In a ruling published this week, the U.S. District Court for the Middle District of Florida, Tampa Division, granted a motion to dismiss in the case of Novo Nordisk, Inc. v. Brooksville Pharmaceuticals. The court ruled in favor of APC member Brooksville in a suit brought by pharmaceutical giant Novo Nordisk, Inc. 

Novo Nordisk had alleged that Brooksville violated the Florida Deceptive and Unfair Trade Practices Act by manufacturing and selling drugs containing semaglutide without FDA approval. The court, however, found that Novo Nordisk’s claim was preempted by the Federal Food, Drug, and Cosmetic Act, which grants the U.S. government sole enforcement authority over such matters.

The court also determined that Novo Nordisk failed to sufficiently plead the elements of a claim under FDUTPA, as they did not demonstrate that Brooksville Pharmaceuticals had violated the Florida Drug and Cosmetic Act. The court granted the motion to dismiss without prejudice, allowing Novo Nordisk the opportunity to amend their claim within twenty-one days.

“This is a victory for shortage-drug compounding, but only an initial victory,” said APC’s Scott Brunner. “The judge rejected Novo’s argument that compounding is ‘unauthorized drug manufacturing’ and affirmed that federal law pre-empts state law on the matter. But he also will allow Novo to amend its claim. One argument Novo is expected to make in that follow-up is that in stating on the record that it compounded semaglutide base, Brooksville has violated Novo’s patent. If that’s their claim, it could be the first case of a court weighing whether FDA’s “essentially a copy’ guidance — which allows pharmacies to prepare copies of FDA-approved drugs when it is “currently in shortage on the FDA shortage list – applies to patented drugs.”