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How Will The Data Protection Ruling On Ketamine Impact Psychedelic Novel Drug Development Moving Forward?

Sep 3, 2021 • 7:25 AM EDT
2 MIN READ  •  By Michael Berger
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Last month, Canada’s Federal Court of Appeals passed a decision from the Ministry of Health to provide a subsidiary of Johnson and Johnson (NYSE: JNJ) data protection for Spravato, a ketamine treatment that has been approved for depression.

The drug is the first ketamine treatment to be approved to treat a mental health indication in both the US and Canada. The court said Spravato is not considered to be an innovative drug and denied a request for data protection rights in Canada.

Last year, Spravato was approved to be a treatment for major depressive disorder (MDD) in adults who have not responded to traditional antidepressants. This comes after Johnson and Johnson’s subsidiary spent approximately 10 years to develop the treatment and we find the ruling to be significant. 

In Canada, data protection rights provide eight years of exclusivity over data that has been presented by the first company to commercialize a pharmaceutical product. Data protection means that a generic manufacturer cannot market a treatment that has the same active ingredient by relying on data that was submitted by the company that initially developed the drug.

Although the ruling is significant, Spravato is also protected by patent rights which means that the product could be protected from generic manufacturing via other legal means. While data protection and patent rights are two separate issues, they both have the same end goal. The goal of data protection and patent rights is to balance incentives for new drug innovation with greater public access to drugs through generic competition. 

The loss of data protection rights for Spravato does not automatically grant any generic manufacturer the rights to issue their own versions of the product and we will monitor how the industry evolves after the ruling. 

Johnson and Johnson’s subsidiary has until the end of September to appeal this decision to the Supreme Court of Canada. We will monitor how the firm responds to the loss of data protection rights and believe that our readers should be aware of this. 

If you are interested in learning more about ketamine treatments, please send an email to support@mushroomstocks.com with the subject “Ketamine Treatments” to be added to our distribution list.

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Michael Berger

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