Contactless Delivery Costs Nexus Approval of a Melinta Drug Copy

Nexus Pharmaceuticals Inc. lost US regulatory approval to sell its copy of Melinta Therapeutics LLC’s injectable antibiotic Minocin, as a federal judge said a contactless FedEx delivery in the Covid-19 pandemic’s first long winter didn’t give Melinta proper notice.

The Hatch-Waxman Act requires that a generic-drug maker notify the maker of the branded version that its copy won’t infringe the drug’s patents, or that the maker of the generic considers them invalid. Upon receiving the notice letter, the maker of the brand drug has 45 days during which it can sue alleging infringement. Filing an infringement suit automatically triggers ...