Questions from the Industry: Do you actually have to grow a new strain to get a patent?
During an appearance on one of my favorite podcasts, Periodic Effects, I was asked a question about plant patents. The intellectual property of plant genetics is a complex subject, and I did my best to answer in a reasonably brief amount of time, but it’s a question that I thought deserved a more thorough answer. This question also is a good place to start this blog because it gets at the very beginning of patent protection: How far down the invention pathway do you need to be before you can claim IP protection?
The question (paraphrased):
There are few questions in the legal world that can be answered definitively, but, fortunately, this is one of them: no, you can’t patent a strain that you’ve never grown just by designing the chemical profile.
It is true that, in some circumstances, you can patent something without actually making it. But those situations are relatively rare. In all instances, to apply for patent protection you must have the idea complete enough that you can explain to someone else exactly how to make and use your invention. Patent attorneys call this reducing the invention to practice. For cannabis cultivars, the only practical way to satisfy this threshold requirement is to actually grow the desired varietal.
There are 3 conceivable routes available that might protect a strain of cannabis: (1) utility patents, (2) plant patents, and (3) the Plant Variety Protection Act. Each option has its own set of benefits and comes with its own particular requirements. Those requirements make it impractical or impossible to obtain protection with only pen and paper.
Utility Patents
Utility patents are the most popular flavor of patent. Utility patents are used to protect methods, devices, and chemical compounds. They last 20 years from the filing date and are an important asset to any company developing new cannabis strains or technology.
Because utility patents can protect novel chemical compounds, the inventor of a new cannabis strain can claim the isolated DNA molecule with a unique genetic sequence (i.e., chemical structure). The claims of these types of patents are typically something like claim 1 of U.S. Patent No. 8,884,100:
Claim 1
An isolated or purified nucleic acid molecule comprising a nucleotide sequence as set forth in SEQ ID NO: 1 or a codon degenerate nucleotide sequence thereof that encodes a polypeptide having aromatic prenyltransferase activity.
The specification then includes the specific genetic sequence referenced in the claim (in the case of the above Claim 1, SEQ ID NO: 1). You may recall from middle-school biology that genetic sequences, or portions thereof, are usually expressed by long strings of the letters A, C, T, & G, representing the DNA sequence’s base pairs.
As our knowledge of the cannabis genome grows and new technology is developed to simulate cannabis genetics, it may be possible to accurately design a genetic sequence that expresses a particular cannabinoid and terpene profile. That still, however, would not be enough to get a utility patent.
Utility patents require that the inventor describe the claimed invention in sufficient detail to enable a person of ordinary skill in the art to make and use it as claimed (for after the patent expires). When the invention involves biological material, like a plant strain, that typically means the inventor must deposit samples with the Patent Office from which others could reproduce the invention:
Where the invention involves a biological material and words alone cannot sufficiently describe how to make and use the invention in a reproducible manner, access to the biological material may be necessary for the satisfaction of the statutory requirements for patentability under 35 U.S.C. 112.
MPEP 2402
In practical terms, there really is no way to satisfy the utility patent requirement to sufficiently describe how to reproduce a particular DNA sequence without getting to the point where you can actually grow the plant yourself.
Plant Patents
Plant patents are another potential option to protect a newly invented cannabis strain. Plant patents were designed specifically to relax the deposit requirement that limits utility patents. There is no deposit requirement for plant patents, but the trade-off, and reason why plant patents are not very popular for cannabis, is that the scope of protection that plant patents afford is extremely limited.
Plant patents can protect new plant varietals that are capable of asexual reproduction. Cannabis is typically a sexually reproducing plant–there are both male and female versions that can contribute genetic material to offspring (but only female plants produce the cannabinoid-rich flowers in which most people are interested). Cannabis plants, however, are relatively easy to reproduce asexually via cloning or cutting.
The rub with plant patents, however, is that they only cover genetically identical copies, reproduced asexually from the claimed plant. That means to infringe a plant patent, one must physically clone the patented plant–a narrow base for an infringement claim.
Still, there are 2 requirements to obtain a plant patent that could not practically be satisfied without growing a sample. First, as part of the plant patent application, the inventor(s) must swear under penalty of perjury that they have, at the time of application, reproduced the claimed plant asexually. Second, the application must include photographs or photo-quality drawings of the plant showing its physical characteristics. Of course, it is possible to lie or submit fake images, but doing so would invalidate the patent and open the inventor to potential criminal liability.
Plant Variety Protection Act
The last vehicle that can protect the IP of a new cannabis strain is the Plant Variety Protection Act of 1970 (“PVPA”). The PVPA provides similar protections to a plant patent but was designed specifically to protect sexually reproducing plants, such as cannabis.
The PVPA, however, has a strict requirement that at least 3,000 seeds of the claimed plant species be deposited with the U.S. Department of Agriculture. This limitation would, quite obviously, prohibit protection under the PVPA for a purely conceptual cannabis variety.
The deposit requirement also adds an additional wrinkle for cannabis breeders. All seed deposits must be made to the USDA depository in Fort Collins, CO. The USDA will not accept any deposits for plants that are classified as controlled substances, including cannabis. Meaning that, for the time being, PVPA protection is unavailable for cannabis plants that do not qualify as hemp (less that 0.3% d9-THC).
And so…
Whether it’s a utility patent, plant patent, or PVPA certification, protecting a new cannabis strain requires a cultivator to actually develop a plant with the desired genetics.