Protecting patents and plant breeders’ rights
By Lei Liu
By Lei Liu
Canada has had its first year of legalization of recreational cannabis and recently commenced the official legalization of Cannabis 2.0 products (edibles, extracts and topicals). Canadian cannabis growers and retailers area all vying for the attention of consumers with different brands and strains of cannabis in a market that is heating up very quickly. While trademarks play a significant role in brand protection, patent and plant breeder’s rights (PBR) are two main forms of intellectual property (IP) protection that offer benefits for plant strains.
The requirements for obtaining patent and plant breeder’s rights are different, as is the scope of protection afforded. A sophisticated grower should be mindful of both rights in order to build a balanced IP portfolio with maximum protection.
Under the Plant Breeders’ Rights Act, a plant breeder may obtain legal protection of a new “plant variety,” namely, a plant grouping defined by a set of unique, genetically-governed characteristics that will not change upon reproduction of the plants in the grouping.
To obtain PBR, an applicant must demonstrate that the variety is: new (the sale of a variety prior to applying for PBR is restricted); distinct (a variety must be measurably different from all varieties of common knowledge, which are known to exist at the time the application was filed); uniform (a variety must be sufficiently uniform in its relevant characteristics); and stable (a variety must remain true to its description over successive generations).
Examination of whether the requirements for distinctness, uniformity, and stability are met involves field trials, a site examination, and submission of information by the applicant. This could represent a challenge for growers who may not have the necessary knowledge, skills or facility to conduct field trials and accommodate site examination.
Once granted, PBR for a hemp or cannabis strain lasts 20 years, and a PBR holder may bring an action in court against any party who infringes its exclusive rights. These include producing and reproducing the propagating material of the variety; selling the propagating material of the variety; importing or exporting the propagating material of the variety; and authorizing (conditionally or unconditionally) the doing of any of these acts. The scope of protection afforded by PBR is limited to a specific plant variety.
In contrast to PBR, patent rights can protect one or more novel and inventive technical features that can be shared by various hemp or cannabis strains, or even different plant species. For example, if through genetic research, one unique characteristic of a cannabis strain (e.g., a specific cannabinoid profile) can be attributed to one or more genetic markers unique to the strain, it may be possible to obtain patent protection for any cannabis strains that have been genetically modified to incorporate the genetic markers.
In order to obtain a patent, an invention must be directed to a patentable subject matter, and must be novel, non-obvious and useful.
Plants are not patentable in Canada (in contrast to certain jurisdictions, such as the United States) because our laws provide that “higher life forms” (which includes plants as well as animals) are not patentable subject matter. However, a cell of a higher life form, methods of making higher life forms, as well as use of a higher life form, may constitute patentable subject matter. Therefore, if a breeder or grower has created a new cannabis cultivar and the cells of the new cultivar can be identified by technical features (e.g., genetic modifications), it may be possible to protect the cultivar and any other cultivars having these technical features via patents.
Unfortunately, traditional breeding methods are not eligible for patent protection under the current practice guidelines of the Canadian Patent Office.
Examination of whether the requirements for novelty, non-obviousness and utility are met does not involve any field trial or site examination, although data are often required to support the advantages of an invention claimed. For novelty and non-obviousness, the Canadian Patent Office generally will carry out a search of known patent or scientific literature databases to identify whether an invention has previously been disclosed or rendered obvious by what is known.
A granted patent provides its owners with the rights to stop others from making, using or selling the invention protected by the patent for a maximum of 20 years from the day the patent application is filed.
Plant Breeder’s Rights vs. Patents
So if a grower has obtained a novel cannabis strain with unique characteristics, how should the grower decide whether to pursue patent protection, plant breeder’s rights, or both?
PBR may be preferred over patent if the grower has the capacity to conduct field trials and accommodate site examinations, but does not understand the genetic factors that lead to the characteristics of the strain. On the other hand, if a genetically modified cannabis strain (for example, strains with altered cannabinoid profiles and strains with altered resistance to mould or pests) is developed, it may be possible to protect the genetic modification itself without being limited to a particular strain. That is, in the latter scenario, the scope of patent protection may be broader than PBR, rendering patent a more attractive option. Of course, in many instances, obtaining both PBR and patent could be the optimal outcome in order to maximize protection.
One important IP consideration for companies interested in entering the cannabis field or developing cannabis products is freedom-to-operate (FTO). While it is expected that a large amount of cannabis-related patent applications have been filed in recent years, many of these applications may remain in the 18-month confidentiality period (patent applications are generally not published until 18 months from the earliest priority date) and cannot be detected by any search. Therefore, even if a FTO search does not reveal any potential patent barrier for product entry in a given market, companies should be alert to the rapidly evolving patent landscape and consider updating the FTO search regularly, especially when new market intelligence is obtained about potential competitors.
Lei Liu, is a patent agent and senior associate at Smart & Biggar. He harnesses his knowledge of biotechnology, biological science and chemistry to help clients protect their valuable innovations.