Psychedelics REMS?
It is likely that the FDA will require a REMS for psychedelic therapies, such as MAPS’ MDMA-assisted therapy. This could come in the form of therapist training and accreditation in-line with MAPS’ training manual, for example. Speaking to Fierce Biotech, MAPS PBC CEO Amy Emerson explained:
“The FDA was unsure what to do with the therapy part of it. Do they look at the therapy training program? What is the label going to say? How much do you put in the REMS [Risk Evaluation and Mitigation Strategy] and how much do you put in the label?”
REMS programs can also be generated for an entire class of drug, such as the Opioid Analgesic REMS which was approved in September 2018 and covers oxycodone, hydrocodone and morphine, among other drugs.
Might we see a similar pan-psychedelics REMS program in the future, at least for psychedelic-assisted therapies?
Perhaps. But, it’s likely that the FDA will evaluate psychedelic therapies on a case-by-case basis, at least to begin with. New Drug Applications for psychedelics are likely to be few and far between in the coming years, with only MAPS, COMPASS Pathways, and Usona Institute engaged in late-stage trials. It’s also worth highlighting that ‘psychedelics,’ especially as currently imagined, are not a homogenous class of drugs. MDMA, for example, is an empathogen. As such, it has different properties to classic psychedelics such as psilocybin and DMT.
Patenting REMS
Now, on to the collision between REMS programs and patents. Importantly, brand manufacturers can attempt to prevent generic competition by patenting the REMS programs themselves. Even where a generic manufacturer obtains a separate REMS allowing them to deviate from the brand manufacturer’s REMS program, the generic may still infringe the brand’s patented REMS program. The FDA, after all, does not make judgments on patent scope or infringement liability. Will “comparable” aspects of the ETASU still fall within the scope of the brand manufacturer’s REMS patent claims?
And to the extent other REMS aspects are still shared, the generic’s product label must include those aspects of the REMS program that also appear on the brand’s label. As such, if the brand has successfully patented its REMS program, the generic is put in a very difficult situation. The generic can either include the REMS program in its product packaging and be liable of inducing infringement of the patent, or omit the REMS program thus violating FDA packaging rules.
i.e., FDA regulations require generics to copy brand labels, and thus they may be copying a patented REMS program in doing so.
“As a result, generics seeking to introduce REMS programs are stuck between the rock of FDA regulations and hard place of patent law.”
Carrier and Sooy, 2017 (pp. 1680)
Beyond this explicit copying of labelling, a REMS patent could be more convoluted. It might, for example, cover an algorithm that uses patient data to calculate the risk of an adverse event. The data used to generate the algorithm may have been derived from clinical trials of the drug, adding another proprietary element.
So, could the patenting of REMS programs be the next frontier in the apparent psychedelics IP skirmish?
Eleusis, one of the earliest psychedelics R&D companies, has a number of published patent applications which seek to cover the screening and monitoring of those undergoing psychedelics therapies.
One such application covers a method of screening candidates for psychedelic therapy through analysis of a language sample. Claims 59 and 167 specifically mention a machine learning algorithm that may be employed to augment the analysis of such a sample.
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