Biotechnology, Agriculture and Law

What are Plant Breeders Rights?

Farmers originally conducted plant breeding, evidently picking the best seeds for next year’s crop. The original seed companies dealt with vegetables, since few people would let their vegetables “go to seed”. In the 19th century the US Navy was charged with bringing back seed samples from around the world, and the US government supplied farmers with seed through the mails.

The major change occurred when Henry A. Wallace (who eventually became FDR’s vice-president) did something non-intuitive. In the 1920s he started crossing weak lines of corn and found that he could produce superior lines.  The superior genes were recessive in those weak lines. This involved a number of crosses and thus a number of growing seasons before a particular line was breed. This was the beginning of commercial hybrid corn (and the Pioneer Seed Company). Hybrid corn has another feature: it does not reproduce true. If you replant it, you might get some of the line, but generally you will get the grandparent lines etc.

The time it took to breed the final seed, the fact it did not “reproduce” and the increase in yields begat the seed industry. Another contributing fact is evolution. Eventually a variety or line ceases having commercial value. With field crops this can happen as “quickly” as 7 – 15 years. Consequently a superior variety is necessary to replaced the “exhausted” one. The result is that farmers generally now buy their seed rather than replant. Hybrid corn is a de facto biological trade secret.

Today there is a plethora of breeding techniques.

Regulation

The world actually tracks two basic regulatory regimes when dealing with plants and crops. One isproduct focused, and also known as science or rules based. The other is process focuses and also known as social or values based. This regulatory dichotomy was first identified by Prof. Grant Isaac then of the University of Saskatchewan. His regulatory matrix is reproduced below.

	SCIENTIFIC RATIONALITY	SOCIAL RATIONALITY
BELIEF	Technological progress	Technological precaution
GENERAL REGULATORY ISSUES
Type of Risk	Recognized/Hypothetical Probable	Recognized/Hypothetical Speculative
Risk Tolerance	Minimum risk	Zero risk
Science	Evidence-based/safety, health	Social Construct/Ethics, Values
Underpinning Theory	Scientific	Humanistic
Risk Assessment	Safety/Health	Safety/Health/Quality “other legitimate factors”
Focus	Product	Process/Production method
SPECIFIC REGULATORY ISSUES
Substantial Equivalence	Accepts	Rejects
Risk Management (RM)	RM is for risk reduction/prevention; safety-health basis	RM is for social responsiveness; socio-economic concerns
Precautionary Principle	Science-based (cost benefit)	Social-based (absolutist)
Burden of Proof	Innocent until proven guilty	Guilty until proven innocent
Structure	Vertical (existing structures)	Horizontal (new structures)
Participation	Narrow: Technical experts/judicial decision making	Wide: Consensus, social dimensions
Labelling	Safety- or nutrition-based—need to know	Consumer right to know
Objective of RM	Risk reduction/Prevention	Socio-economic concerns

Canada has a rules / based / science based regulatory regime. This engages an entire  science column in the matrix as noted above. The fundamental pivot that elicits scrutiny is the product not the process.  To that end GMO / GE plants are not regulated qua GMO.  Rather, a plant comes under regulatory glare whenever is meets the definition of novelty—however that was bred in — mutagenesis, protoplast fusion or rDNA etc.  So in Canada the key legal and regulatory concept is a Plant with Novel Traits, or PNT.

Seeds Act

The Seeds Act fixes whether or not a seed from scheduled crops (generally any of food, feed, fibre)  can be sold in Canada as well as the standards for seed companies and marketing. The definition of “sell” is all-encompassing. Virtually all of the regulatory strictures are found in Seeds Regulations. It is worth noting that the Seeds Act captures primarily field crops and potatoes. Most vegetables and tree fruits fall outside of its compass.

The purpose of the Act and Regulations is to govern the testing, inspection, quality, and sale of seeds. No one can sell or dispose of seeds for consideration unless the seed is registered, at which point it is called a “variety.” The Seeds Regulations also define “seed” to include derivation through biotechnology. The mechanics of the registration system are set out in the Seeds Regulations. Within those chapters are provisions idiosyncratic to certain seed types (e.g., field crops), seed standards, accredited graders, and seed testing.

The touchstones of registration are:

• Merit
• Identification.

Merit requires that the variety is equal or superior to appropriate reference varieties with regard to characteristics that render the variety beneficial for a particular use in a specific area of Canada. This entails documentation including: description of pedigree, origin, methods of development, experiment results, etc.. This often requires 10 or more years of breeding and the production of attendant records.

The pivot of the regime is the recommending committee(s). The recommending committees conduct the growing or experimental trials on the proposed variety. At least two years of co-op trials are required as a prerequisite for subsequent regulation.

The registration committees have sub-committees, generally along three themes: disease resistance, agronomy, and quality. A report is made to the main committee, and a plenary vote is taken.

Registration can be absolute or conditional. Conditional registration divides into three categories:

• Interim
• Regional
• Contract

Interim registration is granted if the seed has merit but further evaluation is still required (because of insufficient data), in which case a registration may be granted for between one and five years. Regional registration is granted if the variety might be problematic—if it has disease susceptibility in certain regions or might be confused with other varieties. Contract registration imposes restrictions on a variety due to its biotechnology (biochemical or biophysical characteristics) that can make that variety confusing or threatening to similar varieties.

Variety registration solely grants permission to sell the seed. It grants NO property rights.

 To secure intellectual property rights in a plant that is:

• a registered variety;
• ornamental (which falls outside of the Seeds Act); or
• a cultivar  that is subject to the Seeds Act but not yest registered

one must registered pursuant to the Plant Breeders Rights Act (PBR), which is the domestic manifestation of the international treaty, the International Convention for the Protection of New Varieties of Plants (UPOV). Other jurisdictions use the term Plant Variety Protection (PVP).

Under s. 4 of the PBR the touchstones for plant registration are

• Distinct
• Uniform
• Stable.

Kindly note any  prior sales of the plant submitted for registration under PBR is fatal.  In other words selling the plant prior to securing PBR is an absolute bar to obtaining PBR.

Once registered the variety  / ornamental / plant is now known as a denomination. The denomination technically is the  actual name of the plant  (“Starburst”) and is a protected term.  However one cannot register a denomination name under the Trade-mark Act because to do so would give the name in effect perpetual existence (since trade-marks are valid for 15 years and can be renewed indefinitely). Conversely a registered trade-mark cannot be a denomination name for the same reasons.  The denomination name protection expires with PBR.

The UPOV system has been revised three times (in 1972, 1978, and 1991), each time strengthening the rights of the breeder. Canada ratified the 1978 version, the US the 1991 edition. It is worth noting in Canada you can patent the gene but not the plant, while but in the US you can patent the plant containing the gene. The practical outcomes are the same, you can enforce your IP rights.

Distinctly Canadian – Plants with Novel Traits or PNTs

Canada does not regulate genetically modified plants qua genetically modified plants. Rather the product – the phenotype — not the genotype or process or production method that attracts regulatory scrutiny.

The principles of Canadian biotechnology policy include:

• Using existing laws to avoid duplication
• Developing clear guidelines for evaluating biotechnology products
• Providing a sound scientific knowledge base on which to assess risk.

This approach is consistent with the OECD Blue Book. In addition, the Canadian Food Inspection Agency’s (CFIA) operating principles include:

• Focusing on the product traits;
• Establishing safety levels and standards for each product, based on best scientific data
• Dealing with safety in the milieu of probability and magnitude of any adverse effects, rather than the absence of risk.

The PNT arose in Canada in the early 1990s when regulators faced the conundrum of the same trait herbicide-tolerant canola was created by different breeding methods: mutagenic, and rDNA. The resulting policy decision held that the potential threat to the environment from the plant traits arose irrespective of the breeding technique that introduced those traits. Henceforth the regulatory focus would be on the “novel” trait, and not on the breeding technique that begot or introduced that novel trait. Breeding techniques of course include rDNA; mutagenesis, somaclonal variation; chromosome doubling; protoplast fusion; inter species crosses; embryo rescue and the dilemma of cisgenes and gene silencing.

Familiarity, the first threshold, encompasses experience with and provenance of the plant. If the plant is familiar, the trait is similar to one already approved, and the trait is derived by a technique that has been traditionally considered safe, then a risk assessment may be omitted. If not, a risk assessment commences to determine if the plant is substantially equivalent to an approved product. This entails both the genomics/proteomics and the effect on the environment. If both familiar and substantially equivalent, then the CFIA assessment ceases. If not, the portion not substantially equivalent undergoes further risk assessment. The crux of PNT is that due to the novel trait from the introduced gene(s), that element of the plant is not substantially equivalent to their progenitors:

The policy interpretation of the regulation is that a plant contains a novel trait if the trait is either not present in plants of the same species already existing as stable, cultivated populations in Canada, or is present but at a level significantly outside the range of that traits in stable, cultivated populations of that plant in Canada. There are three contexts for interpreting novelty: trait introduction, trait modification, and incremental increase.

Nomenclature

Germplasm is plant material with unknown phenotype or genotype. A cultivar is a plant that manifests certain phenotypes but is not registered as either a variety or denomination. A variety in Canada that is both a field crop and has merit and identification is therefore registrable under the Seeds Act. It can now be sold but no IP rights (exclusivity) are bestowed. A variety is then registered under the Plant Breeders Rights Act, granted the variety is distinct, uniform and stable. Now exclusive IP rights vest in that plant now known as a denomination. Those rights subsist for 18 years from issuance.

Denominations are found not only in field crops or tender fruits, but especially in ornamentals (flowers/bushes).  Denomination names cannot be trade-marked and vice versa. A PNT cannot be registered as a variety or denomination until prior regulatory hurdles are met. Thereafter a PNT can become a variety or denomination.

Legal Documentation – Technology Transfer

I am sometimes labeled with the moniker “plant lawyer” which is a tad misleading as being too narrow.  Yes I indeed have domestic and international experience with plants, genetics and agricultural crops. But I also have experience with a plethora of advanced technologies–software, mechanical, optical, chemical processes–in food and other contexts.

I am particularly experienced with the drafting and law applicable to confidentiality agreements (more commonly called non-disclosure agreements) and licenses.

The new issue with confidentiality agreements is the fact that much of the confidential information is really an aggregation of publicly available or public domain data. The exemptions in the CA / NDA must contemplate that reality.

Licenses have a number of issues, not the least of which include import / export provisions (“gray goods”); non-impeachment of the IP; improvement grant-backs & forwards; march-in or reach-through rights; and the scope of field of use. A hidden danger lies in the ubiquitous entire agreements provision. CA/ NDA or even consulting and collaboration agreements precede most licenses.  The question is whether these agreements must mesh and harmonize or the licence takes precedence? Hence the need not only to give effect to the parties’ obligations but also to manifest the parties’ underlying needs and risk allocations.