The U.S. Supreme Court will decide what constitutes “induced infringement” where the generic manufacturer makes statements outside approved labeling that carves out a patented use.
Earlier this year, the Supreme Court agreed to hear the case of Hikma Pharmaceuticals USA Inc. v. Amarin Pharma Inc., which will address the pleading standards in the context of so-called “skinny labels,” where the generic manufacturer submits a Section viii statement under the Hatch-Waxman Act (21 U.S.C. § 355(j)(2)(A)(viii)), proposing a label omitting any indications or uses that are still subject to the innovator’s patents. If the generic manufacturer’s Abbreviated New Drug Application (ANDA) is approved, it may launch a generic version of a brand-name drug before all patents covering the use of that drug have expired and despite the existence of certain patented uses.
In induced‑infringement cases, courts typically focus whether the generic label has adequately excluded the patented use and, more often, whether the generic manufacturer’s advertising or promotional materials nonetheless encourage use of the product for that omitted, patented indication despite the skinny label. The Supreme Court will decide whether, where the drug label fully carves out a patented use, an innovator may plead induced infringement by pointing to statements that the drug is a “generic version” of the branded drug and citing the sales figures for the branded drug, absent any instructions or statements by the generic manufacturer encouraging the patented use.
Background: How the Vascepa® Skinny-Label Dispute Reached the Supreme Court
Amarin’s drug Vascepa® (icosapent ethyl) is approved for two indications: for treating severe hypertriglyceridemia (“SH”) and to reduce cardiovascular risk in certain patients. Hikma received FDA approval to market a generic version of the drug for the CV indication alone and marketed its product as “a generic version of Vascepa” and cited overall Vascepa® sales — most of which, more than 75%, came from the patented cardiovascular use.
Although Hikma later clarified that its generic drug was approved only for the SH indication and added related disclaimers on its website, Amarin sued Hikma for inducing patent infringement. The complaint was originally dismissed, but in June 2024, the Federal Circuit revived Amarin’s lawsuit, finding Amarin had plausibly alleged Hikma encouraged doctors to prescribe its generic version of Vascepa® for patented cardiovascular uses. The Federal Circuit described the case as a “run of the mill induced infringement case” under 35 U.S.C. § 271(b).
Federal Circuit’s Analysis: Why the Court Revived Amarin’s Induced Infringement Claims
Writing for the panel, Judge Alan Lourie emphasized what the dispute did not involve: it was not a typical ANDA case where infringement is assessed before a generic drug reaches the market, nor a case where the label alone was alleged to induce infringement. Instead, the appellate court held that Amarin sufficiently alleged two key elements:
- Direct infringement — that health care providers were prescribing Hikma’s product for patented CV uses; and
- Intent to induce — that Hikma’s statements and materials encouraged that infringing use.
Although Hikma’s label expressly limited its product to the SH indication, the court noted Amarin plausibly alleged physicians would understand aspects of the label and Hikma’s promotional statements as supporting the CV use.
Key Issues Before the Supreme Court: What Hikma and Amarin Want the Justices to Decide
In its petition for certiorari, which the Court has now granted, Hikma argues that the Federal Circuit’s decision threatens the skinny label pathway by exposing generic manufacturers to infringement claims based on routine marketing statements or basic factual descriptions of their products.
Hikma contends the ruling conflicts with existing precedent, creates a split among courts on how inducement claims should be evaluated at the pleading stage, and undermines the balance Congress intended under the Hatch-Waxman Act. In particular, Hikma claims the Federal Circuit’s ruling allows inducement claims against a defendant for marketing a product even though the product “undisputedly lacks any instruction to perform the patented use.”
Amarin takes the opposite view, arguing the case is still at an early stage and that the Federal Circuit correctly allowed the claims to proceed. According to Amarin, Hikma is effectively seeking a form of qualified immunity for generic drug manufacturers that has no basis in statute or case law.
Implications for the Pharmaceutical Industry: What Generic and Brand Drugmakers Should Expect
As the industry awaits the Supreme Court’s decision, both brand name and generic drug companies may want to take another look at how they communicate about their products.
Generic manufacturers may want to review their press releases, product descriptions and website statements for language that may trigger liability, particularly in cases in which their drugs have both patented and unpatented uses. For example, calling a product “equivalent” to the brand name drug with patented uses or referring to sales data that mostly reflects those patented uses could be viewed as encouraging doctors to prescribe the drug for those protected indications.
Likewise, brand manufacturers should also be vigilant and may want to keep records of marketing materials, public statements and online content from generic competitors, since these could help support future induced infringement claims.
Ultimately, the Supreme Court’s ruling may have significant effects on when and how the marketing of generic drugs constitutes inducing patent infringement. With oral argument approaching, the entire pharmaceutical sector will be watching closely.
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If you need assistance with these or related matters, please reach out to attorney Richard J. Basile at (203) 653-5412 and rbasile@harrisbeachmurtha.com; attorney James R. Muldoon at (315) 214-2021 and jmuldoon@harrisbeachmurtha.com; attorney Marina Plotkin at (212) 313-5409 and mplotkin@harrisbeachmurtha.com; attorney Laura Smalley at (585) 419-8736 and lsmalley@harrisbeachmurtha.com; attorney Jesse C. Wang at (212) 912-3570 and jcwang@harrisbeachmurtha.com; or the Harris Beach Murtha attorney with whom you most frequently work.
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