There’s no Magic Answer to the Question, “Can I Patent Magic Mushrooms?”
February 24th, 2021
App, Exclusive, Psychedelics, Top News
“Patent pending” is a phrase you are likely familiar with. You have seen it stamped on the side of some doodad at the mall or heard it on the TV show that you are binge watching, and you think to yourself, “Wow, I wish I could invent something that everyone thinks is really cool”. Most of us have had the same thought at some point. Unfortunately, like most things in life, inventing something that changes lives and then patenting the invention is more complicated than you might think, especially in the biotechnology and pharmaceutical space. Someone on TV might have spent a couple of years and a few thousand dollars creating something in their garage but these costs are small in comparison to the costs required to research, test, and produce new drugs. It can take pharmaceutical companies anywhere from 5 to 15 years and more than a billion dollars in research and development costs to create new drugs. Alone, it is a complicated and costly process that, in the case of naturally derived drugs, is further complicated by certain guidelines that are specific to patents for natural products.
Requirements for Patentability
For an invention to be patented it must meet three requirements – it must be novel, useful, and inventive (non-obvious). Every year pharmaceutical companies make educated guesses, create and screen thousands of molecules, and sometimes find a handful that might treat a disease. These molecules occasionally meet the three requirements outlined above: they are a new molecule, they might be useful because early tests indicate there is the potential for them to have a positive impact on our health, and they are inventive because they are not an obvious application of some process or idea that already exists but just hasn’t been applied in this situation. Historically, nature and evolution have had millions of years to make some happy mistakes that have produced a variety of plants that contain chemicals with medicinal properties. While their few successes have been embraced and utilized to treat disease, those same successes render these chemicals unoriginal and thereby, impossible to patent as new compositions.
But Myriad Patented Something Natural?
Although naturally occurring compounds are ineligible for patent protection, there was a period of time where the US Patent Office granted patents for DNA sequences (genes). Myriad Genetics Inc. was granted patents for both the genetic sequences of the BRCA1 and BRCA2 genes, and the methods to diagnose mutations that predispose women to breast and ovarian cancer. The monopolization of BRCA1 and BCRA2 genetic testing was hugely beneficial for the company until their patents were challenged in 2013. The lawsuit argued that the genetic sequences were products of nature, the claims in the patents were invalid, and that Myriad could not block others from offering genetic testing services to women. The case was eventually taken to the Supreme Court where it ruled that, indeed, just like a natural molecule, a naturally occurring DNA sequence was not eligible to be patented. This ruling forced the US Patent Office to release new guidance for patent examiners to consider when reviewing patents based on naturally-derived molecules.
Three Questions to Answer When Trying to Patent a Natural Product
After being patent-ineligible, then eligible, then ineligible again, genes and natural molecules were deemed to be eligible if they met certain criteria. At first glance the guidelines released by the US Patent Office do not look that complicated, the document contains a flow chart with three questions. These questions evaluate if the invention is a new process or thing; if it is related to natural principles, phenomena, or products; and if the invention is significantly different than the version found in nature. Questions 1 and 2 are the easiest to answer and immediately disqualify the chemical compositions found in nature like psilocybin and psilocin from “magic mushrooms”, among others. Answering question 3 requires the consideration of 12 additional factors. In considering these 12 factors, 6 factors weigh in favor of patent eligibility and 6 against, with the majority dictating the answer to the third question. These 12 factors aid a patent examiner in deciding if a naturally derived invention is significantly different than its natural relative.
How MagicMed Patents Natural Molecules
New research has indicated that the psychedelic molecules produced by mushrooms may possess therapeutic properties for treating mental health and brain disorders. The composition of these natural products cannot be patented. However, structurally and functionally altered derivatives of these molecules are eligible for patent protection if they meet the stringent requirements to be considered significantly different from those found in mushrooms. The processes required to create and synthesize such altered derivatives that meet this high bar would pose a challenge for most companies, but MagicMed’s team is a leader in plant-derived molecular derivatives. This expertise has been critical in MagicMed’s success at modifying those same unpatentable, natural molecules found in mushrooms into derivatives that are novel, useful, and inventive. These modifications have ensured that the therapeutic effects of the parent molecules are enhanced and specialized for a particular indication without the negative side effects.
MagicMed’s collection of drug candidates contained in the derivatives library – aptly titled the Psybrary™ – relies on patent applications that claim the composition and method of synthesis for millions of potential molecules inspired by, but uniquely different, from the classic or natural psychedelics. They are confident that development partners will recognize the value of these compound libraries, in part because each new molecule will benefit from 20 years of patent protection. This period should provide partners with the time required to conduct preclinical and clinical testing with their preferred molecule, and move it through the drug development pipeline to ultimately gain marketing and generate a solid return on their R&D investment.
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