Hikma Pharmaceuticals USA, Inc. v. Amarin Pharma, Inc., 24-889
The Supreme Court granted a petition for certiorari earlier this month with implications for our IP and pharmaceutical clients. The case involves “skinny labels,” or labels for generic products that carve out a patented indication and thus are not FDA approved for that use. Hikma Pharmaceuticals USA, Inc. and Hikma Pharmaceuticals PLC (“Hikma”) have asked the Court to weigh in on the pleading standards for induced-infringement claims involving skinny labels. These claims accuse generic manufacturers of inducing physicians to prescribe a drug for the patented indication that is not on the drug’s label. If the Court overturns the Federal Circuit decision, our branded manufacturer clients would likely find it more difficult to protect their IP by bringing induced-infringement claims on a skinny label.
Hikma’s case stems from its application to the FDA to produce a generic version of a drug called Vascepa®. This application spurred two successive lawsuits. In the first, brand manufacturer Amarin Pharma, Inc., Amarin Pharmaceuticals Ireland Limited, and Mochida Pharmaceutical Co., Ltd. (“Amarin”) sued Hikma for patent infringement. The FDA initially approved Vascepa® to treat a form of heart disease called severe hypertriglyceridemia (“SH”). While litigation was ongoing for patents covering the SH indication, the FDA approved Vascepa® for a second patented indication: reducing cardiovascular risk (“CV”). Hikma then filed a statement with the FDA for its pending application that excluded the CV indication, so the “skinny label” for Hikma’s product referred only to its ability to treat SH. The court in the first lawsuit found the asserted patents infringed but invalid as obvious. Hikma then received FDA approval to launch its generic product.
When advertising these successes from the first lawsuit, Hikma published a series of press releases that became a key part of a second lawsuit. Those releases described its product as “Hikma’s generic version of Vascepa®” and “generic Vascepa®.” Hikma’s press releases also highlighted sales data for Vascepa® that accounted for all uses of Vascepa® and not just Hikma’s approved SH indication. And Hikma listed its generic product on its website as “AB-rated”—meaning therapeutically equivalent for the labeled indications—in the “Therapeutic Category: Hypertriglyceridemia,” a category broad enough to encompass both infringing and non-infringing uses.
Less than a month after Hikma launched its generic product, Amarin filed a second suit alleging induced infringement of patents covering the CV indication based on Hikma’s label and the broad statements in its press releases. The district court dismissed the case, but the Federal Circuit reversed. The Federal Circuit reasoned that Amarin’s allegations about Hikma’s label in combination with its press releases plausibly stated a claim of induced infringement.
Before granting cert, the Court invited the Solicitor General to submit a brief. The Solicitor General’s recommendation that the Court take up the case may have helped persuade the Court to do so. Notably, the Supreme Court declined to take up the issue of skinny labels in a post-trial context in May 2023, Teva Pharmaceuticals USA, Inc. v. GlaxoSmithKline LLC, 143 S. Ct. 2483 (2023).
We are keeping a close eye on this case because of its implications for our clients. If the Supreme Court affirms the Federal Circuit’s decision, our clients who manufacture branded pharmaceuticals may continue to rely on a generic drug manufacturer’s statements in press releases and on its website to bring induced infringement claims on a skinny label. Generic manufacturers in turn may pare back what they say in marketing materials to avoid induced-infringement claims. But if the Supreme Court overturns the Federal Circuit’s decision, the standard for pleading induced-infringement claims will likely rise, making it harder for our clients who make brand-name drugs to bring infringement claims against generic manufacturers based on skinny labels.