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28 June 2022Americas

Companies settle trade secret dispute over anaesthetic ingredient

Drugmaker Genus Lifesciences and pharmaceutical company Mallinckrodt have agreed to settle their trade secret dispute related to a cocaine hydrochloride formulation (HCI).

On Friday, June 24, Genus, Mallinckrodt and Mallinckrodt’s subsidiary SpecGx filed a notice to dismiss the suit with prejudice, following a settlement agreement between the parties.

Back in late 2019, Genus accused Mallinckrodt of misappropriating trade secrets, with Mallinckrodt allegedly using the trade secret information to “commercially enhance the value of” its cocaine HCl product and giving competitors access to secret information.

According to the suit, Mallinckrodt supplied the raw cocaine hydrochloride material for Genus' Goprelto product (a cocaine HCI 4% solution product, used as a nasal anaesthetic).

During a US Food and Drug Administration (FDA) review of Goprelto, the agency found “certain deficiencies” with Mallinckrodt’s cocaine HCI, said the suit.

Mallinckrodt had submitted its drug master file (DMF) 20995—containing confidential information about the processes and facilities used to produce its cocaine HCI—to the FDA. Although Genus didn’t have access to the DMF, it cited the document in its application for approval to the FDA.

Following the FDA’s finding of deficiencies in Mallinckrodt’s cocaine HCI, Genus carried out a “battery of proprietary studies” determining whether the product was safe.

The suit added that these studies contain proprietary information about cocaine HCI and are the company’s trade secrets, but that Genus shared the results with Mallinckrodt on a highly-confidential basis.

Mallinckrodt then incorporated the information into an amended filing for DMF 20995, in violation of their agreement, alleged Genus.

“Mallinckrodt used Genus's trade secret information to commercially enhance the value of Mallinckrodt's cocaine HCl product,” the claim said. “Without Genus's trade secret information, Mallinckrodt's cocaine HCl is deficient and unusable in finished drug products.”

Additionally, Genus accused Mallinckrodt of providing Genus's competitors with letters of authorisation to the enhanced DMF 20995 without Genus's prior written consent.

The dispute was stayed in late 2020 after Mallinckrodt entered bankruptcy proceedings. In June this year it reorganised the business and emerged from bankruptcy.

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More on this story

Americas
3 December 2019   Genus Lifesciences is suing pharmaceutical company Mallinckrodt for misusing trade secrets related to a cocaine hydrochloride formulation.
Americas
1 September 2022   Suit claims a contractor used AltaThera secrets to launch a rival heart arrhythmia drug | Chicago-based company wants the court to add its founder as co-inventor on patent.

More on this story

Americas
3 December 2019   Genus Lifesciences is suing pharmaceutical company Mallinckrodt for misusing trade secrets related to a cocaine hydrochloride formulation.
Americas
1 September 2022   Suit claims a contractor used AltaThera secrets to launch a rival heart arrhythmia drug | Chicago-based company wants the court to add its founder as co-inventor on patent.