Magic mushrooms and pot. Yes, currently people use them for illicit reasons. But the compounds in them are now being investigated for typical pharmaceutical therapeutic properties. And how can investigators protect that R&D investment? We look at some strategies relating to psilocybin (the prime compound in magic mushrooms) and cannabidiol (CBD) found in pot to see how patents and FDA strategies may come into play.
Patents in Psilocybin and Cannabidiol
Unlike typical synthetically produced drugs, patents on the bare-naked compound for psilocybin and CBD are not possible because the actual chemical compounds are naturally occurring. Nevertheless “compound-like” patents can still be obtained. For example, synthetic production of the compound can involve innovations or discoveries on the routes of synthesis, impurity profiles, yield improvements, etc. Furthermore, the companies may discover different polymorphic forms of the molecule. One or more types of these basic patents can provide protection to the investments. But of course, as with any patent strategy, the number of patents don’t matter. And that means statements like “company XYZ has 20+ patents” or “40 patent families” are utterly meaningless. And statements about pending patent applications are meaningless in that pending applications are not enforceable. Though pending applications may provide clues as to where the R&D is heading. Moreover, competitors can use pending applications to guide their own activities. Rather a proper due diligence of a portfolio should examine what is claimed and how broad (and valid) those patent claims are.
Other non-compound like patents are also available. For example as the drugs are sent into clinical trials, more information becomes available relating to methods of use, dosing regimens, formulations, stability data, PK/PD datasets, and even innovative packaging or drug delivery devices. But as with basic patents, there is no magic number of patents or kinds of patents to get. For naturally occurring products, patents on unique harvesting and purifying techniques may be available.
Usually, a method of use patent on the exact FDA approved indication can be an important patent to obtain. Though often times the exact method of use is not yet known and early filed method of use patents may not claim the ultimately approved FDA use. A quick review of psilocybin mentions in the patent office databases show that patents have issued for using it for treatment of depression, weight loss, anxiety, etc. Whether these patents or applications have value remains to be seen because the exact patent claims will matter when the FDA approves the indication of use.
So if no magic mushroom patents, oops magic number of patents exist, then what matters? Drug discovery is an intensive and expensive affair. And as such, patents should be obtained on different aspects of the drug development and delivery. A portfolio that has patents on different aspects provide their own individual protection to that particular aspect. Then when all the aspects are aggregated, the portfolio as a whole is stronger. However, as mentioned earlier, the patent claims matter.
For CBD, it was originally that only one cannabinoid, here cannabidiol, was the only therapeutic cannabinoid. It has been suggested that perhaps CBD itself is not enough and that the real therapy of CBD comes from a mixture of other cannabinoids. See e.g., patent application WO 2019207319. As such, the mixture when isolated could be patentable. We, of course, do not opine on the therapeutic effect and patentability of any mixture.
Example Patents on Psilocybin and CBD
For psilocybin, as mentioned above, a quick review of the patent databases showed patents or pending applications for various methods of using psilocybin to treat certain disease conditions. Some of those conditions include depression, PTSD, weight loss, anxiety, etc. The review also showed certain dosage form deliveries such as traditional pills, controlled release forms, oral films, and nasal sprays.
But to illustrate why it’s important to examine the patent claims, the author arbitrarily plucked one out and points out some issues with it. Compass Pathways owns U.S. Patent No.: 10,519,175 (which issued Dec. 31, 2019). It claims “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.” Other patents are: 10,947,257 and 10,954,259 (to polymorph form A and the dosage form).
A competitor could potentially design around this patent claim. Though at first blush this is a method of use patent, it is not an open ended method of using psilocybin for any disease condition. Nor is it “the” patent on using psilocybin to treat depression; a broader indication. Rather, the method requires using a specified dosage form with specific ingredients. As such, a competitor could: (i) use another polymorph that has different XRPD peaks; (ii) a different level of purity; and (iii) omit the silicified MCC. Psilocybin could exist in multiple polymorphic forms, characterized by different XRPD peaks. And is there something unique about must having to silicified MCC as an ingredient or can that be swapped out? Competitors may be able to design around this patent.
The above example shows why the patent claims matter and why statements like, “the company has the patent on [XYZ]” don’t mean much because it’s too generalized.
With respect to CBD, GW Pharmaceuticals (now Jazz Pharmaceuticals) developed the drug Epidiolex®, which generally is purified CBD that has very low amounts of delta 9-THC. The Orange Book reveals a dozen or so patents, mostly related to Methods of Using the drug (CBD) to treat diseases. Interestingly, the patent portfolio may raise an interesting claim construction question. Many of the patents have a term wherein the amount of delta 9-THC is not more than X%. Because GW makes it drug product from botanic sources, its purification process reduces the amount of the THC. If a competitor, however, makes CBD synthetically, it could have 0.00% of THC, based on the synthetic process. As such, it would be ultra-pure. So can a claim term that says “no more than X% of THC” actually include a product that indisputably has zero percent and could never have any THC in it? Or should the claim be construed to mean that there must be some trace amount of THC in it.
Another patent claims a formulation containing flavoring, sweetener, and sesame oil. As with the psilocybin formulation, could a competitor swap out the sesame oil to avoid the patent? Another patent covers the co-administration with clobazam, which raises questions of whether competitors need to utilize the co-administration information.
FDA & New Chemical Entity (NCE) Exclusivity for Psilocybin
We further understand out of the psilocybin developers, some may be pursuing the §505(b)(1) classical drug approval process whereas others may be using the §505(b)(2) alternate new drug approval pathway. This raises an interesting exclusivity question, specifically whether the 5-year NCE exclusivity can block other approvals. And if so, what kind of block exists.
First, psilocybin may be eligible for the 5-year NCE exclusivity, irrespective of its approval under the (b)(1) or (b)(2) pathways. Let’s play out some possibilities that may arise. Suppose Company A obtains (b)(1) NDA approval first and earns the NCE exclusivity. Company B, pursuing the (b)(2) pathway, likely cannot file its (b)(2) application until the NCE expires (except if Company B files the (b)(2) with a so-called Paragraph IV certification against any Orange Book patent at the NCE-1 date). This is because the (b)(2) is likely relying on the (b)(1) data package in some regard, thus the data exclusivity blocks it.
Let’s reverse the situation where Company B wins the race to NDA approval via its (b)(2) application. Company B will earn the NCE exclusivity. But can the NCE exclusivity block Company A’s (b)(1) NDA? Likely not. This is because a typical (b)(1) application does not rely on the data of another. It creates its own data. See, 21 U.S.C. §355(c)(E)(ii); 21 C.F.R. §314.108.
But because of the importance of the NCE data exclusivity, we envision that Company B may still challenge the (b)(1)’s NDA potential approval to see if it can block the approval or have it withdrawn.
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We help §§505(b)(1) and (b)(2) applicants strategize the timelines for FDA approval, FDA market exclusivities, how the patent portfolio maps onto the product and timelines, how to expedite any patent litigation to resolution so that FDA approvals can be leveraged, and handling related FDA issues.
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At Upadhye Tang LLP, our highly-knowledgeable FDA and IP attorneys have extensive experience with each pathway to FDA approval. We have helped countless clients bring new drugs to market in the quickest, safest, and most cost-effective manner possible. If you would like more information about the 505(b)(1) and (b)(2) application process and how to determine exclusivities, contact Shashank Upadhye at shashank@ipfdalaw.com or 312-327-3326.
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