Regeneron Pharmaceuticals v. United States Department of Health and Human…
Regeneron Pharmaceuticals, Inc. v. United States Department of Health and Human Services
- Kenneth Karas
- 7:20-cv-10488
- U.S. District Court · Southern District of New York
- 4
In Regeneron v. United States, Judge Karas set a deadline for Regeneron’s response to the government’s proposed stay.
Regeneron Pharmaceuticals, the federal defendants, and the litigation challenging the Most Favored Nation Interim Final Rule, including its application to Regeneron’s EYLEA Injection.
What happened
Regeneron Pharmaceuticals challenged the Most Favored Nation rule issued by the Centers for Medicare & Medicaid Services. The court had preliminarily stopped the rule from applying to Regeneron’s EYLEA drug.
The government asked to pause this case while the agency reviewed the rule and considered notice-and-comment procedures. Regeneron opposed a stay and wanted to proceed with summary judgment.
Judge Kenneth M. Karas required Regeneron to respond to the government’s letter by February 9, 2021. The text does not state that the court granted or denied the requested stay.
The detailed version
- Regeneron Pharmaceuticals v. United States Department of Health and Human… · No. 7:20-cv-10488
- Kenneth Karas
- Feb. 2, 2021
Background
The Centers for Medicare & Medicaid Services published the Most Favored Nation Interim Final Rule on November 27, 2020. Regeneron filed eight claims challenging the rule and moved for a preliminary injunction and temporary restraining order.
After a hearing, the court issued a preliminary injunction blocking the defendants from implementing the rule as applied to Regeneron’s EYLEA Injection. The text also states that courts in the Northern District of California and the District of Maryland issued orders blocking or temporarily restraining implementation of the rule. The defendants therefore did not implement the rule on January 1, 2021, as originally planned. The Solicitor General decided not to appeal the preliminary injunctions issued by this court or the Northern District of California.
Request for a Stay
The government stated that the other cases challenging the rule had been stayed, but Regeneron opposed staying this case and wished to proceed with summary judgment. The government asked to seek a stay until a final rule based on the interim rule was published in the Federal Register.
The government argued that a stay would give the new administration time to review the rule, decide whether to issue a final rule after considering comments, and address procedural concerns identified in the court’s preliminary-injunction order. The government also argued that the existing injunctions and its agreement that any final rule’s performance period would begin no earlier than 60 days after publication would prevent prejudice to Regeneron.
The government further stated that the agency was proceeding with notice-and-comment rulemaking, which could narrow the issues in the case or eliminate the need to decide some issues. It offered to report to the court if it withdrew the interim rule or decided not to proceed with it.
Court Action
Judge Kenneth M. Karas did not state in this text that he granted or denied the requested stay. The text ends by directing Regeneron to respond to the government’s letter by February 9, 2021. Accordingly, the described action concerns a proposed litigation stay and a response deadline, not a final decision on Regeneron’s claims or on the stay request.
Read the full 4-page opinion on CourtListener, the free public archive maintained by the Free Law Project.