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Defective Complaint Can Still Have Preclusive Effect Under FCA's First-to-File Bar

Client Alert | 1 min read | 06.12.13

In U.S. ex rel. Heineman-Guta v. Guidant Corp. (May 31, 2013), the First Circuit weighed in on a jurisprudential split over the FCA's first-to-file bar between courts that hold that the earlier-filed complaint must meet Rule 9(b)'s particularity requirement for pleading fraud in order to have preclusive effect and those that do not. Affirming the dismissal of the relator's claims, the First Circuit joined the D.C. Circuit and other district courts in rejecting the application of Rule 9(b) to the first-to-file bar and holding that dismissal is appropriate so long as the earlier complaint put the government on sufficient notice to initiate an investigation into the alleged fraud. 


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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....