The patent application claimed that the treatment rooms were unique because of their "muted colors, high-fidelity sound systems and cozy furniture." A therapist held the hand of a patient in order to assure them. There is a patent that seeks a monopoly on vaginal and rectally delivery of the drug.
Humans have been consuming hallucinogens for a long time. There is a growing scrum of companies that are trying to get a financial edge through a lot of patent claims.
The patent application that described therapy room décor and drug delivery methods was filed by a company that has a value of $450 million. Over the past three years, its competitors have collectively filed more than a hundred applications with the U.S. Patent and Trademark Office.
George Goldsmith, the co- founder and executive chairman of Compass, said that the company's patent strategy was necessary to ensure that psilocybin therapy would be available to people across the globe. Raising hundreds of millions of dollars to conduct clinical trials at 150 sites in Europe and North America is the key to winning over regulators in multiple countries. He said that it is hard and tedious work that can't be done as a philanthropic venture.
Patents are often needed to protect a company's investment in the process of developing new drugs, proving their efficacy and safety through clinical trials, and then winning approval from regulators.
The patent claims by Compass and other companies have provoked howls of mockery from some scientists and patient advocates who warn that corporate efforts to profit from existing drugs could chill academic research and make new therapies too expensive.
Carey Turnbull, the founder of Freedom to Operate, an advocacy group that has been challenging, said that he is not anti capitalist or anti-profit making.
The clash over intellectual property highlights the soaring expectations of investors, philanthropists and researchers who are rushing to shape an emerging field that could change the treatment of depression, substance abuse, post-traumatic stress disorder and other mental health conditions.
Robin Feldman, an expert on pharmaceutical intellectual property at the University of California Hastings College of Law, said that the patent system saddles Americans with high prescription drug prices in the world. She said that it wasn't pretty when you looked under the hood. There is a clash of cultures between those who want to use existing compounds in new and exciting ways crashing up against the reality of the patent system.
The Food and Drug Administration has become more receptive to new uses for the drugs. The agency is considering approval of the uses of MDMA, also known as ecstasy, and psilocybin. Esketamine was approved by the F.D.A. three years ago for the treatment of depression that is resistant to other types of treatment.
For the first time in decades, the National Institute of Health has begun funding research into the effects of drugs, and many of the country's top universities are racing to set up research centers. Many of them have entered into partnerships with drug companies, which are seeking to patent new therapies and share future profits.
The cities of Seattle, Denver, Oakland, Calif., and Washington, D.C. have decriminalized the possession of mushrooms. Oregon will be the first state to offer the therapy.
Most of the companies that didn't exist four years ago have received investment. According to InsightAce Analytic, a market research firm, the drug market is expected to reach $8.3 billion by 2028, but many companies, like their start-up cousins and the overall market, have been buffeted by falling stock prices.
Ritu Baral, an analyst for the investment bank, said that it felt like it came out of nowhere.
Veteran researchers who kept the flame alive during the nation's concerted war on drugs are bracing for the changing terrain. They are thrilled by the gush of promising new studies, positive media coverage and unexpected support from conservative politicians, but also moved by the stories of traumatised combat veterans healed by psychedelic-assisted therapy
Robert Jesse was part of the team that started the research division at the university. He believes that all of humanity is a spiritual tool, not just the wealthy.
A religious group that was seeking to import the natural hallucinogen was represented in the Supreme Court by Mr. Jesse. The court made a unanimous decision in the group's favor.
Mr. Jesse said that the field of psychedelics could be in danger. Talented scientists are leaving academic institutions to take advantage of the surge of money. He and other experts have said that the promise of high returns for investors has led to a decline in philanthropic largess.
It takes a lot of time and money to fight a patent claim and Mr. Jesse is most worried about the flood of patent filings. He said that it is a scorched-earth approach in that a company can generate intellectual property that scares other people from entering the field.
Mr. Goldsmith looks pained when he hears criticism. He and his wife started the company because they were frustrated with the failure of existing drugs to treat their son's depression. Do we try to change the system or do we try to help those people? "Mr. Goldsmith, what do you think?" We made a decision.
Mr. Goldsmith said that the company had been able to get more than $400 million from investors, including the co- founder of PayPal. The company's stock is traded on the stock exchange.
Drug company executives disagreed with the idea that patent filing were attempts to gain a monopoly. The work of scientists trying to enhance the therapeutic value of existing drugs is protected by patents according to the chief executive of Cybin.
Dimenthyltryptamine is a hallucinogen that produces intense experiences. He said that they are brief, sometimes lasting just five minutes to 10 minutes, and that they aren't long enough to help people with severe depression.
Mr. Drysdale said that the company had obtained a patent for an altered version of DMT that would allow sessions to last 30 minutes to 40 minutes. He said that it wasn't modifying the molecule for modification. There is no way to get a return on investment if you don't have intellectual property.
A number of companies, including Cybin, are working to create analogues of the drug that can be used for less time than the current therapy. The goal is to lower the cost of treatment, since many sessions require the participation of two licensed professionals, a safeguard against potential patient abuse that dramatically increases costs.
According to Dr. Stephen Ross, a founding member of New York University's Psychedelic Research Group, he feared that the kind of backlash that killed the field four decades ago could happen again if attempts were made to create shorter episodes. The progress of the past few years could be destroyed by it.
Analysts say that the business model for drugs is problematic. A lot of the therapies are based on just a few sessions. Many of the most lucrative drugs on the market are taken for a lifetime.
Most researchers don't want F.D.A. approval for the compounds alone, but instead for a package that pairs the drugs with talk therapy.
Researchers say that the therapy that prepares patients for taking the drugs and helps them process the experience is key to successful treatment. Giving short shrift to it or overlooking the mind-set of the patient and the place where the sessions take place can lead to bad trips for people with pre-existing mental illnesses.
Dr. Yvan Beaussant is a specialist in palliative care at the Dana Farber Cancer Institute and he is worried that the profit-driven model of drug development will short change psychotherapy.
The kind of talk therapy that works best is the subject of a lot of research. He said that the profit is not forPsychotherapy is not where the profit is for these companies
A group of intellectual property wonks and Archivists are leading the effort to rein in excessive patent claims. They aim to help U.S. patent officials assemble what is known as "prior art," evidence about a drug or therapy that has been overlooked or lost to time that patent examiners can use to reject a flawed or overly broad patent.
Much of the earlier research on drugs was done before the advent of electronic databases, according to a patent lawyer who started Sophia.
Mr. Casimir started the project two years ago after he became alarmed by what he saw as questionable patent claims. If we are doing our job right, the worst, most egregiously overreaching patents will be available on our website for examiners to find.
The organization may challenge patent approvals. Mr. Casimir chuckled when he recalled a company's claim that a combination of drugs was novel. He said that the combination has been around for a long time and is affectionately referred to as "candy flipping."
The company scaled back its claims after being challenged. The company that described room décor and music in its patent application was challenged by the company. The claims were withdrawn in August by the company.
The company is still looking for them outside of the country.
All Rights Reserved © 2024
