What’s in a Name? Psychedelics IP Discussion Heats Up
March 15, 2022
As the psychedelics industry continues to pursue a pharmaceutical business model, the conversation surrounding intellectual property is gaining traction. The business of psychedelic drugs has gained a serious air of legitimacy by modeling itself after the pharmaceutical market. But with this benchmark comes the question of how the industry will marry its goodwill intentions with the hard-nosed business of intellectual property (IP). ... Mason Marks, a senior fellow and project lead with the Project on Psychedelics Law and Regulation at Harvard Law School, said in order to patent a psychedelic substance there needs to be genetic manipulation so that there is a new aspect to the actual substance. “Whether or not you modify the mushroom, you could also patent various methods of growing it and utilizing it, because in those instances, you aren’t patenting the product of nature itself, but a method of producing or using it,” he explained.
The décor of the Nushama Psychedelic Wellness Clinic was designed to look like bliss. “It doesn’t feel like a hospital or a clinic, but more like a journey,” said Jay Godfrey, the former fashion designer who co-founded the space with Richard Meloff, a lawyer turned cannabis entrepreneur. The “journey,” in this instance, is brought on by ketamine, administered intravenously, as a treatment for mental health disorders, albeit one that has not yet been approved by the Food and Drug Administration. ... “There’s nothing suspicious” about off-label prescription use in general, said Mason Marks, a senior fellow at Harvard Law School specializing in the regulations around psychedelics, but ketamine providers need to be careful about over-promising the drug’s benefits, particularly when there’s limited evidence of its efficacy. According to Dr. Dan Iosifescu, a psychiatrist at N.Y.U. Langone, ketamine is also potentially addictive, heightening the risk of using the drug, even in a therapeutic setting.
Oregon proposes only using one type of mushroom for new psilocybin system, and no pills
February 8, 2022
Oregon would only allow the use of one mushroom species in its new psilocybin system and would ban chemically synthesized psilocybin. These are just two details in a release of new draft rules expected Tuesday from the Oregon Health Authority. The rules, crafted by an advisory board of doctors and other public health experts, will be used to create Oregon’s ground-breaking system for allowing the use of psilocybin, the hallucinogenic substance produced by many mushrooms. ... “It is kind of a landmark moment because Oregon is the very first state to have created such a system of regulation,” said Mason Marks, a member of Oregon’s psilocybin advisory board and a senior fellow on the Project on Psychedelics Law and Regulation at Harvard Law School. “These are the very first draft rules that we’re seeing, so it really is a kind of pivotal event.”
A Niche Market Mushrooms
February 7, 2022
Psychedelic mushrooms were touted as a panacea for Oregon’s mental health crisis in 2020, when voters passed a first-in-the-nation measure legalizing the supervised use of psilocybin in state-regulated settings. Backed by Portland-area therapists Tom and Sheri Eckert, the language of Measure 109 promised to improve the physical, mental and social well-being of Oregonians by teaching people about “the safety and efficacy of psilocybin in treating mental health conditions.” ... Psilocybin will mostly be administered instead by facilitators who commit to a 120-hour state-certified training program and apply for a state license. They’ll be trained in the “physical, psychological, and spiritual effects of psilocybin, along with education on ethics, equity, history, and culture,” writes Mason Marks, a law professor in Portland who leads the Project on Psychedelics Law and Regulation at Harvard Law School, and who also sits on the Oregon Psilocybin Advisory Board.
January 31, 2022
A new Harvard Law initiative examines the legal and ethical aspects of therapeutic psychedelics
Oregon Voters Legalized Psilocybin Use. But What About Microdosing?
January 26, 2022
As some of the experts chosen to usher Oregon into the age of psilocybin mushroom therapy sat down last week for a Zoom meeting, two of them had a bone to pick. At issue: whether the Oregon Psilocybin Advisory Board would get to hear from the “Godfather of Microdosing” this week. ... The exchange took place between two academic heavy hitters, both appointed by Gov. Kate Brown to the psilocybin board. Dr. Atheir Abbas is an assistant professor of behavioral neuroscience at the Oregon Health & Science University School of Medicine, while Dr. Mason Marks is an assistant professor at the University of New Hampshire School of Law and a senior fellow at Harvard Law School’s Project on Psychedelics Law and Regulation.
Seattle Legalizes Psychedelics
January 25, 2022
Proponents of the legalization of psychedelics has won a victory. Seattle’s City Council approved a resolution Monday to decriminalize a wide range of activities around psychedelic drugs, including the cultivation and sharing of psilocybin mushrooms, ayahuasca, ibogaine and non-peyote-derived mescaline. The landmark measure extends what is already Seattle city policy not to arrest or prosecute people for personal drug possession to further protect the cultivation and sharing of psychedelic plants and fungi for “religious, spiritual, healing, or personal growth practices.” ... Enacted, the Psilocybin Wellness and Opportunity Act would allow individuals to consume products containing psilocybin and psilocin, the two main active ingredients in psychedelic mushrooms, under the support of a trained and state-licensed psilocybin service administrator. Mason Marks, a senior fellow and project lead on the Project at Psychedelics Law and Regulation at Harvard Law School who helped to draft some sections of the bill, told Marijuana Moment that it “builds on the momentum of previous psilocybin policy reform efforts in Seattle and across the country.” Voters in neighboring Oregon passed an initiative in 2020.
‘Moving Beyond the Counterculture of the ’60s’: Why Some Law Firms See Promise in Psychedelics
November 30, 2021
Last Tuesday, a pharmaceutical company traded on the New York Stock Exchange announced a grant to Manhattan’s prestigious Lenox Hill Hospital to launch a new psychotherapy treatment clinic focused on serving marginalized and underserved communities. ... Apart from FDA-approved medications, which present the prospect of a multibillion-dollar industry by the end of the this decade, Oregon is poised to become the first state to open recreational markets in 2022 for mushrooms containing psilocybin. “People are starting to figure out what they need to do to go to Oregon and set up shop,” said Mason Marks, an attorney with Harris Bricken in Portland who also leads the Project on Psychedelics Law and Regulation at Harvard Law School’s Petrie-Flom Center for Health Law Policy, Biotechnology, and Bioethics.
Latest psilocybin patent highlights the swirling battle over psychedelics intellectual property
October 26, 2021
One of the leading companies racing to develop psychedelics as legal medicines was granted a patent last week for a formulation of psilocybin — the hallucinogenic compound found in magic mushrooms — a decision that highlights the increasingly intense battle around intellectual property for potential medicines in this rapidly growing sector. This is Compass Pathways’ fourth U.S. patent, but its first for a form of psilocybin the company isn’t using in its clinical trials on treatment-resistant depression. The patent works to “expand their intellectual property kingdom,” said Mason Marks, senior fellow and project lead on the Project on Psychedelics Law and Regulation at Harvard Law School: “Like a landlord would want to expand and buy more properties, they’re trying to lock up as much IP as they can to solidify their position in the market.”
The obstacles to decriminalizing psychedelic drugs are political, not legal, say experts
October 13, 2021
The new Project on Psychedelics Law and Regulation (POPLAR) at Harvard Law School recently convened a conference on the future of psychedelics law and regulation.
Startups are betting on a psychedelic gold rush
October 13, 2021
For a long time, Chase Chewning had wanted to try a new type of psychotherapy that uses ketamine, a dissociative anesthetic that’s shown promise as a mental health treatment. Chewning, a veteran who has had several recreational experiences with MDMA and psilocybin, hoped the drug could help him with his PTSD, so he made an appointment at a Los Angeles ketamine therapy clinic operated by Field Trip Health. ... “This is really the most promising development in mental health care to come along, literally, in many decades. And that’s one reason why you don’t want a few companies controlling it,” says Mason Marks, a project lead at Harvard Law’s Petrie-Flom Center who focuses on psychedelics regulation.
A Strategy for Rescheduling Psilocybin
October 12, 2021
An op-ed by Mason Marks: Public and scientific interest in psychedelics such as psilocybin and MDMA is expanding. Once off-limits because of federal prohibition, a trickle of research from the 1990s has grown into a stream. But despite increasing acceptance by the public, and commercial investment in psychedelic therapies, aging federal laws stem the flow of vital research. Psilocybin, a compound produced by many species of fungi, is one of the most well-studied psychedelics. To acknowledge its impressive safety record and potential for treating depression more effectively than existing therapies, the Food and Drug Administration designated psilocybin a breakthrough therapy in 2018 and 2019 for treating drug-resistant depression and major depressive disorder.
Seattle Votes to Decriminalize Psilocybin and Similar Substances
October 5, 2021
Seattle’s city council voted unanimously to relax its rules against naturally occurring drugs, joining a handful of other cities that have decriminalized psilocybin and similar substances since Denver kicked off a wave of such changes three years ago. ... Some high-profile researchers are now calling for federal change. Separately on Monday, the head of Harvard Law School’s Project on Psychedelics Law and Regulation, Mason Marks, advocated for relaxation of laws around psychedelic drugs in order to spur mental health-care innovation. His article, published in peer-review journal Nature Medicine, points out that the current status of psilocybin makes it hard to get federal funding for research, which means that private companies currently fund most research and therefore shape public policy. ... As a Schedule I controlled substance, psilocybin falls in the same category as hard drugs such as heroin. Marks said moving it to a less-restrictive category would help create “more-inclusive clinical trials and unbiased regulatory review” by the U.S. Food and Drug Administration. “Basically, our position is that rescheduling is the best approach. It will solve many problems,” Marks said in an interview.
Oregon Psilocybin Panel Teams Up With Harvard To Research Psychedelic History And Impacts Of Reform
September 7, 2021
An Oregon state panel charged with advising on the implementation of a legal psilocybin therapy program has cleared a team of researchers to produce a comprehensive report on the science, history and culture of the psychedelic as regulators prepare to license facilities to administer it. Members of the Oregon Psilocybin Advisory Board released an initial report in July that reviewed hundreds of studies into psilocybin, as required under the state’s historic, voter-approved 2020 medical legalization initiative. But they were pressed for time and will now be working with a recently established psychedelic research center at Harvard Law School to more thoroughly cover the subject. ... “To the extent that the [Ethical, Legal, and Social Implications] Report can help inform their decision making, it should be made available for that purpose,” [Mason] Marks, who is also the director of Harvard’s first-of-its-kind psychedelics policy center, said. “Hopefully, it can provide a bit of a roadmap for fruitful collaboration between states and the federal government.”
Seattle Overdose Task Force Calls for Decriminalization of All Drugs
September 3, 2021
In response to the Seattle City Council’s request for policy advice on how to curb overdose deaths, a local task force is recommending the widespread decriminalization of all drugs. Psychedelics in particular, the group said, could be a promising treatment to address substance use disorders and mental health issues....Mason Marks, the director of Harvard Law School’s Project on Psychedelics Law and Regulation and a member of Oregon’s official state advisory board for that state’s psilocybin therapy program, called the recommendations “an important step for Seattle to help address its overdose and mental health crisis.” “The City Council can now act confidently on this timely, evidence-based recommendation,” he added.
In the last four months, five states have legalized recreational marijuana, meaning now 30% of the country allows its adult residents to possess and use cannabis. At least two more states are poised to be added to that list following the passage of cannabis legalization bills this year. Marijuana policy experts and advocates say this national trend is indicative of a shift in Americans' perspectives on marijuana. Arguments from elected officials and voters that centered around perceived dangers of marijuana substance abuse or a rise in criminal activities have quelled as evidence has grown to show there are economic, social and health benefits from a state regulated cannabis industry, according to Mason Marks, a law professor at Gonzaga University and a fellow-in-residence at Harvard Law School's Petrie-Flom Center for Health Law Policy, Biotechnology, and Bioethics. "It’s turning out to be very antiquated," Marks said of past opposition to legalizing marijuana. Marks and other experts say there will be stronger legalization efforts in the near future. However, they noted there would still be an uphill battle before the country sees any true national repeal of its marijuana laws.
Marijuana legalization successes pave way for national conversation on drug laws: Experts
November 13, 2020
A majority of voters in five states, both red and blue, passed ballot measures that legalized marijuana on Election Day. This show of support at the polls will put more pressure on other states and the federal government to update its drug policies, according to advocates and experts. "This indicates that people are frustrated with the outdated drug policies from the 1970s," Mason Marks, a law professor at Gonzaga University and a fellow in residence at Harvard Law School's Petrie-Flom Center for Health Law Policy, told ABC News. In some cases, like New York, elected officials are publicly sounding the call for major policy changes. In ballot measures passed in New Jersey, South Dakota, Montana and Arizona, residents over 21 will be able to purchase and consume marijuana for recreational purposes. South Dakotan voters also passed a separate measure that legalized medicinal marijuana in the state. Mississippi will also allow adults to use medical marijuana after voters passed an initiative on Election Day. State legislatures and health departments in the five states will come up with the specific regulations for recreational marijuana next year.
D.C. voters to weigh in on ‘magic mushroom’ decriminalization after months-long campaign
October 9, 2020
Melissa Lavasani took “microdoses” of illegal psychedelic mushrooms to recover from postpartum depression in 2018. After her condition improved, she wanted others to have access to the treatment, working for months to get a ballot initiative decriminalizing it in front of D.C. voters. Initiative 81, also known as the Entheogenic Plant and Fungus Policy Act of 2020, made the ballot after months of wrangling over its legality and a nationwide debate about policing and the medical value of psychedelic drugs. If D.C. voters approve the measure, the nation’s capital would join a handful of cities decriminalizing certain psychedelic plants and fungi, including those known as “magic mushrooms.” ... Vocal opposition to the measure, which was endorsed by the D.C. Democratic Party earlier this month, has been muted. Rep. Andy Harris (R-Md.), who fought marijuana legalization in the city, said in August that psychedelics had “some very limited medical value,” but added that he was concerned about the potential for abuse...Mason Marks, an attorney and physician who teaches health law at Harvard Law School, said “there will still be many critics, but it’s difficult to argue that decriminalization is a bad idea.” Racial justice protests over police shootings that galvanized the nation this summer have made the ballot initiative more relevant, he said. Lavasani, a D.C. Department of Energy and Environment budget officer, called the initiative the “only police reform measure on the ballot.” “Everyone is looking to see how we can improve policing in our jurisdiction, and this is one way to do it,” she said. “This is one step to ending the war on drugs. This is one way to exercise that will if you want to.”