Genus sues Mallinckrodt over secret cocaine hydrochloride studies
Genus Lifesciences is suing pharmaceutical company Mallinckrodt for misusing trade secrets related to a cocaine hydrochloride formulation.
In its suit, filed at the US District Court for the Eastern District of Pennsylvania on Friday, November 29, Genus said that Mallinckrodt supplied the raw cocaine hydrochloride material for its Goprelto product.
Genus’ Goprelto, which received US Food and Drug Administration (FDA) approval in December 2017, is a cocaine hydrochloride (HCI) 4% solution product, used as a nasal anaesthetic.
According to Genus, during the FDA’s review of Goprelto, the agency found “certain deficiencies” with Mallinckrodt’s cocaine HCI.
Mallinckrodt had submitted drug master file (DMF) 20995 to the FDA containing confidential information about the processes and facilities used to produce its cocaine HCI.
Genus did not have access to DMF 20995, but cited the document in its application for FDA approval of Goprelto.
After the FDA found deficiencies in Mallinckrodt’s cocaine HCI, Genus carried out a “battery of proprietary studies” determining whether the product was safe.
According to Genus, these studies contain proprietary information about cocaine HCI and are the company’s trade secrets.
Genus said it shared the result of the studies with Mallinckrodt on a highly-confidential basis.
According to Genus, Mallinckrodt then incorporated the information into an amended filing for DMF 20995, in violation of their agreement.
“Mallinckrodt used Genus's trade secret information to commercially enhance the value of Mallinckrodt's cocaine HCl product,” the lawsuit said.
It added: “Without Genus's trade secret information, Mallinckrodt's cocaine HCl is deficient and unusable in finished drug products.”
Genus is seeking an award of exemplary damages for what it calls Mallinckrodt’s “willful and malicious actions”.
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