News & Insights

Supreme Court Approves Generic Drug Company’s “Skinny Labeling” Strategy, Limiting Enforcement of Important Brand Patent Rights

June 15, 2026

By: Deirdre E. Sanders and Brian T. Moriarty

• Ruling limits Brands’ ability to enforce second generation innovative methods of treatment patents, but article describes ways to address the problem

Case Highlights

In Hikma Pharmaceuticals USA Inc. v. Amarin Pharma, Inc., its first patent case since 2023, the Supreme Court unanimously held that a brand pharmaceutical manufacturer failed to establish that a generic drug company’s strategy of “skinny labeling” was tantamount to inducement of patent infringement. The decision could make it more difficult for a brand drug company to enforce patent rights covering a new second generation use of a drug against a generic’s product marketing that is ostensibly for only old uses.

A preferred strategy for generic drug companies seeking to market a generic version of a brand’s product that has multiple approved uses is to “skinny label” the product. This simply means the generic drug package insert, or label, only lists approved FDA indications that are not covered by the brand’s patents. The label is said to be “skinny” because it omits a label indication covered by the patent. For example, say a drug is originally approved for treatment of high blood pressure. Later, after conducting expensive research and clinical trials, the brand obtains FDA approval for a new indication, the treatment of hair loss. With the passage of time, patents on the original use expire, but the patents on the new use remain viable. The generic seeking to market its generic version of the drug would skinny label a version of the product to only list the unpatented blood pressure indication on its label and cut out the patented hair loss indication. If healthcare providers prescribe the generic drug for the still patented use, the generic would claim that it was not responsible for such infringing use because it did not encourage such use.

Over the past two decades, when the generics “skinny labeled,” the brands often sued for infringement of the new use patent, typically arguing that the label was not “skinny” enough. Brands have argued, for example, that when the generic stated on its skinny label that its drug was therapeutically and bioequivalent to the brand’s drug (i.e., AB rated) and, perhaps, included in its label clinical trial information about the patented use, it was inducing patent infringement of the patented uses. The brand would claim that, although the generic’s label carved out the patented indication, the generic knew that the health care providers would often use the generic version of the drug for the patented use, and thus, the generic’s skinny label would still lead to patent infringement. The result was that sales of the skinny-labeled generic drug would capture markets for both the patented and non-patented uses, preventing the brand from enjoying market exclusivity for its new use and recouping its substantial costs to create innovative and useful new drugs for the public.

Following the skinny label strategy, a generic, Hikma Pharmaceuticals, filed an Abbreviated New Drug Application (ANDA) for Vascepa®, a brand drug of Amarin Pharma, Inc., for a non‑patented severe hypertriglyceridemia (high triglyceride levels) (SH) indication, while carving out a patented cardiovascular (CV) indication. The FDA approved Hikma’s ANDA with the skinny label.  The owner of a New Drug Application (NDA), Amarin Pharma, Inc., brought suit, alleging that the generic’s label, patient information leaflets, website, and press releases constituted active inducement because it implicitly encouraged health care providers and pharmacists to provide the generic drug for the patented CV indication.

Agreeing with the generic that there was no inducement of infringement, the Supreme Court holds that “the central question is whether Amarin plausibly alleged that Hikma actively encouraged infringing uses, not merely whether doctors could plausibly read the alleged statements as instructions to infringe.” In other words, it was not sufficient to establish patent infringement by showing that doctors may use the skinny labeled product for patented and not patented uses, or that it includes label information required to be included by FDA. Instead, the Court ruled that the brand must establish that the generic actively induced others to use the skinny labeled product for patented uses (e.g., advertising its product as acceptable for patented uses excluded from its label).

The Supreme Court rejected the brand’s arguments, holding that the mere possibility -- perhaps even likelihood -- of infringing uses of the generic drug for patented label indications was not enough to establish that the generics “actively induced” infringement. The Court stated that active inducement may, for example, include running an advertisement, but including FDA-mandated information that “might” lead a doctor to wish to use the drug for an approved use not included on the “skinny label” was not sufficient to state a claim for inducement of patent infringement. For example, the Court found that Hikma’s website’s descriptions, including an indication that the drug is “AB” rated (that is, equivalent to the brand drug) do not plausibly constitute statements designed “to stimulate others to commit” infringement, especially where the website clarified that the generic drug is indicated for fewer than all approved indications of Vascepa.

A close reading of the opinion shows that the court has now granted the generics somewhat broader rights than what many observers may have expected. While a generic cannot run advertisements encouraging unlabeled, patented uses, it can tell consumers that its product is “AB” rated and considered equivalent to the brand’s drug, and it can also include in its label information about clinical studies showing the use of the drug for the unlabeled use.  The Court also stated that it is acceptable if the generic provides figures attributable to sales for both unpatented and patented uses.

The Supreme Court’s discussion may unintentionally help generics garner more sales from patented off label uses. More significantly, the decision may cause brands to be less eager to invest funds in developing new uses for already approved products, robbing the public of an important health benefit. The Supreme Court’s ruling raises concerns that there are now less incentives for brands to discover new uses for existing drugs because this decision weakens patent protection for drugs with more than one approved use. A brand may be wary of conducting expensive clinical trials on new uses if the court effectively allows the brand’s patent protection for new uses to be weakened through a skinny labeling strategy.

Drug makers should consider filing a new NDA for a significant new use of the old drug and not including the new use as part of the old drug’s label. This will give the brand a longer period of patent exclusivity for its new indication and thwart the generics’ ability to employ the skinny label strategy. This strategy of seeking multiple NDAs for closely related drug products may increase the cost for a brand to continue to develop needed improvements on existing drugs, but it will allow the brand protect exclusivity markets for its newly- developed indication.

Further, brands should consider additional means of furthering exclusivity by strategic patent prosecution, such as by claiming different treatment regimens or patient populations, as well as methods of drug manufacture. Brands may choose to emphasize their new clinical data that give rise to the new indications that were not in existence when the original product was approved, thus providing new information that distinguishes the original use from the new use.