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Phase I Final Stark Rule Issued

Client Alert | less than 1 min read | 01.31.01

On January 4, 2001, HCFA published the first phase of the long-awaited final rule implementing the federal Ethics in Patient Referrals Act (the "Stark Law") expansion to include ten designated health services. Click here for Crowell & Moring's analysis of the final regulation.

Insights

Client Alert | 6 min read | 11.25.25

Brussels Court Clarifies the EU’s SPC Manufacturing Waiver Regulation Rules

On November 13, 2025, the president of the French-speaking Brussels Enterprise Court ruled in the long-running battle between Sandoz and Regeneron about the correct interpretation of the EU’s Supplementary Protection Certificate (SPC) Manufacturing Waiver Regulation regarding exports to a non-EU market. The Brussels Court dismissed Regeneron’s claim that Sandoz had provided a defective notification and agreed with Sandoz’s interpretation of the Regulation....