[co-author: Ruth Fisher]

The following post explores the bioavailability and efficacy of various cannabis products, followed by a brief overview of the legal protection afforded to each as an intellectual property asset.

Over the millennia, our bodies have evolved to better protect themselves. Protection from outside our bodies comes from our skin, which creates a barrier that’s quite difficult to penetrate by most foreign substances (pathogens). Protection from within our bodies comes from barriers (epithelial tissues) that line all our internal organs and pathways, to make sure nothing penetrates areas it should not. The result of all this protection is that it can be difficult for cannabis substances to penetrate our bodies and travel to the sites needed to generate their effects.

FLOWER

The most common way people consume cannabis is by smoking the buds of the cannabis sativa plant, often referred to as “flower.” When flower is combusted, about three-quarters of the cannabinoids and other active ingredients are lost to incineration and side smoke. Cannabinoids that do make it into the lungs are quickly and easily absorbed and delivered directly to the bloodstream, where they make their way to receptors throughout the body. This direct form of delivery has the benefit of rapid onset, but at the cost of low bioavailability; that is, low rate of absorption.

How can flower be protected as IP? The individual strain of flower can be protected as a plant patent, but this form of protection is rarely used and can be viewed as weak. Most patent protection is found “upstream” of the flower itself and within the agricultural technology that was used to produce the flower in the first place. Major lighting companies protect the technology for their grow lights, and packaging companies protect the machines used to assemble the product that is eventually shipped off to a dispensary. As for branding, trademark protection is not available for flower until cannabis is removed as a Schedule I drug.

VAPING

Vaping is one of the most efficient ways to consume cannabis. Vaping uses lower temperatures than smoking, so the active ingredients of the product are not incinerated. Additionally, as with smoking, vaping cannabis delivers the active ingredients directly to the bloodstream through the lungs, generating rapid onset of effects with relatively high bioavailability of roughly 50%.

IP protection for vaping can vary based on the product within the sub-industry. The consumables of the vaping world are difficult to protect for the same reasons as discussed above with respect to flower. Vape pens and e-rigs, however, are frequently patented and trademarked—and this intellectual property is leveraged by its owners to gain market share in the industry.

TINCTURES, EDIBLES AND TOPICALS

Tinctures are absorbed through the mucous membranes under the tongue and directly to the bloodstream. Absorption through sublingual mucous membranes is less efficient than that through the lungs. Bioavailability with tinctures is thus greater than that for smoking (because cannabinoids are not incinerated), but less than that for vaping.

Edibles pass through the digestive tract, where most of the cannabinoids are killed off, either by stomach acids or by the liver during first-pass metabolism, leaving only about 5% to make it into the bloodstream. Topicals also have very low bioavailability, since they cannot penetrate the skin.

There are many patents for cannabis tinctures, edibles, and topicals—from the formulations, methods of manufacturing, and extraction techniques, to name a few. Like flower, trademark protection is not currently available for these product types until cannabis is federally descheduled. However, marks related to non-consumable CBD products (e.g., topicals) can be registered at the US Patent and Trademark Office as not being ingestible.

CANNABIS SUBINDUSTRIES WITH HEAVY IP FOOTPRINTS

Low bioavailability is clearly a problem in cannabis—only a small fraction of the cannabis compounds actually make it into the user’s body to generate the intended effect. It is thus unsurprising that much research is currently focused on technologies to improve cannabis’ bioavailability. In fact, thousands of patents have already been issued in this area, while significant research is ongoing.

Examples of technologies that improve bioavailability include the following.

• Nanotechnology is being combined with special surfactants to reduce the size of cannabis particles and coat them with substances that enable them to be more easily absorbed into the body. For example, much like Listerine strips that dissolve under the tongue, Kin Slips cannabis strips use nanotechnology to improve sublingual absorption of the cannabis in their strips. A search of the USPTO database of “cannabis and sublingual and absorb” yields almost 7,000 patents.
• Just like nicotine patches deliver nicotine through the skin to help cigarette smokers quit smoking, transdermal skin patches enable cannabis compounds to penetrate the skin and reach the bloodstream, where they can circulate through the body to distant receptors. Papa & Barkley is one of the better-known suppliers of transdermal patches. A search of the USPTO database of “cannabis and transdermal” yields almost 6,500 patents.
• Interestingly, cannabis honey, that is, honey made by bees that have processed cannabis pollen, seems to be much more highly bioavailable than the cannabis in regularly infused cannabis honey. A search of the USPTO database of “cannabis and honey” yields a surprising 1,323 patents!
• Self-emulsifying drug delivery systems (SEDDS) are new promising technologies for increasing the bioavailability of oral (and topical) forms of delivering cannabis by helping active ingredients bypass the liver and directly enter the bloodstream. A search of the USPTO database of “cannabis and ‘self-emulsifying drug delivery’” yields over 200 patents.