Canada: J&J’s Janssen Denied Data Protection Rights For Ketamine Analog Spravato In Canada, Court Rules ‘Not An Innovative Drug’

CANNANNEW REPORT

The Federal Court of Appeals in Canada ratified a Ministry of Health decision to refuse to provide Janssen Pharmaceuticals, a subsidiary of Johnson and Johnson (NYSE: JNJ), data protection for Spravato, a ketamine analog approved for depression. Spravato is the first “psychedelic-like” medicine approved for a mental health indication in both the U.S. and Canada. Ketamine and its treatment protocols are effectively laying the groundwork for the development of an infrastructure that could ultimately result in the introduction of psychedelics in a clinical setting. The Canadian court ruled that Spravato is not an “innovative drug,” therefore ruled to deny it data protection rights in Canada. What Happened? Spravato is a modified version of ketamine developed by Janssen. It was approved in Canada in May 2020 for the treatment of major depressive disorder in adults who have not responded to traditional antidepressants. Classic ketamine was approved decades ago as an anesthetic and became widely used as a fast-acting antidepressant during the time the compound was a generic drug. This substance, also called racemic ketamine, is composed of two molecules called esketamine and arketamine. Chemists refer to these as “enantiomers” which are compounds that have the same atoms but are arranged in “mirrored” positions, therefore giving them different therapeutic potentials. Janssen began developing Spravato in 2010, using just the esketamine enantiomer, which was believed to offer better therapeutic outcomes as an antidepressant and could also grant intellectual property protection, as it is differentiated from classic, or “racemic,” ketamine. However, the Canadian Minister of Health denied data protection for Janssen’s Spravato, in a decision that was backed in a July ruling by the Canadian Federal Court of Appeals. The basis of the argument is backed by understanding Spravato’s main medicinal ingredient as “a variant of a medicinal ingredient in a drug that had been previously approved by the Minister.” For Canadian law, enantiomers…

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Source : Canada: J&J’s Janssen Denied Data Protection Rights For Ketamine Analog Spravato In Canada, Court Rules ‘Not An Innovative Drug’

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