IP Law Daily, PATENT NEWS: Hikma petitions High Court to review Federal Circuit’s expansion of inducement liability in skinny-label dispute with Amarin, (Feb 19, 2025)

By Saurabh Kashyap, B.A., LL.B., LL.M.

Federal Circuit’s ruling expands induced infringement liability despite Hikma’s compliance with Hatch-Waxman Act’s section viii carve-out, the petition asserts.

Hikma Pharmaceuticals USA Inc. and Hikma Pharmaceuticals PLC (Hikma) have filed a petition for a writ of certiorari with the U.S. Supreme Court, seeking review of a Federal Circuit decision that reinstated Amarin Pharma, Inc.'s (Amarin) induced infringement claims against it. Hikma argues that the ruling undermines the Hatch-Waxman Act's Section viii carve-out provision by allowing inducement claims even when a generic manufacturer has entirely removed the patented use from its FDA-approved label. The petition presents questions regarding the scope of 35 U.S.C. § 271(b) and whether a manufacturer can be held liable based solely on references to a branded drug's market and generic substitution practices (Hikma Pharmaceuticals USA Inc. v. Amarin Pharma, Inc., No. 24-889 (U.S. filed Feb. 15, 2025)).

Background. The petitioner, Hikma Pharmaceuticals, is a multinational pharmaceutical company engaged in the development, manufacturing, and marketing of both generic and branded medications. It is a key player in the generic drug industry, supplying lower-cost alternatives to brand-name pharmaceuticals.

The respondent, Amarin Pharma, is a biopharmaceutical company headquartered in the United States and specializes in cardiovascular therapies. It is the manufacturer of Vascepa®, a prescription drug containing icosapent ethyl, which was initially approved for treating severe hypertriglyceridemia. Amarin later obtained additional patents covering Vascepa's use for reducing cardiovascular risk in patients with elevated triglyceride levels.

The dispute arose when Hikma obtained FDA approval for a generic version of Vascepa® through an Abbreviated New Drug Application (ANDA), carving out Amarin’s patented cardiovascular indication via the Hatch-Waxman Act’s Section viii provision. Hikma’s generic label excluded all references to the patented cardiovascular risk reduction indication, limiting its approval to non-patented uses.

Despite this, Amarin filed a lawsuit in 2020, alleging that Hikma induced infringement of its patents under 35 U.S.C. § 271(b). Amarin claimed that Hikma’s marketing materials, public statements, and references to Vascepa’s commercial market encouraged off-label prescribing for the patented cardiovascular indication. The district court dismissed Amarin’s claims, ruling that Hikma had not engaged in active inducement because its FDA-approved labeling did not instruct or encourage the patented use. The court emphasized that Amarin had failed to allege any direct evidence of Hikma encouraging physicians to prescribe its generic product for the patented cardiovascular indication.

On appeal, however, the Federal Circuit reversed, finding that Amarin’s allegations of inducement were plausible. The appellate court concluded that Hikma’s public statements, pricing strategies, and references to Vascepa’s sales market could be sufficient to establish inducement, even in the absence of direct promotional materials instructing infringement. The ruling significantly expanded the scope of inducement liability, raising concerns for generic drugmakers relying on the Section viii carve-out.

Hikma’s arguments. In its petition for certiorari, Hikma presents two critical legal questions concerning inducement liability for generic drug manufacturers. The company argues that the Federal Circuit's ruling threatens the balance established by the Hatch-Waxman Act, particularly the section viii carve-out, which was designed to allow generic manufacturers to market unpatented uses of a drug without being subjected to infringement litigation over indications they have explicitly omitted from their FDA labels. By allowing inducement claims based solely on references to the branded drug's market and generic substitution practices, Hikma contends that the Federal Circuit's decision effectively nullifies the Section viii carve-out and exposes all generic manufacturers to potential litigation.

The petitioner warns that the ruling could significantly deter generic competition and delay patient access to affordable medications. It argues that under the Hatch-Waxman framework, generic manufacturers should be protected from liability when they have lawfully carved out patented uses. However, the Federal Circuit’s decision imposes an unreasonable risk on generic companies, as even routine industry practices—such as insurance coverage references or price listings—could be used to support inducement claims. Hikma asserts that this expansion of liability contradicts the intent of Congress and could discourage generic companies from seeking approval for otherwise lawful products.

Hikma’s petition relies heavily on the Supreme Court’s ruling in Global-Tech Appliances, Inc. v. SEB S.A., 563 U.S. 754 (2011), which established that inducement requires both knowledge of the patent and specific intent to encourage infringement. The petition asserts that Hikma’s actions do not meet this standard because the company never marketed its generic product for the patented cardiovascular indication, its FDA-approved label explicitly carved out the patented use, and it took no affirmative steps to instruct or encourage physicians to prescribe its product for an infringing use.

The petition also cites DSU Med. Corp. v. JMS Co., Ltd., 471 F.3d 1293 (Fed. Cir. 2006) (en banc), where the Federal Circuit reaffirmed that inducement liability requires specific intent to actively encourage infringement. The petition argues that passive commercial conduct, such as generic substitution under state law or listing a generic drug’s price in industry databases, does not constitute active encouragement and cannot satisfy the legal threshold for inducement under § 271(b).

By lowering the evidentiary bar for inducement, Hikma contends that the Federal Circuit’s decision allows speculative lawsuits based on commercial realities unrelated to a generic manufacturer’s intent to encourage infringement. Hikma argues that liability for inducement must be based on affirmative acts rather than third-party decisions, such as those made by prescribing physicians or insurers.

Amarin’s allegations of inducement. Hikma's petition directly challenges Amarin's core allegations that Hikma's marketing of its generic as a "substitute for Vascepa®" in insurance coverage materials and price lists constitutes active inducement. Hikma contends that these references do not reflect any intent to encourage physicians to prescribe its generic for an infringing use but instead comply with regulatory requirements under state and federal substitution laws, which mandate that pharmacists fill prescriptions with a lower-cost generic unless a physician specifies otherwise.

Further, Hikma asserts that these references are part of standard industry practices, where generics are routinely associated with their brand-name counterparts for pricing and insurance purposes. The petition further argues that even if some physicians or insurers prescribe its generic product off-label for cardiovascular risk reduction, that conduct is entirely independent of any actions taken by Hikma itself. The company contends that inducement liability cannot be based on the independent decisions of third parties—a principle reaffirmed in multiple Federal Circuit precedents.

Additionally, Hikma warns that allowing inducement claims to proceed based on passive commercial conduct would create a chilling effect on the generic drug industry. It argues that generic companies would face constant legal uncertainty, making it harder for them to rely on the Section viii carve-out without fear of litigation. The company further asserts that Amarin’s theory of liability would enable brand-name drug manufacturers to weaponize inducement claims against generic competitors, undermining the balance of the Hatch-Waxman Act.

Hikma urges the Supreme Court to clarify the limits of inducement liability in the context of generic drug approvals and reaffirm that generic manufacturers who fully carve out patented indications from their FDA labels cannot be held liable for inducement based on passive commercial conduct. The petition argues that affirmative steps to encourage infringing use—such as explicit promotional materials targeting the patented indication—are required for liability under § 271(b).

Additionally, Hikma seeks reversal of the Federal Circuit’s ruling and reinstatement of the district court’s dismissal of Amarin’s claims, arguing that the appellate decision sets a dangerous precedent that will invite costly and meritless litigation against generic manufacturers. The company contends that allowing such claims to move forward will make it significantly harder for generic manufacturers to enter the market, thereby restricting patient access to more affordable treatment options.

The Case is Dkt. No. 24-889.

Attorneys: Charles Bennett Klein (Winston & Strawn LLP) for Hikma Pharmaceuticals USA Inc. and Hikma Pharmaceuticals PLC.

Companies: Hikma Pharmaceuticals USA Inc.; Amarin Pharma, Inc.; Hikma Pharmaceuticals PLC; Amarin Pharma, Inc.; Amarin Pharmaceuticals Ireland Limited; Mochida Pharmaceutical Co., Ltd.

News: Patent FedCirNews