Abstract
This chapter examines and critically reviews intellectual protection in plant breeding from a legal and economic perspective. The first part analyses the main intellectual property rights applied to plant breeding innovations, patent and breeder’s rights, while the second part offers a justification of intellectual property as applied to plant breeding. It contributes to the debate on patentability of biological matter by elaborating a discussion on the issue of ‘patent quality’ stemming from the lax application of the patentability standards as well as on ethical and moral aspects of patents in plant breeding. It also introduces key concepts for understanding the problem addressed by intellectual property protection in this field, such as the distinction between ‘plants’ and ‘plant varieties’ as well as the concept and implications of different modalities of a breeder’s exception to patent rights.
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Notes
- 1.
In this regard, it should be specified that it was the genetic constitution of agricultural products that was considered as a product of nature. Agriculture products per se or processes could be the object of intellectual protection in the countries adhering to the Paris Convention for the Protection of Industrial Propriety. Article 1(3) of this Convention provides that ‘Industrial property shall be understood in the broadest sense and shall apply not only to industry and commerce proper, but likewise to agricultural and extractive industries and to all manufactured or natural products, for example, wines, grain, tobacco leaf, fruit, cattle, minerals, mineral waters, beer, flowers, and flour’. See Paris Convention for the Protection of Industrial Property, 1883, 21 UST 1583, 828 UNTS 305, 20 March 1883, as last revised at Stockholm, 14 July 1967, and as amended on 28 September 1979.
- 2.
- 3.
The list of ratifications is available on the UPOV website: http://www.upov.int/upovlex/en/notifications.jsp, accessed 24 October 2014.
- 4.
Please note that breeding products can also be protected by other proprietary rights such as trade secrets, trademarks, and geographical indications. Other exclusive rights can be found in private contracts such as material transfer agreement, bag labels and technology use agreements. Another restriction is represented by governmental regulations. For example, seeds undergo an approval process and should be listed in national catalogues before they could be marketed. For the EU Catalogue of Varieties of Agricultural Species, see http://ec.europa.eu/food/plant/plant_propagation_material/plant_variety_catalogues_databases/index_en.htm, accessed 12 March 2014. For an overview of IPRs in plant biotechnology see Boettiger et al. (2004), pp. 1088–1113.
- 5.
With the exception of least developed countries during the transitional periods, the text of TRIPS is binding for all other WTO members.
- 6.
Article 37.3 of the 1991 UPOV closed accession to the Act of 1978 after 31 December 1995 for developing countries and after 31 December 1993 for other countries. Note also that least developed countries have adopted the 1991 UPOV Convention as a result of FTAs with the United States or the European Union.
- 7.
The Indian legislation is an example in point. See The Protection of Plant Varieties and Farmers’ Right Act, The Gazette of India, Extraordinary Part II, Section I, nr. DL-33004/2001. For other Asian countries see Kanniah and Antons (2012).
- 8.
Note that this is the accepted scientific classification according to the current understanding of the biological system. For an explanation see Stace (2000).
- 9.
This classification was first proposed by the father of modern taxonomy, Carl Linnaeus.
- 10.
In this case, the modified plants are called ‘cultivars’. The term ‘cultivar’ derives from ‘cultivated variety’.
- 11.
Note that countries can provide protection for both these types of variety. See chapter V (§§ 52–53) of The Plant Variety Protection Act B.E.2542 (1999) (Thailand), available at http://www.wipo.int/edocs/lexdocs/laws/en/th/th016en.pdf (accessed 3 Dec. 2014).
- 12.
This definition is found in article 1 of the UPOV Convention, article 5.2 of Council Regulation (EC) No 2100/94 on Community Plant Variety Rights, in the decisions of the European Patent Office and in section 41.9 of the US PVPA. This latter adds that ‘A variety may be represented by seed, transplants, plants, tubers, tissue culture plantlets, and other matter’. Please, note that this definition of plant variety responds to commercial and legal considerations rather than to scientific rigor. For more see Janis and Smith (2013), pp. 1570–1577.
- 13.
A gene construct is a ‘functional unit necessary for the transfer or the expression of a gene of interest’. For more see the Glossary of the project ‘Communication Management of Biosafety Research’ funded by the German Ministry of Education and Research, available at http://www.gmo-safety.eu/glossary/667.gene-construct.html, accessed 07 October 2013.
- 14.
- 15.
Dutfield (2011).
- 16.
Convention on the Grant of European Patents of 5 October 1973 as revised by the Act revising Article 63 of the EPC of 17 December 1991 and the Act revising the EPC of 29 November 2000. Please note that the EPC is not an instrument of the EU, although all EU member countries are part of the EPC. The EPC currently applies to 38 countries. Since 1 September 1999, the EPC has incorporated the provisions of the EU directive on biotechnological inventions 98/44/EC in Rules 23 (b)–(e) EPC. It is interesting to note in this regard that the EU directive applies to all EPO members although not all of them are EU members.
- 17.
OJL 213, 30.7.1998, p. 13–21. Hereinafter, EU directive.
- 18.
Compare with UNCTAD-ICTSD (2005).
- 19.
The patent laws of Mexico and Argentina, respectively, article 15 and article 4.a, similarly provide that invention is ‘all human creation that permits the transformation of matter or energy that exists in nature, for the benefit of man and to satisfy his concrete needs’. See Correa (2007), p. 271, note 2.
- 20.
See, for example, article 52.2 of the EPC and article 15 of the Decision No. 486 on the Common Regime on Industrial Property of the Andean Community (WIPO lex).
- 21.
35 US.C. 101.
- 22.
35 US.C. 161.
- 23.
See Correa (2007), p. 272.
- 24.
See the section ‘Inventorship’ of General Information about 35 US.C. 161 Plant Patents, USPTO. Available at http://www.uspto.gov/web/offices/pac/plant/, accessed 12 March 2014.
- 25.
For an historical overview see Kevles, pp. 7–8.
- 26.
This requirement is not provided for plant varieties. Probably the reason lies in the widely acknowledged utility of plant breeding.
- 27.
The EPO is set up on the basis of the EPC in order to carry out the procedures laid down in the EPC.
- 28.
The 2013 Guidelines for Examination of the European Patent Office (hereinafter EPO Guidelines) have highlighted the difference between a discovery and an invention: ‘If a new property of a known material or article is found out, that is mere discovery and unpatentable because discovery as such has no technical effect and is therefore not an invention. If, however, that property is put to practical use, then this constitutes an invention which may be patentable.’ See Part G, Chapter 2, Section 3.1. Thus, the mere isolation of an organism and the identification of its use are sufficient criteria to qualify for patentability. Most of the national jurisdictions apply this criterion. See UNCTAD-ICTSD (2005). See also the US Manual of Patent Examining Procedure (MPEP), Chapter 2107.
- 29.
Note that isolation of biological material as found in nature is explicitly excluded in Brazilian, Andean, Argentinean, and Chilean laws. For more see Bently et al. (2010), p.83.
- 30.
See Transgenic Plant/Novartis II OJ EPO 2000, (Decision 12 G 1/98 of the Enlarged Board of Appeal) 141.
- 31.
Ibidem, para. 3.1.
- 32.
This Act reflects the provisions of the UPOV Convention.
- 33.
Note that some of these plants may also be capable of sexual reproduction. The apple tree is an example. Apples can be sexually reproduced by seed but in this case, the offspring does not have the desired qualities of the parent. This happens only if the apple is asexually reproduced by grafting and budding, layering etc. Therefore, the PPA covers plants capable of sexual reproduction if they have been asexually reproduced.
- 34.
See Chapter I600, Section 1601.
- 35.
It is not clear, however, if they are excluded based on their use as food or on the difficulty of enforcing patents on such plants. For more see Kevles (2002), pp. 8–9.
- 36.
See infra the section on exceptions.
- 37.
Transgenic Plant/Novartis II OJ EPO 2000 (Decision 12 G 1/98 of the Enlarged Board of Appeal) 111–141.
- 38.
Diamond v Chakrabarty, 447 US. 303 (1980).
- 39.
Ex Parte Hibberd, 227 US.P.Q. 443 Bd. Pat. App. (1985).
- 40.
See J.E.M. Agricultural Supply v Pioneer Hi-Bred International, 122 US. 593 (2001).
- 41.
Ex Parte Hibberd, 227 US.P.Q. 443 Bd. Pat. App. (1985).
- 42.
Adapted from Treccani, L’Enciclopedia Italiana Online (Treccani, The Online Italian Encyclopedia), available at http://www.treccani.it/enciclopedia/tag/gene/, accessed 14 March 2014. Note that it is difficult to comprise all complexities that characterize gene expression in one definition. Various definitions of a gene can coexists in different disciplines. For more see Calvert and Joly (2009), pp. 113–114.
- 43.
Calvert and Joly emphasize the role of molecular biology in gene patentability. Supra note, 105–121.
- 44.
A gene sequence obtained in this way is deemed to be a chemical product, therefore, patentable. Other patentable chemical products in the USA are DNA sequences that code for a protein, purified or isolated proteins and transformation vectors containing a gene sequence.
- 45.
See Recital 23 of the directive 98/44EC: ‘Whereas a mere DNA sequence without indication of a function does not contain any technical information and is therefore not a patentable invention’.
- 46.
Joly and Bertrant (2003).
- 47.
Monsanto Technology LLC v Cefetra BV and Others (C-428/08). See the Curia Press and Information. Available at http://curia.europa.eu/jcms/upload/docs/application/pdf/2010-07/cp100073en.pdf, accessed 5 August 2013.
- 48.
See Article 9 of the EU directive.
- 49.
569 U. S. ____ (2013). The decision is available at http://s3.documentcloud.org/documents/713216/scouts genedecision.pdf, accessed 6 August 2013.
- 50.
See pp. 10–18 of the decision.
- 51.
This view is put into question. See pp. 16–17 of the decision.
- 52.
For a better explanation see US National Center for Biotechnology Information, ‘ESTs: Gene Discovery Made Easier’, available at http://www.ncbi.nlm.nih.gov/About/primer/est.html, accessed 5 August 2013.
- 53.
See, for example, Zimmer (2013).
- 54.
Better see Re Fisher, 421 F.3d 1365 Federal Circuit (2005).
- 55.
The Dictionary of Biology Online, http://www.biology-online.org/dictionary/Microorganism, accessed 1 October 2013. See also ‘Microorganism’ (New World Encyclopedia), available at http://www.newworldencyclopedia.org/p/index.php?title=Microorganism&oldid=695572, accessed 9 October 2013.
- 56.
EPO Guidelines, Part G, Chapter II, Section 5.5.1. It is worth noting that the taxonomic classification of viruses is controversial.
- 57.
Environmental Information Centre (2013).
- 58.
The Nobel Prize winner, Lwoff, beautifully explains this issue. See Lwoff (1957), pp. 239, 249.
- 59.
Ibidem, 248.
- 60.
For the US definition see the US Manual of Patent Examining Procedure (MPEP), Chapter 2403. See also Diamond v Chakrabarty, 447 US. 303 (1980).
- 61.
See article 2 of the directive 98/44/EC and Rule 23b (5), (6) of the Implementing Regulations to the EPC.
- 62.
See Kock (2007), p. 286.
- 63.
See Hybrid Plants/Lubrizol (T-320/87) of 10.11.1988.
- 64.
Ibidem, 9.
- 65.
Molecular marker technologies visualize the genetic make-up of a plant and are used in the selection process of plant breeding.
- 66.
EPO, Enlarged Board of Appeal, decision of 9 December 2010 in consolidated cases G 2/07—Broccoli/PLANT BIOSCIENCE and G 1/08—Tomatoes/STATE OF ISRAEL.
- 67.
In practice, the products of plant breeding remain patentable. For more see the report of Then and Tippe (2011).
- 68.
See the first sentence of article 53.2 of the EPC. Note that Dutch patent law exempts from patentability plants obtained by essentially biological processes (Art. 3.1.d of the Dutch Patent Act 2010) while the German Patent Act amended in 2013 its sec. 2a(1)1 in order to exclude from patentability plants exclusively obtained through essentially biological processes. For an explanation see the German Parliament resolution 17/14222.
- 69.
The texts of the decisions are available at http://www.epo.org/law-practice/case-law-appeals/eba/number.html, accessed 17 april 2015.
- 70.
The terms ‘ordre public’ and ‘morality’ are vague concepts to be defined by national laws. A common understanding of these definitions can be carved out by the jurisprudence of EPO. In particular, Plant Cells/Plant Genetic Systems (T 356/93–OJ EPO 1995, 545) has specified that ‘inventions the exploitation of which is likely to breach public peace or social order or to seriously prejudice the environment are to be excluded from patentability as being contrary to “ordre public”’. The concept of morality consists in a common belief that some behavior is right while other behavior is wrong, belief that stems out from accepted norms in a particular culture. For more on the issue see Correa (2007), pp. 289–291.
- 71.
WTO, ‘“Necessity Tests” In the WTO’, 2 December 2003, WTO doc. S/WPDR/W/27.
- 72.
For more see Correa (2007), pp. 5–6.
- 73.
See article 54.2 of the EPC and 35§ U.S.C. 102.
- 74.
See article 56 EPC. The US PA requires the invention not to be obvious (35 USC 103). For the difference between ‘technical step’ and ‘non-obvious’ and its legal implications, see Correa (2007), p. 278.
- 75.
See Visser (2013), p. 103.
- 76.
Manual of Patent Examining Procedure (MPEP), Chapter 2141.
- 77.
See also Correa (2007), p. 278.
- 78.
See the US Manual of Patent Examining Procedure (MPEP), Chapter 2107.01.
- 79.
Ibidem. See also the EPO Guidelines, Part G, Chapter III, Section 4.
- 80.
This provision seems to reflect section 112 of the US PA and article 83 of the EPC. See also the Budapest Treaty on the International Recognition of the Deposit of Microorganisms for the Purposes of Patent Procedure (adopted 28 April 1977, entered into force 19 August 1980) 1861 UNTS 361. This Treaty provides an international framework for the mutual recognition of deposits of microorganisms’ strains.
- 81.
An example of random coincidence discovery is that of a microbiological process involving mutations. See EPO Guidelines, Part H, Chapter III, Section 3.
- 82.
US MPEP, Chapter 2403.02.
- 83.
See 35§U.S.C.154 for US, and article 64 of the EPC for European countries.
- 84.
Bowman v Monsanto Co. et al., 569 U.S. __ (2013). Opinion of Justice Kagan available at http://www.supremecourt.gov/opinions/12pdf/11-796_c07d.pdf, accessed 9 October 2013.
- 85.
Note that the Court did not investigate whether the reward was sufficient to cover R&D costs in line with the economic rationale of patent rights.
- 86.
Feindt (2010), p. 9.
- 87.
For more see UNCTAD-ICTSD (2005), p. 421.
- 88.
Exceptions to patent rights will be thoroughly examined in the next chapter. Here the aim is to provide some basic knowledge in line with the aim of this chapter.
- 89.
An implicit statutory exception might though be carved out of section 35 USC§ 163 of the PPA. Plant patent rights exclude others from asexually reproducing the plant and parts thereof. The sexual reproduction is thus not covered by the PPA. This means that seeds of an apple, for example, can be freely used. However, as explained above, the offspring of sexual reproduction is heterogeneous and does not necessarily retain desirable qualities. Therefore, their commercialization brings no profit.
- 90.
Correa (2005).
- 91.
See also recitals 46–51 of the Directive 98/44/EC and article 14 of the Council Regulation No. 2100/94 of 27 July 1994 on Community Plant Variety Rights. Article 14 allows small farmers to freely use harvested material of some plant species listed in its paragraph 2.a. Other farmers should pay an equitable remuneration. For more information see paragraph 3 of article 14 of the Council Regulation.
- 92.
The Agreement will enter into force as soon as 13 ratifications are reached. As per now, only six countries have ratified the AUPC. For an overview of the signatory countries and ratifications see http://ec.europa.eu/growth/industry/intellectual-property/industrial-property/patent/ratification/index_en.htm, accessed 4 April 2015.
- 93.
Note that patent rights do not allow using patented material.
- 94.
A license on a plant variety becomes necessary when other breeders create essentially derived varieties from the original one. See the section on breeder’s rights for more clarifications.
- 95.
See also Correa (2012), p. 15.
- 96.
It is important to note that the first objections against plant patenting focused on economic and evidential reasons. Objections on ethical, societal, ecological and safety grounds have only been raised in the last years. For more see Van Owervalle (1999), p. 143.
- 97.
- 98.
For an analysis see Cohen and Morgan (2008), p. 289.
- 99.
Monsanto Technology LLC v Cefetera BV and Others, Case C-428/08, 6 July 2010, para. 38.
- 100.
For a specific analysis of ‘raising the bar’ and avoiding the proliferation of economically undesirable patents see Barton (2003), p. 475.
- 101.
See, for example, Harhoff (2006) and Niels Louwaars et al. (2009). The concerns of civil society are also noticeable. For a critical view of patentability criteria see the patent cases in the website of ‘No Patents on Seeds’, available at http://www.no-patents-on-seeds.org/en/information/patent-cases accessed 14 October 2013.
- 102.
The current world backlog stands at over ten million unexamined patents. For more see European Patent Office (EPO) (2011), p. 16. See also EPO Economic and Scientific Advisory Board (2012). In addition, it has been argued that the financing model of the EPO, which is mainly funded from procedural fees and annual fees for pending patent applications and patents in force, creates incentives to grant patent applications in case of doubt. See Feindt (2010).
- 103.
Re Fisher, 421 F.3d 1365 (Federal Circuit 2005).
- 104.
See Feindt (2010), p. 13.
- 105.
Re Kubin, 561 F.3d 1351 (Fed. Cir. 2009). Other cases referring to the patentability of human genes further support the US courts tendency to apply restrictive patent rules. See, for example, Ariad v Eli Lilly, 560 F.3d 1366 (Fed. Cir. 2009) and the recent case Association for Molecular Pathology v Myriad Genetics 569 U.S. 12-398 (2013).
- 106.
See Brassica Protection Products LLC and Johns Hopkins University, Plaintiffs-Appellants, v Sunrise Farms et al. 301 F.3d 1343 (Fed. Cir. 2002).
- 107.
Monsanto introduced a virus-resistant gene taken from Indian melon plants to other type of melons using conventional breeding techniques. The patent is being opposed by Nunhems, the vegetable seed-producing subsidiary of Bayer CropScience and a number of NGOs acting under ‘No Patents on Seeds’ on the basis of lack of inventiveness, clear and complete disclosure and contrariety to morality and public order. See ‘Opposition to Monsanto’s Patent on Indian Melon’, available at http://www.no-patents-on-seeds.org/en/information/news/opposition-monsanto-s-patent-indian-melon, accessed 3 August 2013.
- 108.
Lusser et al. (2011), see Annex 6.
- 109.
Paul and Elder (2013).
- 110.
For a comprehensive understanding of theological and ethical arguments see Evangelical Church in Germany (2013), pp. 69–87.
- 111.
In recent years, a number of organizations operating under the slogan of ‘No patents on seeds’ are attempting to voice societal concerns on the legal flaws of patents in plant breeding. For more see http://www.no-patents-on-seeds.org/en/about-us/home, accessed 3 August 2013.
- 112.
Even though patents are only a component of a multitude of factors that might limit access to food, their role should not be underestimated.
- 113.
See Rangnekar (2000).
- 114.
Note that the Convention came into force only in 1968.
- 115.
See http://www.upov.int/export/sites/upov/members/en/pdf/pub423.pdf, accessed 05 August 2013. For European Union breeders, it is also possible to apply for a Community plant variety protection, which provides for similar rights to those provided in the UPOV Convention. See Council Regulation (EC) No 2100/94 of July 1994 on Community Plant Variety Rights. Although this regulation takes into account the UPOV Convention, it prohibits cumulative protection of the plant variety with breeder’s rights and patents. See article 92 of the Community Plant Variety Rights.
- 116.
- 117.
Article 5 of 1991 UPOV. Please, note that the industry has recently proposed to include DNA fingerprints as an additional requirement for protection. DNA fingerprints are already used in private dispute settlements. For more on this issue see APREBES (2015).
- 118.
See in particular, UPOV, ‘General Introduction to the Examination of Distinctness, Uniformity and Stability and the Development of Harmonized Descriptions of New Varieties of Plants’ (19 April 2002) UPOV doc. TG/1/3.
- 119.
Van Owervalle (1999), pp. 143, 155.
- 120.
- 121.
As specifically stated by article 5 of the 1991 UPOV Convention, the aforementioned acts require the authorization of the breeder, which may make it subject to conditions and limitations. Examples of conditions and limitations which a breeder might include are: remuneration, period of authorization, quantity and quality of the material to be reproduced, methods of production and reproduction, etc. See better UPOV, Explanatory Notes on Conditions and Limitations Concerning the Breeder’s Authorization in Respect of Propagating Material under the UPOV Convention (21 October 2010) UPOV/EXN/CAL/1.
- 122.
Article 14(2), (3) of the UPOV Convention 1991. It should be noted that the full scope of the breeder’s right is also provided for acts that would require the breeder’s authorization during the period of provisional protection. Provisional protection is valid once the right is granted. If the right is not granted, provisional protection is not applicable. See art 13 of the UPOV Convention 1991 and UPOV, Explanatory Notes on Provisional Protection under the UPOV Convention (22 October 2009) UPOV/EXN/PRP/1.
- 123.
For an understanding of ‘reasonable opportunity’ see UPOV Explanatory Notes on Acts in Respect of Harvested Material Under the 1991 Act of the UPOV Convention, UPOV/EXN/HRV/1, 24 October 2013, available at http://www.upov.int/edocs/expndocs/en/upov_exn_hrv.pdf, last accessed 11 December 2014.
- 124.
See article 14 (5) (b), UPOV Convention, 1991. A decision on whether to grant protection to a variety does not take into account whether the variety is essentially derived or not: the variety will be protected if the conditions for protection as set out in Article 5 of the UPOV Convention are fulfilled (novelty, distinctness, uniformity, stability, variety denomination, compliance with formalities and payment of fees). The determination of an EDV is left to the courts to decide. For more on the assessment of EDV see ISF (2005).
- 125.
For more see UPOV, Explanatory Notes on Essentially Derived Varieties (22 October 2009) UPOV/EXN/EDV/1.
- 126.
Louwaars et al. (2005).
- 127.
See Essential Derivation Information and Guidance to Breeders (International Seed Federation 2005), available at http://www.amseed.org/pdfs/EDVInfoToBreeders_0605.pdf, accessed 4 April 2012. See also Helfer (2002).
- 128.
For a detailed analysis of the problematic aspects of an EDV definition see Janis and Smith (2013), pp. 1592–1600.
- 129.
Although this wording does not authorize farmers to sell or exchange seeds with other farmers, these practices are commonly accepted by states as part of farmers’ privilege.
- 130.
Note that 1991 UPOV has restricted the so-called farmers’ privilege provided for by the 1978 UPOV. Under the 1978 UPOV farmers were allowed to save, re-sow, and exchange seed for non-commercial purposes without the authorization of the breeder.
- 131.
Dual protection is also possible under article 27.3 (b) of TRIPS.
- 132.
Please, note that this situation may be common in Europe and in those countries that allow the coexistence of patents and breeder's rights.
- 133.
See arts. 5–9 of UPOV 1991.
- 134.
Article 9 of the EU directive.
- 135.
On the concerns of breeders’ and patent rights intersection see also GHK Consulting in association with ADAS UK for DG SANCO (2011).
- 136.
This paragraph mainly builds upon section 2.1.3 of the report prepared by Louwaars et al. (2009) and is reproduced here with the consent of Niels Louwaars.
- 137.
See Trojan (2012), pp. 8–10.
- 138.
These considerations are based on interviews with stakeholders in the plant breeding sector. For a list of the interviewees see Annex.
- 139.
For more see Kevles (2011).
- 140.
The concept of non-rivalry can be described by the words of Thomas Jefferson: ‘…He who receives an idea from me, receives instruction himself without lessening mine; as he who lights his taper at mine, receives light without darkening me.’ See the letter to Isaac McPherson dated August 13, 1813, available at http://www.let.rug.nl/usa/P/tj3/writings /brf/jefl220.htm, accessed 5 March 2011.
- 141.
Note that countries investing in R&D might create positive externalities for those that do not engage in R&D activities due to the non-rivalry of knowledge.
- 142.
Eaton (2013).
- 143.
Public institutions show a tendency not to patent their innovations in plant breeding techniques. In the EU the ratio of patents of private companies to public institutions was 83 % versus 17 %, in the USA 68 % versus 32 %. For further explanations see Lusser et al. (2011), pp. 35–37.
- 144.
Nordhaus (1969).
- 145.
For more see Kitch (1977), p. 265.
- 146.
- 147.
- 148.
Moser (2013), pp. 3–22.
- 149.
Intellectual property rights represent a policy tool intended to solve appropriability concerns related to knowledge-based goods, rather than a form of real property. See Reichman (1993), p. 75.
- 150.
Lander and Posner (246).
- 151.
Machlup (1958), p. 24.
- 152.
Ibidem, 55.
- 153.
- 154.
Scherer (2009), pp. 167–216.
- 155.
- 156.
- 157.
- 158.
- 159.
For more see Barnett (2011), pp. 178–211.
- 160.
Boldrin and Levine (2008).
- 161.
For an overview of empirical studies on disclosure see Hall and Harhoff (2012), pp. 16–18. They conclude that the social value of disclosure is small compared to the private value of patents.
- 162.
- 163.
- 164.
- 165.
Hadley, supra note, 134. Hadley’s book is available online at http://archive.org/details/economics019432mbp, last accessed 18 October 2013.
- 166.
Eaton (2007).
- 167.
For an overview of the literature see Eaton (2013), pp. 25–26.
- 168.
Butler and Marion (1985).
- 169.
See the study of Jaffe and van Wijk (1995), p. 8.
- 170.
For a discussion of the innovative role of the breeder’s exception for cereal crops see Janis and Smith (2013), pp. 1557, 1601–1606.
- 171.
- 172.
Eaton (2007), pp. 5–6.
- 173.
Shapiro (2009), pp. 291–322.
- 174.
See in specific for research in animal breeding, Joly and Bertrant (2003), p. 5. With regard to plant breeding, the Golden Rice project constitutes an emblematic example with more than 70 patents involved to develop the new rice variety. Kryder et al. (2000), p. 20. A recent study in the Netherlands has, nevertheless, showed that most of the research materials are freely shared among public researchers though some companies apply restrictive conditions in their material transfer agreements (MTAs). See de Jonge and Louwaars (2011).
- 175.
de Jonge and Louwaars (2011), p. 225.
- 176.
This is especially so because agricultural markets are dynamic and values are in continuous evolution. See Wright and Pardey (2006).
- 177.
On licensing patented innovations in presence of asymmetric information see Gallini and Wright (1990), p. 147.
- 178.
When licensing is not refused, companies may alternatively require contracting out experimental use exceptions provided by some countries in patent law. This practice is currently being followed by Monsanto and Syngenta. See Gibson (2009). The effects of such activity on plant breeding are perceived when countries have broad exceptions that allow research with the patented subject matter.
- 179.
A project of Wageningen UR and Bogor Agricultural University in Indonesia developed a new shallot variety resistant to an insecticide, which never reached the market due to the inertia of biotech companies in negotiating licensing conditions. For details on this issue see de Jonge and Louwaars (2011), p. 229.
- 180.
US law provides for compulsory licensing for plant varieties which wide usage is in public interest. See section 7 §USC 2404.
- 181.
Even if the breeding program is not immediately blocked, there is the risk that the patent holder may block the use of the patented material in further stages of breeding to the detriment of downstream companies’ economic and intellectual effort. Therefore, this situation creates high legal uncertainty.
- 182.
See Schumpeter (1976).
- 183.
It is worth emphasizing here that IPRs do not automatically confer monopoly power under EU competition law. EU law requires a case by case examination to determine the existence of monopoly power. The same is affirmed in the Antitrust Guidelines for the Licensing of Intellectual Property issued by the US Department of Justice and the Federal Trade Commission, see DOJ/FTC IP Guidelines, Section 2, p. 4.
- 184.
Coase (1990).
- 185.
For more see Langinier and Moschini (2002).
- 186.
- 187.
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Prifti, V. (2015). Intellectual Property in Plant Breeding. In: The Breeder's Exception to Patent Rights. International Law and Economics. Springer, Cham. https://doi.org/10.1007/978-3-319-15771-9_4
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