Hikma Seeks Rehearing In Vascepa Skinny-Label Case

The full US Court of Appeals for the Federal Circuit should rehear a panel decision from earlier this year that reopened a long running dispute with Amarin over a skinny-label generic version of Vascepa (icosapent ethyl), Hikma has urged in a filing with the court.

The case revolves around a claim of induced infringement by Hikma’s generic of patent-protected indications of Vascepa, even though Hikma had followed the “section viii” statutory framework and fully carved out Amarin’s patented use for reducing cardiovascular risk.

In June, the appeals court reversed a Delaware district court’s January 2022 decision to dismiss the case, finding that Amarin’s allegations against Hikma plausibly stated a claim for induced infringement and highlighting that it had reviewed the allegations of inducement “as a whole, not piecemeal” (see sidebar for full details).

But in its request for an “en banc” rehearing of the June decision, Hikma said the appeals court ruling “contradicts longstanding precedent that requires active steps by the defendant encouraging infringement” and “nullifies labeling carve-outs under section viii and will severely harm generic competition absent rehearing.”

“The panel held that Hikma’s description of its generic drug as a ‘generic version’ of a branded drug, along with references to annual sales of the branded drug, was sufficient to plead induced infringement of a patented method that Hikma undisputedly carved out of its generic product label,” the generics firm pointed out, in a move that “conflicts with this court’s precedent on induced infringement and eviscerates a statutory mechanism that congress enacted to expedite access to generic drugs.”

“Left uncorrected,” Hikma warned, “the decision will deter generic competition and expand the risk of inducement liability even beyond the pharmaceutical industry.”

Specter Of GSK-Teva Case Looms

Noting that the appeals court had previously been “split sharply over whether to rehear its decision in GlaxoSmithKine v Teva” – separate litigation which ultimately saw GSK triumph in an induced-infringement battle over its Coreg (carvedilol) brand (see sidebar) – Hikma said “the concurrence made clear, however, that GSK’s holding was ‘narrow and fact dependent’.”

“As proof, the concurrence cited the district court’s decision in this case, which dismissed Amarin’s complain for ‘fail[ing] to plead inducement based on Hikma’s label or public statements’,” Hikma pointed out. “Yet the panel here reversed that decision – drastically expanding GSK’s holding.”

Moreover, Hikma said, the appeals court’s decision to resurrect the Amarin litigation “also conflicts with GSK’s holding that ‘simply calling a product a generic version is not inducement’.”

Emphasizing that the panel had found that Hikma’s label was “skinny enough” – in that it “does not, as a matter of law, recommend, encourage, or promote [either] infringing use” – Hikma acknowledged however that plausible inducement had been found because Hikma had referred to its product as a “generic version” of Vascepa and quoted total annual sales for the brand, including patent-protected sales.

This was seen by the panel as sufficient to plead “instruction or encouragement to prescribe [Hikma’s] drug for any of the approved uses of icosapent,” including cardiovascular risk reduction, “even though Hikma’s statements never mention CV risk, much less using icosapent to reduce it.”

But the firm argued that “even assuming sales figures could imply intent to substitute Hikma’s generic product for all Vascepa prescriptions (a stretch), that is not enough because the law requires both ‘specific intent and action to induce infringement’.”

“By allowing inducement claims to proceed without any statement by Hikma encouraging the claimed methods, the decision breaks with longstanding precedent and the inducement statute itself, which limits liability to one who ‘actively induces infringement’,” Hikma summarized.

It suggested that the court’s reasoning “assumes physicians plausibly will read Hikma’s press releases, infer they can use Hikma’s ‘generic version’ for all approved uses of Vascepa, and consult Amarin’s Vascepa label – not Hikma’s label – to determine those uses.” But “at most, this is a theory of passive inducement. Amarin failed to plead that Hikma actively induced physicians to use its product for CV uses.”

Allowing Case To Proceed Could Cast Shadow Over Industry

Hikma also drew the court’s attention to the potential impact of the case on the wider generics industry, arguing that allowing the litigation to proceed could have a chilling effect on generic competition in general.

“Even before the decision, commentators viewed Amarin’s lawsuit as ‘a prototype for future litigation’ that ‘may delay or deter generics from entering the market’,” Hikma said. “The decision all but ensures that result.”

“Every generic drug, by definition, is a ‘generic version’ of another product, and market-size discussions are practically unavoidable in communications to investors and the public,” Hikma set out. “If this were enough to plead inducement, every skinny label would be litigated.”

And even if an Amarin victory was unlikely, Hikma argued, allowing the case to proceed could still make generic competitors think twice. Noting that the panel had dismissed Hikma’s concerns as “inflated” because of the “stage of proceedings” on a motion to dismiss, Hikma commented that “true, Amarin’s case is weak, and it is unlikely to succeed. But the precedential harm will already be done.”

“The threat of protracted litigation through fact and expert discovery is enough to deter generic competition,” Hikma warned, observing that “post-launch, skinny-label litigation effectively doubles the cost; Hikma needs to defend a second lawsuit despite winning its Hatch-Waxman case.”

“Under the panel decision, no skinny label is safe,” Hikma concluded. “Even with slim chances of success, patentees will reflexively file suit if they can get past motions to dismiss based on vague and practically unavoidable statements that an accused product is a ‘generic version’ competing for a branded product’s sales.”

“The twin threats of litigation expense and lost-profits damages will deter generic companies from invoking section viii,” the firm concluded, “defeating congressional intent to lower drug prices and harming patients and healthcare providers.”

As part of its recent first-half results announcement – which saw the firm report a 10% sales rise to $1.569bn in the first six months of 2024 – Hikma acknowledged the ongoing Vascepa litigation but said that “at this point, the group does not believe sufficient evidence exists to make a reasonable estimate of any potential liability.”