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Update: Orange Book Listing of Drug Delivery Device Patents After In re Lantus, February 20201 Introduction The U.S. Court of Appeals for the First Circuit recently ruled that Sanofi could potentially be held liable for an antitrust violation for improperly listing an insulin delivery device-related patent in the U.S. Food and Drug Administration’s (“FDA”) Orange… Read more »
Several products approved for marketing as drugs in the US are administered using a device (a drug-device combination product). Companies that own such products often file at least one U.S. patent to protect the device. In addition to obtaining patent protection for the device, a company may also wish to list the device patent in… Read more »
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