The Supreme Court heard oral arguments yesterday in Hikma Pharmaceuticals USA v. Amarin Pharma, Inc., a case with broad implications for the generic industry’s practice of “skinny labeling” and the induced infringement standard for patent law and beyond. IPWatchdog reached out to members of the IP community for their initial takeaways from yesterday’s arguments.
The U.S. Supreme Court heard oral arguments today in Hikma v. Amarin, a closely-watched case that in part asks the Justices to weigh in on whether a drugmaker calling its product a “generic version” while citing public sales information about the branded drug induces infringement of a patented use fully carved out by the generic’s label. Hikma’s petition also asks whether a complaint states an induced infringement claim if it fails to allege any instruction or statement by the defendant mentioning the patented use. While some Justices today questioned why the case was even before them, others seemed concerned about the potential impact of the case for the generic pharmaceutical industry.
Pharmaceutical patent litigators are no strangers to the delicate dance between the Hatch-Waxman Act and 35 U.S.C. § 271(b). On one side of this statutory tightrope lies the Hatch-Waxman Act’s Section VIII pathway, which was designed to expedite affordable generic competition by allowing manufacturers to seek Food and Drug Administration (FDA) approval solely for unpatented indications—the proverbial “skinny label.” On the flip side lies Section 271(b), which imposes strict liability on anyone who “actively induces” patent infringement.
The U.S. Supreme Court today denied certiorari in EscapeX IP, LLC v. Google LLC, letting stand a precedential decision of the U.S. Court of Appeals for the Federal Circuit (CAFC) affirming a district court’s award of more than $250,000 in attorneys’ fees to Google and finding that EscapeX had pursued a “frivolous” patent infringement lawsuit against Google and its attorneys had acted recklessly in prolonging the litigation.
Seven retired federal judges have filed an amicus brief supporting U.S. Court of Appeals for the Federal Circuit (CAFC) Judge Pauline Newman’s Supreme Court petition seeking review of her case against CAFC Chief Judge Kimberly Moore for what she has dubbed Moore’s “unlawful” removal of Newman from her duties on the court. The judges’ amicus brief argues that “permitting misconduct of the sort alleged here to proceed unchecked and unexamined by the federal courts poses a grave threat to the independence of all federal judges, particularly the 50% of judges who are 68 or older.”
The U.S. Supreme Court today denied a petition for certiorari challenging the U.S. Court of Appeals for the Federal Circuit’s (CAFC’s) use of Rule 36 summary affirmances in appeals from the Patent Trial and Appeal Board (PTAB). CPC Patent Technologies petitioned the Court in March of this year asking the Justices to consider the question: “Whether the Federal Circuit can affirm a PTAB decision without opinion in contravention of the clear statutory requirement of an ‘opinion’ when reviewing such decisions.”
The U.S. Supreme Court on Monday denied a petition for a writ of certiorari filed by Rebecca Curtin, leaving in place a decision by the U.S. Court of Appeals for the Federal Circuit (CAFC) that barred her from opposing the trademark registration for “RAPUNZEL” for dolls and toy figures. The Court declined to review the CAFC’s holding that a consumer lacks the statutory entitlement to oppose a trademark registration under 15 U.S.C. § 1063 because such consumer interests fall outside the commercial zone of interests protected by the Lanham Act.
The Supreme Court’s decision to hear Hikma Pharmaceuticals USA Inc. v. Amarin Pharma, Inc. is puzzling—and revealing. On its face, the case presents a narrow question: whether a generic drug manufacturer can be held liable for inducing patent infringement based on how it markets a product approved under a so-called “skinny label.” The dispute turns on whether Hikma’s conduct plausibly encouraged physicians to prescribe its generic drug for a patented use. But the Court’s decision to grant certiorari reflects something broader: a continued focus on lowering drug prices through faster generic entry, even at the risk of undermining the patent incentives that make pharmaceutical innovation possible.
The U.S. Supreme Court today granted certiorari to a petition brought by internet service provider (ISP) Grande Communications Networks LLC, appealing from a U.S. Court of Appeals for the Fifth Circuit decision that upheld a jury verdict holding Grande Communications liable for contributory infringement against a group of major U.S. record labels. The Supreme Court granted certiorari and then vacated the judgment and remanded the case to the Fifth Circuit for reconsideration under the Court’s recent opinion in Cox Communications, Inc. v. Sony Music Entertainment.
The U.S. government filed its brief in opposition yesterday to Janssen Pharmaceuticals and Bristol Myers Squibb Company’s (BMS) petition for writ of certiorari challenging the government’s Medicare Drug Price Negotiation Program. A split U.S. Court of Appeals for the Third Circuit decision in September 2025 affirmed a grant of summary judgment to the government that the imposition of the Program via the Inflation Reduction Act (IRA) does not violate the companies’ constitutional rights.
The U.S. Supreme Court on Wednesday reversed a decision by the U.S. Court of Appeals for the Fourth Circuit, ruling that internet service provider Cox Communications, Inc., is not contributorily liable for its subscribers’ copyright infringement. In a 7-2 decision authored by Justice Thomas, the Court held that a service provider is contributorily liable for a user’s infringement only when it intended for its service to be used in that way, which is established only if the provider either encouraged the infringement or designed the service specifically to facilitate it.
The U.S. Supreme Court on Monday granted the Solicitor General’s motion for leave to participate in oral argument as amicus curiae and for divided argument in Hikma Pharmaceuticals USA Inc. v. Amarin Pharma, Inc., a case concerning induced patent infringement in the pharmaceutical skinny label context. The order followed the filing of a merits response brief by Amarin on March 20, defending the U.S. Court of Appeals for the Federal Circuit (CAFC) decision that found Amarin plausibly alleged that Hikma Pharmaceuticals actively induced infringement of patents covering uses of Amarin’s cardiovascular drug Vascepa.
Today, the U.S. Supreme Court issued an order list denying a petition for writ of certiorari filed by inventor Noah Healy to challenge rulings upholding a patent examiner’s subject matter eligibility rejection under 35 U.S.C. § 101 at the U.S. Patent and Trademark Office (USPTO). Healy’s pro se petition challenged the U.S. Court of Appeals for the Federal Circuit’s decision to affirm the examiner’s rejection as violating the meaningful review requirements of the Administrative Procedures Act (APA) due to conflicting statutory theories on patentability that were never sufficiently explained by the agency.
The latest chapter in the long-running saga of inventor Gil Hyatt is beginning to unfold. The current fight is over prosecution laches—and whether the doctrine even exists. In his last appeal to the Federal Circuit, Hyatt argued that prosecution laches is not available in Section 145 proceedings because it is inconsistent with the Patent Act of 1952, as confirmed by recent U.S. Supreme Court rulings in Petrella v. Metro-Goldwyn-Mayer (2014) and SCA Hygiene Products Aktiebolag v. First Quality Baby Products (2017). Whether Hyatt is correct about prosecution laches being inconsistent with the 1952 Patent Act, it is clear that the Supreme Court has unequivocally ruled in both Petrella and SCA that laches simply does not exist when there is a statutorily prescribed timeframe to act.
In 2008, a medical device company I represented, Datascope Corporation, won a hard-fought victory at the U.S. Court of Appeals for the Federal Circuit. That court reversed a verdict of patent infringement rendered by a federal jury in Baltimore in a suit brought by Johns Hopkins University and its licensee against my client. Johns Hopkins Univ. v. Datascope Corp., 543 F.3d 1342 (Fed. Cir. 2008).