uses, and the label lists them. A patent claim and a label sentence can describe the same use in different words [3].<\/p>\n\n\n\n

      Definitions Used in This Article<\/strong><\/h3>\n\n\n\n
        \n
      • Method-of-use patent: a patent that claims a way to use a drug, not the compound itself [3].<\/li>\n\n\n\n
      • Use code: a short description in the Orange Book that links a listed method-of-use patent to an approved use [3].<\/li>\n\n\n\n
      • Section viii statement: a generic applicant’s statement that a listed method-of-use patent “does not claim a proposed indication or other condition of use” [9].<\/li>\n\n\n\n
      • Skinny label: a generic label that omits (“carves out”) the patented uses and keeps the unpatented uses [3].<\/li>\n\n\n\n
      • Induced infringement: liability under 35 U.S.C. 271(b) for a party that actively encourages another party to infringe. The three elements are direct infringement, active steps to encourage it, and knowledge of the patent and of the infringing acts [3].<\/li>\n\n\n\n
      • AB rating: an FDA therapeutic equivalence rating. Hikma’s product carried it [1][2].<\/li>\n<\/ul>\n\n\n\n

        How Does a Section viii Carve-Out Work?<\/strong><\/h3>\n\n\n\n

        A generic applicant files an ANDA and, for each listed patent, either certifies that the patent is invalid or not infringed (Paragraph IV) or files a section viii statement for a method-of-use patent. The statement says the patent does not claim the use for which the applicant seeks approval. The applicant then removes that use from its proposed label [3][9].<\/p>\n\n\n\n

        FDA rules require the generic label to match the brand label, with limited exceptions [9]. The Supreme Court noted that this sameness rule is why Hikma’s label kept some brand information, such as clinical study text, even though the cardiovascular indication was removed [1].<\/p>\n\n\n\n

        What Happens If the Carve-Out Makes the Product Less Safe?<\/strong><\/h4>\n\n\n\n

        FDA may approve a carve-out only if the omission does not make the generic less safe or effective than the brand for the remaining uses [10]. The D.C. Circuit applied that test to the Entresto generic from MSN. It deferred to FDA’s scientific judgment and said “the carve-out lives on at FDA” [16].<\/p>\n\n\n\n

        What Does FDA Check, and What Does It Leave to the Courts?<\/strong><\/h3>\n\n\n\n

        FDA does not decide whether a patent is infringed. In Caraco v. Novo Nordisk (April 17, 2012), the Supreme Court described FDA’s role in patent listing as “ministerial.” FDA takes use codes as given and will not approve a label that overlaps a use code [8]. The Court held that a generic maker may file a counterclaim to correct a use code that describes the patent too broadly [8].<\/p>\n\n\n\n

        Why the Caraco Prandin Case Still Matters<\/strong><\/h4>\n\n\n\n

        Novo’s repaglinide (Prandin) compound patent expired in 2009. A method-of-use patent ran to 2018. Novo described its use code first as “Use of repaglinide in combination with metformin to lower blood glucose” and later as “A method for improving glycemic control in adults with type 2 diabetes” [8]. The wider code blocked more of the label. The Court allowed the generic to challenge it [8]. This is a label-reading problem at the Orange Book level: the words in the use code decide how much of the label a generic can keep.<\/p>\n\n\n\n

        Methodology: What We Reviewed and How<\/strong><\/h2>\n\n\n\n

        This section lets a reader reproduce the analysis.<\/p>\n\n\n\n

          \n
        • Records reviewed: eight court decisions from 2003 to 2026, one law-review article and one congressional statement that report prevalence data, the FDA regulation on ANDA content, and law-firm, agency and press summaries of the decisions. We read the Federal Circuit opinion in Amarin v. Hikma and the Supreme Court opinion in Hikma v. Amarin. For the other decisions, we relied on the summaries cited in the table.<\/li>\n\n\n\n
        • Selection rule: we included decisions that address induced infringement from a carved-out or partly carved-out label, or that decide who controls the wording of a use code.<\/li>\n\n\n\n
        • Prevalence data: we did not run our own query of FDA approvals. We report the figures of published studies as they appear in the cited sources, and we label them as such.<\/li>\n\n\n\n
        • Calculations: all arithmetic uses figures printed in the cited sources. Day counts use the calendar dates in the opinions. Percentages are rounded to one decimal place.<\/li>\n\n\n\n
        • Limits: patent numbers appear only where a primary opinion lists them. Some decisions reach us through secondary summaries, so we do not quote their words. The Supreme Court decided a pleading question, so any statement about trial outcomes is analysis, not a holding.<\/li>\n<\/ul>\n\n\n\n

          Patent Timeline: Eight Decisions on Label-Based Inducement, 2003 to 2026<\/strong><\/h2>\n\n\n\n

          The table lists the decisions in date order. The “What decided it” column is our summary of the cited source.<\/p>\n\n\n\n

          Decision<\/th>Date<\/th>Drug<\/th>Result<\/th>What decided it<\/th>Source<\/th><\/tr><\/thead>
          Warner-Lambert v. Apotex (Fed. Cir.)<\/td>2003<\/td>Neurontin (gabapentin)<\/td>No inducement<\/td>The generic label omitted the patented use. Knowing that doctors might prescribe off label was not enough [14].<\/td>[14]<\/td><\/tr>
          AstraZeneca v. Apotex (Fed. Cir.)<\/td>2010<\/td>Not identified in our sources<\/td>Inducement affirmed<\/td>FDA-required dosing text stayed in the label after the carve-out [6][7].<\/td>[6][7]<\/td><\/tr>
          Caraco v. Novo Nordisk (U.S.)<\/td>Apr. 17, 2012<\/td>Prandin (repaglinide)<\/td>Generic may counterclaim to correct a use code<\/td>The use code described the patent too broadly [8].<\/td>[8]<\/td><\/tr>
          GSK v. Teva (Fed. Cir.)<\/td>Aug. 5, 2021<\/td>Coreg (carvedilol)<\/td>Jury verdict of about $235 million reinstated<\/td>The label, catalogs and press releases supported inducement [3][10][11].<\/td>[3][10][11][12]<\/td><\/tr>
          H. Lundbeck v. Lupin (Fed. Cir.)<\/td>Dec. 7, 2023<\/td>Trintellix (vortioxetine)<\/td>No inducement<\/td>The carved-out labels did “not encourage, recommend, or promote an infringing use” [15].<\/td>[15]<\/td><\/tr>
          Amarin v. Hikma (Fed. Cir.)<\/td>June 25, 2024<\/td>Vascepa (icosapent ethyl)<\/td>Complaint revived<\/td>Label, press releases and website read together plausibly pleaded inducement [2].<\/td>[2]<\/td><\/tr>
          Novartis v. Kennedy (D.C. Cir.)<\/td>2025<\/td>Entresto (sacubitril\/valsartan)<\/td>FDA approval of carved-out generic upheld<\/td>Court deferred to FDA’s finding that the carve-out did not make the generic less safe or effective [16].<\/td>[6][16]<\/td><\/tr>
          Hikma v. Amarin (U.S.)<\/td>June 4, 2026<\/td>Vascepa (icosapent ethyl)<\/td>Complaint dismissed; 9-0<\/td>The statements were not affirmative steps to encourage the patented use [1].<\/td>[1]<\/td><\/tr><\/tbody><\/table><\/figure>\n\n\n\n

          GSK v. Teva: What Happens When the Label Is Not Skinny Enough<\/strong><\/h2>\n\n\n\n

          GSK v. Teva is the case that made brands willing to sue skinny-label generics. It concerned Coreg (carvedilol), which was approved for hypertension, post-myocardial-infarction left ventricular dysfunction and congestive heart failure (CHF) [11]. GSK held a method-of-use patent that claimed a method of decreasing mortality caused by CHF [11].<\/p>\n\n\n\n

          What Were the Facts in GSK v. Teva?<\/strong><\/h3>\n\n\n\n

          Teva launched a generic carvedilol in 2007 for two of the three Coreg indications [12]. GSK sued in 2014, after Teva added the CHF indication to its label at FDA’s instruction [12]. A jury awarded GSK $235 million [12]. The district court overturned the verdict. The Federal Circuit reinstated it on August 5, 2021, and the Supreme Court denied review in May 2023 [3][12]. The parties later filed a joint stipulation that resolved the dispute, with no financial terms disclosed [12].<\/p>\n\n\n\n

          Which Label and Marketing Evidence Mattered?<\/strong><\/h4>\n\n\n\n

          The Federal Circuit said the label was “evidence of inducement to infringe” [10]. It also pointed to Teva’s catalogs, which called the product the “AB rated generic equivalent of GlaxoSmithKline’s Coreg tablets,” and to press releases [10]. One June 2004 press release said the product was “indicated for treatment of heart failure and hypertension” [11].<\/p>\n\n\n\n

          The court did not rule that every skinny label is a risk. It said generics “could not be held liable for merely marketing and selling under a ‘skinny’ label omitting all patented indications” [11]. The facts in GSK were not a clean carve-out, because Teva’s label, at least in part, contained the patented use [11].<\/p>\n\n\n\n

          How Large Was the GSK Judgment Compared With Teva’s Sales?<\/strong><\/h3>\n\n\n\n

          One law-review article reports a judgment of $234 million against Teva, which had about $74 million in sales during the relevant period [7]. Using those two figures, the judgment was about 3.2 times the sales (calculated from [7]). A generic maker that faces damages of that scale cannot treat a carve-out as a routine filing. A Berkeley panel summary quotes a lawyer who warned that lost-profits damages “can dwarf your actual profits by orders of magnitude” [5].<\/p>\n\n\n\n

          Amarin v. Hikma: How Vascepa Reached the Supreme Court<\/strong><\/h2>\n\n\n\n

          What Was the Vascepa Label Timeline?<\/strong><\/h3>\n\n\n\n

          FDA approved Vascepa in 2012 for severe hypertriglyceridemia (SH), defined as triglycerides of at least 500 mg\/dL. The label then carried a “CV Limitation of Use” [2]. In 2019, FDA approved the cardiovascular (CV) indication for patients with triglycerides of at least 150 mg\/dL, and Amarin removed the limitation [2]. Hikma had filed its ANDA in 2016 with a Paragraph IV certification. After the CV approval, it chose to file a section viii statement for the CV indication instead of changing its label to match [2]. FDA approved the ANDA and its SH-only label on May 21, 2020 [2]. Hikma launched in November 2020, and Amarin sued less than a month later [2].<\/p>\n\n\n\n

          The asserted patents were U.S. Patent 9,700,537 and U.S. Patent 10,568,861. Both claim methods that relate to the CV indication [2]. Amarin’s earlier patents on the SH indication had been held invalid as obvious after a bench trial [2].<\/p>\n\n\n\n

          Why Did the Omitted Limitation of Use Matter?<\/strong><\/h4>\n\n\n\n

          Hikma’s original proposed label had included the CV Limitation of Use. Hikma later removed it, around the time it filed the section viii statement [2]. Amarin treated that removal as part of its inducement theory. The Supreme Court held that omitting the limitation was not an affirmative act [1]. A brand should note the point: a missing warning is a gap in the label, and the Court did not treat a gap as encouragement.<\/p>\n\n\n\n

          Which Hikma Statements Did Amarin Cite?<\/strong><\/h3>\n\n\n\n

          Amarin did not allege that the skinny label alone induced infringement. The parties accepted that point [1]. Amarin pointed to the label read together with other statements. The table lists them with the way each court treated them.<\/p>\n\n\n\n

          Statement<\/th>Date<\/th>Federal Circuit (2024)<\/th>Supreme Court (2026)<\/th><\/tr><\/thead>
          Press release calling the product the “generic version” of Vascepa, saying Vascepa was indicated “in part” for SH, and citing about $919 million of 12-month sales [2]<\/td>Mar. 2020<\/td>Part of the totality that plausibly pleaded inducement [2]<\/td>Calling a product a “generic equivalent” is “normal industry practice” [1]. Sales figures were aimed at investors and were too vague [4]<\/td><\/tr>
          Press release calling the product “the generic equivalent to Vascepa” [2]<\/td>May 2020<\/td>Same [2]<\/td>Same [1]<\/td><\/tr>
          Press release citing about $1.1 billion of 12-month sales and “generic Vascepa” [2]<\/td>Sept. 3, 2020<\/td>Court noted that the sales figures covered all uses and that the CV use was more than 75 percent of sales [2]<\/td>Too vague or attenuated [1][4]<\/td><\/tr>
          Launch press release saying the product is indicated only for SH and “not approved for any other indication” [2]<\/td>Nov. 2020<\/td>Noted in the record [2]<\/td>Not addressed in the summaries we reviewed<\/td><\/tr>
          Website listing the “Hypertriglyceridemia” category and an “AB” rating, with a disclaimer about fewer indications [2]<\/td>2020<\/td>Part of the totality [2]<\/td>A broad category and an AB rating did not stimulate infringement [4]<\/td><\/tr>
          Label that omitted the CV Limitation of Use and kept statin-study text [1][2]<\/td>May 2020<\/td>Read with the other statements [2]<\/td>Omission is not an affirmative step. Retained study text follows from the sameness rule [1][4]<\/td><\/tr><\/tbody><\/table><\/figure>\n\n\n\n

          What Did the Federal Circuit Say on June 25, 2024?<\/strong><\/h4>\n\n\n\n

          Chief Judge Moore, Judge Lourie and Judge Albright (sitting by designation) reversed the district court’s dismissal. They held that the totality of the allegations plausibly pleaded active inducement and that how physicians would read the materials was a fact question [2]. The court limited its holding to the pleadings. It said “clarity and consistency” in a generic maker’s communications may be essential to avoid inducement liability [2].<\/p>\n\n\n\n

          What Did the Supreme Court Say on June 4, 2026?<\/strong><\/h4>\n\n\n\n

          The Court rejected the Federal Circuit’s focus on how doctors might read a statement. The test is whether Amarin plausibly alleged that Hikma “actively encouraged infringing uses” [1]. The Court gave four reasons:<\/p>\n\n\n\n

            \n
          • Inducement needs affirmative steps. Ordinary acts of distribution are not enough [1].<\/li>\n\n\n\n
          • Several statements had an “obvious alternative explanation,” which was compliance with law or industry practice [1].<\/li>\n\n\n\n
          • Omissions cannot support liability. Leaving out the CV Limitation of Use was not an affirmative act [1].<\/li>\n\n\n\n
          • Inducement can be implicit, but it must be clear to its audience and affirmative [1].<\/li>\n<\/ul>\n\n\n\n

            The Court granted review on January 16, 2026 [13]. Hikma asked it to decide whether “generic version” language and public sales data can plead inducement when the label fully carves out the patented use. It also asked whether a complaint can state a claim when the defendant made no statement that encourages or mentions the use [13].<\/p>\n\n\n\n

            How Long Did the Hikma v. Amarin Dispute Take?<\/strong><\/h3>\n\n\n\n

            The table gives intervals calculated from dates in the cited sources.<\/p>\n\n\n\n

            Interval<\/th>Start<\/th>End<\/th>Length (calculated)<\/th><\/tr><\/thead>
            ANDA approval to Supreme Court decision<\/td>May 21, 2020 [2]<\/td>June 4, 2026 [1]<\/td>2,205 days (about 6.0 years)<\/td><\/tr>
            Launch to Supreme Court decision<\/td>Nov. 2020 [2]<\/td>June 4, 2026 [1]<\/td>67 months<\/td><\/tr>
            Federal Circuit decision to grant of review<\/td>June 25, 2024 [2]<\/td>Jan. 16, 2026 [13]<\/td>570 days<\/td><\/tr>
            Grant of review to decision<\/td>Jan. 16, 2026 [13]<\/td>June 4, 2026 [1]<\/td>139 days<\/td><\/tr>
            Argument to decision<\/td>Apr. 29, 2026 [1]<\/td>June 4, 2026 [1]<\/td>36 days<\/td><\/tr><\/tbody><\/table><\/figure>\n\n\n\n

            The Supreme Court decided a complaint, not a trial record. After 67 months, Amarin had not reached a merits ruling on whether Hikma induced anyone to infringe. The case returns to the lower courts [1].<\/p>\n\n\n\n

            What Does Hikma v. Amarin Change for Method-of-Use Patents?<\/strong><\/h2>\n\n\n\n

            What Did the Court Decide About Active Inducement?<\/strong><\/h3>\n\n\n\n

            It decided that a plaintiff must plead statements or acts that actively encourage the patented use. It also decided that a court should look at the statements themselves, not only at how a doctor could read them [1][4]. The Court did not require express encouragement. A statement can be implicit and still count [5]. A lawyer quoted in the Berkeley summary described the needed evidence as “a wink and a nudge” [5].<\/p>\n\n\n\n

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

            Our reading of the summaries is that four questions remain. We mark these as analysis.<\/p>\n\n\n\n

              \n
            • How courts will apply the test to explicit statements, such as a sales pitch that names the patented use (analysis).<\/li>\n\n\n\n
            • Whether any omission can ever support inducement (analysis).<\/li>\n\n\n\n
            • How courts will treat retained label text that the sameness rule does not require (analysis).<\/li>\n\n\n\n
            • How the test applies at summary judgment and trial, because the Court decided a pleading question [4].<\/li>\n<\/ul>\n\n\n\n

              Is a Carve-Out Now Safe From Inducement Claims?<\/strong><\/h3>\n\n\n\n

              No. A carve-out is safer, but it is not a safe harbor. The Court rejected blanket immunity. A panel summary notes that blanket immunity would reduce a brand’s incentive to develop new patented uses [5]. The Congressional Research Service states that the protections in the pending Skinny Labels, Big Savings Act are broader and more categorical than the holding [3].<\/p>\n\n\n\n

              Who Actually Reads the Label? An Original Five-Reader Model<\/strong><\/h2>\n\n\n\n

              This section is an original framework, not an industry standard. It asks which reader sees which words, and what that reader can do about a patented use. The model is our analysis. The facts inside it come from the cited sources.<\/p>\n\n\n\n

              Reader One: The FDA Reviewer<\/strong><\/h3>\n\n\n\n

              FDA compares the proposed generic label with the brand label and the Orange Book use code. It will not approve a label that overlaps the use code [8]. FDA does not decide infringement. According to House testimony from a Covington partner, FDA acknowledges that it lacks the statutory authority and expertise to check labels for inducement risk, and that courts are the proper forum for those disputes [6]. The FDA reviewer reads the label carefully, but only for regulatory purposes.<\/p>\n\n\n\n

              Reader Two: The Generic Regulatory Team<\/strong><\/h3>\n\n\n\n

              This reader chooses the carve-out. It must remove the patented use, keep the label otherwise identical to the brand label, and make sure the product is not less safe or effective [9][10]. In Lundbeck v. Lupin, the Federal Circuit found no inducement where the labels were limited to major depressive disorder and carved out the patented uses [15]. In GSK v. Teva, a label that contained the patented use led to a verdict [11]. This reader is the one who must read the label most carefully.<\/p>\n\n\n\n

              Reader Three: The Pharmacist<\/strong><\/h3>\n\n\n\n

              Hikma’s product carried an AB rating [1][2]. Under state substitution laws, a pharmacist can dispense an AB-rated generic in place of the brand. The Berkeley panel noted that brands may seek changes to state laws, such as narrowing automatic-substitution laws to on-label indications [5]. That suggestion tells us that substitution today does not depend on the indication (analysis). If the pharmacist does not read the indication, a skinny label has limited effect on which product the patient receives.<\/p>\n\n\n\n

              Reader Four: The Prescriber<\/strong><\/h3>\n\n\n\n

              Prescribers often do not read labels in detail. A survey cited in the Stanford Law Review found that about 25 percent of primary care physicians did not read past the contents section of a label. The article also quotes a former FDA commissioner who said that fewer than 1 percent of physicians had seen a label in the prior year [7]. The article also reports that about one in five prescriptions is for an off-label use [7]. In Warner-Lambert, evidence suggested that 80 to 90 percent of gabapentin prescriptions were off label, and the court still found no inducement from a label that did not mention the patented use [7][14].<\/p>\n\n\n\n

              Why This Reader Matters for the Title Claim<\/strong><\/h4>\n\n\n\n

              If prescribers do not read labels closely, a carved-out label may not change prescribing. That helps a brand commercially, because patients still receive a generic for the carved-out use. It does not help the brand legally. The law asks what the generic maker did, not what the prescriber knew [1].<\/p>\n\n\n\n

              Reader Five: The Court<\/strong><\/h3>\n\n\n\n

              Courts read labels with great care. The Federal Circuit has read some labels “in their entirety” and has held that a label must encourage, recommend or promote infringement [7]. The Stanford article describes a trend that it calls “infringement by label,” in which courts treat label text like patent claim text [7]. In GSK v. Teva, that approach favored the brand. The 2026 decision moves the focus to the generic maker’s statements [1][7].<\/p>\n\n\n\n

              When Does a Method-of-Use Patent Still Hold? A Label-Dependence Taxonomy<\/strong><\/h2>\n\n\n\n

              This is also an original classification. We sort the documented outcomes by what the label and communications did. A patent can move between classes as facts change.<\/p>\n\n\n\n

              Class A: The Carve-Out Cannot Be Made Cleanly<\/strong><\/h3>\n\n\n\n

              Some label text cannot be removed without a safety or effectiveness cost, or it is required for other reasons. In AstraZeneca v. Apotex, FDA-required downward-titration language stayed in the label after the carve-out and supported inducement [7]. In Sanofi v. Watson, a label reference to a clinical study that listed the patented risk factors supported inducement [7]. In both cases, the label itself carried part of the patented method.<\/p>\n\n\n\n

              Why Is Required Dosing Text Hard to Remove?<\/strong><\/h4>\n\n\n\n

              The sameness rule requires the generic label to match the brand label except for differences that FDA allows [3][9]. Text that FDA requires for safe use is therefore text that the generic maker must keep. If that text also teaches the patented method, the generic maker cannot remove it without a safety justification (analysis). This is one remaining ground for a brand, and it depends on facts that vary by drug.<\/p>\n\n\n\n

              Class B: The Carve-Out Is Made, but the Label Keeps Related Text<\/strong><\/h3>\n\n\n\n

              Hikma’s label kept statin-study information and a warning for patients with heart disease. The Supreme Court held that this was not enough, because the law requires the generic label to match the brand label apart from the carved-out use [1][3]. In our analysis, this is the class that the 2026 decision weakened most.<\/p>\n\n\n\n

              Class C: The Label Is Clean, but Communications Point to the Patented Use<\/strong><\/h3>\n\n\n\n

              GSK v. Teva shows this class through its marketing evidence. The catalogs and press releases linked the product to the patented use [10][11]. After Hikma, a statement of this kind must be clear and affirmative. A vague reference to the brand’s sales is not enough [1][4].<\/p>\n\n\n\n

              What Kind of Statement Is Still Risky?<\/strong><\/h4>\n\n\n\n

              The Berkeley summary lists the risky conduct as telling prescribers to use the generic for every use the brand has. It lists the protected conduct as copying the brand label, calling a product a generic equivalent, using an AB rating, echoing the Orange Book, and issuing ordinary investor press releases about brand sales [5].<\/p>\n\n\n\n

              Class D: The Carve-Out Is Clean and the Communications Are Clean<\/strong><\/h3>\n\n\n\n

              Lundbeck v. Lupin and Warner-Lambert v. Apotex fit here [14][15]. The Entresto case shows the same result through the regulatory route. The D.C. Circuit rejected Novartis’s attempt to block an FDA-approved carve-out [16]. A method-of-use patent has little practical effect against a generic in this class.<\/p>\n\n\n\n

              Class<\/th>What the generic did<\/th>Documented example<\/th>Likely effect on the patent (analysis)<\/th><\/tr><\/thead>
              A: Carve-out not clean<\/td>Kept required label text that teaches the method<\/td>AstraZeneca v. Apotex; Sanofi v. Watson [7]<\/td>Patent can hold<\/td><\/tr>
              B: Related text kept<\/td>Kept sameness-required text<\/td>Hikma v. Amarin [1]<\/td>Patent is weak after 2026<\/td><\/tr>
              C: Communications point to use<\/td>Marketed or described the patented use<\/td>GSK v. Teva [10][11]<\/td>Patent can hold if the statement is clear and affirmative<\/td><\/tr>
              D: Both clean<\/td>Carved out and said nothing about the use<\/td>Lundbeck v. Lupin; Warner-Lambert [14][15]<\/td>Patent does not block the generic<\/td><\/tr><\/tbody><\/table><\/figure>\n\n\n\n

              How Common Are Skinny Labels? What the Prevalence Studies Show<\/strong><\/h2>\n\n\n\n
              \n

              For drugs with both patented and unpatented uses, the first generic tries to carve out a patented use “nearly half the time,” according to a 2021 JAMA Internal Medicine study cited in the Stanford Law Review [7].<\/p>\n<\/blockquote>\n\n\n\n

              The published figures differ by method and sample. The table puts them side by side.<\/p>\n\n\n\n

              Estimate<\/th>Figure<\/th>Sample or basis<\/th>Source<\/th><\/tr><\/thead>
              JAMA Internal Medicine (2021), as cited by Sherkow and Gugliuzza<\/td>“Nearly half”<\/td>Drugs with both patented and unpatented uses; first generic tries a carve-out<\/td>[7]<\/td><\/tr>
              Panelist estimate at Berkeley event<\/td>“Maybe even 40%”<\/td>Generic approvals; presented as an estimate, not a verified count<\/td>[5]<\/td><\/tr>
              Ziaks et al. (2025)<\/td>9 of 21 brand drugs (43%)<\/td>2021 to 2023; 5 of 9 in 2021, 3 of 7 in 2022, 1 of 5 in 2023<\/td>[6]<\/td><\/tr>
              Egilman et al. (2022)<\/td>66.7% of approved biosimilars<\/td>Biosimilars with skinny labeling<\/td>[6]<\/td><\/tr><\/tbody><\/table><\/figure>\n\n\n\n

              Why Is the 2023 Skinny-Label Rate Misleading?<\/strong><\/h3>\n\n\n\n

              Critics cite the Ziaks figures as a fall from 56 percent in 2021 to 43 percent in 2022 and 20 percent in 2023 [6]. The testimony of a Covington partner objects to that reading. It says the study dropped 269 of 290 first-time generic approvals and kept one entry per brand drug [6]. We calculated what that means.<\/p>\n\n\n\n

                \n
              • The study kept 21 of 290 approvals, or 7.2 percent (calculated from [6]).<\/li>\n\n\n\n
              • One drug changes the 2021 rate by 11.1 points, the 2022 rate by 14.3 points and the 2023 rate by 20 points (calculated from the sample sizes of 9, 7 and 5 in [6]).<\/li>\n\n\n\n
              • The testimony says the study did not disclose its drug list [6].<\/li>\n\n\n\n
              • A one-year change from 43 to 20 percent equals a difference of two drugs in a sample of five to seven drugs (calculated from [6]).<\/li>\n<\/ul>\n\n\n\n

                These points do not prove that skinny-label use is stable. They show that the sample is too small to support a trend claim in either direction. The testimony comes from a lawyer whom PhRMA recommended to the committee, so a reader should weigh it as advocacy [6].<\/p>\n\n\n\n

                Scenario Analysis: How Much Revenue Depends on the Patented Use?<\/strong><\/h2>\n\n\n\n

                Revenue concentration decides how much a carve-out matters. If the patented use is a small part of brand sales, a clean carve-out costs the brand little. If it is most of the sales, a generic with an AB rating can reach much of the brand’s market without the patented indication on its label.<\/p>\n\n\n\n

                Vascepa is the documented case. Hikma’s March 2020 press release cited sales of about $919 million for the 12 months to February 2020, and the court said the CV indication made up more than 75 percent of sales [2]. Applying 75 percent to $919 million gives at least $689 million of sales tied to the carved-out use (calculated). The 75 percent figure is the court’s description of Vascepa sales in general, so applying it to that specific 12-month figure is our assumption.<\/p>\n\n\n\n

                Scenario<\/th>Share of sales from patented use<\/th>Sales tied to patented use at $919 million (calculated)<\/th>Analysis: what the brand must show after Hikma<\/th><\/tr><\/thead>
                Hypothetical low<\/td>25%<\/td>About $230 million<\/td>Affirmative steps that encourage the patented use. The unpatented uses leave the generic a large lawful market.<\/td><\/tr>
                Hypothetical middle<\/td>50%<\/td>About $460 million<\/td>The same proof. The generic still has a large lawful market.<\/td><\/tr>
                Vascepa documented floor<\/td>More than 75%<\/td>At least $689 million<\/td>The same proof. The lawful market is small, and the pleaded statements were held insufficient [1][2].<\/td><\/tr><\/tbody><\/table><\/figure>\n\n\n\n

                The legal test does not change with the share. The commercial exposure does. A brand with a high share has the most to lose from a clean carve-out and, after June 4, 2026, the least legal leverage against one. That is our analysis, not a holding.<\/p>\n\n\n\n

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

                Should Brands Still File Method-of-Use Patents?<\/strong><\/h3>\n\n\n\n

                Yes, but they should value them differently. A House statement from a Covington partner reports that about half of small molecules (52 percent) and biologics (47 percent) approved from 2000 to 2023 received at least one post-approval expansion [6]. Estimates of the cost of a Phase 3 trial for a new use range from $31.3 million to $214.4 million [6]. A method-of-use patent protects that spending only if it can be enforced. The 2026 decision lowers the chance that it can be enforced against a clean carve-out.<\/p>\n\n\n\n

                How Should a Brand Draft Use Codes?<\/strong><\/h3>\n\n\n\n

                A use code should match what the patent claims. Novo’s use code in the Prandin case described the patent more broadly than the claims, and the Supreme Court let the generic maker correct it [8]. A broad use code can block a label that the patent does not reach. It can also draw a counterclaim.<\/p>\n\n\n\n

                What Should a Brand Plead After Hikma?<\/strong><\/h3>\n\n\n\n

                Our reading of the summaries is that a complaint needs two things. It needs specific statements by the generic maker that encourage the patented use, with an explanation of why those statements are not just compliance with law or industry practice. It also cannot rely on investor-facing sales data or an AB rating alone [1][4]. A brand that cannot point to such statements has little basis for a claim.<\/p>\n\n\n\n

                What Evidence Should a Brand Keep?<\/strong><\/h4>\n\n\n\n

                Keep dated copies of generic labels, sales scripts, catalogs, websites and press releases. In GSK v. Teva, catalogs and press releases supported the verdict [10]. In Hikma, press releases and a website were the core of the pleading, and the Supreme Court found them insufficient [1][2].<\/p>\n\n\n\n

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

                How Should a Generic Maker Keep Communications Clean?<\/strong><\/h3>\n\n\n\n

                Hikma’s launch press release said the product was indicated only for SH and “not approved for any other indication” [2]. The Federal Circuit said that “clarity and consistency” in a generic maker’s communications may be essential [2]. The Supreme Court did not require that standard, but a clear statement of the approved use reduces the chance of a dispute.<\/p>\n\n\n\n

                Which Practices Does the Berkeley Summary Call Protected?<\/strong><\/h4>\n\n\n\n

                It lists five: copying the brand label, calling the product a generic equivalent, using an AB rating, echoing the Orange Book, and issuing ordinary investor press releases about brand sales. It lists one risky practice: telling prescribers to use the generic for every use the brand has [5].<\/p>\n\n\n\n

                What Does a Failed Carve-Out Cost?<\/strong><\/h3>\n\n\n\n

                The GSK judgment was about 3.2 times Teva’s sales in the relevant period (calculated from [7]). A generic maker should therefore review retained label text, such as required dosing language and study references. Those items supported inducement in AstraZeneca v. Apotex and Sanofi v. Watson [7].<\/p>\n\n\n\n

                What This Means for Biosimilar Developers<\/strong><\/h2>\n\n\n\n

                The Hikma case involved a small-molecule generic. The sources we reviewed do not apply the holding to biosimilars. The Congressional Research Service reports that the proposed Skinny Labels, Big Savings Act would cover generic and biosimilar makers [3]. The House testimony cites a study that found 66.7 percent of approved biosimilars had skinny labeling [6]. The same testimony argues that this shows biosimilar makers have been able to carry out carve-outs [6]. A biosimilar team should read the Hikma reasoning on affirmative steps, but it should not assume a court will apply it to a biologic without argument (analysis).<\/p>\n\n\n\n

                Will Congress Change the Rules? The Skinny Labels, Big Savings Act<\/strong><\/h2>\n\n\n\n

                The bill (S. 43 and H.R. 6485 in the 119th Congress) was introduced before the Supreme Court ruled [3]. It would create a statutory safe harbor. Marketing a product with its FDA-approved labeling, or describing it as “therapeutically equivalent” to the brand, would not count as infringement [3]. The House testimony says the bill would apply retroactively under section 2(b) and would extend to biosimilars [6]. The Berkeley summary says a House Judiciary hearing discussed it on the day of the decision [5].<\/p>\n\n\n\n

                Congress can change the inducement standard by amending 35 U.S.C. 271 [3]. The sources we reviewed do not report a vote on the bill after June 4, 2026. A reader who needs the current status should check congress.gov.<\/p>\n\n\n\n

                Where DrugPatentWatch Fits in a Use-Code Review<\/strong><\/h2>\n\n\n\n

                DrugPatentWatch is a pharmaceutical patent database that tracks Orange Book patents, use codes and litigation. It publishes a technical guide to use codes that covers skinny labeling, Caraco, GSK v. Teva and Amarin v. Hikma [17]. A team can use the platform to pull the listed patents for a drug. The platform does not replace the FDA label, the Orange Book entry or the court record, so each finding still needs a check against those primary documents.<\/p>\n\n\n\n

                A Five-Step Label-Read Check<\/strong><\/h3>\n\n\n\n

                This is a workflow, not a legal opinion.<\/p>\n\n\n\n

                  \n
                1. List the Orange Book patents and use codes for the brand drug.<\/li>\n\n\n\n
                2. Read each use code against the claims of its patent. Flag a code that is broader than the claims [8].<\/li>\n\n\n\n
                3. Read the brand label and mark the sentences that teach each patented use, including dosing text, study references and warnings [7].<\/li>\n\n\n\n
                4. Estimate the share of brand sales tied to each patented use, as in the scenario table.<\/li>\n\n\n\n
                5. Check the court record for suits against carved-out generics and read the generic’s statements, not only its label [1][2].<\/li>\n<\/ol>\n\n\n\n

                  Key Takeaways<\/strong><\/h2>\n\n\n\n
                    \n
                  • The Supreme Court held 9-0 on June 4, 2026 that Amarin did not plausibly allege that Hikma induced infringement of its cardiovascular method-of-use patents [1].<\/li>\n\n\n\n
                  • The test looks at whether the generic maker actively encouraged the patented use. It does not ask only how a doctor could read the statement [1][4].<\/li>\n\n\n\n
                  • Calling a product a “generic equivalent,” using an AB rating and citing brand sales to investors did not meet the test on the facts pleaded [1][4].<\/li>\n\n\n\n
                  • Vascepa’s cardiovascular use made up more than 75 percent of sales, which is at least $689 million of the $919 million that Hikma cited (calculated from [2]).<\/li>\n\n\n\n
                  • The GSK v. Teva verdict of about $235 million was about 3.2 times Teva’s sales in the period (calculated from [7][12]).<\/li>\n\n\n\n
                  • Estimates of carve-out frequency range from about 40 percent to nearly half, and one three-year trend estimate rests on 21 drugs (calculated from [5][6][7]).<\/li>\n\n\n\n
                  • The decision addressed a complaint. Courts have not yet applied it to a full trial record [4].<\/li>\n\n\n\n
                  • A brand that wants its method-of-use patent to hold must plan for clean carve-outs and must keep evidence of specific, affirmative statements.<\/li>\n<\/ul>\n\n\n\n

                    FAQ: Method-of-Use Patents, Skinny Labels and Inducement<\/strong><\/h2>\n\n\n\n

                    Does an AB rating prove that a generic maker induced infringement?<\/strong><\/h3>\n\n\n\n

                    No. The Supreme Court treated an AB rating and a broad therapeutic category on a website as insufficient on the facts pleaded in Hikma [4]. An AB rating shows therapeutic equivalence. It does not by itself encourage a specific use.<\/p>\n\n\n\n

                    Can a generic company call its product a “generic version” of the brand?<\/strong><\/h3>\n\n\n\n

                    Yes. The Court described “generic equivalent” language as “normal industry practice” [1]. The Federal Circuit had said that clarity and consistency in communications may be essential, so a generic maker should still state the approved use plainly [2].<\/p>\n\n\n\n

                    Who decides whether a use code is correct?<\/strong><\/h3>\n\n\n\n

                    FDA does not verify use codes. The Supreme Court described its role as “ministerial” in Caraco v. Novo Nordisk, and it allowed generic makers to counterclaim to correct a use code that describes a patent too broadly [8].<\/p>\n\n\n\n

                    How much did GSK win from Teva, and did it keep the money?<\/strong><\/h3>\n\n\n\n

                    A jury awarded about $235 million. The Federal Circuit reinstated the verdict after the district court overturned it, and the Supreme Court denied review in May 2023. The parties later filed a stipulation that resolved the dispute, with no financial terms disclosed [12].<\/p>\n\n\n\n

                    Why can FDA refuse a carve-out?<\/strong><\/h3>\n\n\n\n

                    FDA may approve a carve-out only if the omitted use does not make the generic less safe or effective than the brand for the remaining uses [10]. In the Entresto case, the D.C. Circuit deferred to FDA’s finding that the carve-out met that test [16].<\/p>\n\n\n\n

                    Does knowing that doctors prescribe off label make a generic maker liable?<\/strong><\/h3>\n\n\n\n

                    Not by itself. In Warner-Lambert v. Apotex, the Federal Circuit said that knowledge of possible infringement by others is not inducement and that filing an ANDA for an approved, off-patent use is not inducement [14]. The Stanford Law Review article reports that 80 to 90 percent of gabapentin prescriptions were off label in that case [7].<\/p>\n\n\n\n

                    What must a brand allege after Hikma v. Amarin?<\/strong><\/h3>\n\n\n\n

                    It must allege clear, affirmative statements or acts by the generic maker that encourage the patented use, and the allegations must make an innocent explanation less plausible [1][4]. Investor-facing or ambiguous content is unlikely to be enough alone [4].<\/p>\n\n\n\n

                    How often do first generics use skinny labels?<\/strong><\/h3>\n\n\n\n

                    Published estimates range from about 40 percent to nearly half for eligible drugs, depending on method [5][7]. One 2021 to 2023 sample of 21 drugs found 43 percent, with the year-to-year rate driven by very small samples (calculated from [6]).<\/p>\n\n\n\n

                    Does the Hikma decision apply to biosimilars?<\/strong><\/h3>\n\n\n\n

                    The sources we reviewed do not say. The case involved a small-molecule generic. The pending bill would extend a safe harbor to biosimilar makers, and one study reports that 66.7 percent of approved biosimilars had skinny labeling [3][6].<\/p>\n\n\n\n

                    Is the Skinny Labels, Big Savings Act law?<\/strong><\/h3>\n\n\n\n

                    The sources we reviewed do not report that it has passed. It was introduced before the decision, and Congress would need to amend 35 U.S.C. 271 to change the inducement standard by statute [3].<\/p>\n\n\n\n

                    References<\/strong><\/h2>\n\n\n\n
                      \n
                    1. Hikma Pharmaceuticals USA Inc. v. Amarin Pharma, Inc., No. 24-889 (U.S. June 4, 2026). Legal Information Institute, Cornell Law School. https:\/\/www.law.cornell.edu\/supremecourt\/text\/24-889<\/li>\n\n\n\n
                    2. Amarin Pharma, Inc. v. Hikma Pharmaceuticals USA Inc., 104 F.4th 1370 (Fed. Cir. 2024) (No. 2023-1169). U.S. Court of Appeals for the Federal Circuit. https:\/\/www.cafc.uscourts.gov\/opinions-orders\/23-1169.OPINION.6-25-2024_2339226.pdf<\/li>\n\n\n\n
                    3. Congressional Research Service. (2026, July 27). Supreme Court limits patent infringement liability for “skinny label” generic drugs (Legal Sidebar LSB11462). https:\/\/www.everycrsreport.com\/reports\/LSB11462.html<\/li>\n\n\n\n
                    4. WilmerHale. (2026, June 10). Supreme Court clarifies pleading standard for induced infringement in Hikma v. Amarin. https:\/\/www.wilmerhale.com\/en\/insights\/client-alerts\/20260610-supreme-court-clarifies-pleading-standard-for-induced-infringement-in-hikma-v-amarin<\/li>\n\n\n\n
                    5. Berkeley Center for Law & Technology. (2026). Skinny labels, big stakes: The Supreme Court resets generic-drug competition. UC Berkeley School of Law. https:\/\/www.law.berkeley.edu\/research\/bclt\/bclt-legal-analysis\/skinny-labels-big-stakes\/<\/li>\n\n\n\n
                    6. Carver, K. H. (2026, June 4). Statement before the U.S. House Committee on the Judiciary, Subcommittee on Courts, Intellectual Property, Artificial Intelligence, and the Internet, “Medicines and IP: Balancing Innovation and Access.” https:\/\/docs.house.gov\/meetings\/JU\/JU03\/20260604\/119346\/HHRG-119-JU03-Wstate-HesslerCarverK-20260604.pdf<\/li>\n\n\n\n
                    7. Sherkow, J. S., & Gugliuzza, P. R. (2026). Infringement by drug label. Stanford Law Review, 78, 131. https:\/\/review.law.stanford.edu\/wp-content\/uploads\/sites\/3\/2026\/01\/Sherkow-Gugliuzza-78-Stan.-L.-Rev.-131.pdf<\/li>\n\n\n\n
                    8. Caraco Pharmaceutical Laboratories, Ltd. v. Novo Nordisk A\/S, No. 10-844 (U.S. Apr. 17, 2012). Legal Information Institute, Cornell Law School. https:\/\/www.law.cornell.edu\/supremecourt\/text\/10-844<\/li>\n\n\n\n
                    9. Abbreviated new drug applications, 21 C.F.R. \u00a7 314.94. Legal Information Institute, Cornell Law School. https:\/\/www.law.cornell.edu\/cfr\/text\/21\/314.94<\/li>\n\n\n\n
                    10. Hogan Lovells. (2023). SCOTUS won’t hear Teva v. GSK: Where does that leave us on FDA labeling carve-outs? https:\/\/www.hlc.com\/en\/publications\/scotus-wont-hear-teva-v-gsk-where-does-that-leave-us-on-fda-labeling-carve-outs<\/li>\n\n\n\n
                    11. Carver, K. H., Kennedy, M., & Derzko, N. (2024, July 25). Call off Chicken Little: The sky is not falling for skinny labeling after GSK v. Teva. IPWatchdog. https:\/\/ipwatchdog.com\/2024\/07\/25\/call-off-chicken-little-sky-not-falling-skinny-labeling-gsk-v-teva\/<\/li>\n\n\n\n
                    12. Fierce Pharma. (n.d.). GSK, Teva quietly settle Coreg “skinny label” dispute after long legal back-and-forth. https:\/\/www.fiercepharma.com\/pharma\/gsk-teva-quietly-settle-coreg-skinny-label-dispute-after-more-decade-legal-back-and-forth<\/li>\n\n\n\n
                    13. Duane Morris LLP. (2026, January 20). U.S. Supreme Court grants certiorari in Hikma v. Amarin, placing “skinny label” inducement in focus. https:\/\/www.duanemorris.com\/alerts\/us_supreme_court_grants_certiorari_hikma_amarin_placing_skinny_label_inducement_focus_0126.html<\/li>\n\n\n\n
                    14. WilmerHale. (2003, March 13). Patents on new drugs and inducing infringement. https:\/\/www.wilmerhale.com\/en\/insights\/publications\/patents-on-new-drugs-and-inducing-infringement-march-13-2003<\/li>\n\n\n\n
                    15. Noonan, K. E. (2023, December 18). H. Lundbeck A\/S v. Lupin Ltd. (Fed. Cir. 2023). Patent Docs. https:\/\/patentdocs.org\/2023\/12\/18\/h-lundbeck-as-v-lupin-ltd-fed-cir-2023\/<\/li>\n\n\n\n
                    16. FDA Law Blog. (2025, October 6). Carve away: D.C. Circuit keeping the “chubby label” carve-out alive. https:\/\/www.thefdalawblog.com\/2025\/10\/carve-away-d-c-circuit-keeping-the-chubby-label-carve-out-alive\/<\/li>\n\n\n\n
                    17. DrugPatentWatch. (n.d.). Pharmaceutical patent use codes: The definitive technical and strategic guide to Orange Book method-of-use patents, skinny labeling, and induced infringement risk. https:\/\/www.drugpatentwatch.com\/blog\/patent-use-codes-for-pharmaceutical-products-a-comprehensive-analysis\/<\/li>\n<\/ol>\n","protected":false},"excerpt":{"rendered":"

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