Lately the investment community has been all atwitter about the recent legalization of industrial hemp that came with the passage of the 2018 Farm Bill. Not only did the Farm Bill expand the rights to cultivate hemp, defined as a plant of the species Cannabis sativa having a tetrahydrocannabinol (THC) content of 0.3% or less, it also extended protection under the Plant Variety Protection Act (PVPA) to seed-propagated hemp and asexually produced hemp.
What’s interesting is that prior to the 2018 Farm Bill, there was never an outright prohibition under the PVPA against the protection of seed-propagated hemp, it’s just that in order to obtain a certificate from the Plant Variety Protection Office (PVPO) – the Office charged with the administration of the PVPA implementing regulations – an applicant must meet certain fulfillment requirements, which include making and signing a full written disclosure of the breeding methods and selection criteria used to produce the variety. I suppose that might raise suspicion that the breeder may be violating the Controlled Substances Act (CSA) and serve as evidence in support of an alleged violation.
In any event, the removal of this former barrier to PVPA protection of hemp varieties may open a floodgate of new applications for certificates covering new and distinct strains of hemp. The new PVPA implementing regulations have been drafted and should be published for comment soon.
It gets more interesting. With the removal of hemp, several cannabis-containing or -derived products still remain on Schedule I, which is a list maintained by the Drug Enforcement Administration (DEA) of drugs that have no currently accepted medical use. The remaining listed cannabis products include marijuana and extracts thereof, cannabinoids, cannabis resin and THC, although drug products containing cannabidiol (CBD), which is a cannabinoid, were rescheduled by the DEA in September of last year if approved by U.S. Food and Drug Administration (FDA) if they contain less than 0.1% residual THC.
The FDA, having the authority to determine whether drugs have medical uses and approve them for use, will hold a public hearing on May 31, 2019 – Scientific Data and Information about Products Containing Cannabis or Cannabis-Derived Compounds – where stakeholders can present information on the topic. Based on the hearing title, it seems like the FDA may be interested in gathering information on products derived from cannabis, and specifically from hemp, related to their therapeutic potentials.
However, industrial hemp has a multitude of non-medical uses, so its value is not dependent on medical uses. Currently, the United States ranks behind only Canada and China in hemp production, and tariffs on Chinese imports into the U.S. may mean added demand from U.S. producers.
If you are an investor or business owner in this area, good for you, and with the passage of the 2018 Farm Bill, you now have a new way to protect your intellectual property with a Plant Variety Protection Certificate!
For more information on this topic, please contact Scott Lloyd at email@example.com.
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firstname.lastname@example.org | 301.575.0357
Scott Lloyd is a registered patent attorney who specializes in intellectual property counseling and commercialization work. He has served as a technology commercialization specialist and advisor to companies in a diverse array of markets, including biotechnology, pharmaceuticals, medical devices, food and beverage, specialty chemicals, technology, and engineering. In addition, Mr. Lloyd spent ten years as in-house general counsel to small and mid-sized companies, where he managed corporate matters and resolved commercial disputes in addition to intellectual property strategy, and now serves in the same capacity for entrepreneurial clients. He serves as counsel to small and mid-sized business owners seeking to implement growth strategies and succession plans.
While in house, Mr. Lloyd has also contributed to the successful formation of international affiliates of domestic businesses as well as a $400,000,000 business acquisition.
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