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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.
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 of an already-approved drug (such as esketamine, an enantiomer of ketamine) cannot qualify for data protection since they’re not considered an "innovative drug,” wrote lawyers from the Torys law firm.
What Is Data Protection And Why Is It Important?
In Canada, data protection essentially provides eight years of exclusivity over data presented by the first company to commercialize a pharmaceutical product when applying for approval, according to David Wood, chief legal officer at Psygen Industries Ltd., and principal at R-Group Legal.
Data protection means that no generic manufacturer can market a drug product with the same active ingredient by relying on data submitted by the company that initially developed the drug.
"This doesn't prohibit a follow-on company from submitting its own application, but it would mean repeating all of the development work done for a drug—everything, start to finish,” said
Graham Pechenik, a cannabis and psychedelics patent attorney who heads Calyx Law.
“This is important because unless a competitor has filed their own clinical data and other material required to bring a competing drug product to market, then this protection may effectively provide eight years of exclusivity in the Canadian market,” Wood added.
While data protection and patent rights are two separate issues, they are both intended to achieve the same ends, Pechenik said.
The goal of both instruments is to balance incentives for new drug innovation with greater public access to drugs through generic competition.
“Patent rights are generally broader, can last longer, and can prevent anyone from doing what's covered by the patent claims,” Pechenik explained.
What This Means For Esketamine In Canada
From a data exclusivity perspective, the Minister of Health’s decision could give any company permission to seek approval for esketamine for treatment of depression in Canada, using Janssen’s development data.
However, since Spravato is also protected by patent rights, Janssen’s product could be protected from generic manufacturing via other legal means.
“Patents can, and often do, monopolize aspects of a drug product other than the active ingredient of the drug product,” Wood noted.
This means that losing data protection for Spravato does not automatically grant any generic manufacturer the rights to issue their own versions of the product.
Could This Decision Produce A Ripple Effect In The U.S.?
Janssen has a tighter grip on data exclusivity for Spravato across the Canadian border.
Prior to 2007, the U.S. Food And Drug Administration refused to award new chemical entity status to enantiomers of previously approved racemic mixtures, similar to what Canada's law does now, Pechenik pointed out.
That changed with a congressional enactment of the FDA Amendment Act of 2007, which granted single enantiomers five years of market exclusivity under certain circumstances.
In the United States, Spravato was approved by the FDA on March 5, 2019.
“It was approved as a New Chemical Entity, and therefore has data exclusivity which expires on March 5, 2024. The FDA "Orange Book" also lists three patents that cover it, expiring in 2027, 2031, and 2035,” says Pechenik.
What’s Next For Janssen?
Janssen has until the end of September 2021 to appeal this decision to the Supreme Court of Canada, though Wood explained that appeals to the Supreme Court are not available as a right and require a review process by the court.
If the issue presented to the court is not deemed of “public importance” or otherwise
significant, the ruling body could deny the appeal.
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