As the nascent psychedelics industry continues to grow, the ethical, legal, and social implications of patenting psychedelic compounds are becoming more apparent. Problematic patents and what can be done to address them has become a topic of conversation and considerable debate within the psychedelic field.
While limiting patents in the field of psychedelics, encouraging the formation of patent pledges and working towards large-scale patent reform have been suggested as a few strategies for long term psychedelic patent reform, the nonprofit Porta Sophia has been providing a needed stop-gap to help improve the existing patent approval process.
Porta Sophia is building an online database and searchable library of historical, scientific and cultural information pertaining to psychedelics that they say will support the work of both innovators and patent examiners to prevent problematic, or “bad,” patents from being granted in the first place.
Opening a Doorway to Psychedelic Prior Art
Porta Sophia, which means doorway to wisdom, was founded in late 2020 when patent attorney David Casimir and long-time colleague Bill Linton, co-founder of the nonprofit medical research organization Usona Institute, began discussing new patents being granted in the psychedelic space.
“There were some patents issuing from the patent office that seemed inappropriate,” Casimir says. “And when I dug a little bit deeper, it was clear what was happening.”
Among other requirements, in order for a patent to be granted by the U.S. Patent and Trade Office (USPTO) the invention or technology must be novel, non-obvious and offer utility to society. The bulk of a patent examiner’s work is verifying if these criteria are being met, which they do by searching for peer reviewed literature, existing patents, and other sources of information that point to previous public knowledge of the technology or invention, or similar innovations.
This body of knowledge in patent law is called “prior art.” When it comes to the history, science and culture of psychedelics, prior art is not well known or easily accessed by patent reviewers. “Without appreciating the full scope and content of the prior art a patent examiner quite simply cannot properly do their job,” says Graham Pechenik, patent attorney and founder of Calyx Law.
When Casimir and Linton looked more closely at these inappropriate patents, it became clear that the inaccessibility of information was part of the problem. “The patent reviewers simply weren’t finding the relevant prior art,” Casimir says.
They saw this as a solvable problem. Together with Zachary Kemmerer, a research associate at the University of Wisconsin-Madison, Casimir and Linton surveyed all existing psychedelic patents and ongoing applications. At the time, there were several hundred pending applications but very few issued patents.
“We figured, based on those numbers, we could actually review every one of them and make sure the relevant prior art was made available in a database. And that effectively launched Porta Sophia’s work,” Casimir said.
Bad Patents in the Burgeoning Psychedelic Industry
A patent is a temporary government-granted monopoly, given in exchange for innovation that benefits the public. The term “bad patent” is often used to describe those that make overly broad claims, are not true innovations, or are filed strictly with the intention of scooping up intellectual property rights.
In the commercial psychedelic field now taking shape, early patents can greatly influence who gets to control medicinal compounds, their cost and their accessibility. If history is any indicator, the effects of bad patents could be far-reaching and damaging to the future of the space—for researchers, innovators, investors, patients and the general public alike.
“I see ‘bad’ or problematic patents as generally falling into three categories: bad in terms of quality, bad in terms of policy, and bad in terms of ethics,” says Pechenik.
By low quality patents, Pechenik means those rewarded to technologies that fail to meet basic requirements around novelty and non-obviousness, but are granted primarily due to insufficient awareness of, access to, or understanding of the prior art by the patent examiner. “These are patents that should never have been granted,” he says.
Bad policy patents are considered those that protect only incremental advancements of an existing technology or innovation. An example of this is the patenting of “me-too” drugs which cover only a minor alteration of a chemical compound that is technically novel but makes no meaningful improvement in therapeutic benefit or efficacy.
Regarding ethics, Pechenk says that patents can be “bad” in a number of ways. “Unethical actors may take advantage of the knowledge that patent examination is imperfect,” he explains. Patents can be used to secure swaths of intellectual property simply to extort rent or settlement money from innovators or other entities in the field. Patent litigation might cost millions of dollars, which in itself can act as a deterrent to both innovators and investors. “[These patents] end up slowing down or shutting off progress in a field, sometimes for many years.”
While patents can be challenged after they have been granted, the cost of doing so can climb into seven figure territory. Groups like Freedom to Operate have mounted such challenges, but with the hefty price tags this is not likely to be a widely utilized channel for dealing with questionable psychedelic patents.
Porta Sophia’s approach is to identify bad patents before they are granted, then provide prior art during a period where third-party submissions are accepted by the Patent Trade Office. These submissions are in turn relayed to the patent filer, who can tighten up claims or otherwise improve the patent before the reviewer examines it.
“Given all the reasons that make psychedelics prior art particularly difficult for a patent examiner to find, this can be especially useful in the psychedelics field to help prevent low quality patents,” said Pechenik.
Unfortunately this tack doesn’t work when patent filers elect to pay extra for a relatively new fast-tracking option called “Track One.” This option costs $1,050-$4,200 (depending on the size of the entity) and allows for the complete resolution of an application within 12 months. Because patent applications are held in secret for 18 months after filing, a Track One application effectively eliminates the public comment period.
The team at Porta Sophia has begun to develop relationships with the Patent and Trade Office by establishing direct communication with examiners and providing them with relevant prior art for applications they are handling. “We’ve reached out to the patent office directly to get Porta Sophia incorporated into their internal databases,” Casimir told The Microdose. “That has not happened yet. That’s something we’ll continue to try to do.”
Collecting Prior Art Through a Global Community
Porta Sophia’s team now includes both full- and part-time staff, including IT, research, data and legal experts who are working to identify bad patents and collect the necessary prior art that can be used to help improve them. The nonprofit organization is also supported by volunteers, like Casimir and other patent attorneys, academics, and researchers, and funded through donations.
Porta Sophia has also recently launched a new initiative, the Archival Researchers Network, to build a global volunteer community of psychedelic experts, researchers and archivists to strategically seek out hard to access prior art, especially for ongoing patent applications they identify as high priority. The Porta Sophia team identifies patents most in need of prior art submissions, then disseminate requests to the network to find the relevant materials.
The Archival Researchers Network kicks off on June 1 with a series of presentations from ARN volunteers that will discuss current patent challenges in the psychedelic landscape, and they will be virtual, free and open to the public.