National Farmers Union submission to the Canadian Intellectual Property Office (CIPO) Consultation on Proposed Manual of Patent Office Practice (MOPOP) change relating to patentable subject-matter, July, 2025
The National Farmers Union is a voluntary direct-membership, non-partisan, national farm organization made up of thousands of farm families and farm workers across Canada. Founded in 1969, the NFU advocates for policies that promote the dignity, prosperity and sustainable future of farmers, farm families, farm workers and their communities. The NFU has particular expertise in seed policy and intellectual property rights, and in new genetic technologies. We advocate for a public-interest, publicly-funded seed regulatory system. We pay close attention to intellectual property rights, including patents, and their potential to unduly restrict access to or permit monopoly control of seed by an increasingly powerful and concentrated corporate seed industry.
We are pleased to offer our comments to this consultation process on patentable subject matter in regard to the proposed changes to Chapter 23 of the Manual of Patent Office Practice (MOPOP), Biotechnology and Medicinal Inventions.
Key points:
- Improved clarity due to more accessible language.
- Improved clarity due to consistent structure for each example, laying out claims and the rationales as to whether they are patentable, and more detailed explanations for why a claim is/is not patentable subject matter.
- Improved clarity re overbroad claims
- Improved clarity re “found” or “discovered” plants and cells are not patentable
- Questions raised re
- Boundary between “higher life form” and cells
- Boundary between “use” of higher life form and the life form itself
- Patentability of “descendent” cells
We appreciate the updated language used in the Draft, as it is more accessible, the text is structured consistently and is easier to understand the rationales for each category of claim discussed.
We agree with the interpretation that excludes cells that are in a plant or animal and whole plants or animals from being patentable.
We assert that descendent cells (Section 23.02.01a(i)) are NOT patentable subject matter primarily because they are inseparable from unpatentable higher life forms:
- Descendent cells are not “inventions” – they are produced by the parent organism without significant human intervention or the use of any “art”.
- Descendent cells necessarily occur within and are integral to higher life forms, such as a seed, tuber, or corm, which are higher lifeforms and thus not patentable. Descendent “cells” cannot be separated from the higher life form that that reproduces. A descendent cell has no independent existence.
- A descendent cell can only by “found” and thus is not an invention. The reproduction and potential/likely recombination of genes and chromosomes occurs through a biological process under the control of the parent organism.
- A cell cannot express traits independently of the plant, and are thus unknowable unless it is allowed to become a higher lifeform and thus, unpatentable matter. Even if the DNA for the claimed traits is characterised, the cell does not automatically or necessarily express the traits exactly the way the parent did when the descendent plant grows. Even if the plant is cloned and its cells have identical DNA to its parent, growing conditions and epigenetic factors influence gene expression. Small variations in parent genomes can confer phenotypic variations due to how the genes are regulated during cell and plant development.
- Claims regarding descendent cells are overbroad, as reproduction is an unlimited phenomenon – the descendants of a patented organism could extend indefinitely into the future as long as conditions allowed for it to reproduce. The future organisms may contain the DNA described and associated with the phenotypic traits in the parent, but their expression as actual material traits in progeny has the potential to, and will likely change over future generations, as growing conditions and epigenetic responses interact with cell processes and genetic changes, including regulatory DNA and RNA.
- Patenting of descendent cells would seem to be a method for a company to maintain an income stream from licencing progeny of a patented variety indefinitely, as each generation of progeny could re-start the clock. This would give undue power over plant genetics to patent-holders. Canada already has Plant Breeders Rights legislation that allows plant breeders to obtain PBRs for new varieties that are distinct, uniform and stable, and to control access to the propagating material of the protected variety for a period of 20 to 25 years depending on the crop kind. Plant Breeders Rights is a type of Intellectual Property right that applies to new plant varieties (higher life forms and thus not patentable material).
In Section 23.02.01a(i) under Example 1, Claim 1 – the plant cell cannot be patentable for several reasons. First, the cell cannot exist/could not come into existence without being part of a higher organism. It is already established that seed are not patentable material for this reason. A cell that is part of a seed is therefore not patentable. In this example the parent plant has not been precisely described: it has only a sample deposited, which may or may not be genetically consistent, and whether it is phenotypically consistent can only be determined after growing the seed, a higher life form. Allowing patenting of claims like this example would be overbroad, as the patent-holder would be able to restrict access to this seed/plant/genetics without disclosing what makes it an invention: there is no description of what process was used to create it, nor the method for how would a person skilled in the art could achieve the same results. Allowing this type of claim would be inconsistent with the accepted norms for patents, and allow undue control over seed and plant genetics.
In Section 23.02.01a(i) under Example 1, Claim 5 – this type of claim cannot be allowed because it relies only on phenotypical characteristics of the plant – which do not exist at the level of the cell, and cannot be determined from a single cell of the progeny unless/until it is grown into a plant (unpatentable higher life form). The claim is also overbroad because it is possible for an unrelated plant to exhibit all the agronomic, morphological, and quality traits listed in Table 1. If there was an infringement case, it would be impossible to determine whether the cells in the plant in question were descendant of the SB22 variety or had the characteristics of SB22 for other reasons.
| Example 1: | |
| An application discloses the development of a soybean plant variety designated SB22. The description indicates that variety SB22 shows uniformity and stability for all of the agronomic, morphological, and quality traits described in Table 1 but does not disclose any genetic characterization of the variety nor any of its traits. A deposit of seeds of variety SB22 was made under ATCC Accession number 6789 prior to the filing date of the application. The description states that descendant plants of variety SB22 may be produced using any type of conventional plant breeding method, including selfing, backcrossing and outcrossing soybean plant variety SB22. | |
| Claims: | |
| A plant cell from a soybean plant designated variety SB22, wherein representative seed of variety SB22 has been deposited under ATCC accession number 6789. | Patentable |
| A plant cell from a soybean plant, wherein the plant is a descendant of soybean variety SB22 and representative seed of variety SB22 has been deposited under ATCC accession number 6789. | Not patentable |
| The plant cell of claim 2, wherein the descendant plant expresses all of the traits defined in Table 1. | Patentable |
| The plant cell of claim 3, further wherein the descendant plant has inherited all of the traits defined in Table 1 from the soybean plant having representative seed deposited under ATCC accession number 6789. | Patentable |
| A plant cell from a descendant plant of soybean variety SB22, wherein representative seed of variety SB22 has been deposited under ATCC accession number 6789, and wherein the descendant plant is produced by self-pollinating SB22 and expresses all of the agronomic, morphological, and quality traits of SB22 listed in Table 1 as determined at the 5% significance level when grown in the same environmental conditions. | Patentable |
Therefore, we assert that Descendent Cells are non-patentable material because they cannot be produced or characterized independently of the higher organism that creates the reproductive material (seed, cutting, tissue) and because the phenotype and/or traits of the progeny cell cannot be known unless and until the descendent grows and forms a plant, which is unpatentable as a higher life form.
23.02.03 Processes to produce life forms
We recognize the distinction between the process used to create a higher life form and the higher life form itself. However, in this section there are two process claim examples that fail to meet the requirements for patentable subject matter.
In Section 23.02.03 under Example 2 – Claim 1, this type of claim should not be patentable subject matter because it is also overbroad. The stated rationale is that this claim does not specify what kind of plant breeding would constitute infringement – it covers any and all breeding techniques. The kale plant is obviously a higher life-form, and thus unpatentable. The “use” of the plant for breeding is something people can easily do without using particular technical methods – it is common knowledge. The “use” claim of the kale variety for breeding is a de facto higher life form patent, which is not allowed. Furthermore, the plant breeder who may have created this novel kale plant already has access to the Plant Breeders Rights Act and Regulations to protect its intellectual property rights if the new variety is distinct, uniform and stable.
Example 2 – Claim 3 is also questionable and also contradicts claim 1, since Claim 1 does not require the breeder to determine whether the genetic make-up of the descendent matches the parent but still claims patent rights to it. Claim 3 is not possible since the plant breeder would have to destroy the cells in order to asses whether they had the DNA covered by the patent. To actually produce descendent cells, seeds and plants would be required, and they are unpatentable higher life forms. Furthermore, there is no “invention” involved in assessing whether the descendent cells contain specific DNA sequences – this is a mere technical step, already in common use in plant breeding. It can also be seen as a fishing expedition – to search for something that, if found, could then be used to claim patent-rights. The “inventor” did not place the DNA in the descendent cell.
| Example 2: | |
| An application discloses new kale variety K23, which is described as having numerous features that are desirable for commercial production and breeding programs. Suitable descendant plants of the variety are screened for the presence of a nucleic acid marker (SEQ ID NO: 71). The description indicates that a deposit of seeds of the variety was made at NCIMB under accession number 230203 prior to the filing date of the application. | |
| Claims: | |
| Use of a kale plant of variety K23 for breeding, wherein a sample of its seed has been deposited under NCIMB No. 230203. | Patentable |
| The use of claim 1, wherein the plant is crossed with another kale plant to produce descendant plants. | Not patentable |
| The use of claim 2, further comprising isolating DNA samples from the descendants and assessing whether the samples comprise a nucleic acid having the nucleotide sequence set forth in SEQ ID NO:71. | Patentable |
| A kale plant of variety K23 for use in breeding, wherein a sample of its seed has been deposited under NCIMB No. 230203. | Not Patentable |
All of this respectfully submitted by
The National Farmers Union
July 9, 2025
