Mavenclad® (cladribine)
Case Name: Merck KGaA v. Hopewell Pharma Ventures, Inc., Civ. No. 22-1365-GBW-CJB, 2025 WL 3485555 (D. Del. Dec. 4, 2025) (Williams, J.)
Drug Product and Patent(s)-in-Suit: Mavenclad® (cladribine); U.S. Patent Nos. 7,713,947 (“the ’947 patent”) and 8,377,903 (“the ’903 patent”)
Nature of the Case and Issue(s) Presented: Merck sued multiple defendants alleging infringement of the patents-in-suit in response to defendants’ filing ANDAs seeking approval to make and sell generic cladribine. Hopewell filed successful IPRs challenging Merck’s asserted patent claims. As a result, the court stayed Merck’s actions pending the resolution of any appeal of Hopewell’s IPRs. IPR2023-00480 and IPR2023-00481. The court also granted Merck’s alternative request for tolling of the 30-month stay of final approval as to Hopewell’s ANDA. On January 10, 2025, the court informed all parties that, “unless good cause is shown, the Court w[ould], for purposes of judicial efficiency, impose a global stay that includes Plaintiffs’ actions against the other Defendants until the conclusion of any appeal in IPR2023-00480 and IPR2023-00481.” Merck did not oppose. Apotex responded that “if [it] can approach the [C]ourt following a favorable decision in the IPR [A]ppeals and request that its 30-month stay be lifted, without waiting for a mandate, Apotex would be amenable to a global stay.” Apotex also responded that it’s 30-month stay should not be tolled or otherwise extended. The court sua sponte ordered a global stay, and did not toll the 30-month stay applicable to Apotex’s ANDA.
On October 30, 2025, the Federal Circuit issued an opinion affirming the PTAB’s decision invalidating all the asserted claims, but had not yet issued its mandate. Hopewell moved for an emergency lifting of the regulatory 30-month stay in its case. The court denied Hopewell’s motion.
Why Merck Prevailed: Hopewell sought relied on two grounds: (i) not lifting the 30-month stay would cause irreparable competitive harm; and (ii) Merck failed to reasonably cooperate in expediting this action on appeal to the Federal Circuit.
Hopewell’s first argument is premised on the fact that because the regulatory stay was tolled for Hopewell, but Apotex’s 30-month stay has since expired, once the FDA approves Apotex’s ANDA, Apotex will be able to launch at-risk, while Hopewell would face a “potentially months-long delay in reaching the market.” Merck countered that “the continued tolling of the statutory stay is consistent with the purpose of the Hatch-Waxman Act” because Hopewell filed an IPR and “requested a delay of this proceeding” and must therefore suffer the consequences of its actions. Ultimately, the court concluded that it lacked the power to lift the regulatory stay to prevent an alleged injustice. “Hopewell has not provided, nor could the Court identify, any case where the duration of the statutory stay was changed to prevent a perceived injustice.” To lift the stay, the court must have decided that (i) the patent-in-suit is invalid or not infringed; (ii) the patent-in-suit is infringed; or (iii) either party to the action failed to cooperate reasonably in expediting the action. “Congress has made its policy choices clear in the text of the statute.” Until the mandate is issued, the court cannot decide that the asserted claims are invalid.
Hopewell’s second argument—that Merck dragged out the appeal and therefore failed to reasonably cooperate in expediting the action—was also rejected. “The problem for Hopewell, however, is that any unreasonable failure of Merck to cooperate in expediting the IPR Appeals is not a failure of Merck to reasonably cooperate in expediting the present infringement action.” Therefore, again, the court held that it lacked the authority to shorten the 30-month stay based on an unreasonable failure to cooperate in expediting the IPR Appeals.
