Rerolled from a High Times Original Article
Cultivators in the United States have been breeding new Cannabis cultivars since the 1960s, seeking to combine or enhance cultivar characteristics such as yield, flavor, aroma, potency, and neurological/physiological effects. Both federal legalization of hemp (i.e., less than 0.3% THC) and increasing state legalization of marijuana have brought about considerable financial opportunities for companies that develop commercially desirable cultivars. But, the development, refinement, and stabilization of Cannabis cultivars requires substantial investments of time and money. However, options for protecting those investments through intellectual property (IP) safeguards remain limited for marijuana cultivars.
Relevant IP protections for Cannabis cultivars include plant patents, plant variety protection certificates, and utility patents. Below, we provide an overview of each; but, before diving in further, we note that the need for seed deposits to obtain certain IP protections may present an insurmountable hurdle. United States depositories will not take seeds or tissue derived from marijuana cultivars (i.e., greater than or equal to 0.3% THC). Industry innovators would be well-served by considering their IP strategy before federal marijuana legalization removes these impediments.
Plant patents protect any new and distinct variety of plant that has been asexually reproduced. Unlike trademark law, patent law has no legal use requirement. Consequently, plant patents can cover both marijuana and hemp. All that is required is that the cultivar be:
- novel—patentee was the first to discover the cultivar or breed and select it;
- distinct—differs from known related cultivars by at least one characteristic;
- uniform—the cultivar’s characteristics are consistent from one plant to another; and
- stable—the cultivar’s characteristics are fixed from generation to generation.
Asexual reproduction (i.e., cloning) satisfies the uniformity and stability requirements. Plant patents permit the holder “to exclude others from asexually reproducing the plant, and from using, offering for sale, or selling the plant reproduced, or any of its parts, throughout the United States, or from importing the plant so reproduced, or any parts thereof, into the United States.”
The upside to plant patents is that they are relatively inexpensive and easy to obtain; moreover, plant patents do not require seed deposits. The downside, however, is that, because plant patents only cover plants that have been asexually reproduced, a holder of a Cannabis plant patent will likely be required to prove that an alleged infringer used a clone of the patented cultivar. Thus, the value of plant patents depends on potential infringers’ need to use a clone of the patented cultivar. Accordingly, the productions afforded by plant patents are rather narrow as compared to the following two forms of protection.
Plant Variety Protection (PVP)
Plant Variety Protection (PVP) certificates generally provide broader protections than plant patents because they protect both sexually and asexually reproduced cultivars. Like plant patents, the cultivar must be new, distinct, uniform, and stable. PVP certificates permit the holder to exclude others from various activities including selling, importing, or exporting the cultivar or using the cultivar for breeding purposes; just Google “7 U.S.C. § 2541” for the list.
The upside to PVP certificates is that they cover sexually reproduced plants. The downside is that the applicant must deposit at least 3,000 seeds, which essentially bars patents for marijuana cultivars. The term of protection for PVP certificates lasts for twenty (20) years (twenty-five for a tree or vine). The seed deposits do not become available to the public until expiration. However, PVP certificates are subject to a “research exemption” that would allow a person with access to your protected cultivar to use it in a breeding program to develop other cultivars for non-commercial purposes.
Utility patents offer the most comprehensive protection. Most utility patent filings for Cannabis are directed to extraction methods, product formulations, and medical uses. Nevertheless, utility patents can be extremely useful for protecting a plant and its parts, including everything from breeding methods to genetic modifications (both traditionally bred hybrid plants and laboratory-made transgenic plants). Utility patent protection requires that the invention be:
- useful—the subject matter has a useful purpose;
- novel and non-obvious—did not exist prior to being bred and selected, and was not an obvious combination of prior cultivars;
- adequately described and enabled—sufficient disclosure in the application to allow another cultivator to make and use the claimed cultivar; and
- not a product of nature—the invention involved human activity that transformed the subject matter from its natural state.
Although utility patents are often associated with high costs and complexity, these factors can be controlled through a focused approach. For example, transgenic plants can be adequately described and enabled by describing the method of producing the transgenic plant or describing the gene responsible for the claimed phenotype through, for example, depositing the sequence of the gene of interest. Satisfying the description and enablement requirements for traditionally bred cultivars can be difficult, and has traditionally been accomplished through a seed or tissue deposit.
Developing an IP Protection Strategy for Your Cannabis Cultivar
Before seeking patent or PVP protections, a threshold question must be asked: was the cultivar commercialized, offered for sale, or publicly disclosed more than one year prior to the filing date. If so, an application for a patent or PVP certificate cannot succeed.
If prior disclosure is not a problem, weigh the practical considerations associated with each type of cultivar protection while considering (1) where in the breeding process you are, and (2) what your business wants to achieve. A cultivar exhibiting a desirable phenotype that has yet to be stabilized for seed production may be an ideal candidate for a plant patent, particularly if you plan to maintain that cultivar for cloning. If you can surmount the deposit requirement, PVP may prove the preferred protection for seed-propagated plant cultivars. If your cultivar has specific traits obtained through extensive development and aggregation into one genotype, a utility patent may alleviate PVP “research exemption” concerns, assuming you can overcome the current deposit issues for marijuana.
A final option that permits you to stake your claim is to file a provisional patent application for your cultivar. A provisional application provides the applicant up to one year to convert the provisional application into a utility patent application. This buys you time to determine if you really want to jump through the hoops necessary to fully protect your cultivar, while allowing you to legitimately mark the seeds and/or clones as patent pending.
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Rerolled from High Times