Psilocybin Technology https://psilocybintechnology.com The latest in psilocybin technology Thu, 05 Nov 2020 00:36:25 +0000 en-US hourly 1 https://wordpress.org/?v=5.5.3 Graham Pechenik and Noah Potter discuss Psychedelic Patents https://psilocybintechnology.com/graham-pechenik-and-noah-potter-discuss-psychedelic-patents/ https://psilocybintechnology.com/graham-pechenik-and-noah-potter-discuss-psychedelic-patents/#respond Wed, 04 Nov 2020 17:13:06 +0000 https://psilocybintechnology.com/?p=5342 The New Amsterdam Psychedelic Law blog recently published a video discussion between  Graham Pechenik and Noah Potter about “Who owns psychedelics: patents and state therapeutic access laws.” The blog is ...

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The New Amsterdam Psychedelic Law blog recently published a video discussion between  Graham Pechenik and Noah Potter about “Who owns psychedelics: patents and state therapeutic access laws.”

The blog is run by Noah Potter is a commercial litigator but not a patent attorney.  He interviews Graham Pechenik who is an expert in psychedelic patent law.

In the interview, they discuss the following points:

  • General requirements for patentability and how psychedelic patents fit into that picture
  • Compass Pathways (very narrow) patent to very specific, particular forms of psilocybin.  Mr. Pechenik believes that Compass’s IP will not be relevant to the Oregon psilocybin service centers contemplated by Oregon Measure 109 because those service centers are unlikely to use Compass’s particular crystalline form of psilocybin.
  • Paul Stamets‘s attempts to patent combinations (e.g., the Stamets “stack”) of natural ingredients.
  • How patent law would (and would not) affect the future of the psychedelic landscape.  Mr. Pechenik believes that patents will benefit the industry — in different ways for different businesses. A rising tide lifts all boats.
  • Mr. Pechenik notes that patents don’t necessarily need to be used solely to maximize profits.  He notes that patents could be used to serve the public good.  This could be accomplished by licensing agreements that prioritize the public good.

 

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MindMed – Two Steps Closer to Next Generation Magic Mushroom Formulations https://psilocybintechnology.com/mindmed-two-steps-closer-to-next-gen-magic-mushroom-formulations/ https://psilocybintechnology.com/mindmed-two-steps-closer-to-next-gen-magic-mushroom-formulations/#respond Thu, 24 Sep 2020 19:04:57 +0000 https://psilocybintechnology.com/?p=5307 Over the past several months, MindMed has taken two important steps towards the next generation of psychedelic compositions — formulations that harness the Entourage Effect.  First, MindMed recognized the potential ...

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Over the past several months, MindMed has taken two important steps towards the next generation of psychedelic compositions — formulations that harness the Entourage Effect.  First, MindMed recognized the potential for formulating combinations of active ingredients.  Second, they have expanded their focus to include psilocybin derivatives as active ingredients.

Combinations of Active Ingredients

On August 25th, 2020, MindMed announced a Phase 1 clinical trial “combining MDMA and LSD…. The Phase 1 MDMA-LSD trial is scheduled to start in Q4 of this year in Basel, Switzerland.”  This area of research is groundbreaking because it is the first legitimate clinical trial on a formulation that leverages the synergies between multiple compounds.  See Entourage Effect, e.g., here, here, or hereFormulations with multiple actives (like those found in nature) are better than single active ingredients.  This is why cannabis users prefer full spectrum products to pure THC.  It’s also why people drink coffee instead of pure caffeine dissolved in water.

Psilocybin as an Active Pharmaceutical Ingredient

On September 24, 2020, MindMed announced that they were expanding their research focus to include psilocybin.  According to their press release they are researching the differences between LSD and psilocybin. “MindMed is interested in understanding how psilocybin or LSD affects humans differently so that it can design better later stage trials or potentially even combine substances in future next-generation psychedelic assisted therapies for patients.”  This is a great first step.  Next, MindMed (or someone else) would benefit from exploring all of the other active components in magic mushrooms, like baeocystin, norpsilocin, aeruginascin, etc..

Putting the Pieces Together

MindMed has now opened the door to combination products and also started work with psilocybin.  The next step will be making formulations of multiple tryptamines. In other words, making formulations that combine psilocybin with other active tryptamines that are found in magic mushrooms.

Such formulations will harness the “Entourage Effect” that is provided by consuming magic mushrooms.  (Magic mushrooms have multiple psilocybin derivatives– not just psilocybin– which contribution to the clinical properties of magic mushrooms).

Starting with naturally occurring magic mushrooms, this could be accomplished as illustrated below.  Alternatively, psilocybin derivatives could be easily synthesized and purified in the laboratory.

Naturally occurring psychoactive mushrooms contain many active ingredients. Those ingredients can be extracted with a solvent to eliminate the insoluble structural material of the mushroom. That extract can be further processed, to separate out the molecules present in the extract — resulting in a collection of isolated individual molecules that are much easier to study scientifically.
Psilocybin is just one of those molecules. Psilocybin can also be produced synthetically. Synthetic psilocybin can exist as a number of different salts and crystalline forms. Compass pathways is only claiming one new crystalline form of synthetic psilocybin.

 

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COMPASS Pathways’ $100+ Million Crystalline Form Patent https://psilocybintechnology.com/compass-pathways-100-million-crystalline-form-patent/ https://psilocybintechnology.com/compass-pathways-100-million-crystalline-form-patent/#comments Sat, 05 Sep 2020 19:21:08 +0000 https://psilocybintechnology.com/?p=5285 Compass Pathways Plc. has developed a crystalline form of psilocybin (COMP360) that makes other crystals (like the Hope Diamond, pictured above) look cheap.  Over the last four years, Compass has ...

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Compass Pathways Plc. has developed a crystalline form of psilocybin (COMP360) that makes other crystals (like the Hope Diamond, pictured above) look cheap.  Over the last four years, Compass has built a company around this crystalline form.  Earlier this year, Compass received a patent on this crystalline form.  Now, Compass is going public. And despite zero revenue and plenty of expenses, Compass is already valued at anywhere from $100 to $500 Million.

Why?  Patents.  Specifically, the company’s clever strategy of patenting a novel crystalline form of psilocybin.

Compass Pathways IPO on Nasdaq under the symbol CMPS

On Friday August 25, 2020, Compass Pathways filed to go public on the Nasdaq Global Market under the symbol CMPS.  According to the documents filed with the U.S. Securities and Exchange Commission, Compass plans to raise $100 million through the IPO. According to Bloomberg‘s accounts from “people familiar with the matter, who asked to not be identified because the details aren’t public,” Compass’s “[m]ost recent funding rounds suggest a value of more than $500 million, before proceeds from the initial public offering….”

According to the “Financials” section of the above mentioned SEC S-1 document (see page 118) Compass is not making any money but they are burning through a ton of cash.  They have raised $116M in equity offerings and also issued about $25 Million in promissory notes, which have now converted into equity. (page 129).  As of August 20, 2020, Compass had about $72 Million of this cash remaining.

Why is Compass worth between $100 to $500 Million?

Patents.  And a very clever strategy for attaining them. After spending 4 years and about $60 Million, Compass is not making any money.  However, Compass has developed patent assets that protect its psilocybin product, COMP360.  See Compass Pathways’s PatentsIn January of 2020, Compass Pathways issued a press release stating “that it has been granted US Patent No 10,519,175 (“the ‘175 patent”), relating to methods of treating drug-resistant depression with a psilocybin formulation, by the US Patent and Trademark Office.”  See also Compass Pathways’s Crystalline Form Patent.

Here, Compass deserves some high praise for their approach to patenting psilocybin. Florian Brand, co-founder and CEO of ATAI Life Sciences, Compass’ biggest investor, recognized the importance of being able to “re-ornament chemical compounds in a way that makes them new — and patentable.”  See Investors.com. Mr. Brand explains, “If you talk about the psychedelic compounds, the well known ones, like psilocybin and ibogaine, you certainly have to be a little bit more creative, once there’s a lot of knowledge on these molecules, to establish an ability to block [competitors from entering the space].” He continued: “We are working with attorneys on this, across the platform, with all companies, to have a strong ability to block in place. It ranges from composition of matter, to use patents to process formulation and manufacturing patents.”

Although psilocybin is a natural product and has been in the prior art (in both mushrooms and as an isolated compound), Compass developed a novel crystalline form of psilocybin. By recognizing that COMP360 is a novel crystalline form, Compass’s IP team at Cooley LLP was able to craft a patent strategy based on the differences between Compass’s crystalline form and those already in the prior art.  And it worked!

In allowing Compass’s claims, the patent examiner at the USPTO explained the importance of Compass’s crystalline form data.  Specifically, the examiner’s reason for allowing Compass’s claims hinged on the difference between (A) the characteristics of the crystalline form of psilocybin recited in Compass’s claims and (B) the characteristics of the crystalline form of psilocybin recited in “the closest prior art of record….”  This distinction made it possible for Compass to patent its crystalline form of psilocybin despite 60 years of prior art related to the compound psilocybin and thousands of years of use within naturally occurring mushrooms.

Now, Compass’s patents covering COMP360 (their crystalline form of psilocybin) support an IPO of $100MM+.  As discussed below, Compass plans to use the proceeds from the IPO to develop its most valuable asset: COMP360.

What is Compass’s Plan?

Compass plans to use proceeds from the IPO to fund clinical trials for “COMP360,” its psilocybin crystalline form product. According to the S-1 document filed with the SEC, Compass intends to use the proceeds from the IPO for the following:

  • Fund Phase II clinical trials for COMP360 (their crystalline form psilocybin product), beginning in 2020;
  • Fund R&D for use of COMP360 for other indications beyond Treatment-resistant depression. (The indications being explored in Compass’s investigator initiated studies include: bipolar type II disorder, body dysmorphic disorder, chronic cluster headache, depression in cancer, MDD, and severe TRD.)
  • Fund other business activities, including R&D for other novel drug compounds and strategic investments in digital technologies to complement their therapies

Compass’s Crystalline Psilocybin Makes Diamonds Look Cheap

Looking at the big picture, Compass’s present $100-500 Million dollar valuation and the company’s future all rests on the foundation of a single crystalline form of psilocybin. This one new crystalline form of an old compound (psilocybin) has made it possible for Compass to earn patent protection on its COMP360 product.  That IP is Compass’s most valuable asset.  For comparison, the famous Hope Diamond is worth an estimated $250 Million dollars, making it an exceptionally valuable crystal.  Arguably, Compass’s IP team has already made a more valuable crystal with COMP360, its novel crystalline form of psilocybin.

 

 

 

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MagicMed – The First Psychedelic Patent Troll? https://psilocybintechnology.com/magicmed-the-first-psychedelic-patent-troll/ https://psilocybintechnology.com/magicmed-the-first-psychedelic-patent-troll/#comments Fri, 04 Sep 2020 19:37:30 +0000 https://psilocybintechnology.com/?p=5280 Is MagicMed Industries Inc. the first patent troll to enter the psychedelic space? Or has MagicMed come up with a brilliant plan that will benefit the entire psychedelics industry by ...

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Is MagicMed Industries Inc. the first patent troll to enter the psychedelic space? Or has MagicMed come up with a brilliant plan that will benefit the entire psychedelics industry by providing access to new psychedelic compounds?  The short answer is that only time will tell.  We’ve provided a short discussion below.  Please feel free to offer your thoughts by commenting below.

MagicMed is Clearly Focused on Developing Patents for New Psychedelic Compounds.

On July 9, 2020 MagicMed Industries Inc. (“MagicMed”) announced that it filed a provisional patent application with the United States Patent and Trademark Office (USPTO) covering composition of matter, drug formulation and process of preparation claims for novel psilocybin derivatives.  MagicMed characterized that patent filing as the first in a series of applications that together will protect the Company’s broad portfolio of novel psilocybin molecular derivatives, the PsybraryTM.

On August 24th, 2020, MagicMed issued a press release confirming the company’s intention to file patent applications.  According to the press release, “MagicMed Industries intends to file numerous patents to stake broad claims over the new derivative molecules contained in the Psybrary™, from which the company’s partners can gain a significant competitive edge in new product development using molecules that are fully patent protected.”

According to MagicMed, “[t]he initial focus of the Psybrary™ is on psilocybin, and is expected to expand to other psychedelics, including MDMA, ketamine, ibogaine, mescaline and ayahuasca.”

What is MagicMed’s Psybrary?

Based on MagicMed’s press releases, the term “Psybrary” refers to a library of different psychedelic molecules, “derivative molecules,” presumably because they are based on known psychedelics like psilocybin. MagicMed defines term “Psybrary” in their August 24th, 2020 press release as a “collection of novel psychedelic derivatives we are amassing through an industry leading combination of synthetic biology and medicinal chemistry.”  This approach is interesting.  Instead of synthesizing the compounds via synthetic chemistry, MagicMed is using synthetic biology (bioengineering) and medicinal chemistry (usually reserved for studying the properties of compounds as opposed to making the compounds themselves).

What is MagicMed’s Strategy?

MagicMed is synthesizing new psychedelic compounds with the intention of selling or licensing them to others in the industry. (“MagicMed is employing a diversified partnership model.  What that means is we see ourselves as enablers of the entire sector.”)

MagicMed does not have aspirations of conducting clinical trials but rather intends limit their focus to developing new psychedelic compounds. (“We are really good at creating new drug candidate psychedelic derivatives, but don’t aspire to get into clinical trials ourselves.”)

What Value is MagicMed Creating?

Patents.  Plain and simple.  MagicMed is clear about this point.  They are synthesizing psychedelic compounds and patenting them. “We anticipate filing many patents and synthesizing many new molecules, which our partner companies can screen to find their ideal drug candidate to select and advance into further development.”

“The Psybrary we anticipate will be a highly valuable resource for our partners, as it will contain many new molecules to screen, increasing their chances of finding an ideal drug candidate, and each molecule will come with a commercially-friendly manufacturing method and have its composition patent protected. We expect this will be a big asset for our partners, and could be a big hurdle for those who don’t partner with us.”

In other words, MagicMed’s “partners” can use the compounds in their Psybrary without getting sued for patent infringement.  And MagicMed’s patent portfolio can be view as a moat (aka “big hurdle”) around those compounds “for those who don’t partner with us.”

Is MagicMed the First Psychedelic Patent Troll?

Good question.  The term “patent troll” best describes a non-practicing entity that seeks to extract royalties from other practicing entities by leveraging its patent portfolio.  Whether or not MagicMed qualifies as a patent troll probably depends on what R&D MagicMed contributes to the industry.

On the one hand, MagicMed is candid about their lack of interest in clinically developing their compounds in favor of “partnering” with others interested in doing that work.  This feels like trolling because the patent owner is holding downstream research hostage in order to extract a profit by enforcing patents on technology that the patent owner has no intention of using itself.

On the other hand, MagicMed appears focussed on filling a longstanding unmet need for making psychedelic compounds. The industry wouldn’t have the ability to work with these compounds at all without MagicMed’s efforts in synthesizing them.  Arguably, their patent portfolio will enable them to enjoy some form of compensation for making those compounds available to the rest of the world.  Additionally, some have pointed to a lack of IP in the psychedelic space as a major limitation to attracting meaningful investment capital.  Creating patent assets solves this problem, allowing for growth in the space.

 

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Aion Therapeutics Files Five Patent Applications https://psilocybintechnology.com/aion-therapeutics-files-five-patent-applications/ https://psilocybintechnology.com/aion-therapeutics-files-five-patent-applications/#respond Fri, 04 Sep 2020 18:32:19 +0000 https://psilocybintechnology.com/?p=5277 In an September 3, 2020 press release on Psilocybin Alpha, Aion Therapeutics reported that it was “pleased to announce that the Company has filed five patent applications with the United ...

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In an September 3, 2020 press release on Psilocybin Alpha, Aion Therapeutics reported that it was “pleased to announce that the Company has filed five patent applications with the United States Patent and Trademark Office (USPTO) pertaining to new treatments combining healing compounds in medical cannabis with healing compounds from mushrooms (edible and psychedelic), and other natural plants known for their medicinal properties.”

The press release also clarified that these are provisional patent applications.  “Aion Therapeutic’s intellectual property counsel, Pinnacle IP Strategies LLC (“Pinnacle“), drafted and will prosecute the patent applications. According to Pinnacle, Aion Therapeutic’s provisional patent filings in the U.S. will provide Aion Therapeutic a right of priority under the Paris Convention to pursue patent protection to Jamaica, as well as, priority for over 170 countries under the Patent Cooperation Treaty (“PCT“). Establishing an effective filing date for Aion Therapeutic’s inventions in the U.S. preserves that priority date – with up to one year to pursue a subsequent filing in any country that is a party to those agreements.”

In a previous post about How to Evaluate Psychedelic Patents, we distinguished between issued patents, pending patent applications, and provisional patent applications. The later two have not been issued/granted and must first be examined in order to see if the claimed invention is both (1) New and (2) Non-obvious in view of the prior art.  (Prior art means anything published before the application’s priority date, which in Aion’s case appears to be sometime in the summer of 2020.

In the case of Aion Therapeutics, it is unclear how the company will overcome the prior art issued associated with other (much earlier filed) patent applications that are directed to (what appears to be) very similar subject matter.  For example, this patent application by inventors Murat KÜÇÜKSEN and Neset KÜÇÜKSEN shows up on Google Patents by searching for Psilocybin + Cannabinoid.  The application has a priority date of January 18, 2017 and “relates to the use of one or more cannabinoids and/or terpenes in combination with psilocybin and/or psilocin for use in the prevention or treatment of psychological or brain disorders. Preferably the one or more cannabinoids are taken from the group cannabidiol (CBD); cannabidiolic acid (CBDA); tetrahydrocannbidivarin (THCV); tetrahydrocannbidivarinin acid (THCVA); cannabichromene (CBC); cannabichromenic acid (CBCA); cannabigerol (CBG) and cannabigerolic acid (CBGA).”

One possibility is that the Aion technology does not use psilocybin and/or psilocin but relies on other “psychedelic” components from mushrooms.  (The above mentioned KÜÇÜKSEN application is limited to combinations that include psilocybin and/or psilocin with the cannabinoid(s).).   Another possibility is that the Aion technology avoids the use of the cannabinoids listed above as part of the KÜÇÜKSEN application.

The idea of combining a psilocybin derivative with a cannabinoid does have tremendous promise because of the potential for harnessing the Entourage Effect and making formulations that are better than single active ingredients (see, e.g., Compass Pathways use of pure psilocybin without the other synergistic actives in magic mushrooms). But, can Aion pursue this technology without running into competing IP, like the KÜÇÜKSEN application? Moving forward, it will be interesting to learn more about Aion’s patent portfolio, especially what makes it “novel” as we watch the situation develop.

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5 Tips for Evaluating Psychedelic Patents https://psilocybintechnology.com/5-tips-for-evaluating-psychedelic-patents/ https://psilocybintechnology.com/5-tips-for-evaluating-psychedelic-patents/#comments Tue, 07 Jul 2020 17:51:50 +0000 https://psilocybintechnology.com/?p=5135 In previous articles, Psilocybin Technology wrote about the emerging psychedelics industry and its newfound focus on intellectual property. The recent and dramatic increase in patent filings gives rise to questions ...

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In previous articles, Psilocybin Technology wrote about the emerging psychedelics industry and its newfound focus on intellectual property. The recent and dramatic increase in patent filings gives rise to questions about how to evaluate intellectual property within the relatively new (but no longer infant) psychedelics space.  

At a high level, analyzing psychedelic patents is pretty straight forward.  Start with the claims in the application and ask whether the subject matter defined by those claims is (1) New, (2) Non-obvious, and (3) adequately enabled, described, and defined within the application.  These criteria highlight the critical importance of the patent’s priority date, which determines what body of evidence is available to inform those questions.

In practice, evaluating a patent portfolio can take weeks and tens or hundreds of thousands of dollars of analysis from a patent attorney.  This article seeks to give investors some tips for performing a simple litmus test for a psychedelic patent portfolio.

Below are 5 key questions for investors to consider when evaluating a psychedelic patent portfolio.

Five Key Questions for Investors to Ask about Psychedelic Patents

#1 – When you say “Patents,” do you mean Patented or Patent Pending?

  • The term “patent” is often used interchangeably to describe any type of patent application. See, e.g., Troy Farah’s most recent Double Blind article (published July 10, 2020) about toad venom, where he describes the subject matter published in a pending application (WO2014115113A1) as “already been patented.” This article illustrates the widespread confusion in the psychedelic space between patents, patent applications, patent publications. And, there is a big difference between a published or pending application and a granted (or issued) patent.  For example, the “patent” identified by Mr. Farah is not a patent but rather a pending application that has been abandoned in all but one of the territories where the applicants initially sought patent coverage. 

    Screenshot from Google patents, showing the status of International Patent Application No. PCT/IB2014/058524, which published as WO2014115113A1. Notably, the application has since been ABANDONED in all territories but Japan, where the application is still PENDING. The application has not issued into a patent anywhere in the world.
  • The word “patent” describes a granted patent not a pending patent application. The former refers to claims that have issued after being examined by the patent office in view of the post relevant prior art. Granted patents are presumed to be valid because they have been evaluated by the patent office prior to issuance. The patent office has determined that the claims are new (aka novel) and non-obvious. 
  • Pending applications have not been granted; many have not been substantively examined; some haven’t been examined at all. Evaluating pending patent applications requires determining how the patent office will examine the claimed subject matter and making an educated guess as to what claims will be allowed. The documents exchanged between a patent applicant and the patent office are published, providing insight as to the ultimate disposition of the case.  
  • Provisional applications are not published and never get examined. They merely serve as priority documents for applicants wishing to pursue non-provisional applications. Accordingly, there is no objective information about the value of a provisional application available in the patent file, leaving all of the guesswork to investors.

#2 – What is the priority date of the patent or application?

  • Only new and non-obvious inventions are patentable. The novelty and non-obviousness (or inventive step) of those inventions are evaluated based on the priority date of the application.
  • An invention is new if it was not disclosed in any publication before the priority date of the patent application claiming the invention.
  • Any disclosures published prior to the priority date of the patent application are collectively referred to as the “prior art.” The priority date determines what is (and is not) prior art. Was the invention new and not obvious at the time of the priority date.  As we discussed elsewhere, the recent explosion of psychedelic technologies didn’t really start until 2018 or 2019.  So, inventions having priority dates prior to this gold rush have a tremendous advantage as to what constitutes prior art during examination.  By contrast, applications filed in 2019 or 2020 have significantly greater risks of encountering “prior art” issues.  
  • An invention is non-obvious if the prior art would not have rendered it “obvious” to a person of ordinary skill in the psychedelics industry.
  • The priority date is critical because it defines what is (and is not) prior art.  This is critical in the psychedelics industry where technology is evolving rapidly. Today’s groundbreaking idea could seem obvious next year. To maintain objectivity during the examination process, an invention is evaluated for novelty and non-obviousness based on its priority date.
  • Below is an example of a patent document, which shows where the priority information is printed. This is Compass Pathway’s crystalline form patent.  Note the priority date of October 9, 2017. In the relatively new psychedelics space, a priority date from 2017 is excellent because it precedes the ongoing race to file patents on psychedelic technology.
Portion of the face of Compass Pathway’s U.S. Patent 10,519,175 B2, showing data about the application. Here, at section 30, the Foreign Application Priority Data shows that Compass claim priority dating back to October 9, 2017, which (in the psychedelic space) is a very good, i.e., relatively early priority date.

#3 – What is the claim scope of the patent or patent application?

  • The most important part of any patent document is the claims. The claims define the invention. The claims define the property that is owned (or sought to be owned in a pending application) by the applicant. Often patent documents have flashy titles or expansive language in some parts of the application but extremely narrow claims.  Accordingly, it’s important to evaluate the claimed property, which is defined by the claims.
  • Do the claims define compounds, compositions, methods, processes, or something else?  David Nichols, Ph.D., a professor emeritus of medicinal chemistry and molecular pharmacology at Purdue University correctly explains that “The strongest patents are based on novel molecules,” i.e. compounds or compositions of matter. Patents claiming compounds or compositions of matter provide protection for all uses of those materials and offer the highest possible level of protection for psychedelic inventions. 
  • An article published in Lucid News describes several fall back positions for claiming patentable subject, including Compass Pathways’s strategy for patenting a novel crystalline form of psilocybin.
  • Companies that do not have compound (or composition of matter) patents will likely argue that claims to other types of subject matter (e.g., methods of use) are just as good. That’s a red flag. The company is already working with derivative technology. The compounds or compositions are already in the prior art, which is why they can’t claim them.  For a recent example, see MindMed’s July 2020 Corporate update where Stephen Hurst repeatedly de-emphasized the importance of composition of matter patents.  Because the MindMed team is working with prior art compounds, LSD and 18-MC, they are unable to claim compositions of matter.  Accordingly, the “close to a dozen” patent applications they filed (since March 2019) are probably directed to methods of use and/or other less valuable subject matter.
  • Do the claims in the patent cover the company’s product?  This sounds like a dumb question but it’s often overlooked. Even if a psychedelics a company has an extensive patent portfolio and a promising product line, a smart investor should ask to see how the claims cover each specific product of interest.  This can be accomplished with a claim chart, which is beyond the scope of these high-level tips.

#4 – How many claims are in the patent or patent application

  • Does the patent portfolio have multiple claims directed to the technology of interest?  Does it claim the technology in multiple different ways?
  • Each patent claim is a distinct property.  Protecting a product with multiple patent claims multiples the level of protection. A competitor challenging the validity of the IP would need to invalidate all claims covering the product.  Ideally, a company would protect a compound, compositions (or formulations) containing the compound, methods of making the compound and the formulations, and methods of using them to treat various diseases and conditions.  
  • Ideally a patent has a collection of claims that define the invention as various levels of generality, with some claims capturing the broadest reaches of the innovation and other narrowly tailored to a particular embodiment in order to avoid prior art problems.  Here, companies often claim a genus of compounds, various subgenuses of compounds, specific molecules, and also specific forms or formulations of the molecules.

#5 – How many applications are in the portfolio?

  • Much like the number of claims in an application, the number of applications in the portfolio provides some high-level insight regarding a company’s IP strategy. 
  • Does the company frequently and consistently capture new innovation in patent application throughout the research and development process?  Or was the company happy enough to simply check the “IP” by filing a couple of applications?  Either of these strategies allows a company to say that they “have IP.”  But, the value of that IP can be considerably different. 

Conclusions – Look for lots of claims with early priority dates

The above 5 tips are simple, high-level questions to get started with evaluating a patent portfolio for a psychedelics company.  Assessing the value of a specific portfolio requires studying each claim in each application in view of the prior art that was available at the earliest priority date for that application.  That analysis can be resource intensive.  The above tips are intended to offer investors some simple ways to quickly identify potential strengths and weaknesses in a psychedelic company’s IP portfolio. While anyone can file a provisional patent application and boast “we have patents pending,” portfolios that have diverse claims, carefully directed to the product(s) of interest, with early priority dates are probably going to provide the most value in the long run.

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Psychedelic Patents – The Cat’s Out of the Bag https://psilocybintechnology.com/psychedelic-patents-the-cats-out-of-the-bag/ https://psilocybintechnology.com/psychedelic-patents-the-cats-out-of-the-bag/#comments Sun, 05 Jul 2020 19:24:35 +0000 https://psilocybintechnology.com/?p=5128 Patents on Psychedelics are No Longer a Novel Idea In January of 2020, we published an article about “Psychedelic Investment Opportunities,” in which reiterated our earlier position (from 2019) that ...

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Patents on Psychedelics are No Longer a Novel Idea

In January of 2020, we published an article about “Psychedelic Investment Opportunities,” in which reiterated our earlier position (from 2019) that Intellectual Property would become a key consideration within the nascent psychedelic industry. We pointed out that “Although many entities have started filing patents directed to psychedelics, the space is still relatively new and uncrowded.  As the space develops, the importance of good intellectual property will increase; and the likelihood of creating meaningful intellectual property will probably decrease.  Accordingly, investing in companies developing new, broadly applicable technologies with a strong commitment to intellectual property seems to be the best strategy as we enter 2020.”  

Other industry experts have now echoed Psilocybin Technology’s sentiments.  For example, Matthew Baggott, former director of data science and engineering at the biotechnology corporation Genentech, explains “As psilocybin nears approval for depression, you will see many other groups applying for patents involving other psychedelic tryptamines.”  Based on the increasing number of patent filings and patent-centered press releases, it appears that the future is now. The importance of psychedelic patents is no longer a prediction.  It’s a fact. The race to patent psychedelic technology has exploded throughout the first half of 2020. Below are a few highlights of how companies are describing their intellectual properties strategies. 

Recognized Importance of Patents in the Emerging Psychedelic Industry

Below are several examples of disclosures pertaining to patents in the psychedelic space.  Although these are just snippets from the mainstream media, they illustrate two clear trends. First, in 2019-2020, the industry’s attention to intellectual property has increased dramatically. Second, much of the patent related activity appears to be focused on marketing rather than research and development, raising questions as to whether any of the recent IP has any value outside of attracting attention through press releases using the work “patent” in the title.

Some have noted the importance of this buzzword.  For example, on January 22, 2020, Vince Sliwoski of Harris Bricken noted that Compass’s COMP360 patent is not the only patent application related to psilocybin, but it has generated a lot of press.  Others have pointed out the importance of a substantive IP strategy. For example, in March of 2020, Gretchen Temeles of Duane Morris, LLP wrote an article about “Patent protection of psychedelic therapeutics,” in which she observed that “the renewed interest in psychedelics has spawned an increase in commercial activity and an increase in the number of patent applications and granted patents covering psychedelics.” Dr. Temeles advised that  “companies in the psychedelic therapeutics area would do well to take a page out of the cannabis playbook…. As commercialization in the psychedelic therapeutics area moves forward, those companies with strong patent portfolios will be at a competitive advantage.” See Analogy to Cannabis.

In any event, the psychedelics industry has fully embraced the importance of intellectual property and started filing patent applications on questionable inventions.  As a result, investors will need to change their thinking when it comes to evaluating IP.  Instead of asking whether a company has filed patents, a savvy investor will need to take a closer look at when the patent applications where filed and how the growing number of disclosures may affect those filings.

  • In December of 2019, Psilocybin Technology published an article describing Silo Wellness’s patent strategy. At the time, the aggressiveness of Silo Wellness’s intellectual property strategy was noteworthy.  At the time, their webpage emphasized its “Provisional Application for a Patent for metered dosing formulations” and directed readers to an entire page dedicated to Intellectual Property.  On that page (since removed), Silo Wellness explained: “We have filed [in July 2019] a provisional application for a patent to cover metered dosing formulations of plant and fungal compounds for oral, nasal, sublingual, and topical use. We are developing solutions for metered dosing for mushrooms, Ayahuasca/DMT, and peyote/mescaline.”  The intellectual property was apparently developed by Michael Hartman, who has developed extensive metered-dose inhaler IP for other pharmaceutical companies. Silo Wellness further highlighted it’s IP-guided strategy by describing its dual focus on technology and IP:  “The problems we are attempting to address through protectible IP (patent and trade secrets) are as follows: 1. How to deliver a predictable and safe experience; and 2. How to make them palatable. 
  • According to their December 2019 press releases, Yield Growth Corp. and its subsidiary Flourish Mushroom Labs “has filed 13 patents to protect its extraction method and formulas and one patent for the use of compounds in psychedelic mushrooms to treat obesity and diabetes and to aid in weight loss.” See Yahoo Finance. According to their press release on Bloomberg, “Yield Growth earns revenue through multiple streams including licensing, services and product sales.” In a subsequent press release on May 14, 2020, Yield Growth announced that its subsidiary “NeonMind has filed a U.S. provisional patent application to protect the invention that the administration of psilocin and/or psilocybin results in overall weight loss in individuals….” Then, less than one month later, the company issued another press release, announcing that “Neonmind expands development of psychedelic patent portfolio” and promoting its June 5, 2020 filing of another patent application. Then, on June 18, 2020, the company issued another press release about filing another patent application. In that press release, Dr. William Panenka, Chair of the NeonMind Scientific Advisory Board explained, “As part of our overall patent strategy, we are establishing defensible intellectual property around multiple compounds that act on these receptors and intend to follow this with rigorous clinical trial work to establish efficacy.”
  • According to their webpage, Frontier Neurochem “has developed patent-pending technologies and formulations of Psilocybe mushroom and Iboga alkaloids extracts meeting cGMP Pharma-grade standards for safe and effective pharmaceuticals.”
  • ThinkMyco describes its business focus as the “development of unique technologies and IP spanning the whole range of fungi based growth industries.”
  • In April 2020, Debra Borchardt reported that “Orthogonal Thinker Takes Steps Towards Patenting Psilocybin Product.”  Ms. Borchardt explained that Orthogonal’s steps involved filing a provisional patent application.
  • In an April 22, 2020 press release, Kevin O’Leary and Bruce Linton backed MindMed announced that the company “…discovered and filed a patent application in the United States (preserving all worldwide rights) for a neutralizer technology“MindMed, working with the Liechti Laboratory, will continue to research and build a patent portfolio around psychedelic compounds that create novel approaches to medicine.”
  • On April 29, 2020, Revive Therapeutics issued a press release advertising that “The Company has key provisional patent applications with the U.S. Patent and Trademark Office that cover methods of production of psilocybin-based formulations, including sublingual sprays, effervescent tablets, hard-shell capsules, sublingual and transmucosal delivery systems (i.e. gum drops, oral strips, dosing pens). Furthermore, Revive has a patent-pending portfolio that includes Psilocybin extraction and crystallization methodologies.”
  • On May 26, 2020, Shayla Love wrote an article in Vice predicting that “As magic mushrooms make the shift from recreational drug to mental health treatment, patients won’t be eating caps and stems, but a synthetic product made in a lab—one that can be patented and profited from.”
  • On June 29, 2020, North Sur Resources and Mindset pharma issued a press release touting their intellectual property and explaining that “Mindset is an Ontario-based psychedelic pharma company that has filed multiple patents for new, pharmacologically optimized psychedelic medicines.” That press release further stated that “Mindset has filed multiple patent applications describing its new chemical entities and is advancing a group of compounds through pre-clinical screening in order to identify one or more lead compounds to select for clinical trials. Mindset’s goal is to develop a broad portfolio of psychedelic-inspired intellectual property around novel drugs and related synthesis processes that will grow in value as the psychedelic medicine space develops and regulatory acceptance increases.”

The above publications demonstrate how the psychedelic industry has now recognized the value of intellectual property. The trend can be further illustrated by using Google’s search tools to search for relevant articles by date.  For example, prior to 2020 there were far fewer mentions of psychedelic related intellectual property. Prior to 2019, there were only a few pages of Google results relevant to the topic. And prior to 2018, it’s hard to find articles discussing the topic at all.

But is your patent worth anything?

In conclusion, the psychedelic’s industry has moved into what was once a wide open space for developing technology.  Prior to about 2018, the opportunities for patenting new psychedelic technologies were virtually limitless. Now the situation has changed. New psychedelic companies are emerging every week.  And each new psychedelic company claims to have intellectual property that will guarantee its dominance over the future of the industry. Now that the psychedelic patent landscape has started to fill up with new players, the patent-related questions have also evolved. While simply filing a patent application was significant prior to about 2019, the new question is whether a particular patent application has any value given the influx of other entities racing to claim similar inventions.  The industry has already seen the rise and impending fall of Compass Pathways patent, which foreshadows the next wave of IP questions in the industry.

** Here is a link to 5 High Level Tips for Evaluating a Psychedelic Patent Portfolio.

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MAPS Speakers Discuss Importance Entourage Effect and “Minor” Tryptamines https://psilocybintechnology.com/maps-speakers-discuss-importance-entourage-effect-and-minor-tryptamines/ https://psilocybintechnology.com/maps-speakers-discuss-importance-entourage-effect-and-minor-tryptamines/#respond Wed, 01 Jul 2020 19:30:14 +0000 https://psilocybintechnology.com/?p=5115 Scientists at MAPS Webinar Series Discuss the Importance of “Minor” Tryptamines and the Entourage Effect Recently, several experts in psychedelic medicine have presented at MAPS webinar series hosted by Shannon ...

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Scientists at MAPS Webinar Series Discuss the Importance of “Minor” Tryptamines and the Entourage Effect

Recently, several experts in psychedelic medicine have presented at MAPS webinar series hosted by Shannon Smadella. The series draws from a diverse group of speakers, including Mark Haden, Nan Shuni Giron, Nan Shuni Giron, Dr. Dennis McKenna, Paul Stamets, Rick Doblin, Erika Dyck, Zoe Helene, Chris Dyer, Duncan Trussell, Kuauhtli, Dr. Monnica Williams, Dr. Bia Labate, and Wade Davis.  The series covers a broad range of topics, several of which pertain to science and highlight the state of the art as follows:

  • There is a growing appreciation for the importance of the entourage effect provided by consuming psychedelics in their natural form; 
  • But, natural products are not “standardized,” making them unsuitable in contexts where it’s important to administer a precise amount of known ingredients;
  • And, although the scientific community has made significant progress studying some single molecules in natural products, our understanding of the “minor” components is still in the dark ages, presumably due to a lack of reliable compounds.

Growing Recognition of the Entourage Effect

Magic mushrooms contain psilocybin but they are not the same as psilocybin. On the MAPS website, Paul Stamets notes that “Psilocybin is one molecule of several that can cause altered states of consciousness” in magic mushrooms.  In other words, there is a difference between (a) pure psilocybin and (b) the cocktail of active ingredients naturally present in magic mushrooms.  Here, Mr. Stamets notes that “Psilocybin mushrooms have been used for thousands of years” whereas “Psilocybin as a molecule has been used for a few dozen.” Mr. Stamets points out that “the single-molecule medicines available for psychotherapists have failed to show the same level of positive outcome,” indicating that consuming the full spectrum of compounds provided by naturally occurring magic mushrooms may have advantages over “the reductionist view” of using single purified molecules.

Mr. Stamets’s insightful points lead to his ultimate question: “Where and when can the use of the natural form of psilocybin mushrooms be appropriate for psychotherapy and cognitive health?”  On the Joe Rogan Podcast #1385, he suggests an answer: We need standardized formulations that provide multiple magic mushroom active ingredients.

Unmet Need for Standardized Formulations of Multiple Compounds

Given the advantages of consuming natural products, why does the industry appear to be moving towards making compositions with only a single active ingredient, like pure psilocybin?  In a recent interview with Joe Rogan, Mr. Stamets explains, “The problem with natural products is how do you standardize them to the active constituent when you have more than one active constituent, you know, how do you standardize them all?”  Here, Mr. Stamets appears to recognize the benefits of both (1) “standardizing” psychoactive drugs, i.e. using known amounts of known ingredients and also (2) preserving nature’s cocktail of active ingredients.  What would this look like in practice?

One might envision making formulations that include multiple active ingredients from magic mushrooms in standardized precisely dosed amounts. For example, a formulation that includes psilocybin and another magic mushroom active, like baeocystin.  Another example would be formulations that include both psilocybin and aeruginascin. See Gartz, J., Int. J. of Crude Drug Research Volume 27, 1989 – Issue 3, pp. 141-144. (“It seems that the significant amounts of the indole derivative aeruginascin can modify the pharmacological action of psilocybin to give an euphoric mood during psychosis with hallucinations.”) Alternatively, one might envision standardized formulations that exclude psilocybin and provide only the “minor” alkaloids, such as baeocystin, norbaeocystin, norpsilocin, and/or aeruginascin. Many other examples are possible and different combinations of these molecules could have different benefits for different people in different situations.  

The Massive Potential of “Minor” Components

Psilocybin is one promising molecule but it’s just the tip of the iceberg. The cannabis industry has recently learned this lesson: THC was once considered the single active ingredient in cannabis; but now scientists recognize the importance of other molecules like CBD as well as the importance of combining different cannabinoids and terpenes to modulate or optimize the properties of the formulation.  On this topic, the previous week’s speaker at the MAPS webinar, Dr. Dennis McKenna also discussed the importance of some lesser known, “minor” components in psychoactive plants and fungi.

On June 16th, 2020, Dr. Dennis McKenna presented a talk titled “Psychopharmacognosy: Prospects for Discovering Novel Psychedelics in Nature.” Dr. McKenna notes that “most people are familiar with the major natural psychedelics, such as psilocybin mushrooms, Ayahuasca, San Pedro cactus, Peyote, etc. All of these have a rich cultural and historical background, and the pharmacology and chemistry of the active constituents is well understood.” For example, scientists have made considerable progress studying and understanding the pharmacology of psilocybin, which has been touted as “the active constituent” of magic mushrooms.  Dr. McKenna contrasts these advances in single molecule pharmacology with our relatively poor understanding of natural medicinals and the many “minor” compounds that contribute to their pharmacology: “Yet hidden within the vast biodiversity of the planet, undiscovered psychedelics remain poorly investigated, if they are known to science at all.”  

Although both Dr. McKenna and Mr. Stamets recognize the potential importance of “minor” compounds, scientific studies in this area are just beginning to emerge.  For example, it wasn’t until 2017 that Dirk Hoffmiester discovered the compound norpsilocin in magic mushrooms. And it wasn’t until 2020, that Sherwood et al. published a synthetic method for producing norpsilocin and other minor magic mushroom compounds in the laboratory.  In that 2020 paper, the authors explained that “few studies have been conducted to evaluate pharmacological activity of these tryptamines, largely due to lack of availability of the compounds.” In other words, the first step to studying compounds is sourcing the compounds.

By synthesizing norpsilocin, Sherwood’s team was then able to conduct the first pharmacological screening of the compound.  Surprisingly, they found that it is even more potent than psilocin (the active metabolite of psilocybin) at 5-HT2A but strangely does not produce a “head twitch response” characteristic of “tripping” when administered to laboratory animals. Could norpsilocin provide some of the therapeutic benefits of magic mushrooms without the trip?  Based on Paul Stamets’s account of consuming pure baeocystin (a prodrug of norpsilocin), this seems possible: “So, here we found an analog of psilocybin that does not get you high, that’s legal, that reduced anxiety. I think it’s the tip of the proverbial iceberg.” See Joe Rogan Podcast #1385.

Sherwood’s team also synthesized aeruginascin, baeocystin, and norbaeocystin, opening up similar areas of research. Aeruginascin is a particularly interesting compound because it has been implicated in causing temporary paralysis (see Sherwood) and/or heightened euphoria (see Gartz).  Although the mainstream media (e.g., Vice, DoubleBlind) has recently discussed the importance of these phenomena, the pharmacology of aeruginascin has not been scientifically studied.  Notably, aeruginascin’s putative active metabolite (it’s dephosphorylated analog, 4-OH-TMT) has not been synthesized, which could be responsible for the lack of research in this area. Milne et al. observed 4-OH-TMT as a fermentation product of genetically engineered Saccharomyces cerevisiae but they did not isolate the compound or study its pharmacology.

 

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Patent Attorney Charles Boulakia joins Flourish Mushrooms https://psilocybintechnology.com/patent-attorney-charles-boulakia-joins-flourish-mushrooms/ https://psilocybintechnology.com/patent-attorney-charles-boulakia-joins-flourish-mushrooms/#comments Wed, 05 Feb 2020 18:09:19 +0000 https://psilocybintechnology.com/?p=4152 On February 4, 2020, the Yield Growth Corporation announced that Patent Lawyer, Charles Boulakia was appointed to the Flourish Mushroom Labs Advisory Board. According to the press release Mr. Boulakia ...

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On February 4, 2020, the Yield Growth Corporation announced that Patent Lawyer, Charles Boulakia was appointed to the Flourish Mushroom Labs Advisory Board. According to the press release Mr. Boulakia “has over 20 years of experience in the preparation and prosecution of patent applications in a variety of industries including: biotechnology, chemistry, biofuel, oil and gas and pharmaceuticals.”  Mr. Boulakia is a registered patent agent (reg. no. 58,616) at the United States Patent and Trademark Office. According to his firm’s webpage, Mr. Boulakia is a partner of Ridout & Maybee LLP in the firm’s Toronto office.

Yield Growth CEO, Penny White Discusses New Patent Attorney, Charles Boulakia

According to Yield Growth CEO, Penny White, “Our plan is to develop proprietary processes for the cultivation, extraction and processing of psilocybin magic mushrooms, and also develop data through trials about dosages and uses of psilocybin for therapeutic use.”  Towards these goals, Ms. White expressed her enthusiasm that “Charles [Boulakia’s] expertise will be an enormous asset as we develop our intellectual property strategy. He will also be instrumental in our efforts to scientifically prove certain therapeutic benefits of magic mushrooms.”

Yield Growth and Flourish Mushrooms Recent Patent Filing Efforts

On December 10, 2019, Yield Growth Corporation announced that its subsidiary Flourish Mushroom Labs filed a U.S. provisional patent application relating to “methods of using serotonin antagonists, in particular, psychedelic mushroom actives, for weight loss. See Yahoo Finance. See Psilocybin Technology’s article discussing how this work was originally considered groundbreaking.  Presumably, Mr. Boulakia will assist Flourish Mushrooms by developing this and other intellectual property assets.  From the press release, it also appear that Yield Growth and Flourish Mushrooms are in the process of developing an intellectual property strategy.

Based on the press release and other publicly available information , it is unclear how Mr. Boulakia will assist with “scientifically prov[ing] certain therapeutic benefits of magic mushrooms.”  Although Mr. Boulakia’s impressive academic record includes an M.Sc. (Biochemistry) from McGill University’s Cancer Research Centre (1996), his recent professional activity does not seem focused on conducting the clinical research required to “prove certain therapeutic benefits of magic mushrooms.”  Such scientific studies are typically conducted by medical doctors and research scientists.

Importance of Patents and Intellectual Property in Nascent Psychedelic Space

Despite a lack of clarity regarding the scope of Flourish Mushrooms’s IP portfolio or how Charles Boulakia will assist in  “scientifically prov[ing] certain therapeutic benefits of magic mushrooms,”  Yield Growth and Flourish Mushrooms are 100% clear about the importance of intellectual property within the nascent magic mushroom industry. See also Psychedelic Investment Opportunities.

Arguably, entrepreneurs looking to invest in psychedelics could generate the greatest returns by investing in research and development relevant to the future of the psychedelic industry.  Entrepreneurs could pursue patent protection for psilocybin technology and then leverage that advantage when the laws change.  E.g., decriminalization or legalization of magic mushrooms.  Following this logic, several entities, including Compass Pathways, Paul Stamets, CaaMTech, and Tassili Life Sciences have invested in intellectual property related to psychedelics.

 

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COMPASS Pathways’s Crystalline Form Patent https://psilocybintechnology.com/compass-pathwayss-crystalline-form-patent/ https://psilocybintechnology.com/compass-pathwayss-crystalline-form-patent/#comments Fri, 17 Jan 2020 20:09:37 +0000 https://psilocybintechnology.com/?p=3893 Recently, Compass Pathways issued a press release stating “that it has been granted US Patent No 10,519,175 (“the ‘175 patent”), relating to methods of treating drug-resistant depression with a psilocybin ...

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Recently, Compass Pathways issued a press release stating “that it has been granted US Patent No 10,519,175 (“the ‘175 patent”), relating to methods of treating drug-resistant depression with a psilocybin formulation, by the US Patent and Trademark Office.” According to COMPASS, “the patent covers the use of COMPASS’s synthesized investigational psilocybin formulation, COMP360, in a psilocybin therapy protocol for patients with treatment-resistant depression.” 

Given that psilocybin is an old drug, how did COMPASS get a patent covering its psilocybin product?

Answer: By recognizing that COMP360 is a novel crystalline form, COMPASS’s IP team at Cooley LLP was able to craft a patent strategy leading to the issuance of the ‘175 patent despite 60 years of prior art related to the compound psilocybin.  

Below we discuss the scope of COMPASS’s ‘175 patent and the clever IP strategy that led to the company’s success in acquiring that patent.

Claims of COMPASS’s US Patent No. 10,519,175

The ‘175 patent issued from COMPASS Pathways’s U.S. Patent Application No. 16/155,386 (“the ‘386 application”), which we discussed in a previous article.  During the prosecution of the ‘386 application, COMPASS amended the claims into the version which ultimately issued into the ‘175 patent.  The issued claims include a single independent claim (claim 1) and twenty dependent claims.  Claim 1 defines the the following subject matter:

“1. A method of treating drug resistant depression comprising orally administering to a subject in need thereof a therapeutically effective amount of an oral dosage form, wherein, the oral dosage form comprises:

crystalline psilocybin in the form Polymorph A characterized by peaks in an XRPD diffractogram at 11.5, 12.0, 14.5, 17.5, and 19.7°2θ±0.1°2θ, wherein the crystalline psilocybin has a chemical purity of greater than 97% by HPLC, and no single impurity of greater than 1%; and

silicified microcrystalline cellulose.”

Dependent claims 2 – 21 all require the elements recited in claim 1 in addition to the further limitations specified by each dependent claim.  Accordingly, all of the claims in the ‘175 patent require specific crystalline form attributes. In other words, all of the claims in COMPASS’s patent issued on account of incorporating the crystalline form data into the claims.

Patent Examiner’s Reason for Granting COMPASS’s Patent

The patent examiner at the USPTO explained the importance of its crystalline form data.  The examiner’s reason for allowing Compass’s claims was the difference between (A) the characteristics of the crystalline form of psilocybin recited in Compass’s claims and (B) the characteristics of the crystalline form of psilocybin recited in “the closest prior art of record, Folen.”  See Folen, V. A., X-ray powder diffraction data for some drugs, excipients, and adulterants in illicit samples. Journal of Forensic Science 1975, 20, 348-372.

 

The Genius of COMPASS Pathways’s Patent Strategy – Claiming Crystalline Forms

Psilocybin is an old compound.  Psilocybin has been known since at least 1958, when Hofmann isolated it from so-called “magic mushrooms.” Given that patents are only granted on “new” and “non-obvious” subject matter, acquiring a patent for COMPASS’s product, COMP360 was not an easy ask.  Nevertheless, COMPASS’s lawyers (Sandhya Deo of Cooley LLP) were able to pull a rabbit out of a hat in getting an allowance for U.S. Patent No. 10,519,175. 

Recognizing that psilocybin was a known compound, the IP team focused on the novel features of COMPASS’s product, COMP360.  That product apparently has new, non-obvious crystallographic features, which can be included in the definition of COMPASS’s invention, adding novelty despite all of the prior art related to psilocybin. 

Crystalline form patents often provide pharmaceutical companies with opportunities for acquiring patent exclusivity on drugs that have already existed in the prior art, such as psilocybin in the case of COMPASS’s product, COMP360. According to Barash Law,

“A solid-form patent strategy is even more important in drug repurposing where older chemical entities which either never made it to market or which were used in a different indication are being re-tasked. While new method of treatment patents may be available in such circumstances, more valuable composition of matter/drug substance patents should be considered when scientifically reasonable. Such strategies may involve creating new polymorphs, crystalline or amorphous salts or cocrystals to create a new composition of matter estate and Orange Book listing protections.”

In drafting the claims to crystalline form inventions, the applicant often relies on analytical data collected from x-ray diffraction experiments. “Because it can be difficult to characterize crystalline forms using organic chemistry nomenclature, one often relies on solid-state analytical data as a surrogate to define the metes and bounds of such claims.”  Such is the case with COMPASS’s claim strategy in US Patent No 10,519,175.  Although the claims are method claims (not composition of matter claims), COMPASS relied on solid-state analytical data to define the metes and bounds of those method claims: “…crystalline psilocybin in the form Polymorph A characterized by peaks in an XRPD diffractogram at 11.5, 12.0, 14.5, 17.5, and 19.7°2θ±0.1°2θ.”

Crystalline Form Patents for Psychedelics

COMPASS’s remarkable achievement in acquiring US Patent No 10,519,175 raises questions about other crystalline form patents.  Prior to COMPASS’s patent grant, many in the art considered “old” psychedelic compounds unpatentable by virtue of their being part of the public domain.  However, COMPASS’s success with psilocybin crystalline form patents suggests that other “old” compounds could be packaged into new, patentable inventions by leveraging opportunities created by x-ray crystallography.  Will crystalline form patents be the next gold rush for companies pursuing IP on previously known compounds?

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