Recently the U.S. Patent and Trademark Office rejected a patent application for a cannabis strain because the same type of cannabis was mentioned in an online blog. The fact that cannabis having a THC content greater than 0.3% is still a Schedule 1 drug had no bearing on patentability.
This means that the days when intellectual property (IP) protection for cannabis could not be obtained simply because of its legal status are gone. With states legalizing cannabis for medicinal and even recreational use, the Federal Government is slowly starting to warm up to the proposition of granting IP protection to cannabis breeders, growers and/or owners (collectively “breeders”).
As of July 2019, there are three different vehicles through which IP protection for cannabis can be granted at the federal level. They are:
- U.S. Utility Patents,
- U.S. Plant Patents, and
- USDA Plant Variety Protection (PVP) Certificates.
Although some degree of overlap exists between the rights conferred by these three vehicles, each one of them grants different kinds of protection to breeders. The type of protection sought can be strategically chosen based on the breeder’s business model.
Utility Patents
A utility patent provides arguably the best form of protection for cannabis strains. This is because a utility patent can be used to claim the plant itself, a clone, tissue, or a cell of the cannabis plant without regard to whether the plant is sexually or asexually reproduced.
As an example, Biotech Institute (Biotech), a major player in the field, has obtained U.S. Utility Patent No. 9,095,554, claiming a cannabis strain. Although the claims of the Biotech patent are drawn to the plant, they are actually focused on the contents of the inflorescence of the plant. The inflorescence is the flower or “fruit” of the plant, which is where the money is.
Utility patents have a relatively long lifespan. They expire 20 years from the application filing date. Since the examination of the application before grant may take anywhere from under 1 year all the way up to 5 or 6 years in rare cases, there is still plenty of time left to enforce the patent against an infringer.
However, utility patent applications for cannabis strains are rare. This may be because of a combination of factors. First, the claimed strain cannot be one that is found growing in the wild. The strain must be the result of a person’s efforts to improve a plant found in nature. In addition, the improved plant must be new and non-obvious, and it must have some sort of utility.
These requirements raise difficulties not typically found when dealing with traditional inventions such as mechanical and electrical devices where the utility of the device is readily apparent and the abundance of old devices makes it easier for a patent Examiner to determine whether the gadget is actually new and non-obvious.
However, if obtained, a utility patent application can be used “to exclude others from making, using, offering for sale or selling the invention throughout the United States or importing the invention into the United States.” 35 U.S.C. § 154. That is good protection.
U.S. Plant Patents
A plant patent can also be used to protect a cannabis strain. The big difference between utility and plant patents is that a plant patent can be obtained only for an asexually reproduced plant, while a utility patent can be obtained for both sexually and asexually reproduced plants.
Plant patents may be granted for “any distinct and new variety of plant, including cultivated sports, mutants, hybrids, and newly found seedlings, other than a tuber propagated plant or a plant found in an uncultivated state.” 35 U.S.C. § 161.
While the statutory language above defines the broad limits of patentability, there is one specific requirement, among others, which relates to the heart of a cannabis plant patent. That is the showing that the specific cannabis plant sought to be patented is different from known, related cannabis plants by at least one distinguishing characteristic. The distinguishing characteristic must be more than a difference caused merely by the growing conditions, fertility levels of the plant, etc.
As an example, in plant patent PP27,475 the distinguishing characteristic of the patented cannabis plant is an “extraordinarily high” level of Limonene. This characteristic of the patented plant is unexpected because both parents of the plant have low levels of Limonene. Because of this characteristic, the breeder claims that the patented cannabis plant has beneficial health effects.
It is readily apparent that the distinguishing characteristic of the cannabis plant is what makes it valuable, which is exactly why the breeder wants to protect it.
Of course, plant patent applications must satisfy other requirements, too. For example, the plant for which patent protection is sought must not have been obvious to a person “having ordinary skill in the art” as of the effective filing date of the application. In addition, subject to certain exceptions, the plant must not have been patented, in public use, on sale, or otherwise available to the public before the effective filing date of the application.
The issuance of cannabis plant patents is a relatively recent phenomenon, and as of July 2019 there are only 4 issued patents. As the legalization of cannabis continues to expand at the state level, and with breeders continuing to develop new strains with beneficial health effects, we can certainly expect that number to grow.
The benefit of obtaining a plant patent for cannabis is that the breeder, or the person who obtains the rights to the patent from the breeder, can “exclude others from asexually reproducing the plant, and from using, offering for sale, or selling the plant so 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.” 35 U.S.C. §163.
In other words, the person who owns the plant patent can sell the patented cannabis plant to a buyer, but the buyer cannot in turn asexually reproduce that plant for his/her benefit.
The term of a plant patent is the same as that of utility patents mentioned above.
USDA PVP Certificates
Last but not least are PVP Certificates. With the enactment of the 2018 Farm Bill, the Federal Government removed cannabis having no more than 0.3% dry weight THC (aka hemp) from Schedule I. This enabled the PVP Office to process applications for hemp varieties and to accept hemp seeds, which was previously against the law.
PVP Certificates confer patent-like rights on the breeder with the two notable exemptions: the farmers exemption and the research exemption.
Subject to these exemptions, a breeder can protect any strain of cannabis, whether propagated sexually or asexually, as long as the strain produces no more than 0.3% THC by dry weight.
In order to qualify for a PVP certificate, the hemp sought to be protected must be new, distinct, uniform and stable.
PVP certificates for hemp have a 20-year term from the date of issue and prohibit others from, amongst other things, marketing and selling the protected hemp variety, subject to the farmers and research exemptions.
Thus, the three IP protection vehicles listed above can be used alone or in combination with one another in order to build an IP portfolio which the breeder can monetize and/or use for other goals.