Protecting Newly Bred Cannabis Strains with Plant PatentsFebruary 28, 2017
As the long-lived, legal hemp industry continues to flourish and the burgeoning medicinal and recreational cannabis markets expand, growers and breeders of cultivars in the Cannabaceæ family (which also happens to include the genus of Hops plants) are looking for a way to protect their investments. Creating a new variety or “strain” of a plant species takes years because breeders must verify 4 criteria of their creation:
- Novelty – The strain must be actually new (i.e., not known, used, or sold elsewhere previously).
- Distinctness – The strain must have unique characteristics (i.e., traits that are clearly distinguishable from other varieties).
- Homogeneity – The strain must be uniform (i.e., the unique characteristics do not vary across plants).
- Stability – The strain must remain true (i.e., does not change after repeated propagation).
These criteria were identified in the 1960s by the International Union for the Protection of New Varieties of Plants (UPOV). The UPOV recognized the global benefit that cultigen innovation can have on farming, hunger, and poverty through improving the yield, quality, and resistance of agricultural products while decreasing environmental effects and reliance on old landraces. To encourage the creation of new varieties, the UPOV established a Convention for obtaining intellectual property rights in each of its member states (e.g., the United States, EU, OAPI, Chile, China), thus enabling international protections. The UPOV provides a Plant Variety Database (PLUTO) for researching where protection for particular strains has been applied for and granted.
In the United States, intellectual property protection for breeders’ strains under the UPOV Convention last 20 years and can be sought in 3 ways:
- Plant Variety Protection (through the Department of Agriculture (USDA))
- Plant Patent (through the Patent and Trademark Office (USPTO))
- Utility Patent (through the USPTO)
While there have been utility patents for the extraction and use of Cannabis plants, historically, most likely due to the Plant Patent Act of 1930 being subsequent to rising regulations and public disfavor of Cannabis products at the turn of the century, there have been no Plant Variety Protections or Plant Patents granted for the strains themselves—until now.
At the very end of 2016, the USPTO granted the first Plant Patent ever for a new strain of Cannabis. U.S. Plant Patent No. 27,475 was issued boasting distinctly high levels of THC combined with “an unusual complement of terpenes”, in which the levels of Beta Myrcene, Beta Caryophyllene, and Linalool are low and the Limonene content is extraordinarily high. This grant marks the test case proving the patentability of Cannabis strains despite their federal legal status under the Controlled Substances Act.
Because particular U.S. protections of plant varieties falls under the patenting system, applications for Plant Patents are subjected to the same scrutiny as Utility Patent applications and, when granted, hold the same force. Namely, the subject matter of Plant Patent applications must be non-obvious and include some minimal level of utility. For example, in PP27475, noted above, the results of crossing the two parent strains was unexpected, and the patent disclosure notes that use of the strain “may prevent some cancers and may cause apoptosis of cancer cells in vivo” and that “the high levels of limonene may slow down the build-up of plaque in the arteries and reduce the effect of low-density lipo-proteins on the circulatory system”. Such particular medicinal benefit is not necessary to satisfy the utility requirement, however. A strain may have utility in many ways, such as a particular color or visual characteristic, smell, taste, shape, strength of fibers, viscosity of oils, or enrichment of soil, for example.
Under the UPOV Convention, varieties must be protected according to their genus, species, and denomination. For example, in the case of PP27475, the strain is identified as Cannabis sativa for its genus and species, with ‘Ecuadorian Sativa’ as its denomination. The denomination will be the same in all the UPOV member states. The denomination must (a) enable identification of the variety, (b) be different from any others for the same or closely related species, (c) be neither misleading nor confusing regarding the nature of the variety or identity of the breeder, (d) not affect prior rights of others, and (e) not include rights that hamper its free use as a denomination, even after expiration of the breeder’s right. This may raise issues with state or federal trademarks, so care should be taken when determining strain names and branding.
With the eventual entry of Big-Pharma and Big-Ag into the Cannabis industry, breeders and growers would be wise to protect their propriety strains now before the field becomes overcrowded. What may prove key to the innovation and enforcement of Cannabis strains is the genome sequencing movement by such organizations as the International Cannabinoid Research Society and the Cannabis Evolution Project. Genetic mappings of Cannabis strains can show how distinct certain strains, which can aid in future breeding plans, and how similar strains are to each other, which may help with monitoring infringement. These and other tools may be used by those in the Cannabis industry to truly set themselves apart.
Finally, the first-inventor-to-file update to the U.S. patent system applies, so breeders should generally file early and often, keep detailed records of their breeding procedures, utilize non-disclosure agreements and other instruments to maintain confidentiality throughout the breeding process, and, as always, consult with a patent attorney.