Court Declines To Lift 30-Month Stay To Prevent Alleged Unfair Competitive Advantage Between Generics 

The U.S. District Court for the District of Delaware refused to lift the 30-month regulatory stay, which had been tolled, on the Food and Drug Administration’s (FDA’s) approval of Hopewell’s Abbreviated New Drug Application (ANDA), even though a later-filed generic could potentially beat first-filer Hopewell to market.¹

Statutory background

The 30-month stay of FDA approval, 21 U.S.C. § 355(j)(5)(B)(iii), was enacted as part of the Hatch-Waxman Act. In relevant part, it provides:

If the applicant made a certification described in subclause (IV) of paragraph (2)(A)(vii), the approval shall be made effective immediately unless, before the expiration of 45 days after the date on which the notice described in paragraph (2)(B) is received, an action is brought for infringement of the patent that is the subject of the certification and for which information was submitted to the Secretary under subsection (b)(1) or (c)(2) before the date on which the application (excluding an amendment or supplement to the application), which the Secretary later determines to be substantially complete, was submitted. If such an action is brought before the expiration of such days, the approval shall be made effective upon the expiration of the thirty-month period beginning on the date of the receipt of the notice provided under paragraph (2)(B)(i) or such shorter or longer period as the court may order because either party to the action failed to reasonably cooperate in expediting the action . . . .²

Factual background

Plaintiffs Merck KGaA, Merck Serono SA, and Ares Trading SA (collectively, “Merck”) filed suit against Hopewell Pharma Ventures, Inc. (“Hopewell”) and other generic defendants alleging infringement of U.S. Patent Nos. 7,713,947 and 8,377,903 after Hopewell and the others filed ANDAs for Merck’s MAVENCLAD® product.³

Hopewell successfully challenged the validity of Merck’s patents through inter partes review (IPR), where the Patent Trial and Appeal Board (PTAB) invalidated the claims of Merck’s patents.⁴ In November 2024, Hopewell filed its Emergency Motion to Stay the Case Pending Resolution of any Appeal of the IPR decisions, arguing that the district court should stay the action “so that the parties and the Court can stop devoting resources to a case in which no trial is necessary.”⁵ Merck opposed the motion, alternatively requesting that if the district court granted the stay, the court should also toll “Hopewell’s statutory 30-month stay under 21 U.S.C. § 355(j)(5)(B)(iii) for the pendency of the litigation stay.”⁶ Ultimately, the court granted Hopewell’s motion.⁷ Yet the court also agreed with Merck’s position and tolled the 30-month regulatory stay of FDA’s approval of Hopewell’s ANDA.⁸

In addition, the court granted a global stay for the actions against the other generic defendants, including Apotex.⁹ Indeed, Apotex did not oppose the global stay as long as its 30-month regulatory stay would not be tolled or otherwise extended.¹⁰ Accordingly, in granting the global stay, the court did not toll Apotex’s 30-month stay from receiving FDA approval.¹¹ Thus, the action was stayed, but Apotex’s 30-month regulatory stay continued to run.

On October 30, 2025, the Federal Circuit affirmed the PTAB’s decisions invalidating all of the asserted claims in the IPRs.¹² As of December 4, 2025, the Federal Circuit had yet to issue a mandate.¹³

The district court’s decision

Hopewell asked the district court to lift the regulatory stay on two grounds: “(1) [N]ot lifting the regulatory stay would cause irreparable competitive harm; and (2) Merck failed to reasonably cooperate in expediting this action on appeal to the Federal Circuit.”¹⁴ The court rejected both arguments.

To the first point, Hopewell argued that by tolling the regulatory stay against it, but not Apotex, the court created a situation where Apotex, a later filer who played no part in invalidating Merck’s patents, would be able to launch at risk, while Hopewell’s ANDA approval would still be stayed.¹⁵ The court found that it “lack[ed] the power to lift the regulatory stay to prevent an alleged injustice.”¹⁶ Relying on the language of the Hatch-Waxman Act, the court found that it had the authority to change the duration of the regulatory stay if the patent were found invalid or not infringed.¹⁷ Hopewell provided no authority for the court to adjust the duration of a regulatory stay to avoid an alleged injustice.¹⁸ Rather, the court held that in order to change the duration of that stay, it must decide that: “(1) [T]he patent-in-suit is invalid or not infringed; (2) the patent-in-suit is infringed; or (3) either party to the action failed to reasonably cooperate in expediting the action.”¹⁹ Because the Federal Circuit has yet to issue its mandate, the court declined to find the asserted claims of the patents-in-suit invalid.²⁰ “[T]he Court holds that it cannot lift the Regulatory Stay to prevent the risk of Apotex from receiving final FDA approval to launch its generic product before Hopewell, however ‘unfair’ Hopewell claims such a launch would be.”²¹

The court rejected Hopewell’s second argument that Merck failed to “reasonably cooperate” in pursuing the action.²² Rather, the court found that “any unreasonable failure of Merck to cooperate in expediting the IPR Appeals is not a failure of Merck to reasonably cooperate in the present infringement action.”²³ Apparently, only delays in the underlying litigation — not IPRs or their appeals — are pertinent under the governing statute.²⁴ Even so, the court found that Merck’s filing its notice of appeal on the last possible day was not an unreasonable failure to cooperate in expediting the IPR appeals.²⁵ Nor did Merck’s request for a 60-day extension of time to file its opening brief, which was denied, support Hopewell’s position.²⁶ The only alleged improper conduct of Merck that Hopewell asserted that delayed the ANDA litigation was Merck’s filing a joint status report on the deadline. The court found that this was not a failure to reasonably cooperate in expediting the action given that the actual deadline was met.²⁷

Takeaways

Ultimately, the district court found Hopewell’s situation to be a “situation of Hopewell’s own making” and denied Hopewell’s motion to lift the 30-month stay.²⁸ The case is fact-specific and, therefore, generalizations cannot be drawn; however, it does lend support to the old saying “be careful what you wish for.”