Suggestion on Patent Act Modification regarding Genetically Modified Plants
Kwang Shin
1. INTRODUCTION - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - -
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1.1. Why are Genetically Modified Plants (GMPs) needed? - - - - - - - - - - - - -
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1.2. What are the potential IP issues? - - - - - - - - - - - - - - - - - - - - - - - - - - - - -
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2. THE ROLE OF PATENT LAW IN GMP PATENTING
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3. PATENTABILITY OF HIGHER LIFE FORMS AND ITS INFRINGEMENT
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3.1. Current authorities - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - -
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3.2. Recent recognition on patenting of higher life forms and its infringement
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4. THE UNIQUE NATURE OF GMPs
4.1. Plant cells are totipotent
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4.2. Plant propagation is uncontrollable - - - - - - - - - - - - - - - - - - - - - - - - - - -
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5. ISSUES REGARDING GMO PATENTS - - - - - - - - - - - - - - - - - - - -- - - - - -
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5.1. GMP patents presuppose infringement of existing rights
5.2. GMP patents eliminate choices
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5.3. GMP patents are used not as a shield but as a sword
5.4. GMPs create unfair competition
5.5. Summary
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6. ISSUES IN PREVIOUS DECISIONS
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6.1. Patent infringement - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - -
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6.1.1. Does intention matter?
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6.1.2. From individual assessment to population dynamics - - - - - - - - - - - -
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6.2. Patent liability
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6.2.1. Is a limitation on the patent rights of GMPs required?
6.2.2. Is liability on the patent rights of GMPs required?
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6.3. Implication of free cultivation and conflict of regulation
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6.4. Power balance
6.5. Remedy
6.6. Summary
7. SUGGESTION
7.1. The role of Parliament
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7.1.1. Introduction to ethical considerations on patents - - - - - - - - - - - - - - -
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7.1.2. Implementation of patent liability - - - - - - - - - - - - - - - - - - - - - - - -
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7.2. The role of the Court - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - -
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7.2.1. The weaker-centered cost allocation regime - - - - - - - - - -- - - - - - - -
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7.2.2. Consideration on gene dynamics and intention
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7.3. International concerns
8. Conclusion
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2
1. INTRODUCTION
1.1. Why are Genetically Modified Plants (GMPs) needed?
The world’s population is expected to grow from 6 billion in 1999 to 9 billion by 2050.1
The existing agricultural technology does not harvest sufficient produce to support this
population growth. Biotechnology was introduced to address this need to increase harvest.
The genetic modification of crops has a long history.2 Humans have genetically modified
plants and animals through domestication and controlled breeding for some thousand years. 3
Humans have attempted to select only the most ideal traits from the parent animals and plants
from which to breed the succeeding generations. Genetically modified plant is not a novel
concept.
The potential use of GMPs is not restricted to increasing yields. For example, GMPs can
be designed with
enhanced nutritional profiles,
readily applicable for developing
pharmaceuticals. 4 This huge potential accelerated the research and development (R&D)
investments on GMPs. Since their first large-scale introduction in 1996, the area planted with
transgenic crops had grown to 200 million acres worldwide in 2004 - 59% of that land being in
the United States.5 The increased yield and other characteristics of GMPs garnered higher profits
for farmers. For example, Roundup Ready soybeans, resistant to the non-selective-herbicide
Bernad Gilland, “World population and food supply: Can food production keep pace with population growth in the
next half-century?” (2002) 27 Food Pol’y 47 at 59.
2
Harold Richard and Susan Hefle, “Plant Biotechnology and Food Safety Evaluation in Transgenic Plants: Current
innovation and future trends” in Neal Stewart, Jr., ed., Transgenic Plant: Current innovations and future trends
(Wymondham: Horizon Scientific Press, 2003) 217 at 218.
3
Sabrina Safrin, “Treaties in Collision? The Biosafety Protocol and the World Trade Organization Agreements”,
(2002) 96 Am. J. Int’l L. 606 at 606.
4
George York, “Global Foods, Local Taste and Biotechnology: The new legal architecture of international
agricultural trade”, (2001) 7 Colum. J. Eur. L. 423 at 430.
5
James Clive, Preview: Global Status of Commercialized Biotech/GM Crops: 2004, ISAAA Brief, No. 32. ISAAA,
(Ithaca: ISAAA, 2004) at 4.
1
3
(NSH) glyphosate, are reported to save farmers hundreds of millions of dollars annually. 6 This
seems to be a huge success, but some say it is not enough. Scholars have argued that
biotechnology has had limited commercial success to date in horticultural crops,7 and that the
part of the reason is the constraints on Intellectual Property (IP) rights.8
1.2. What are the potential IP issues?
There are two major IP issues with regard to GMPs: 1) protecting the GMP research
results and 2) addressing the conflicts among stakeholders, particularly concerning the
infringement of researchers’ rights.
The four main avenues to protect GMP research results are through (i) plant variety
certificate rights, (ii) plant patent rights, (iii) trade secrets, and (iv) utility patent rights.9 Among
them, the key regimes are the first two: plant breeder’s rights for sexually propagated plants, and
plant patents for asexual plants.10 The recognition of such rights raises the issue regarding the
GMP itself; if a gene is patentable, how wide should its scope be? Also, there are potential
impacts resulting from the cultivation of GMPs: (i) “environmental” impacts, such as influences
on biodiversity and landscape, and (ii) “economic” impacts, such as losses suffered by organic
farmers who allege cross-pollination or contamination of organic crops by GMPs grown in
vicinity of their farms.11
This paper suggests a new paradigm for patent law in Canada to recognize the unique
6
Janet Carpenter, Case Studies in Benefits and Risks of Agricultural Biotechnology: Roundup Ready soybeans and
BT field corn (Washington: National Center for Food & Agricultural Policy, 2001) at 3.
7
J. Bradford et al. “Chanllenges and Opportunities for Horticultural Biotechnology” (2004) 58 Calif. Agric. 68 at 71.
8
George Graff et al. “The Public-Private Structure of Intellectual Property Ownership in Agricultural
Biotechnology” (2003) 21 Nat. Biotechnol. Pol’y 989 at 995.
9
V. Santoniello et. al., Agricultural and Intellectual Property Rights (Oxon: CABI Publishing, 2000) at 11.
10
Chidi Oguamanam, “Tension on the Farm Field: The Death of Traditional Agriculture?” (2007) 27 Bulletin of Sci.,
Tech. & Soc. 260 at 264.
11
Christopher Rodgers, “Coexistence or Conflict? A European perspective on GMOs and the problem of liability”
(2007) 27 Bulletin of Sci., Tech. & Soc. 233 at 233.
4
characteristics of GMP that differentiate them from other patentable physical materials. While
there are many issues surrounding GMPs, such as environmental effects and food safety, these
topics are beyond the scope of this paper. This paper is focussed on issues related to patent law.
2. THE ROLE OF PATENT LAW IN GMP PATENTING
Patents for inventions are issued and protected solely under the Patent Act.12 The Act
protects the ideas of the patentee, and under this protection, the patentee can recoup the initial
outlay and recover a profit commensurate with the market value of the invention.13 Moreover, a
Canadian patentee has the exclusive right to produce and use the invention, as well as to sell it to
others.14 As such, patent law is often said to operate for economic ends and is an unsuitable
guide for moral and ethical questions.15
However, rewarding the patentee is not the primary purpose of the patent system.
According to the Canadian Biotechnology Advisory Committee (CBAC), patent system aims at
attaining the public good. 16 In the United States, it was held that the awarding of patents is
directed to the disclosure of advancements in knowledge that will benefit society - not a
certificate of merit, but an incentive to disclose.17 Considering this purpose of patent law, the
incentive for a patentee to disclose his or her invention should be proportional to the social
benefit. It also follows that if non-benefiting users are harmed as a result of allowing a new
patent, this balance can be disrupted.18 This is unfair to the non-profiting parties. Therefore, it
12
David Vaver, Intellectual Property Law (Toronto: Erwin Law, 1997) at 113.
Ibid.
14
Patent Act, R.S.C. 1985, c.P-4. s. 44.
15
George Poste, “The Case for Genomic Patenting” (1995) 378 Nature 534 at 534.
16
Canadian Biotechnology Advisory Committee (CBAC), Patenting Higher Life Forms: Report to the government
of Canada Biotechnology Ministerial Coordinating Committee (Ottawa, CBAC, 2002) at 8.
17
Sinclair & Carroll Co., Inc. v. Interchemical Coporation, 325 US 327 (1945) at 330-331 cited in ibid. at 7.
18
Norman Siebrasse, “The Innocent Bystander Problem in the Patenting of Higher Life Forms” (2004) 49 McGill
L.J. 349 at 365-366.
13
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seems that ethical and moral considerations are required in assessing the patentability of a new
invention when that invention could influence the balance of existing interests.
Plants, together with seeds and non-human animals, have been classified as higher life
forms in Canada and not patentable.19 The formulation of patent policy with respect to higher life
forms calls for a commitment to justice: “a commitment to ensure a fair distribution of benefits
and burdens” through a balancing of interests of the various stakeholders in any given field.20 If a
GMP patent raises any issues that has not been considered previously, patent law needs to
intervene in order to strike the right balance amongst stakeholders.
3. PATENTABILITY OF HIGHER LIFE FORMS AND ITS INFRINGEMENT
3.1. Current authorities
In Canada, there are three main authorities on gene patents and patent infringement of
GMPs. In Harvard College v. Canada (Commissioner of Patents), after reviewing the definition
of “invention” and the scheme of the Patent Act, Justice Bastarache, writing for the majority,
concluded that higher life forms are not included in the definition of an “invention”.21 Although
the Patent Act does not explicitly differentiate between lower and higher life forms, making such
a distinction “is nonetheless defensible on the basis of common sense differences between the
two”.22 Thus, Harvard College could not patent its cancer-susceptible mouse that they thought
was “produced” in their laboratory.
On the other hand, Monsanto Canada successfully defended its patent on the genetically
19
CBAC, supra note 16 at 30.
CBAC, supra note 16 at 8.
21
2002 SCC 76, (2002), 219 D.L.R. (4th) 577 at para. 155. [Oncomouse]
22
Ibid.,21 at para. 147.
20
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modified canola cell. 23 In that case, the patent was not for the whole plant but only the cell
containing a specific gene that could induce resistance against Monsanto’s NSH, glyphosate. The
defendant Schmeiser, a farmer who had grown naturally-pollinated glyphosate-resistant canola,
was sued by Monsanto and held liable for infringing Monsanto’s patent. 24 Thus, it is now
possible for organic farmers such as Schmeiser to be held liable for the gene drift of GMPs.
In Hoffman v. Monsanto Canada, a group of organic farmers tried to obtain redress for
the damage caused by drifts of canola pollen containing the glyphosate-resistant gene coming
into their organic canola fields.25 Their claim was based on negligence, nuisance, strict liability
and trespass. 26 They also relied on pollution liability provisions of provincial environmental
statutes.27 However, the court did not accept this claim, because Monsanto had done all that they
were required to do and no bad faith was found. 28 Unfortunately, the court in Hoffman was
constrained by the procedural dictates of class actions and could not fully deal with the complex
legal issues implicated in genetic contamination.29
Court decisions suggest that even though a whole GMP, being a “higher life form”, may
not be patentable in Canada, a single gene or cell can be patented. When those genes are mixed
with non-GMPs in the cultivation process, the farmers who do not grow GMPs have the burden
of ensuring that they do not infringe on the rights of the GMP patentee, either intentionally or
unintentionally. The company that sells the seeds is not liable so long as they follow the statutory
guidelines of what to do.
23
Monsanto Canada v. Schmeiser, 2004 SCC 34, [2004] 1 S.C.R. 902. [Schmeiser]
Schemeiser, ibid.
25
Hoffman v. Monsanto Canada, 2005 SKQB 225. [Hoffman]
26
Hoffman, ibid. at para. 38-133.
27
Environmental Management and Protection Act, S.S. 2002, c. E-10.21. s. 13(3).
28
Hoffman, supra note 26 at para. 38-195.
29
Hoffman, supra note 26 at para. 269.
24
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3.2. Recent recognition on patenting of higher life forms and its infringement
In Europe and the United States, it appears that there are no barriers to the patentability of
genetically modified plants, animal organs or tissues, and even human organs or tissues. 30 In
Canada, after the decision of Oncomouse, the CBAC recommended that the higher life forms
such as plants, seeds and non-human animals that meet the criteria of novelty, non-obviousness
and utility, be recognized as patentable subjects.31 However, the CBAC also recommended that
the scope of patent rights on these be applied with certain limitations: (i) that a farmer’s privilege
exception to infringement be incorporated into the Patent Act to permit farmers to save and sow
seeds from patented plants or to breed patented animals in certain circumstances; (ii) that the
innocent bystanders exception to infringement be incorporated into the Patent Act to preclude
infringement claims against innocent farmers whose lands become inadvertently spread with
patented plants; and (iii) that a research and experimental use exception be incorporated into the
Patent Act to exempt certain research activities from infringement.32
Canada has long recognized the need to take into account public benefit and
technological developments for the purposes of best utilizing monopolized knowledge. For
example, according to the Canadian Plant Breeder’s Rights Act, the rights holder of a new
variety of sexually produced plant has the exclusive right to (i) produce and sell the variety in
Canada for the purpose of distributing the propagating material of the protected plant variety; (ii)
make repeated use of the plant to produce another variety; (iii) make repeated use of the
protected variety for use in the production of ornamental plants or cut flowers; and (iv) license a
David Morrow and Colin Ingram, “Of Transgenic Mice and Roundup Ready Canola: The decisions of the
Supreme Court of Canada in Harvard College v. Canada and Monsanto v. Schmeiser” (2005) 38 U.B.C.L. Rev. 189
at 219.
31
CBAC, supra note 16 at 16.
32
Ibid. at x.
30
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third party to do any of the above acts.33 However, these rights are subject to two restrictions: the
protected varieties may be used for breeding and developing new plant varieties, and farmers
may save and use their own seeds of the protected varieties without infringing on the holder's
rights. The same concepts should be adopted in genomic patent rights.
I will review the decisions made in the three cases discussed above to illustrate that the
current Patent Act is inadequate to deal with issues regarding GMPs with their unique
characteristics that set them apart from patentable physical materials and animals. I propose that
the Act ought to be amended to take into account the conflicting interests of stakeholders, and
the unique nature of GMPs.
4. THE UNIQUE NATURE OF GMPs
4.1. Plant cells are totipotent
In Oncomouse, the Supreme Court distinguished between higher life forms and lower life
forms.34 In Schmeiser the Court held that the patent only applied to the chimeric gene and the
plant cells into which the gene was inserted, not to the whole plant. 35 However, since the gene
and the cells are in every part of the plant, any uses of that plant would infringe the patent.
Therefore, the entire plant could effectively be protected from unlicensed use through the patent
over its cells and genes. As such, the decision in Schmeiser effectively allowed Monsanto to
acquire patent protection over the whole organism, that was not allowed previously in
Oncomouse..36
The majority in Schmeiser did not fully consider the key differences between a plant cell
Plant Breeders’ Rights Act, S.C. 1990, c. 20. s.5(1).
Oncomouse, supra note 21.
35
Schmeiser, supra note 24 at para. 138.
36
Richard Gold and Wendy Adams. “The Monsanto Decision: The thin edge or the wedge” (2001) 19 Nature
Biotech. 587 at 587.
33
34
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and an animal cell: plant cells are totipotent; animal cells are usually not.37 That plant cells are
totipotent means that all plant cells have the potential to develop into an entire organism.
Conversely, in animals, only the reproductive cells such as eggs have this potential. An alreadydifferentiated animal cell does not perform the same functions as another cell in a different part
of the organism even though they possess the same gene. The oncomouse of Harvard College
had the same gene in all of its cells, but only the differentiated cell of a specific organ had the
susceptibility that the College claimed. Therefore, only the entire organism would have the
characteristic that the college wanted to claim. Furthermore, the living, entire mouse is useful for
a specific carcinogenicity research for which a single cell cannot be used.
However, in the case of totipotent plant cells, each cell of a glyphosate-resistant canola of
Monsanto not only has the same gene but also has the same function insofar as resistance is
concerned, and each cell could produce another whole plant with exactly the same gene structure
of equal resistance to glyphosate. For plants, one cell may equal a fully grown plant, and it is
enough to patent a cell to effectively exercise control over the whole GMP, as seen in Schmeiser.
This is where confusion arises. Even though the majority in Schmeiser held that a patent on the
cell is not a patent on the plant, they used the phrase “patented plant” in the judgement. 38
Evidently, a patent on a GMP cell should be seen as a patent on the whole plant, or it should not
be allowed at all if a patent on the whole plant is really to be avoided. From this point of view,
the dissent in Schmeiser has rightly argued that a patent would be invalid if the subject is a whole
plant in the context, 39 and that Schmeiser had not infringed Monsanto’s patent by saving,
37
Stephen Nottingham, Eat your genes: How genetically modified food is entering our diet, (New York: Zed books,
1998) at 22.
38
Schmeiser, supra note 24 at para. 2.
39
Schmeiser, supra note 24 at para. 134.
10
planting, or selling glyphosate-resistant seeds since the patent did not extend to the plant itself.40
4.2. Plant propagation is uncontrollable
Most patented products are not self-replicable; they require human intervention to be
produced. In other words, their production and reproduction is controllable. However, a plant is
self-propagating, and its mechanism of pollination in the open air, and thus, its self-propagation
is difficult to control.
In GMP research, the potential of outcrossing is one of the biggest concerns. In the
United States, the primary concern behind permitting commercial cultivation of a GMP variety is
biosafety - the unintended release and spread of a potential plant pest. 41 However, the risk of
crossover of genes between GMPs and non-GMPs is not clear. A study of canola pollen drift
across South Australia has concluded that unwanted gene transfer occurred in only 0.07% of
cases, supporting the argument that non-GMPs were not in any serious danger.42 On the other
hand, in the case of Arabidopsis thaliana, a crucifer, the outcrossing rate of genetically modified
genes was about 20% higher than that of non-modified ones.43 The geographic range of gene
drift is another issue under debate. Wind can carry pollen across distances of over 2.5 kilometers,
crossing from one field to another.44 In the case of maize, it has been concluded that it is possible
to produce GM-free (less than 0.9% contamination) maize grains by spacing GMPs and non-
40
Schmeiser, supra note 24 at para. 163.
Alan McHughen, Stuart Smyth, “US Regulatory System for Genetically Modified [genetically modified organism
(GMO), rDNA or transgenic] Crop Cultivars” (2008) 6 Plant biotech. J. 2 at 5.
42
Mary Reiger et al., “Pollen Mediated Movement of Herbicide Resistance between Commercial Canola Fields”
(2002) 296 Science 2386 at 2387.
43
Joy Bergelsoon et al, “Promiscuity in Transgenic Plants” (2002) 395 Nature 25 at 25.
44
P.L. Metz, E. Jacobson, and W.J. Stiekema, (1997) “Aspects of the Biosafety of Transgenic Oilseed Rape
(Brassica napus L)” (1997) 46 Acta Bot. Neerl. 51 at 58.
41
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GMPs 20 meters apart,45 but finally a 200-meter distance was generally recommended between
two genotypes of maize.46 There are conflicting indications on the degree of risk of gene drift.
However, despite the technological development to limit gene flow, no gene flow
mitigation technology is 100% effective. 47 Gene escape is inevitable and its spread is
uncontrollable. Special attention is warranted when considering patent policies on GMPs.
5. ISSUES REGARDING GMO PATENTS
People see agricultural field as a part of the natural environments. However, upland
paddy fields and orchards are not “natural”. Usually, there is only rice in a rice paddy, only apple
trees in an apple orchard, and only barley in a barley field. Nature alone does not segregate
species in that manner; these are result of artificial intervention by human beings. Agricultural
land is more akin to a factory for the crop production, than a part of nature. But if that is the case,
why should there be any issues in obtaining a patent on the product (crop) produced from that
factory (field)? – it is because GMPs have unique characteristics that raise new issues about its
patentability.
5.1. GMP patents presuppose infringement of existing rights
In the past, a new patent did not force people to change their established practices. For
example, the introduction of the computer, the lightbulb and the camera did not prevent people
from using calculators, candles and paintings. However, patent rights on GMPs can necessitate
Joaquima Messeguer et al., “Pollen-mediated Gene Flow in Maize in Real Situations of Coexistence” (2006) Plant
Biotech. J. 633 at 641.
46
B.L. Ma, K.F. Subedi, and L.M. Reid, “Extent of Cross-Fertilization in Maize by Pollen from Neighbouring
Transgenic Hybrids” (2004) 44 Crop Sci. 1273 at 1281.
47
National Research Council (U.S.). Committee on Biological Confinement of Genetically Engineered Organisms.,
Biological Confinement of Genetically Engineered Organisms, (Washington: National Academic Press, 2004) at 9.
45
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change of behaviour: once the chimeric gene escapes, farmers are required to rearrange their
practices or take additional precaution against potential patent infringement. 48 And the
significant fact is that the escape is not preventable. Thus, GMP patents will inevitably infringe
the rights of many non-GMP farmers to keep their practice.
5.2. GMP patents eliminate choices
Clearly, GMPs can transform non-GMPs into GMPs regardless of the intent of non-GMP
farmers. Farmers do not have control over the process. If effect, they are forced to purchase the
GMP to avoid infringement, or they are increasingly fewer options of what they can grow. The
same applies to consumers. In many countries, the government requires food companies to
indicate if their product - for example, a chocolate bar - contains GMPs, so that the consumer
could make an informed choice. So what happens if all chocolate bars contain GMPs?
Consumers have no choice but to buy the GMP-containing chocolate bar.
This has not been the case in traditional patentable products. Development of the cordless
iron did not sweep out the corded iron from the market. It simply provided another option for
manufacturers and consumers to choose from. Then it is market dynamic that chooses the better
product to survive through the competition process. It is also possible that both choices survive
by differentiating themselves from each other in some ways, for example, in pricing. According
to economists, having more options generally increases utility for consumers by providing
alternatives so that they can choose what better fits their tastes, and thus, promotes the public
good. It can be concluded then that patent rights on GMPs work against the public good by
limiting options and inhibiting fair competition.
48
Schmeiser, supra note 24.
13
5.3. GMP patents are used not as a shield but as a sword
Aspirin was extracted from the willow tree. People used to chew willow leaves when
they had a fever, and it was one brilliant scientist who separated the active ingredient from the
willow, named it aspirin, and obtained a patent right to it. However, it did not prevent people
from continuing to chew the willow as they had done previously. The patent on aspirin was a
shield for the patentee, and not a sword against previous practice. However, Schmeiser allows
GMP patents to be used as swords against existing farming practices, such as saving seeds for
next year’s cultivation.
In the United States, Monsanto filed 100 seed piracy cases and recovered over $15
million by 2005, winning virtually every case .49 Monsanto earned money not only selling their
seeds but also suing farmers who were just repeating their old practices. Unintentional
infringement of GMP patents is a serious threat to farmers. Monsanto can use their patent as a
sword against farmers who had never intended to infringe on any patent rights. What can
Canadian farmers do after Schmeiser? It is highly likely that many farmers would just obtain
licenses and use Monsanto’s seeds, even though they would use herbicides other than glyphosate,
just to avoid a trial.50 Schmeiser had spent $400,000 in the lawsuit against Monsanto,51 and many
farmers cannot afford such costs. On the other hand, as seen from the Hoffman decision,
Monsanto may not be entitled to any damages under current authorities. Exercising patent rights
against existing practices is not a desirable consequence of granting patent rights and does not
comply with one of the main purposes of patent law of promoting the public good.
Paul Elias, “Saving Seed is Latest Tech Piracy” Wired (14 January 2005), online: Wired
<www.wired.com/news/technology/0,1282,66282,00.html>.
50
Keith Aoki, “Recent Skirmishes in the Seed Wars” 11 Cardozo J. Intl. & Comp. L. 247 at 297.
51
Stephen Leahy, “Monsanto ‘Seed Police’ Watching Farmers” IPS-Inter Press Service (14 January, 2005), online:
<http://ins.onlinedemocracy.ca/index.php?name=News&file=article&sid=4497>.
49
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5.4. GMPs create unfair competition
A group of public breeders in the United States had been breeding a cauliflower cultivar
which was resistant to cauliflower mosaic virus. Just before commercialization, after spending a
long period of time in breeding, they received an unwelcome notice that Monsanto has gotten a
patent right over the very gene that expresses the resistance against cauliflower mosaic virus.52
Breeders were prohibited from commercialization of the new cultivar. Breeders could not obtain
any right to the new cultivar until they had fixed the trait into cauliflower even though they had
actually used that gene for a long time. However, seed companies could get a patent right after
they figured out the function of the gene, without requiring any successful outcome of a new
cultivar. “Knowing it first” would trump “using it first”. Again, this is different from the aspirin
case. Aspirin could only be used in its separated form and did not prevent the traditional use.
This might create a lot of “submarine” patents that basically promote unfair competition between
traditional breeders and biotechnology seed companies.
5.5. Summary
Some suggest that if higher life forms are to be patentable in Canada, care must be taken
to ensure that these patent holders should be granted at least equal rights with respect to their
biological inventions compared to holders of patents on non-biological inventions.53 However,
the unique characteristics of plants and the potentially undesirable consequences of GMP patents
suggest the opposite - that GMPs should be dealt with separately. Now, I will review the court
decisions mentioned previously in greater detail.
52
53
Jim Dunwell, “Review: Intellectual Property Aspect of Plant Transformation”(2005) Plant Biotech. J. 371 at 374.
CBAC, supra note 20 at 22.
15
6. ISSUES IN PREVIOUS DECISIONS
6.1. Patent infringement
In Schmeiser, the plaintiff, Monsanto had the onus of proving infringement.54 But it was
held that the onus is impractical and unduly burdensome if the patent holder must prove not only
the possession of the patented seed by the defendants but also their intention to infringe. 55
However, according to the decision in Hoffman where it was held that the farmers failed to prove
any of negligence, nuisance, strict liability and trespass on Monsanto’s side, it is now much more
difficult for farmers to prove liability of seed companies under the common law property
doctrines. 56 In addition, in order for a farmer to take advantage of the defence of innocent
possession, he/she would have to be able to demonstrate that the presence of the crop was
accidental and that he/she acted quickly to arrange for its removal.57
6.1.1. Does intention matter?
Schmeiser decision confirmed that intention is generally an irrelevant factor in analysing
patent infringement.58 The court focused on what the alleged offender did, rather than what he
intended to do.59 However, it was also held that the absence of intention to gain an advantage
from the patented invention may be relevant to rebut the presumption of use.60 If the intention
matters when there is possession without use,61 as was the case in Schmeiser, one might escape
liability by showing lack of intention to use the patent. However, the court adopted the “standby” use concept, which means potential use of glyphosate on the field here, and held that
54
Schmeiser, supra note 24 at para. 29.
Schmeiser, supra note 24 at para. 53.
56
David Catechi, “Two Wrongs Don’t Make A Patent Right” (2005) 56 Hastings L.J. 769 at 780-782.
57
Schmeiser, supra note 26 at para. 86.
58
Schmeiser, supra note 26 at para. 49.
59
Schmeiser, supra note 26 at para. 920-921.
60
Schmeiser, supra note 26 at para. 54.
61
Schmeiser, supra note 26 at para. 50.
55
16
Schmeiser was liable based on the potential and that he was not an innocent bystander.62 The
court also found that Monsanto’s rights to the gene are recognized by law and that Schmeiser
could not rely on lack of intent to defend against the infringement claim.63 With this decision,
farmers have little defence for the consequence of gene drift that happens against their intention.
One of the problems in the majority opinion in Schmeiser is that adopting the concept of
“stand-by” use mistakenly presupposed glyphosate as the only herbicide that could have been
used for Schmeiser’s glyphosate-resistant canola. Herbicide is meant to kill weeds, not canola.
Surely, it is possible that Schmeiser could choose some herbicides other than glyphosate, still
effectively control the weeds and avoid “use” of the Monsanto’s patent.
A more fundamental issue in Schmeiser is that it transformed the test for infringement from “has there been a use of the invention?” to “might the defendant benefit from possession of
the invention in the future?”64 The new test would produce odd results. During flowering season,
canola plant pollen is carried by wind to other plants and pollinates those other plants. The patent
rights recognized in Schmeiser could define the time of pollination as the time of infringement,
as the patented gene will likely be transferred to other canola fields during that time - when no
one can imagine what is happening in the field. To prevent this nonsense, there should be a way
to evaluate the intention of farmers, however difficult and burdensome it may be to the patentees.
6.1.2. From individual assessment to population dynamics
The court in Schmeiser held that:
[W]here a defendant’s commercial or business activity involves a thing of which a
patented part is a significant or important component, infringement is established. It
is no defence to say that the thing actually used was not patented, but only one of its
62
Schmeiser, supra note 26 at para. 95.
Schmeiser, supra note 26 at para. 911, 930.
64
Robert Burrell and Stephen Hubicki, “Patent Liability and Genetic Drift” (2005) 7 Env. L. Rev. 278 at 283.
63
17
components.65
By applying this principle to the facts of the case, the majority found that Schmeiser’s
unlicensed collecting, saving, and planting of the patented seeds comes from gene drift as well as
his harvesting of the resulting crop constituted “use” that infringed Monsanto’s patent. 66 It was
also held that the applicant thus deprived Monsanto of the full enjoyment of its monopoly in
canola crops containing the patented gene.67
What is being discussed here is every patented gene or cell and every plant containing the
patented gene or cell. In Schmeiser case, as much as 98% of the field was planted with canola
that contained Monsanto’s patented gene. This is not a reasonable basis for a decision. If GMP
pollens moves to non-GMP field and pollinate all of them, only one cell of each plant has the
gene. If we count each cell, the portion of cells containing patented gene would be less than
0.01% of a plant, while it would be 100% if we count the portion of plants that contains the gene.
I suggest we focus on the mass of the patented gene in a field to make an infringement decision.
When we are dealing with the issue of a GMP patent, we should not consider each cell or plant
but gene or cell population dynamics. Therefore, the question instead should be: how is the
distribution of the gene (or cell) in the field of the person allegedly infringing on the patent? This
also makes sense when we think of how genes are spread. For example, if there was 100%
outcrossing between a GM canola field and a purely organic canola field, theoretically, all the
seeds from the organic field could become glyphosate-resistant, but only half of their total gene
mass would be patented because the progeny seeds would take half the gene from the GMPs and
the other half from the organic plants. By taking gene population dynamics into account, certain
guidelines can be established over what would constitute a breach of the patent, and this would
65
Schmeiser, supra note 24 at para. 78.
CBAC, A Brave New World: Where biotechnology and human rights intersect (Ottawa: CBAC, 2005) at 6-34.
67
Schmeiser, supra note 24 at para. 74.
66
18
help to differentiate between innocent bystanders and intentional infringers.
6.2. Patent liability
6.2.1. Is a limitation on the patent rights of GMPs required?
The risk that a GMP may invade natural habitats and cause environmental problems has
been suggested since the beginning of biotech farming.68 Though this view largely originates
from experiences of invasions of exotic plants, it provides a context for examining gene drift and
the relationship between the rights of the patentee and those of farmers with regards to GMPs.
Once an artificial gene escapes into other fields, how can one avoid using them? The use
of herbicides is not a solution. Both GMPs and non-GMPs are of the same species; herbicides
that kill the GMPs will also kill the non-GMPs. The use of glyphosate, their differing factor, is
also not an option, because that would eliminate the non-GMPs, and not the GMPs. Furthermore,
in the case of canola which has a long dormant period of 4-10 years, once the chimeric gene is
introduced to a non-GMP canola field, it would not be enough even to kill every GMP to get rid
of the chimeric gene, because the pollinated seed can germinate 10 years later, again
contaminating non-GMPs. As such, it is almost impossible to grow organic rapeseeds in Canada
GMP cultivation is widespread and causes the inevitable cross-fertilization of non-GMPs. This
reduces the freedom of choice for both farmers and consumers.
The CBAC suggested that there should be legal limits on a patentee’s ability to exploit
their invention, especially where that invention may pose a risk to human or animal health, or to
the environment. 69 The inevitable and uncontrollable risk of a GMP patent, such as gene
P.J. Regal, (1993) “The True Meaning of “Exotic Species” as a Model for Genetically Engineered Organisms”
(1993) 49 Experientia 225 at 233; M. Willianson, “Invaders, Weeds and the Risk from Genetically Manipulated
Organisms” (1993) 49 Experientia 219 at 223-224.
69
CBAC, supra note 16 at 3.
68
19
wandering, is not what could have been anticipated by the patent system for physical matters and,
thus, would not be properly reflected by the current patent law. To strike a balance between the
patent rights on GMP and its risk on other stakeholder, there ought to be a limitation on patent
rights proportional to the potential risk.
6.2.2. Is liability on the patent rights of GMPs required?
In Hoffman, the farmers suggested that Monsanto’s glyphosate-resistant plants were like
weeds in their fields. The court held that;
[T]he analogy to contamination of land by weed is … too close to make it certain
that the plaintiff’s argument on this point cannot succeed. It can be argued that just
as weeds make it difficult or impossible to grow a conventional crop successfully,
so too does contamination by GM canola make it impossible to grow organic
crops.70
However, the court also held that “the significance of the distinction argued by the
defendants is one which must be assessed … by the trial judge on the whole of the evidence.”71
In addition, it was found that there was not enough foreseeability and proximity to establish a
prima facie duty of care between Monsanto and the farmers72; therefore, the “weed” argument
may not have had a chance to be utilized. However, I would like to look into another aspect of
that assertion for the discussion of patent liability. “Weed” is a comparative concept but on its
own does not define a certain kind of plant. A maize plant is a crop in a maize field but becomes
a weed in an orange orchard. As such, a GM canola in an organic farm could be a weed—and
one that is impossible to exterminate. The fitness cost - the cost a new genotype organism should
pay to win competition with existing genotype organisms - of herbicide tolerance proved low in
canola. This indicates that glyphosate-tolerant canola would not lose the competition with non70
Hoffman, supra note 26 at para. 108.
Ibid.
72
Ibid. at para. 67.
71
20
GMP canola in the natural selection process, making GMP control even more difficult.73
Considering the fact that there is no perfect way of preventing gene drift, cross
pollination is predictable from the point when the GMP seeds are sold, irrespective of the
cultivation practices of any farmer. Cross pollination is an external cost to the canola farming
industry caused by a seed company like Monsanto. When external cost occurs, the party who
creates the cost does not always need to be the party who pays for them,74 but it should be in the
case of gene escape. In Schmeiser or Hoffman, the patentee’s product generates costs for others
who want to avoid passive infringement, and the patentee earns a profit by inducing external cost.
Therefore, the patentees are in better position to internalize the external costs, and it is unfair if
the farmers are forced to pay them.
Furthermore, there is a motive for seed companies to either intentionally disseminate
chimeric genes or ignore its spread. If a gene is widespread, it would make it meaningless to
regulate the gene; therefore, seed companies can avoid regulations by spreading their patented
genes. Farmers do not have this kind of motive to promote gene transfer. This also supports the
argument that some kind of liability should be put on seed companies to prevent such unexpected
and undesirable consequences.
6.3. Implication of free cultivation and conflict of regulation
The court in Hoffman held that;
[D]efendants received approval of the federal government for the unconfined
release of their GM canola varieties prior to their release. The imposition by the
A.A. Snow, R.B. Jorgensen, “Fitness costs associated with transgenic glufosinate tolerance introgressed from
Brassica napus ssp. oleifera (oilseed rape) into weedy Brassica rapa” in Lutman, P.J.W., ed., BCPC Symposium
Proceedings No. 72, Gene flow and agriculture – relevance for transgenic crops (Staffordshire: British Crop
Protection Council, 1999) at 137-142.
74
Tim Pelt, “Is Changing Patent Infringement Liability the Appropriate Mechanism for Allocating the Cost of
Polllen Drift?” (2006) 31 Iowa J. Corp. L. 567 at 577.
73
21
courts of a duty of care not to release these substances into the environment would
therefore appear to be in conflict with express governmental policy.75
This indicates that there would be a conflict between regulations on seeds and regulations
on food. The GM canola could be freely cultivated, disseminating their pollen, without any
control on them as seeds. But what if some parts of an organic canola field are outcrossed by
pollen from the GM canola? The harvest is not organic now, and there is no practical way to get
rid of the seed pollinated with the GM canola, thus, the whole organic field may lose commercial
value due to the regulation on them as food.76 As a result, only the farmers of non-GMP are
subject to both seed companies’ threats and regulatory supervision; that is unfair. The gene flow
occurs in both directions. People have bred specific traits into many crop plants through
conventional breeding, and those crops with the new traits cultivated in the normal, open farming
system without causing conflicts. The fact that one of them is patented does not make the
situation any different. Either the GMPs should be cultivated in confinement, or the GMP
patentees should be prevented from arguing infringement over escaped genes.
The various regulations regarding GMPs - as seeds, food, and gene containers - ought to
be integrated so that they would not impose an unreasonable burden on only one of the several
stakeholders. Whether this could be done by excluding farmers from the potential patent
infringement or by amending all the laws, Parliament’s intervention seems inevitable.
6.4. Power balance
In considering possible remedies for patent infringement issue of GMPs, the current
power imbalance between GMP seed companies and non-GMP farmers should be examined.
However, as a result of Hoffman, it is extremely difficult for farmers to raise a claim against seed
75
76
Hoffman, supra note 26 at para. 71.
In Canada, organic or GM-free foods need to contain no more than 0.9% of GM crop.
22
companies for damages caused by gene drift.
In 1996, around 600 Canadian farmers planted NSH-resistant canola, covering 50,000
acres. By 2000, approximately 20,000 farmers had planted these in 4.5 to 5 million acres,
accounting for nearly 40% of all canola grown in Canada. 77 By 2002, this percentage had risen
to approximately 65%. 78 These figures may suggest that biodiversity has been quickly
diminishing over the last 10 years. But more importantly, it indicates that even though non-GMP
farmers would want to sell their product under the label of “GM-free,” no one can be sure that
this would be entirely accurate, until after the harvest.
In upholding Monsanto’s gene patent, the court in Schmeiser assumed that intellectual
property rights trump farmers’ property rights over their crops.79 The Federal Court of Appeal in
Schmeiser, whose decision was affirmed by the Supreme Court of Canada, stated that:
[T]here is no authority for the proposition that ownership of a plant must
necessarily supersede the rights of the holder of a patent for a gene found in the
plant. On the contrary, the jurisprudence presents a number of examples in which
the rights of ownership of property are compromised to the extent required to
protect the patent holder’s statutory monopoly. Generally, the existence of such a
conflict of rights is not relevant to the determination of infringement but only when
fashioning the remedy if infringement is found.80
Even where farmers choose to use GM canola, the power imbalance favours the seed
companies. Monsanto instituted the Technology Use Agreements (TUA) to which any farmer
who wants to purchase Monsanto’s seeds has to sign. It prevents farmers from giving unused
seeds to others or saving seeds for the next season. In addition, pursuant to the TUA, Monsanto
reserves the right to enter freely onto farmers’ properties and inspect a grower’s fields for seed
77
Schmeiser, supra note 24 at para. 10.
Council for Biotechnology Information, “Benefits of Biotech Crops Have Fueled Rapid Growth in Canada” online:
<www.canola-council.org/about/overview.html>.
79
Chidi Ogunamanam, supra note 10 at 266.
80
Monsanto Canada v. Schmeiser, 2002 FCA 309 at para 51.
78
23
pirating whenever it wishes to do so.81
With all these, the non-GMP farmers now have less options, a bigger burden, and a
weaker argument.to claim against seed companies. The CBAC, in an attempt to balance the
interests of the patent holder and “innocent-but-technical” infringer, proposed that the Patent Act
ought to provide protection to the latter where they can show evidence of their innocence.82
6.5. Remedy
In Schmeiser, the majority found that Schmeiser earned no profit from Monsanto’s
invention and Monsanto was not entitled to the profits awarded by the trial judge. 83 Some argue
that this decision is perverse because farmers who choose to infringe the patent by cultivating
infringing crop will only be forced to disgorge their profits in the event that they are forced to
spray their crops with glyphosate.84 But we need to consider that the advent of biotechnology,
particularly GMPs, created a new profit and risk in the agricultural industry. As we have
observed, most of the profits go to seed companies, while most of risks go to the farmers - in
particular, to the non-GMP farmers. This imbalance should be addressed in the remedies.
Thought should also be given to defining what is “natural”. Between traditional forms of
agriculture and biotechnology-based agriculture, there is a controversy regarding the definition
of nature. Promoters of genetic modification locate their practices within “nature’s own
methods”.85 However, if a GMP is a part of nature, it would not have been patented in the first
place. Therefore, it would be reasonable to favour the party with more natural practices. In
Nicole Nachtigal, “A modern David and Goliath Farmer v. Monsanto: Advising a grower on the Monsanto
Technology Agreements” (2001) 6 Great Plains Nat. Resources J. 50 at 59.
82
CBAC, supra note 16 at 15.
83
Schmeiser, supra note 24 at para 102-104.
84
David Morrow and Colin Ingram, supra note 31 at 214.
85
Sheldon Krimsky and Roger Wrubel, Agricultural Biotechnology and the Environment (Urbana: University of
Illinois Press, 1996) at 9.
81
24
addition, large corporations and huge teams of researchers are now the standard. Therefore, they
have deeper pockets than any other stakeholders in the GMP debate, and this is important when
assigning liability.86
6.6. Summary
The majority in Schmeiser applied patent principles developed in the manufacturing
context. However, as a result, it effectively extended patent protection to higher life forms (e.g.,
plants) that are composed of patented inventions, namely, patented cells.87 The court also looked
to whether the defendant’s activity deprived the inventor of full enjoyment - whether in whole or
in part, directly or indirectly - of the monopoly conferred by law. There would be no problems if
it was about non-living physical matter. However, with the inevitability and uncontrollability of
gene escape and ensuing potential costs to shield the organic plants, the decision unfairly
burdened organic farmers with a latent patent infringement claim. In addition, now the burden to
monitor gene drift, at least partly, has been moved from the patentee to the farmers.88 Moreover,
the disparity between regulations on food and regulations on GMPs has marginalized the organic
farmers, burdening them with too many obligations when they are already in a far weaker
position than their adversaries. After three major cases that attracted international attention, it is
time to devise measures to deal with these issues in an integrated manner.
7. SUGGESTION
7.1. The role of Parliament
Van Cleve, “Regulating Environmental and Safety Hazards of Agricultural Biotechnology for a Sustainable
World” (2002) 9 Wash. U. J. L. & Pol’y 245 at 258.
87
CBAC, supra note 66 at 6-34.
88
Robert Burrell and Stephen Hubicki, supra note 64 at 283.
86
25
In the United States, Environmental Protection Agency seeks to preclude gene flow
between GMPs and their wild relatives, as this is the primary means of gene escape,89 though the
risk is currently not clear. In EU, it was held that the precautionary principle can be invoked to
justify legislative action where there is more than a hypothetical risk of damage, even if the risk
that exists cannot be fully demonstrated by available scientific means.90 This principle could be
applied to GMP patenting and relevant issues. The CBAC also suggested that it is the
Parliament’s responsibility to establish policies in respect of the patenting of higher life forms.91
The uncertain scope of potential civil liability arising from the release of GMPs may
require statutory measures to deal with the coexistence of GMPs and non-GMPs. In the EU, the
rationale underlying the development of coexistence measures is to uphold the choices of both
the producers and the consumers. Farmers should have the ability to make a choice between
conventional, organic, and GM crop produce. Likewise, consumers should also have a
meaningful choice with regard to the type of agricultural produce and type of production that
they prefer.92
7.1.1. Introduction to ethical considerations on patents
In Canada, genes can be patented if they are new, non-obvious and useful. 93 Patent
examiners do not have discretion to consider moral or ethical issues when determining
patentability. 94 This is adequate in dealing with controllable physical materials, but it is not
enough for genes with their uncontrollable behaviour. Therefore, the condition of being new,
89
Alan McHughen and Stuart Smyth, supra note 42 at 10.
Pfizer v. European Commision, [2002] ECR 11-3305 cited in supra note 11 at 234.
91
CBAC, supra note 16 at 7.
92
Christopher Rodgers, supra note 11 at 244.
93
Richard Gold, “Patent in Genes (prepared for CBAC)” (Ottwa: CBAC, 2000) at ii.
94
Timothy Caulfield et al., “Biotechnology Patents and Embryonic Stem Cell Research: Emerging Issues (Part I)”
(2004) 1 JIBL 98 at 102.
90
26
non-obvious and useful should be the necessary condition but not a sufficient one in a GMP
patent application.
The patent officer needs discretion in reviewing a patent on GMPs so that he or she can
take into account conflicting interests. Any applications on gene patenting should be open for
public comments. The officer also needs authority to levy an annual fee for the patent. This
already provided for in the Plant Breeder’s Rights Act, where new varieties of sexually produced
plants can be protected, but the owner of the right must pay a given fee for that right. The only
difference here would be that the fee should vary from patent to patent based on what conflicting
interests exist.
7.1.2. Implementation of patent liability
The CBAC suggested that social and ethical considerations raised by biotechnology
should continue to be addressed outside the Patent Act, subject to further study. 95 There will
always be issues regarding biotechnology of plants and non-human animals regardless of
whether or not they are patented.96
The major conflict regarding GMPs is between seed companies, such as Monsanto, and
non-GMP growing farmers. Essentially, it is a conflict between property rights and intellectual
property rights. In Schmeiser, it was held that the issue is not about property rights but patent
protection, and that ownership of the patent-infringed matter is no defence to a breach of the
Patent Act.97 This position from the court indicates that solutions outside the Patent Act would
not be able to deal with the different interests effectively.
There could be various social liabilities on the part of seed companies regarding GMPs,
95
CBAC, supra note 16 at 5.
Ibid. at 17.
97
Schmeiser, supra note 24 at para 96.
96
27
but the one to organic farmers for the lost value and added cost by the unavoidable outcross
should be one of the primary concerns. If an organic farmer cannot charge organic food prices
because of contamination by GMPs, he or she should be compensated for that loss of profits. If
the farmer is led to abandon harvested seeds either because they are contaminated or because a
potential claim may lay against him from the seed companies, that farmer too should be
compensated for the cost of buying new organic seeds.
One of the most controversial issues in the debate of GMP and non-GMP coexistence is
to whom the liabilities should apply. In England, it was suggested that liability should lie with
the industry and not with the farmers.98 In Europe, Article 174 (2) of the EC Treaty states that
“Community policy on the environment shall … be based on the precautionary principle and on
the principles that preventive action should be taken, that environmental damage should as a
priority be rectified at source and that the polluter should pay”.99 Similarly, I suggest that any
undesirable and uncontrollable externality created by a patent should be internalized by the party
who created that externality and now holds the patent right.
7.2. The role of the Court
Commercial cultivation of GMPs is managed by regulations other than patent law.
Therefore to uphold a common law claim of damages to a farmer’s property (land or crop) by
gene escape would arguably conflict with the statutory authorization process allowing
commercial cultivation or sales of GMPs and the principles on which it is established. 100
Therefore, if the Parliament does not amend the relevant laws and regulations to comply with
Environmental Audit Committee, “GM Foods - Evaluating the Farm Scale Trials” online: Hansard
<http://www.parliament.uk/parliamentary_committees/environmental_audit_committee/eac05_05_04.cfm>.
99
Treaty Establishing the European Community, 24 December 2002, Article 174 (2).
100
Christopher Rodgers, supra note 11 at 239.
98
28
each other, the role of the court is limited. Justice Smith’s approach in Hoffman reveals the
judiciary’s inability to address the socio-economic impacts of agricultural biotechnology. 101
However, the court still can work on distributing the cost fairly when there are no amendments
of GMP related laws.
Even though the court in Schmeiser found that there was a patent infringement, it did not
award compensation to Monsanto because Schmeiser had not gained any profit out of
Monsanto’s patent. Even though it was a passive protection of farmer’s rights, this could an
example of how the court should intervene in these disputes. In addition to this passive
protection, the organic farmers also need to be able to make active tort claims such as nuisance
or negligence against seed companies. The development of a remedy for GMP contamination
cases might depend on the courts’ willingness to apply damages, through which the farmers’
property rights would be protected with financial compensation.102 The grounds to impose limits
on a patent holder’s exploitation of his or her inventions may be found in competition law,
criminal law, and in regulations governing research practices or facilities, product safety,
labelling requirements and other areas.103
7.2.1. The weaker-centered cost allocation regime
In balancing the different interests, whose benefit are at issue should be considered. Also,
as most of the concerns addressed in this paper suggest, the balancing is a zero-sum game. The
ideal solution would respect the rights of vulnerable stakeholders - which, in this case, is the non-
Maria Lee and Robert Burrell, “Liability for the Escape of GM Seeds: Pursuing the ‘victim’?” (2002) 65 Modern
L. Rev. 517 at 518.
102
Christopher Rodgers, supra note 11 at 244.
103
CBAC, supra note 16 at 3.
101
29
GMP farmer -- while ensuring that the negative externalities are minimized.104
If outcrossing is unavoidable, and could cause undesirable consequences to any of the
relevant parties, it is simply a matter of allocating the costs of pollen drift. In these instances,
legal mechanisms other than patent law could be used to impose cost penalties resulting from
pollen drift.105 For example, an English court held that defendants were liable in nuisance if they
were aware that their statutorily licensed activity was damaging the plaintiff’s property.106
7.2.2. Consideration on gene dynamics and intention
A gene patent holder may profit from uncontrolled dissemination of the engineered gene.
This results in seed companies taking no precaution over their product as they are required to do,
and this in turn could result in a higher rate of patent infringement by innocent farmers.
Therefore, there should be a way to protect farmers from unintentional infringement of GMP
patents. One way to do this is by analyzing the size of the portion of the patented gene in the
whole gene mass in a field, rather than how many plants have the patented gene. It is not easy to
decide on a threshold, but I would suggest 50% as a guideline to judge whether the crossover
was intentional or unintentional. Fifty percent is the maximum figure that could result from a
100% crossover rate between GMPs and non-GMPs.
This is fair when we think of the nature of the seeds sold by seed companies. Most of
them are hybrid seeds; this means that if someone re-sows the seeds harvested from the hybrid
seeds, many of them do not have the same genetic traits of their parent seeds, or have weaker
traits. Therefore, if a farmer wants a specific trait that is protected by a patent, saving and resowing is not an ideal way, and it is not a big threat to the seed companies.
Richard Spinello, “Property Right in Genetic Information” (2004) 6 Ethics & Information Tech. 29 at 38.
Tim Pelt, supra note 76 at 588.
106
Savage v. Fairclogh [2000] Env LR 183 CA.
104
105
30
7.3. International concerns
An effective intellectual property regime must have international scope. 107 Canada’s
existing international obligations should be considered when designing measures to deal with
GMPs. Both the World Trade Organization Agreement on Trade-Related Aspects of Intellectual
Property rights (TRIPS) 108 and NAFTA 109 contain anti-discrimination clauses that guarantee
equal patent protection regardless of the field of technology or the origin of the invention. If
Canada were to impose special standards on certain areas of patent law, it could be in violation
of TRIPS and NAFTA.
However, a non-discriminatory, principled approach could work without violating these
treaties. For example, TRIPS includes an exception to patentability where any inventions could
be excluded in the interests of protecting “human, animal, or plant life or health or... avoiding
serious prejudice to the environment”.110 If we prepare a policy, separate from patent law, which
would apply to all GMPs without discrimination, there would be no problems in adopting a new
approach.
8. Conclusion
A patent has only been seen as a right. But considering the characteristics of GMPs, the
Patent Act should also recognize potential liabilities in GMP patents. The courts have indicated
that the breach of a patent would be judged by the result, regardless of the intention. Considering
Carlos Lopez, “Intellectual Property Reform for Genetically Modified Crops: A legal imperative” (2004) 20 J.
Contemp. Health L. & Pol’y 367 at 369-370.
108
Agreement on Trade-Related Aspects of Intellectual Property Rights, 15 April 1994, 33 I.L.M. 81 Article 27.
entered into force 1 January, 1995)[TRIPS].
109
North American Free Trade Agreement Between the Government of Canada, the Government of Mexico and the
Government of the United States, 17 December 1992, Can. T.S. 1994 No. 3, 32 I.L.M. 289. (entered into force 1
January 1994)[NAFTA].
110
TRIPS, supra note 112.
107
31
the properties of plant propagation and public policy, this approach needs to be changed. While
the most effective measure would be to amend the Patent Act, the courts should also try to
distribute the externalities caused by GMP patents in a fair manner, with consideration of the
factors such as public safety, ecological influences, and ethical aspects of gene patenting.
Judicial creativity in this area is required to deal with new form of technology and its attendant
problems the patent law seems unable to anticipate, because it is still rooted in concepts designed
to deal with mechanical inventions. 111 The courts should exercise its discretion to prevent
unreasonable results arising from outdated provisions of the existing legislation.
Would these measures and the reduced economic incentives interfere with the
development of biotechnology? Likely not; Richard Gold points out that there is little empirical
proof that the patent system actually encourages innovation in the biomedical field, and that even
without patent rights, other market forces may lead to a similar level of innovation in the
biotechnology sector.112 The critics of IP rights in GMPs worries that it would enable the seed
companies, that already hold a dominant position over farmers, to wield too strong economic and
political power in the use of GMPs. 113 The discussions in this paper indicates that it is looming
large. It is time to recognize a new set of right respecting GMPs. But for the time being, the
current patent law should respond in order to handle GMP-related issues in a reasonable and
integrated manner.
111
Maria Lee and Robert Burrell, supra note 105 at 537.
Richard Gold, “Making Room: Reintegrating basic research, health policy, and ethics into patent law” in
Timothy Caufield & Bryn Williams-Jones, eds., The commercialization of genetic research: Ethical, legal and
policy issues (New York: Kluwer Acadamic/Plenum Publishers, 1999) 63 at 68.
113
Carlos Lopez, supra note 111 at 369.
112
32
BIBLIOGRAPHY
Legislation
Environmental Management and Protection Act, S.S. 2002, c. E-10.21. s. 13(3).
Patent Act, R.S.C. 1985, c.P-4. s. 44.
Plant Breeders’ Rights Act, S.C. 1990, c. 20. s.5(1).
Jurisprudence
Harvard college v. Canada (Commissioner of Patents), 2002 SCC 76, (2002), 219 D.L.R. (4th)
577.
Hoffman v. Monsanto Canada, 2005 SKQB 225.
Monsanto Canada v. Schmeiser, 2002 FCA 309.
Monsanto Canada v. Schmeiser, 2004 SCC 34, [2004] 1 S.C.R. 902.
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