Merck KGaA, Merck Serono SA, and Ares Trading SA v. Hopewell Pharma Ventures, Inc., et al.

Summary

The United States District Court for the District of Delaware denied Hopewell Pharma Ventures, Inc.’s motion to lift the 30-month FDA approval stay associated with its ANDA for a generic version of MAVENCLAD®. The court held that it lacked authority to lift or shorten the statutory stay based on alleged competitive unfairness or alleged delays in related inter partes review appeals, and concluded that Hopewell’s own request for a litigation stay weighed against its position. The court ordered the parties to file a joint status report within one day after the Federal Circuit issues its mandate.

Holdings

1. The district court lacks authority under the Hatch-Waxman Act to change the duration of the 30-month regulatory stay solely to prevent a perceived injustice or competitive disadvantage.
2. The court lacked authority to shorten the regulatory stay based on an alleged failure to reasonably cooperate in expediting the IPR appeals because the statutory provision concerns cooperation in expediting the particular infringement action, not a related administrative appeal.
3. Merck's filing of documents at the applicable deadline, its unsuccessful request for an extension in the IPR appeal, and its alleged delay in providing its portion of a joint status report did not warrant shortening the regulatory stay.

Questions Presented

1. Whether the district court had authority under the Hatch-Waxman Act to lift or shorten Hopewell's 30-month regulatory stay merely to prevent an alleged competitive injustice.
2. Whether Merck's alleged delays in the IPR appeals and in submitting a joint status report constituted a failure to reasonably cooperate in expediting the infringement action under 21 U.S.C. § 355(j)(5)(B)(iii).
3. Whether the court could determine that the asserted patent claims were invalid before the Federal Circuit issued its mandate affirming the PTAB decisions.

Disposition

other