Shrinking the Scope of Skinny Label Liability
The Hatch-Waxman Act
Prescription drug costs remain a large burden for American patients, and brand-name drugs are the leading factor in that frustration.[2] While name brand prescriptions only account for about ten percent of prescriptions dispensed in the United States, they make up almost seventy-five percent of total drug spending.[3] Patent protection and regulatory exclusivity, allow brand manufacturers to set their prices without competition, and patients on name brand drugs often face higher copays until that drug’s protections expire.[4] Insurance companies compensate for these prices by charging larger premiums or reduced coverage, impacting every American with health insurance.[5]
Traditionally, generic companies had to wait until every patent covering a brand-name drug expired before entering the market.[6] The Drug Price Competition and Patent Term Restoration Act of 1984—commonly known as the Hatch-Waxman Act—created a way to relieve some of the growing pressure and costs caused by the long periods of brand-name drugs monopolizing care.[7] The Act created a statutory exemption from certain claims of patent infringement, allowing a “generic competitor to file an abbreviated new drug application (ANDA).”[8] More significantly, the Act allows generics to start the drug application process and testing before any of the brand-name patents actually expire.[9] A generic company can include a Paragraph IV certification when filing an ANDA, which is a formal claim that the generic drug either does not infringe upon the brand’s remaining patents, or those patents are invalid.[10] Filing a Paragraph IV certification is legally treated as an artificial act of patent infringement, despite not making, using, or selling the alleged drug, so the brand name company is immediately notified when a generic files one relating to their drug.[11] This allows patent disputes to resolve before a generic version is ever manufactured or sold.[12] If a patent owner is going to bring an infringement act against the ANDA applicant, it must be within forty-five days of receiving notice of the generic brands’ ANDA submission.[13] The FDA has a thirty month stay, where they must suspend approval until a court reaches a decision, or the patents on the drug expire.[14] If the generic manufacturer wins, or the patent holder fails to sue within the forty-five days, the FDA can approve the generic even while some patents technically remain effective.[15]
Skinny Labels
Alternatively, generic manufacturers can submit a section VIII statement, which asserts that they will market the drug only for uses not covered by the brand name’s patents.[16] This “skinny label” of generics carves out the patented uses.[17] These certifications do not eliminate the possibility that an approved ANDA interferes with the patented use of a drug.[18] Because a generic drug is “biologically equivalent” to its branded counterpart, medical professionals regularly prescribe a generic in place of the brand name, even for patented uses.[19] If this infringement is induced by the generic manufacturer, they can be held liable for encroaching on the brand name’s patent rights.[20] Under 35 U.S.C. § 271(b), a party may be liable for actively inducing another to infringe a patent.[21] To establish induced infringement, a patent owner must show that a third party directly infringed the patent, that the defendant know the induced conduct constituted infringement, and that the defendant took active steps to encourage that infringement.[22] In the context of skinny labels, the question is whether a generic manufacturer’s labeling or marketing actively encourages physicians to prescribe a drug for a patented use, rather than merely making such use possible.[23]
Paragraph VI and section VIII statements both exist to allow generics to compete sooner, and both are designed to walk right up to the line of patent protection without crossing it. In June, the Supreme Court clarified where that line sits for skinny labels in Hikma Pharmaceuticals USA Inc. v. Amarin Pharma, Inc.[24]
Hikma v. Amarin
In 2012, the FDA approved Amarin’s drug Vascepa for treatment of severe hypertriglyceridemia (the “SH indication”).[25] Later, the FDA also approved it for cardiovascular risk reduction in patients already taking statins (the “CV indication”), and Amarin obtained method-of-use patents covering that use.[26] Hikma, a generic manufacturer, initially filed for an ANDA in 2016 with a paragraph IV certification, which was lead to the district court invalidating that patent.[27] They later sought approval for a “skinny label” under a section viii certification, carving out the still-patented CV indication, marketing its generic drug only for Vascepa’s older, now unpatented SH indication.[28] Amarin sued, alleging that Hikma actively induced physicians to prescribe its generic for the patented CV use anyway, pointing to statements across Hikma’s label, patient leaflet, website, and press releases.[29] Ultimately the district court dismissed Amarin’s induced infringement claim for a failure to state a claim upon which relief can be granted.[30] On appeal, the Federal Circuit reversed, siding with Amarin, holding that it was “at least plausible that a physician could read” Hikma’s statements as encouragement to infringe.[31]
The Supreme Court unanimously reversed and remanded the Federal Circuit’s ruling in June of this year.[32] Writing for the Court, Justice Jackson held that induced infringement requires “active steps”—affirmative, purposeful conduct designed to bring about infringement—not simply statements that a doctor could interpret as encouragement.[33] The Court found that Hikma’s label was merely complying with the statutory “duty of sameness,” and any omissions could not establish active inducement, and the remaining statements were too vague to show plausible intent to induce infringing use.[34] The decision rejects a Federal Circuit trend to hold generic manufacturers liable for medical professionals interpreting skinny label marketing and statements as instructions to infringe.[35]
Implication for Patent Infringement
The Supreme Court did not close the door on inducement claims in skinny-label cases and confirmed that implicit encouragement does infringe on patent.[36] However, the statements made by the generic must reflect that “active steps” were taken by the defendant to encourage infringing use.[37] The Court rejected Hikma’s argument that inducement must always be expressed, explaining that implicit encouragement suffices so long as it is “clear and “affirmative,” and directed to bring about infringement rather than just have the capability to be read that way.[38] The Court clarified that references to the name-brand products, sales figures, and other routine comparative language in a generic’s marketing or labeling are not enough to cross that line on their own.[39] The Court’s decision draws a shaper distinction between ordinary commercial communications and purposeful, infringement-directed messaging.[40] By reaffirming that inducement requires affirmative conduct aimed at encouraging infringement—not just statements a physician might infer as encouraging infringement—the decision represents a win for generic manufacturers.[41]
References
[1] Photo by Roberto Sorin, A Pile of Pills Sitting Next to Each Other on Top of a Table, Unsplash (Sep. 13, 2021), https://unsplash.com/photos/a-pile-of-pills-sitting-next-to-each-other-on-top-of-a-table-RS0-h_pyByk.
[2] See Ravi Gupta, Nilay D. Shah, PhD, & Joseph S. Ross, MD, MHS, Generic Drugs in the United States: Policies to Address Pricing and Competition, 105 Clin. Pharmacology & Therapeutics 329, 330 (2019), https://pmc.ncbi.nlm.nih.gov/articles/PMC6355356/pdf/nihms-998327.pdf.
[3] See id. at 329.
[4] See id.
[5] See Charles Phelps & Guriprasad Madhavan, Patents and Drug Insurance: Clash of the Titans?, 10 Sci. Translational Med. 1 (Nov. 14, 2018), https://www.science.org/doi/epdf/10.1126/scitranslmed.aat6902.
[6] See The Hatch-Waxman Act: A Primer, Congressional Rsch. Serv. 4 (Sep. 28, 2016), https://www.congress.gov/crs-product/R44643#fn49.
[7] See id.
[8] See 21 U.S.C §§355(j)(2)(A)(ii), (iv) (2018).
[9] See id.
[10] See 21 U.S.C §§355(j)(2)(A)(vii)(IV).
[11] See 35 U.S.C. §271(e)(2).
[12] See Paragraph IV Certification, PatentBrief, https://patentbrief.org/paragraph-iv-certification (last visited Oct. 17, 2026).
[13] See 21 U.S.C. § 355(j)(5)(B)(iii).
[14] See 21 U.S.C. § 355(j)(2)(A)(vii)(IV); see also Christina D. Brown-Marshall & Dexter Whitley, Hatch-Waxman 101, Fish & Richardson (Apr. 15, 2024), https://www.fr.com/insights/thought-leadership/blogs/hatch-waxman-101-3/.
[15] See 21 U.S.C. § 355(j)(5)(B)(iii).
[16] See 21 U.S.C. § 355(j)(2)(A)(viii).
[17] See “Skinny Labels” for Generic Drugs Under Hatch-Waxman, Congressional Rsch. Serv. (July 27, 2026), https://www.congress.gov/crs-product/IF12700.
[18] See Hikma Pharmaceuticals USA Inc. v. Amarin Pharma, Inc., 608 U.S. 580, 586 (2026).
[19] See id.
[20] See 35 U.S.C. §271(b).
[21] See id.
[22] See Hikma Pharmaceuticals USA Inc., 608 U.S. at 581.
[23] See id.
[24] 608 U.S. 580 (2026).
[25] See Hikma Pharmaceuticals USA Inc., 608 U.S. at 587.
[26] See id.
[27] See id.
[31] See id.
[32] See id. at 595.
[33] See id. at 590.
[35] See Hikma Pharmaceuticals USA Inc., 608 U.S. at 590 n. 3
[36] See Hikma v. Amarin: What the Supreme Court’s Decision Means for Pleading Induced Infringement, Cooley LLP (June 17, 2026), https://www.cooley.com/news/insight/2026/2026-06-17-hikma-v-amarin-what-the-supreme-courts-decision-means-for-pleading-induced-infringement.
[37] See id.
[38] See id.
[39] See Shashank Upadhye, Practical Tips After U.S. Supreme Court’s Hikma v. Amarin Case, Legal500 (July 1, 2026), https://www.legal500.com/intelligence/united-states/intellectual-property/practical-tips-after-us-supreme-courts-hikma-v-amarin-case.
[40] See id.
[41] See id.
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