Abstract
This paper tries to provide a fresh insight on a highly disputed, although very sectorial topic, represented by intellectual property protection on genetically modified seed and, in general, on agricultural biotechnology products. Both because of the wide employ of seeds and plant varieties in agriculture and for the international relevance of intellectual property protection, domestic perspectives on this very topic soon become obsolete, partial and useless. Intellectual property protection on agricultural biotechnology products is a charged topic for a number of reasons. First of all, seeds are the starting point of very complex value chains in all economies. That does not relate exclusively to food. Indeed, plants have now a role in a wide number of very diverse industries such as biofuels or textiles or construction materials. Most of all, seeds are indispensable for the production of vegetables, for a large part of the worldwide population the primary, if not exclusive, ingredient of the daily diet.
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Notes
- 1.
The world population is expected to grow from the current 6.4 billion people to 9.3 billion in 2050, with a yearly growth of 77 million.
- 2.
For instance, researchers have been experimenting natural, eco-compatible polymers to reduce consumption of water. See, for instance, Demitri et al. (2013).
- 3.
But a ruthful critique to agricultural biotechnology comes from the influential work of Altieri (2015).
- 4.
See Brenchley et al. (2012).
- 5.
Bread wheat is a crucial crop for human life, since it accounts for 20 % of the calories consumed by humans. The current threat for wheat is a fungal disease identified as Ug99 (also known as stem rust), which is responsible for severe losses of crops in Africa, Asia and the Middle East since 1999. The study of the genome becomes instrumental to identify techniques that make wheat more resistant.
- 6.
There have been situations in which intellectual property protection has been sought also where the recurrence of an invention was doubtful, although investments for discovery had been significant. It is the case of the Myriad Genetics case, where the applicant tried to retain patent protection on two genes (BRCA1 and BRCA2) sequenced (an activity that required intense effort) even if the genes where not technically invented. See Association for Molecular Pathology v. Myriad Genetics, 569 U.S. (2013).
- 7.
At least in the United States, the federal government has had a crucial role in supplying farmers with seeds for over 100 years, before the private industry took over and started lobbying for increased intellectual property protection. For a detailed account of the evolution of the industry, see Center for Food Safety & Save Our Seeds, Seed Giants vs. Farmers, Washington, D.C., 2013, 13 (reporting that by the turn of the 19th Century the U.S. Department of Agriculture had distributed over a billion bags of seeds to farmers in the United States).
- 8.
The problem is not a new one. It had been already described by Busch et al. (1990).
- 9.
For an uncompromising reading see Shiva (2015).
- 10.
One remarkable case involves the production of transgenic corn in Italy. Until recently, there have been cases brought before administrative judges to challenge the decision of health authorities to deny authorization to put in commerce and employ in agriculture transgenic varieties. See, for instance, T.a.r. Lazio 23 Aprile, 2014, n. 4410, in Ambiente, 2014, 548, confirmed by Cons. Stato 6 febbraio 2015, n. 605 (not yet published).
- 11.
See Center for Food Safety & Save Our Seeds, Seed Giants vs. Farmers, cit., 15.
- 12.
This feature is recognized as structurally distinctive for biotechnologies; see for instance art. 2, par. 1, lett. (a) of European Directive 98/44/EC.
- 13.
For a discussion on the alternative options, see Downing-Howk (2004).
- 14.
One remarkable difference that emerges in considering exhaustion of rights relates to software, that, alike seeds, is not self-reproducing but, like seeds, can be “generative” of further products by preserving a constant trait. Quite interestingly, the U.S. Supreme Court held that a sale of a product that incorporates a software process technology causes the exhaustion effect. See Quanta Computer, Inc. v. LG Electronics, Inc., 553 U.S. 617 (2008). For a comment on the decision see also The Doctrine of Patent Exhaustion: The Impact of Quanta Computer, Inc. v. LG Elecs., Inc., in 14 Va. J.L. Tech. 273, 283 (2009). Software and seeds have been considered showing some common traits by Leaven (2008), that criticizes the different conclusions on exhaustion. But the argument of similarity goes back to the opinion of the advocate general Mischo in the European case SPRL Louis Erauw-Jacquery c. La Hesbignonne SC (in ECR, 1988, 1919).
- 15.
Because of the nature of technology (a process), protection extends to the outcome of the process, that is the genetically modified seed.
- 16.
The seed-wrap licensing practice has been approved by a number of lower courts in the United States and then affirmed by the U.S. Supreme Court in J.E.M. v. Pioneer, 534 U.S. 124 (2001) at 145.
- 17.
The context is of a typical business-to-business transaction, with standardized terms unilaterally written and imposed to farmers by the owner of the critical (intellectual property protected) resource.
- 18.
The International Seed Federation has expressed its view on the topic of exhaustion by stating that there should be no exception for farm-saved seeds under any form of intellectual property right (see ISF View on Intellectual Property, Rio de Janeiro, 2012, 26).
- 19.
And it is a difference that comparatively is stronger in Europe than in the U.S., after the ECJ decision in UsedSoft GmbH v. Oracle International Corp. (ECJ 3 July 2012, C-128/11), that has interpreted the European directive on software as meaning that the right of distribution of a copy of a computer program is exhausted if the copyright holder who has authorized, even free of charge, the downloading of that copy from the internet onto a data carrier has also conferred, in return for payment of a fee intended to enable him to obtain a remuneration corresponding to the economic value of the copy of the work of which he is the proprietor, a right to use that copy for an unlimited period. For a comment, Göbel (2012).
- 20.
For a discussion of techniques of contract formation in comparative perspective see Granieri (2015).
- 21.
As a matter of fact, the Doha Development Round negotiations started in 2001 are still blocked and agriculture is one of the most relevant dealbreakers.
- 22.
According to some sources, Monsanto is responsible for the commercialization of 90 % of all genetically modified organisms worldwide. It has been also the topic for a documentary by Robin (2015), where all the major critiques towards the company are counted by the author.
- 23.
In at least one case, Monsanto’s patent claims are direct to a method for controlling weeds with its technology. See US patent n. 5,352,605 its reissue RE39,247 (claim 32): «A method for selectively controlling weeds in a field containing a crop having plant crop seeds or plants comprising the steps of: (a) planting the crop seeds or plants which are glyphosate-tolerant as a result of a recombinant double-stranded DNA molecule being inserted into the crop seed or plant, the DNA molecule having: (i) a promoter which functions in plant cells to cause the production of an RNA sequence, (ii) a structural DNA sequence that causes the production of an RNA sequence which encodes an EPSPS enzyme having the sequence domains: -R-X.sub.1-H-X.sub.2-E-(SEQ ID NO:37), in which X.sub.1 is G, S, T, C, Y, N, Q, D or E; X.sub.2 is S or T; and -G-D-K-X.sub.3-(SEQ ID NO:38), in which X.sub.3 is S or T; and -S-A-Q-X.sub.4-K-(SEQ ID NO:39), in which X.sub.4 is A, R, N, D, C, Q, E, G, H, I, L, K, M, F, P, S, T, W, Y or V; and -N-X.sub.5-T-R-(SEQ ID NO:40), in which X.sub.5 is A, R, N, D, C, Q, E, G, H, I, L, K, M, F, P, S, T, W, Y or V, .Iadd. provided that when X.sub.1 is D, X.sub.2 is T, X.sub.3 is S, and X.sub.4 is V, then X.sub.5 is A, R, N, D, C, Q, E, G, H, I, L, K, M, F, S, T, W, Y or V.Iaddend.; and (iii) a 3’ non-translated DNA sequence which functions in plant cells to cause the addition of a stretch of polyadenyl nucleotides to the 3’ end of the RNA sequence where the promoter is heterologous with respect to the structural DNA sequence and adapted to cause sufficient expression of the EPSPS enzyme to enhance the glyphosate tolerance of the crop plant transformed with the DNA molecule; and (b) applying to the crop and weeds in the field a sufficient amount of glyphosate herbicide to control the weeds without significantly affecting the crop».
- 24.
Because genetically-modified seeds are resistant to glysophate, while natural seeds are not, Monsanto’s agents can easily verify whether one field is planted with natural or modified seeds. Spraying herbicides will kill the natural plants and weeds and will keep alive genetically modified varieties. If the farmer cannot show the bag where the seeds were stored, he is clearly an infringer. Monsanto has been also criticized for the forceful manners of its agents in collecting evidence, sometimes trespassing farmers’ property. Monsanto’s practices are also described by Johns (2009, p. 16). Enforcement techniques can produce false positives in case of the so called blown-by seeds, that is, situations in which genetically modified varieties are found in fields where seeds had not been used intentionally by farmers, but brought by the wind from adjacent fields.
- 25.
U.S. courts introduced the distinction between conditioned and not conditioned sales; exhaustion only applies to the latter and not in all cases in which the seller has put conditions in the terms of the agreement, which is exactly the case with seed-wrap licenses.
- 26.
- 27.
The Court of Appeals had been more cautious and justice Kagan affirmed that the decision did not aim to apply to all instances of «self-replicating products», although «such inventions are becoming even more prevalent, complex, and diverse»; see Monsanto Co. v. Bowman, 657 F.3d 1341 (Fed. Cir. 2011).
- 28.
Importantly, national solutions about exhaustion are extremely important because international sources, such as the Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPs), refuse to deal with this topic and leave it up to states sovereignty.
- 29.
For a discussion of the current dimension of exhaustion in European Union law, see Schovsbo, The Exhaustion of Rights and Common Principles of European Intellectual Property Law, in Ohly (edited by), Common Principles of European Intellectual Property Law, Tübingen, 2012, 169.
- 30.
ECJ 19 April 1988, C-27/87, SPRL Louis Erauw-Jacquery c. La Hesbignonne SC, in ECR, 1988, 1919.
- 31.
Opinion of Advocate General Mischo of 9 December 1987, SPRL Louis Erauw-Jacquery c. La Hesbignonne SC, par. 11 (in ECR, 1988, 1919).
- 32.
The interpretation of the Directive followed by the European Court of Justice is consistent with the purpose to maintain a difficult equilibrium for all the interests involved in this matter. For instance, in Monsanto v. Cefetra, the ECJ stated that art. 9 of the Directive define a level of harmonization that does not allow national Member States to increase the level of protection; see ECJ July 6, 2010, C-428/08.
- 33.
The protection for plant varieties is also available in the U.S. with the Plant Varieties Protection Act (PVPA). The relationship between utility patents and plant varieties patents has been discussed in J.E.M. Ag Supply, Inc. v. Pioneer Hi-Bred International, Inc. 534 U.S. 124 (2001). The case is discussed by Daniels (2003), Rives (2001), Nilles (2000).
- 34.
To some extent, the grower can limit the ability of farmers to do certain things by contractual restrictions, but without relying on property rights. Acts contrary to the restrictions only qualify as breach of contracts, not as infringement.
- 35.
See Ferran (2014).
- 36.
One often quoted example of biopiracy is the case for the “devil’s claw” (Harpagophytum procumbens), an herb native of the eastern and southern Africa that local communities of the San people used as an anti-inflammatory and now widely employed in the pharmaceutical industry.
- 37.
The Protocol was adopted on October 29, 2010. See Tania Bubela, E. Richard Gold, Genetic Resources and Traditional Knowledge. Case studies and Conflicting Interests, EE, 2013. Catherine Rodhes, Governance of Genetic Resources, EE, 2013. Charles Lawson, Regulating Genetic Resources, EE, 2012.
- 38.
Levidow and Carr (1997), reported that unpaid royalties to less developed countries amount to 5.4 billion USD.
- 39.
As of the date of this writing (February 2015), the Protocol has been ratified by 59 States, out of the 196 Parties of the CBD.
- 40.
There might be coordination problems in implementing the Protocol in Europe that might eventually jeopardize its effectiveness. The European Union is one of the signatories of the agreement, together with European Members States. Since several measures will depend on states, there is the genuine risk that institutional activisms of the European Union will collide with prerogative of Member States in implementing the instrument.
- 41.
Importantly, the protocol also refers to, and protect, the traditional knowledge associated with genetic resources (see art. 7 of the Nagoya Protocol). Traditional knowledge is for genetic resources what complementary know-how is for a patented technology. It resides in indigenous and local communities and is part of their tradition.
- 42.
Due diligence is the pillar of the Protocol as far as circulation of genetic resources is concerned. In each transaction, each party belonging to an implementing state will be subject to the duty to ascertain whether the resource has been lawfully acquired (that is, in compliance with the principle of access). In the past, it was suggested that one solution to ease the identification of the origin of resources was force applicants to declare the source of the material in the patent application. The solution had been opposed, as burdensome, by the International Seed Federation (Disclosure of Origin in Intellectual Property Protection Applications, Bangalore, 2003). Very likely it will be considered again as a possible way to mitigate the duty of due diligence.
- 43.
Reverse technology transfer is the situation in which a state is supposed to pay to access resources that are subject to proprietary rights of a third party, although such resources were originally from the recipient state.
- 44.
The status quo is represented by a situation in which seed grabbing is actually practiced as in an era of colonialism land grabbing was justified by a doctrine of terra nullius. The Protocol recognizes sovereignty over national resources and rebuts the principle of free appropriability of common resources. A solution that is close to liability rule was adopted by a number of national legislations in the U.S., where farmers are allowed to use second generation seeds for sowing, by compensating the rights holders, as reported by Leaven, The Misinterpretation of the Patent, cit., 140.
- 45.
Since 1996, the U.S. territory is the land that is cultivated more than others with genetically modified varieties, followed by Argentina, Canada, Brazil, China and South Africa.
- 46.
As reported by Center for Food Safety & Save Our Seeds, Seed Giants vs. Farmers, cit., 12, three companies (Monsanto, DuPont, and Syngenta) now control 53 % of the global market for seeds, while the top ten companies have a joint market share of 73 % (and many of them are U.S. corporations).
- 47.
One often quoted side effect in terms of moral hazard of the massive resort to genetically modified varieties is the increase in the consumption of pesticides/herbicides, which is not necessarily an unwanted consequence from the perspective of the producer of such substances.
- 48.
Many legal systems, including the European Union, have regulated the downstream activities that are required for a genetically modified product to reach the market. Regulation here serves the additional purpose of controlling the impact of the technology on human health and the environment, without discouraging research and development.
- 49.
Yet, it is an option that someone would pursue firmily; see for instance Boldrin and Levine, Against intellectual monopoly, cit., 243 («[P]rogressively but effectively abolishing intellectual property protection is the only socially responsible thing to do»).
- 50.
See Kesan, Licensing Restrictions, cit., 1086, with a further discussion of the complexity of the value chain in the agro-industry.
- 51.
GURTs are typically split into two categories: those that restrict the use at variety level (V-GURTs) and those that restrict at trait level (T-GURTs). One remarkable case of GURT is one jointly developed by the Delta and Pine Land Company in cooperation with the U.S. Department of Agriculture (USDA). See International Seed Federation, Genetic Use Restriction Technologies, Bangalore, 2003 (position paper describing V-GURT development).
- 52.
States have different options to pursue a strategy of attracting foreign investors. Magic (2003, p. 6), stated that «attracting FDI—and consequently technology transfer—solely by means of strengthening IPR is not a good long term economic strategy for a developing country because it will not do nothing to build a domestic industry of high-tech R&D».
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Granieri, M. (2016). Genetically Modified Seeds, Intellectual Property Protection and the Role of Law in Transnational Perspective. In: Bellantuono, G., Lara, F. (eds) Law, Development and Innovation. SxI - Springer for Innovation / SxI - Springer per l'Innovazione, vol 13. Springer, Cham. https://doi.org/10.1007/978-3-319-13311-9_6
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