Bionorica is a medium-sized (~€340MM annual revenue) German herbal extracts company that owned a patent covering the extraction and application of THC from hemp to treat several diseases. They sold their cannabis business, patent included, to Canopy in May of 2019 for €225.9MM. The patent is granted in Europe and the USA, it’s still pending in a couple other jurisdictions (Canada not being one of them).
Starting with the abstract:
“The present invention relates to a plant extract from a low-tetrahydrocannabinol (THC) variety of Cannabis sativa subsp. sativa for the treatment of disease. The invention further relates to the production of the extract and pharmaceutical compositions comprising said extract and the uses thereof.”
The patent in essence covers several processes of extracting ‘compounds’ from a low-THC cannabis plant and applying the extract to treat a variety of medical issues. The patent has a couple oddly worded sections. Firstly, it describes the extract to be low-THC extracted from a low-THC plant but never talks about CBD. It mentions CBD once:
“Another known but non-psychoactive cannabinoid from cannabis sativa female cannabis plants is cannabidiol (CBD). Medical it has anticonvulsant and anxiolytic, anti-inflammatory, against nausea and intraocular pressure-lowering.”
I put compounds in quotes above because the patent never directly identifies an active compound. It lists treatments that overlap what CBD could be used for, but never provides a concentration or amount of CBD in any of the formulations. Personally, I think not directly identifying CBD as an active compound was used intentionally so they didn’t have to limit the coverage to any range of CBD. I may be wrong, but this is the first formulation for use patent I’ve seen without a defined active ingredient and range. The only defining compound of the formulation is the low-range of THC.
The second oddly worded section is the treatment section being focused on topical application of the extract, followed by a formulation section that attempts to cover all delivery methods:
“In a particular embodiment, the pharmaceutical or dermatological composition further comprises pharmaceutically acceptable excipients and additives. The pharmaceutical compositions or compositions of the invention are prepared with conventional solid or liquid carriers or diluents and customary pharmaceutical and technical excipients according to the desired mode of administration with a suitable dosage in a manner known per se. Preferred formulations consist of a dosage form which is suitable for topical, oral, inhalative, intranasal, enteral or parenteral, for example ip (intraperitoneal), iv (intravenous), intramuscular or percutaneous administration. Such dosage forms are, for example, tablets, coated tablets, dragees, pills, capsules, powders, creams, ointments, lotions, liquids such as syrups, gels, injectable liquids, for example for ip, iV, in or percutaneous injection, nasal sprays, but also inhalation sprays etc. Depot forms, such as implantable preparations, and suppositories are also suitable. The individual preparations give the extracts according to the invention, depending on their nature gradually or the entire amount in a short time to the body. For oral administration, capsules, pills, tablets, dragees and liquids or other known oral dosage forms may be used as pharmaceutical preparations. In this case, the drugs may be formulated to either release the drugs in a short time and deliver them to the body or have a depot effect, so that a longer-lasting, slow supply of active ingredients to the body is achieved. In addition to at least one plant extract according to the invention, the dosage units may contain one or more pharmaceutically acceptable carriers, for example substances for adjusting the rheology of the drug, surface-active substances, solubilizers, microcapsules, microparticles, granules, thinners, binders such as starch, sugar, sorbitol and gelatin, further fillers such as silica and talc, lubricants, dyes, fragrances and other substances.”
The range of extraction methods listed within the patent is just as long and obnoxious. The patent lists other drugs or agents that can be used in the formulation to assist with the intended therapeutic effect.
The efficacy they provide to the claims involve treating a few patients skin itchiness caused by things like fungal infections or eczema. Tests were limited from a couple people to a couple dozen at most with no controls.
The value of this patent is interesting to look at because on the surface it looks appealing. Broad coverage of use, loosely defined formulations and active ingredients, what’s not to love? The problems become apparent when you take a closer look. This patent’s formulation currently gets around European CBD regulations, but that means it has no protections on use. Circumventing medical regulations prohibits certain claims from being made and prevents others from competing since you exist in a space that requires no efficacy or claims to sell a product, in this case CBD cream. Any competitor can create CBD cream circumventing the same regulations and sell a competing product. The patent only becomes a protection in Europe and the USA if the product is taken through clinical trials to show efficacy for the intended use.
In the USA you face similar issues to Europe, you have to go through clinical trials to make claims and a market to sell similar products already exists. Manufacturers are currently making CBD cream under state cannabis laws and they don’t need to make claims to sell their product.
In summary, while this patent looks good at face value I question the real world impact this could have. Since the patent isn’t preventing competition from existing, or impeding them, under current regulations; it’s value can only come from someone paying to use it. Bionorica found someone to pay for it, can Canopy?