Beyond The Printed Page | April 29, 2022

MAPS: Walking The Talk On Intellectual Property?

Source: Life Science Leader
Ben Comer_2022_1

By Ben Comer, Chief Editor, Life Science Leader

Amy Emerson

The Multidisciplinary Association for Psychedelic Studies Public Benefit Corporation (MAPS PBC), a for-profit research and commercialization arm of the nonprofit MAPS, is conducting confirmatory Phase 3 trials for MDMA-assisted therapy for the treatment of PTSD. Pictured on the cover of our May issue, Amy Emerson, CEO of MAPS PBC, emphasized in an interview with Life Science Leader that MAPS is not interested in using patents or intellectual property to discourage other companies from competing in the emerging psychedelic-assisted therapy space. Patient access, not maximizing profits, is “the most important factor of our intellectual property strategy, because our mandate is to advance public benefit through access to healing,” wrote MAPS PBC in an email following the interview.

To underscore the difference in how MAPS PBC thinks about patents and intellectual property, compared with other drug developers, the organization went on to write that the “current American drug development model incentivizes patents for for-profit companies, but intellectual property claims can drive up the costs of treatments and make them less accessible. Intellectual property tools also can be applied within a patient access framework to promote health equity, and if we were to pursue a patent it would be for that purpose.” A fine sentiment, but is it believable? Most every biopharmaceutical company talks about putting patients first, but that typically doesn’t prevent them from protecting their IP against competing interests, in court when necessary.

In April, after the May issue of Life Science Leader was finalized for publication, MAPS and MAPS PBC announced the publication of what it called “the first validated commercial synthetic process for producing multi-kilogram batches of MDMA under current Good Manufacturing Practices.” Published in the American Chemical Society’s ACS Omega, a peer-reviewed scientific journal, the article, which describes the manufacturing process, “establishes ‘prior art,’ contributing to MAPS’ patient access strategy by making intellectual property public,” MAPS said in the announcement.   

In the biopharmaceutical industry, the term “prior art” describes “previously published patent applications, issued patents, or just technical publications generally… really anything that forms the basis of what the public might understand to be the state of a technology, or state of the art,” explains Matt Zapadka, a patent attorney at Arnall Golden Gregory, LLP. Openly publishing a process for the mass production of a substance like MDMA is part of a changing environment with respect to psychedelic drugs, as well as cannabis products, notes Zapadka. “A few years ago, people weren’t really announcing that they had better ways to make what a lot of people would consider to be illicit drugs,” Zapadka says. “There is a real tidal shift happening.”

It is unclear if MAPS has filed any patents in conjunction with its publication, which would determine whether other organizations could adopt the MAPS manufacturing process wholesale, for their own MDMA production. The publication itself does not confer any intellectual property or patent rights, says Zapadka. As MAPS PBC moves closer to an FDA decision on MDMA-assisted therapy, which it anticipates will happen in the second half of 2023, other psychedelic drug developers will be watching to see how the organization commercializes its therapy, and how it handles any associated intellectual property it is granted between now and then.