INTELLECTUAL PROPERTY RIGHTS (IPRS)

    INTELLECTUAL PROPERTY RIGHTS (IPRS) AND KNOWLEDGE SHARING IN FLAX BREEDING VIKTORIYA GALUSHKO, CAMILLE D. RYAN AUGUST 2010 1|Page     Tabl...
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INTELLECTUAL PROPERTY RIGHTS (IPRS) AND KNOWLEDGE SHARING IN FLAX BREEDING VIKTORIYA GALUSHKO, CAMILLE D. RYAN

AUGUST 2010

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  Table  of  Contents    

INTRODUCTION ..................................................................................................................... 3 OVERVIEW OF THE FLAX INDUSTRY ........................................................................................ 4 The Role of Flaxseed Trade for Canada ......................................................................... 7 STRUCTURE OF THE FLAX BREEDING INDUSTRY AND IP LANDSCAPE ....................................... 8 OPERATING IN AN IP WORLD: SURVEY RESULTS ................................................................... 19 IP Protection Strategies ................................................................................................ 19 Patenting decisions: patent or not?........................................................................... 19 The role of Plant Breeders Rights (PBRs)................................................................. 22 Material Transfer Agreements (MTAs) ..................................................................... 23 Sharing of knowledge and research tools.................................................................. 24 Impact of stronger IP protection on research ........................................................... 27 Hindrances to varietal development in flax industry................................................. 28 CONCLUSIONS ..................................................................................................................... 30 REFERENCES ....................................................................................................................... 31    

Table  of  Figures     Figure 1. Linseed area harvested around the world, 1992-2008.......................................................6 Figure 2. Fiber flax area harvested around the world, 1992-2008....................................................6 Figure 3. World linseed production, 1992-2008...............................................................................6 Figure 4. World fiber flax production, 1992-2008 ...........................................................................6 Figure 5. World production of oilseeds in 2008 ...............................................................................8 Figure 6. Number of registered flax varieties developed by private sector, 1990-1999 ................12 Figure 7. Number of registered flax varieties developed by private sector, 2000-2008 ................13 Figure 8. Number of registered flax varieties developed by public sector, 1990-1999..................14 Figure 9. Number of registered flax varieties developed by public sector, 2000-2008..................15 Figure 10. Importance of various motives when filing for a patent ...............................................20

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INTELLECTUAL PROPERTY RIGHTS (IPRS) AND KNOWLEDGE SHARING IN FLAX BREEDING VIKTORIYA GALUSHKO1, CAMILLE D. RYAN2 INTRODUCTION Recent research findings suggest that flaxseed offers a number of health benefits given high content of Omega-3 acids in its oil. In the past, the primary use of flaxseed was in the manufacture of paints, coatings, linoleum and other industrial products. In recent years, however, flax/linseed has gained popularity as an important addition to diets of health conscious consumers and as a supplement for animal diets in the production of more nutritious foods. This change in demand for flax as a source of oil for human consumption has shifted flax breeding efforts from ‘meeting minimum standards’ to breeding for yields, fatty acids and higher oil content. Up until now flax breeding has been performed primarily through traditional techniques with a limited application of biotechnology. At the same time the major competing oil crops such as soybeans and canola have been experiencing substantive private investment and the extensive application of genetic engineering techniques in production of varieties. This, in turn, has helped producers to benefit from the incorporation of valuable crop traits and has contributed to a success of these crops in the field. Given the enormous amount of biotech-related research efforts in other oil crops, biotechnology seems a likely route for the flax breeding industry particularly if it is to remain competitive for the long term. The problems associated with the use of biotechnology and associated intellectual property rights (IPRs) are well documented (Walsch et al. 2003, Walsch et al. 2005). The implications of IPRs in current and future flax breeding programs – and in the evolution of those programs - are of key interest to this study. The following questions inform our study: if flax breeding relies more on biotechnology, would research in the flax industry be hampered by IPRs – a situation that we found in the canola industry (Galushko 2008)? Is there evidence that the flax industry has already stepped onto the patent route and this

                                                                                                                          1

 Assistant Professor, Faculty of Arts (Economics), University of Regina, Regina, Saskatchewan Research Associate, Department of Bioresource Policy, Business and Economics, University of Saskatchewan, Saskatoon, Saskatchewan. 2

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has hindered research? Is there evidence that propensity of researchers to patent has undermined cooperation in a small world of flax breeding? Interviews with Canadian flax breeders serve as the primary source of information within the context of this study. This study also includes a detailed analysis of patents pertaining to flax/linseed breeding to identify the IP landscape. A search of the UPOV database for flax/linseed varieties is also performed to analyse the location and extent of global flax breeding efforts. The remainder of the paper is structured as follows. First, we start with a short overview of the flax industry. This section is followed by a description of flax breeding efforts globally and a discussion of the current IP landscape and patents that can potentially interfere with the current flax breeding programs in Canada. Then the results of the survey on the impact of increased IPRs on the flax breeding community are presented. The paper concludes with a brief summary of the results. OVERVIEW OF THE FLAX INDUSTRY Flax is an ancient crop and the use of flax in food and linen cloth production in Europe and Asia dates back to 5000-8000 BC. (Berglund 2002). In North America, the history of flax is more recent with flax believed to be first grown in Canada in 1617 in Quebec City (Kenaschuk and Rowland 1995). In the past, the principal use of flax was industrial in manufacture of paints, coatings and linoleum. Over the past decades, however, a shift in consumer preferences towards healthful food has created new opportunities for the flax industry. The introduction of low linolenic acid flax varieties has increased the use of the crop in the food industry and in agriculture. For the most part, flaxseed is consumed as food in China and India while in Europe and North America flaxseed is used more as a feed source (AAFC 2002). Over the last century, as cotton and soybeans were entering the scene, the importance of flax as a source of fibre for cloth production and food oil declined. The renewed interest in flax has been partially due to research findings suggesting that it can provide a variety of health benefits such as heart disease reduction. Flaxseed is characterized by high content of omega-3 fatty acids in its oil, which is an increasingly popular addition to diets of health conscious consumers. Flaxseed is also fed to poultry to produce more nutritional eggs marketed as “Omega Eggs”. The significant fibrous flax cultivation areas are in China, Belarus, France, Russian, the Netherlands, and Ukraine. According to Food and Agriculture Organization (FAO) Statistics, in 2008 the world linseed and fibre flax production accounted for 2.2 and 0.9 million tons, respectively. The top two producers of linseed are Canada and China, with

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the two countries supplying 39% and 22% of the world linseed, respectively (Figure 2). Canada has consistently led the world in production for over twenty years. While China has been a leader in fibre flax production for decades (Figure 2 and Figure 4), the emergence of China as the second largest producer of linseed is recent. In 1992, there were only about 79 thousand hectares of flax in China. As the western countries started locating their linen textile businesses in Asia and China transformed into the major producer of high-quality linen clothing, it significantly increased its own domestic production of flax to reduce the cost of raw materials. Strengthening of demand for linseed in the European and American markets (both for human consumption and manufacture of environmentally friendly paints and other industrial products) also contributed to an expansion of area under linseed cultivation in China. In 1994 the area attributed to linseed production was 667.8 thousand hectares (up 745% compared to the 1992 level) and it has fluctuated around 450 thousand hectare level since 2000 (Figure 1). The second significant linseed cultivation area is India. Although linseed acreage in India is almost a quarter of the world acreage and is very close to the area occupied by linseed in Canada – the largest producer (Figure 1), the yields that are the lowest in the world place India much below Canada on the production ladder (Figure 3). Flax used to play an important role on US farms and back in 1970s there were close to 800 thousand hectares (two million acres) of flax grown in the United States (Thomas Jefferson Agricultural Institute 2010). Its importance substantially declined since early 1970s and by 1990 there were only 102.4 thousand hectares of linseed reportedly grown in the US. This area increased to 386.5 in 2005 before witnessing a significant drop to 137.6 thousand hectares by 2008 (FAO statistics 2010). Today, the United States accounts for slightly less than seven percent of the world linseed production ranking fourth overall (Figure 2). According to the Interactive European Network for Industrial Crops and their Applications (IENICA), there has been a decline in European linseed production since 2000. In fact, between 1999 and 2002, IENICA reported a production drop of 85% largely due to the introduction of Agenda 2000 to support enlargement of the EU3 (Holmes 2009: 23). These changes to the Common Agricultural Program (CAP) have led to subsidy cuts, which have significantly impacted production levels across several                                                                                                                           3

 The Agenda 2000 strategy incorporates a continuation of agricultural reform made in 1988 and 1992 the purpose of which is to stimulate competitiveness, bearing in mind environmental impacts, ensuring fair income for farmers, simplifying legislation and decentralising the application of legislation in agriculture (European Commission 2009a, European Commission 2009b).  

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member countries (Holmes 2009). Germany, for example, reduced linseed production from 194 thousand tons in 1998 to about 4 thousand tons by 2008 (FAO statistics 2010). The position of Netherlands has also been weakened by a reduction of direct financial support for flax cultivation from the Dutch government after 2005 due to the reform of the Common Agricultural Policy. Conversely, both French and Belgian flax growers continue to receive financial support from their respective governments by means of subsidies and have been able to maintain a strong position in terms of flax cultivation (Vromans 2006). Also, the significantly higher labour and land costs in the Netherlands as compared to Belgium and France have contributed to the Netherlands weakened the position in terms of flax cultivation (Vromans 2006). A significant reduction in harvested linseed area occurred in Argentina where linseed production has almost been abandoned. Argentina moved from being a major producer of linseed in early 1990s with the area harvested of 565.3 thousand hectares in 1990 and production of 514.2 thousand tons, but turned into a marginal producer with only about 9.5 thousand hectares seeded with flax in 2008 representing only 0.4% of the world linseed production (FAO Statistics 2010).

Figure 1. Linseed area harvested around the world, 1992-2008

Figure 2. Fiber flax area harvested around the world, 1992-2008

Figure 3. World linseed production, 1992-2008 Source: Compiled from FAOStat

Figure 4. World fiber flax production, 1992-2008

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Overall, linseed production appears to have declined over the last decade almost everywhere in the world. This reduction in recent years is associated with flax offering lower returns to farmers, relatively speaking, than most other grains or oilseeds (ICIS 2007). The Role of Flaxseed Trade for Canada Canada is the world’s largest exporter of flax accounting for 80% of the global flax trade. The flax industry in Canada is estimated to generate $800 million per year approximately, a large portion of which is generated through exports alone. Canada exports linseed oil, linseed meal, and flax fibre. According to the information derived from the Trade Analyzer database, supported by Statistics Canada, the value of linseed exports reached a record high of $470 million in 2008 and was down to $292 million in 2009, which is slightly above the fifteen-year average of $277 million in exports of linseed. 70% of Canadian flax is exported to Europe. Belgium has consistently been a major destination of Canadian linseed. The early 2000s witnessed an increase in the share of Belgium in total Canadian exports up to 74% and in recent years Belgium’s share declined to around 60% (2008 export statistics). Canadian exports to Belgium declined significantly in 2009 (from a value of $304.3 million in 2008 to $96.7 million), which was the result of finding traces of GMO flax (Triffid flax) in Canadian shipments to Europe. In the past, the US (Minnesota, North Dakota), the Netherlands and Japan were also identified as major trading partners. The share of Japan, however, declined from around 10% in late 1990s to slightly over 1% in 2009. In 2009, China showed strong demand for Canadian flaxseed with exports to China almost tripling and reaching $88.9 million (30% of total exports) – taking advantage of Triffid related market crisis and excess stores of flax. Canada also exports linseed oil. The U.S. market is the major destination for Canadian linseed oil exports and in 2009, exports to the United States were valued at $7.7 million representing almost 50% of Canadian linseed oil exports. Other important trading partners are China and Japan, though the volume exported to Japan has declined slightly in the last few years.

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STRUCTURE OF THE FLAX BREEDING INDUSTRY AND IP LANDSCAPE The small scale production of flax seed (2.2 Million tons in 2008) (see Figure 5) and the fact that it is a self-pollinating crop4 translate into nominal efforts in research, relatively speaking, by the private and public sectors.

 

Figure 5. World production of oilseeds in 2008 Source: USDA, FAO (linseed only)

In recent years flax breeding efforts have shifted from ‘meeting minimum standards’ to breeding for yields, fatty acids and higher oil content. Canada, Western and Eastern Europe are centres for flax breeding. Public flax breeding in North America started in the early 1900s to meet increased demands by the linseed oil industry (Fu et al. 2003). In the early 1900s, flax breeding in Canada was solely performed at the Central Experimental Station in Ottawa but by the end of 1960s the flax breeding laboratories extended to Indian Head, Saskatchewan, Winnipeg, Manitoba, and to Fort Vermillion and Beaverlodge, Alberta. These public breeding efforts were eventually consolidated into one breeding program that moved to Winnipeg and later to Morden, Manitoba. A modest flax breeding program was carried out at the University of Saskatchewan from 1920s to 1960s and this program was subsequently extended when the Crop Development Centre                                                                                                                           4

 A personal communication with a flax breeder in Canada revealed that about 80% of the seed in flax is brown bagged essentially, leaving only 20% of the seed market to seed companies on an annual basis.  

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at the University of Saskatchewan initiated a flax breeding program in 1974 (Duguid 2009). Throughout the last century, private sector efforts for flax breeding were nominal. What little breeding activity has been carried out has been conducted by only two private companies in Canada; Agricore United, which later evolved into Viterra5 (Manitoba) and Parsons Seeds Ltd. (Ontario). In late 1990s, Agricore United initiated a high linolenic flax breeding program and trademarked the product under “NuLin”. Currently, there are four flax breeders in Canada: one at Viterra, one at Agriculture and Agri-Food Canada in Morden and two at the University of Saskatchewan Crop Development Centre. According to the information compiled from UPOV Variety Registration database, the private sector released five new flax varieties and the public nine new varieties in the past decade. In the United States, flax breeding efforts were carried out in Minnesota and in South and North Dakota. Breeding activities significantly decreased in recent years with Minnesota terminating its breeding program in 1984 while South and North Dakota reduced its effort to 0.5 and 0.9 scientist years, respectively (North Dakota State University 2010). Several years ago, the USDA/ARS flax improvement efforts at North Dakota State University were reduced to the maintenance of its Flax World Collection while coordination of regional testing was moved to Ames, Iowa five years ago (Duguid 2009). In Western Europe, flax breeding is performed primarily by private companies. Breeding efforts are concentrated in France, the Netherlands and in the United Kingdom. In the Netherlands, the major flax breeding programs are lead by van de Bilt   Zaden & Vlas B.V., Wiersum B.V. Landbouwbureau, and Limagrain Nederland; in the United Kingdom by Agrifusion, John Turner Seed Developments, and Limagrain UK, all, of which, are private firms. In France, the major flax breeding private companies are GIE Linea, Agri Obtentions, and Laboulet Semences. GIE Linea consists of a private company, LIN2000, and three flax stripping cooperatives. In a partnership between the Institute National de la Recherche Agronomique (INRA) (the leading European agricultural research institute) and LIN2000, GIE Linea was entrusted with the task of conducting flax breeding, in particular, to produce cold tolerant flax varieties. In recent years, the companies based in France have combined their research and breeding efforts through partnerships, with INRA playing a major role as a supplier of the genetic material for these projects. France’sflax breeding industry is also characterized by the involvement of cooperatives. The leading cooperatives are Terre de Lin and Cooperative Liniere de Fontaine Cany. Terre de Lin has been in operation for more than 50 years and currently has a research team of seven people.                                                                                                                           5

  Viterra was formed as a result of a take over of Agricore United by the Saskatchewan Wheat Pool in 2006.

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In Eastern Europe, most of the flax breeding efforts are carried out by public institutions. In Lithuania, for example, flax breeding has been on-going since 1922. Since 1966, however, flax breeding has been performed at the Upyte Research Station of the Luthianian Institute of Agriculture. In Russia, the main flax breeding agencies are: AllUnion Research Institute of Flax, Kaluga Research and Development Agro-Industrial Institute, Viatka State Academy of Agriculture, Pskov Research Institute of Agriculture, Smolensk Region A. Engelgardt State research station, Tomsk Region State Agricultural Research Station and some others. Flax breeding efforts in the Czech Republic, have historically been carried out at individual state research stations which were subsequently consolidated into the state breeding enterprise (Institute) OSEVA in Prague in 1977 (AGRITEC 2008). The purpose of this consolidation was to combine genetic research, plant breeding and seed production under a single organizational umbrella. In 1993, the Czech research breeding environment witnessed a dramatic change with public research institutes, specializing in particular crops, evolving into limited liability companies (Ltd.). The public flax breeding institute was transformed into ‘AGRITEC, Research, Breeding, and Services Ltd.’, a principal flax breeding program in Czech Republic that operates as a private non-profit institution. All potential profits generated by AGRITEC must be completely reinvested in research (AGRITEC 2008). AGRITEC partners with the national breeding companies Selgen a.s. and SEMO. Substantial progress has been made in China during the last several years both in biotechnological and traditional methods of breeding resulting in the registration of several fibre or linseed varieties (Pavelek and Tejklová 2005). The major breeding research efforts are located at the Flax Research Institute under the Academy of Agricultural Sciences of Heilongjiang Province and The Institute of Industrial Crops in Heilongjiang, Hulan. Flax breeding efforts around the world are mapped in Figures 6. The number of registered varieties, for the purposes of this illustration, is used as a proxy for breeding efforts. A search of the UPOV Variety Registration database for applications to national listings and PBRs identified 433 flax varieties registered worldwide prior to 2008. The applications to national listings or PBRs that were withdrawn from consideration within 1-2 years after application submission were excluded from the analysis as those were either renamed, and therefore already appear in the data under a different name, or were not released for commercial production. The year of a variety release was assumed to be the year when application to add the variety to national listings was submitted or when PBR application was submitted, whichever occurred first. It should be noted that the

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varietal listing may not be complete as countries voluntarily report to UPOV. Thus, some countries may underreport varieties. Despite this, the UPOV database appears to include the countries where major flax breeding efforts take place. A notable exception, however, is Belarus. The UPOV database did not contain any records specific to Belarus specifically and only few varieties were identified in Russia’s records. Therefore, the number of flax varieties released in Belarus is likely to be underestimated on the map. A general picture that arises from the map is that efforts in flax breeding appear to have declined over the last decade. In 1990s, the global private sector registered 91 varieties worldwide, the public sector registered 83 varieties, cooperatives (France) 18 varieties, and private sector in collaboration with public institutions released a total of 7 varieties. Since 2000, these numbers are lower: private sector released 62 varieties, public institutions – 55 varieties, cooperative and public-private partnerships registered 4 and 4 varieties, respectively. Private breeding efforts measured by the number of varieties appear to have increased in France only and have declined in other countries. There is some evidence, however, that breeding efforts by cooperatives and public-private partnerships (PPPs) in France have declined in the last decade. Eighteen varieties produced by cooperatives in 1990s while only 4 were registered in the last decade. In Western Europe, the 1990s saw a small involvement of the public sector in flax breeding, while no public varieties were either added to national listings or applied for PBRs since 2000. This may be an indication of either a significant reduction in public breeding efforts or a complete abandonment of public flax breeding programs in Western Europe. Conversely, breeding efforts in Eastern Europe have consistently been dominated by public institutions.

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Figure 6. Number of registered flax varieties developed by private sector, 1990-1999

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Figure 7. Number of registered flax varieties developed by private sector, 2000-2008

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Figure 8. Number of registered flax varieties developed by public sector, 1990-1999

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Figure 9. Number of registered flax varieties developed by public sector, 2000-2008

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While the global flax breeding industry is dominated by the public sector effort (particularly in North America and Eastern Europe), the demand for flax as a nutritional product along with reduced R&D costs due to increased application of biotechnologies may attract more private firms into the industry. Greater involvement of the private sector in flax breeding industry can shift its character. There is evidence that with more identifiable patentable pieces of intellectual property (IP), arising from applications of genomics, research may get hampered as private companies seek IP protection for their breeding methods and technologies (Galushko 2008). We performed a patent search to identify what has been patented in flax breeding and how many of those patents can potentially hinder progression in flax science. We use both the United States Patent and Trademark Office database and Patent Lens, for our patent search. Patent Lens is a worldwide, open-access, free full-text patent informatics resource and includes all patent grants and applications listed in the United States Patent and Trademark Office, Australian Patent Office and the European Patent Office. It also includes PCT patents. The Patent Cooperation Treaty (PCT) is an international patent law treaty that was concluded in 1970. The Treaty provides for a unified procedure for filing applications to protect inventions in multiple jurisdictions and, thus, an application filed under the PCT is referred to as an international application. A search of the USPTO serves as an auditing exercise to ensure that we have captured any and all relevant patents.   The search strategy of the full text of the databases included a search of the claims based on the terms “linseed” or “flax” or “linum” or “flaxseed” in combination with a search of abstracts based on the terms “oil” and “content”. A combined dataset (sourced from the USPTO6 and Patent Lens databases) consisting of 144 patents (filed for and/or granted) was generated which includes title, abstract, date published/filed and – when available – lapse date. Ninety eight of these records were generated through a search of Patent Lens while the remaining 46 were found in the USPTO database. This dataset was further refined by eliminating duplicate patents wherever possible (including some PCT patents). A final dataset comprised of a total of 104 patents was generated that includes 45 PCT patent applications, 50 US patents, 9 EP patents,   Once the data was gathered, we arranged to meet with one of our most senior flax breeders (from the CDC) to review these patents and to identify those patents that in his/her opinion may, in any way, impact or impede breeding research and strategies.   The Crop Development Centre (CDC) uses pure breeding techniques to develop its flax varieties. Our breeding expert stated that transformational patents or patents that claim for or elude to the use of transformative techniques to develop varieties are not of interest                                                                                                                           6

 Although  Patent  Lens  includes  USPTO  patents,  we  conduct  an  additional  search  of  the  USPTO  to   augment/check  our  results.    Even  by  using  the  same  search  terms,  a  search  of  the  Patent  Lens  database   alone  appears  to  miss  key  patents  of  interest  to  this  study.    Completing  an  additional  search  of  the  USPTO   database,  removing  duplicates  provides  us  with  a  more  complete  list  of  relevant  patents.      

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to the CDC. Transformative techniques, broadly speaking, refer to the genetic alteration of a cell through the uptake and expression of foreign genetic material. According to our expert, obtaining approval for flax varieties developed through transformative techniques is extremely costly. The overhead costs incurred in the process would be prohibitive for both the institution and for downstream partners (seed companies) as well. Based upon this, transformational patents are deemed non-relevant by our breeding expert. Promoter patents are considered to be transformational patents and are also deemed non-relevant. Of interest, though, are composition patents. A compositional patent refers to a piece of intellectual property that protects a composition of matter. The USPTO places this type of patent under the category of utility patents. The claims of a compositional patent specifically describe the chemical and molecular structure of the new matter.   After a review of our patent list, our expert identified that there are very few patents out there that create uncertainty for the CDC breeding program. Several records were eliminated from our patent list as they were considered completely extraneous (with pure industrial applications such as those patents related directly to the manufacture of cigarette papers or oil extraction processes). However, our expert did identify four patents (grants and applications) that may warrant further investigation:   Patent #US7655833, granted in February 2010, was filed by Brookhaven Science Associates, LLC, Upton NY (US) and, according to the patent, “…provides coding sequences [for]...decreasing and increasing saturated fatty acid content in plant seed oils”. This patent claims for a gene that can generate a certain fatty acid ratio. Our expert suggested that it may be possible that the CDC has and is using that particular gene in their current breeding program. This has yet to be confirmed. A PCT patent application (WO 2007/051302) filed in May, 2007 by Peterson and Golas (of Winnipeg, MB), pertains to the “…uses of HiOmega flax (linseed) oil…with higher than normal alpha linolenic acid content…” The claims of this invention are “…in the production of stronger, more scratch and solvent resistant industrial products such as alkyd resins, epoxidized oils, epoxies, inks, coatings such as paints, enamels, varnishes and films and anti-spalling concrete preservatives”. Despite the industrial application of this patent, it is deemed important. Our expert claimed that the applicant ‘Golas’ has been investing heavily in flax-related research and this patent application may be a signpost of further IP protection activity. Thus, it is worthwhile following up on any and all related activities. Another PCT patent application, WO 2008/129227, filed in October 2008 by the University of Warwick, was deemed of interest by our expert. The patent application – titled Improved Plant Oil Production – outlines a compositional patent which claims for monodehydroascorbate reductase (MDAR4) that is ‘discovered’ to have “…a key role in the accumulation and breakdown of oil in plant seeds… [and] …Transformed plants in which MDAR4 activity is suppressed, whether by mutation of the gene encoding MDAR4, or by sense or antisense suppression for example, have an oil content which is

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greater than unmodified or wild type plants”. Our expert suggested that the gene referred to in this patent may be a gene that is already resident in flax. Thus, this patent could create some uncertainty for the breeding program. A final patent of interest, US 6870077, granted in 2005 was filed by E. Kenaschuk of Morden, MB. It is a patent for a breeding method to increase the proportion of linolenic acid in the oil of flax. Specifically, the patent describes “…production of and uses for flax seed having a linolenic acid content of greater than 65% based on total fatty acid content…” Although this patent does not appear to create uncertainty for CDC breeding programs, our expert questioned the validity of this patent and its ability to generate returns or provide optimal protection for its inventor. The patent refers to only specific varieties in its claims. Thus, the breeding method outlined and protected by the patent could potentially be used in other varieties not stated in the claims. An interesting spin on these observations is that the work by the inventor (Kenaschuk) in the aforementioned patent had been funded by Golas, the co-applicant for the PCT patent (WO 2007/051302) outlined above. Nothing conclusive can be drawn on the results and observations of our preliminary patent analysis. Our expert does not claim to be an expert in patent law. He/she merely suggests that, on face value, these particular patents warrant further investigation. Our expert also suggests that some patents may be more relevant for private sector breeders (i.e. transformational patents). However, he/she stated that there are several very small family plant breeding companies that do not conduct transformation-type research in flax due to cost constraints. And, like the CDC, few or no patents would create uncertainty for them and their breeding programs. It is important to note that our results do not explicitly include Canadian patents as we limited our search to Patent Lens and the USPTO. However, our expert assures us that any patent applied for in Canada pertaining to flax or linseed would most certainly be applied for in the US jurisdiction given the strong trading relationship between Canada and the US. Therefore, our search of the USPTO would capture any and all related patent applications and grants filed through the Canadian Intellectual Property Office.   A final note on the patent analysis is US5973227. This patent, titled simply Flax transformation, was filed jointly by A. McHughen and T. Wijayanto in 1998 and granted in 1999. The assignee is the University of Saskatchewan. The patent claims for a method for producing a transgenic flax plant. According to our expert, this patent was filed in order for the CDC to have free use of technology. Essentially, it was a ‘defensive’ or ‘freedom to operate’ patent strategy that was designed to protect the public good and ensure that developments continue to occur in the public sector. In summary, given that the flax is a small crop, the flax breeding is performed by a small number of companies and, as such, there are only a very limited number of relevant patents pertaining to flax/linseed. Thus, there is no reason to believe that the strengthening of IPRs - globally and nationally - has significantly impacted the flax

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breeding community in Canada. The following section presents the results of a survey of Canadian flax breeders and is intended to shed some light on the issues associated with trend towards stronger IP protection. OPERATING IN AN IP WORLD: SURVEY RESULTS While flax is, relatively speaking, a small crop and the costs of IP protection might not be justified, in recent years the flax research industry has witnessed a surge in patenting activity. Firms patent research inputs, seeds and plants. For example, low-linolenic linseed is a novel development and the Commonwealth Scientific and Industrial Research Organization (CSIRO) (Australia) has filed patent applications covering the plants, seeds and seed products in several countries. The question arises: what are the major reasons for protection of IP, what are the most common methods to protect IP and what are the implications of stronger IP protection for the breeding community? To gain insight into these issues we conducted a survey of flax breeders in Canada. Unfortunately, we were not able to arrange for an interview with the private flax breeder at Viterra. Thus, only the responses of three public breeders are included in the analysis. While collecting the views of private breeders in Western Europe would add flavour to the study, this study currently has a Canadian focus and extending the analysis beyond Canadian border is part of future research. IP Protection Strategies Patenting decisions: patent or not? Historically, patenting of intellectual property in plant breeding was not viewed as an acceptable practice for a number of reasons. The primary one was due, in large part, to what is deemed as the ‘cumulative nature’ of plant breeding. As past achievements in plant breeding are viewed as foundational to all current and future breeding programs, granting monopoly power over such research materials was considered to be against public interest. Essentially, patents were viewed as inhibitors to the widest possible dissemination of genetic information and knowledge by impeding free exchange of research inputs amongst breeding institutions. In the last couple of decades public institutions have become active players in the patent system but the importance of patents and the patenting process has varied from crop to crop. In the context of flax, and according to our respondents, there appears to be little to no interest in patenting on the part of public institutions involved in flax breeding : “I don’t really worry about it [patenting] very much because we, the institution, really don’t have the resources to go down the patent route –

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you have to have deep pockets to do that [enforce patents]. If you are never going to enforce those patents, what is the point of having it patented in the first place?” Substantial search and enforcement costs appear to be the primary reason for not pursuing the patenting route. Additionally, though, there was agreement from respondents that patents are antithetical to serving public interest and that any and all resources generated (data/information/technologies/germplasm) should be placed into the public domain. Despite these strong views on patenting, all respondents did indicate that their protection of IP has increased over the last 5-10 years. By definition, patents render excludability to inventions and are intended to limit access to those inventions. A natural question then arises: if public institutions get involved in patenting, has the mandate of the public institutions to disseminate knowledge as widely as possible lost its importance over the years or is public patenting still consistent with this mandate? To answer this question, we have looked into the motives behind patenting inventions in the flax sector. The results are presented in Figure 10.

 

Figure 10. Importance of various motives when filing for a patent Making the technology broadly available does fall within the mandate of public institutions in Canada and this is deemed as an important motive behind protecting the

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technology. As was mentioned by one public breeder patenting is an important element of making the technology publicly available as it can prevent private companies from patenting and holding exclusive rights over their technologies: “Well, if you don’t take out a patent and yet you know a company’s going to, or maybe you suspect a company is going to take a patent in that area, then you do that first to be proactively reactive”. Generating licensing income and ensuring freedom to operate (FTO) rank second in importance when considering patenting inventions. One breeder asserted that: “...we would hopefully generate licensing income and… I know in the past we certainly have done them [patents] in an attempt to ensure FTO, but we would not enforce these patents and allow others to use them, particularly players in the public domain”. Patenting to ensure FTO, however, seems to be becoming obsolete. mentioned that:

One breeder

“...there are all kinds of ways to get around these patents and then they are fought for years and years and these are companies that have deep pockets to do it. So, even though you get a patent [and] it looks like you’ve got FTO, you may find out afterwards that you don’t”. Survey results support that, in the Canadian flax industry, the reason for public institutions to patent is to ensure that the public interests are observed and access to breeding materials/technologies is unencumbered. It was mentioned that the breeding community is likely to experience negative impacts if patents are sought by private companies. The private sector has different and opposing incentives to patent their inventions. This was stressed by one breeder: “I fundamentally disagree with biological patents because I think they are anti-progressive. They don’t allow for progression in science… The industry and others use them [patents] for blocking more than they use them as a strategic defense mechanism, rather than as a proactive tool in the science”. As was mentioned by the breeders patenting is not a common practice in the Canadian flax industry because there are cheaper ways to achieve dissemination and disclosure of knowledge. Publication in journals was noted to be an effective and widely accepted way

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to manage intellectual property. This view was tempered, however, by the reality that publishing could, in fact, only serve as an ineffective defense tactic in the long run: “You know you could publish and theoretically that means that it cannot be patented again, but there have been multiple instances where they allowed all sorts of things – biological things - that were in the public domain to be patented”. Based upon our results, it appears that public flax breeders ‘philosophically’ oppose patenting or, at the very least, have a cynical viewpoint of the protection mechanism. Practically speaking, however, they have had to yield to institutional-based strategic approaches to managing IP that have evolved over the years to include patent protection. The role of Plant Breeders Rights (PBRs) Plant Breeders Rights (PBRs) play an important role in protecting developed varieties. Flax varieties developed at public institutions are not marketed by the institutions themselves but by other actors that view for those rights through a tender process. At AAFC, for example, once a variety is recommended for registration they open the floor for seed companies to submit proposals to market that particular variety. After submission, the proposals are evaluated by a committee consisting of scientists, senior management, and a breeder. When evaluating proposals, company experience and capacity (e.g. capacity to handle a closed loop system if the variety must be distributed under this system) are the two major factors taken into consideration. After the best proposal is selected, a licensing agreement - which specifies royalty arrangements among other things - is negotiated and signed between AAFC and the company. The seed company then purchases the breeder seed from the AAFC and distributes it to growers. The Crop Development Centre (CDC) at the University of Saskatchewan follows a similar procedure to the one described above. The key distinction between the two institutions in commercializing their varieties lies in application of Plant Breeders’ Rights (PBRs). As part of the bid most seed companies request that PBRs are applied to the varieties they will be marketing. AAFC conducts all paper work and administrative tasks associated with PBRs including application for and maintenance of PBRs. The AAFC then invoices the company for these PBR-related expenses. At the CDC, on the other hand, the breeders themselves are responsible for the paper work while the seed company that markets their varieties applies for and maintains PBRs. While PBRs are considered to be of high importance to seed companies that market flax varieties, the respondents were not aware of any instances when PBRs had to be enforced

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and/or producers were taken to the court for infringement. Furthermore, one breeder indicated that: “...we know that 80% of the seed in flax is brown bagged...so the seed companies maybe [only extract] 20% seed [value] on an annual basis”. Material Transfer Agreements (MTAs) Historically speaking, germplasm and material exchange amongst breeders was carried out under an informal “Code of Ethics” or a collegial ‘gentlemen’s agreement’. IPRs have dramatically changed this practice. Our survey of flax breeders has revealed that material transfer agreements (MTAs) to facilitate the transfer of germplasm and related materials are currently used quite consistently by breeders as both a proactive and defensive tool; and as a fore-sighting tool. Generally, MTAs are beneficial to those who initiate them because they reduce the risk of material being misappropriated. In this way, MTAs serve as a defensive tool: “MTAs are very important simply because you don’t want someone taking your germplasm or maybe even research tools and co-opting or even patenting them”. As a fore-sighting tool, MTAs can help avoid misunderstandings amongst breeders. They are contractual tools that outline the terms regarding how the material can be used and what can be deemed as infringement of rights. The following quotes support the validity of MTAs as a fore-sighting tool: “I guess MTAs may slow down the research process a little bit but they may facilitate it and encourage it in longer term because you may find yourself in situations in the future where if you don’t do that [don’t sign MTA] then there is a lot of grey area and misinterpretation as to what you could do with that piece of knowledge. For germplasm I have seen situations where, 10-15 years down the road after something had been freely exchanged, problems arose. The same people that knew what the deal was 10-15 years ago are not in place today and this can create lots of problems down the road”. Similarly, “I’ve become very sensitive to IP – that’s probably why I do MTAs and I’ve become a little more formal with how I get germplasm into the

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program or obtain germplasm to utilize for crossing and so forth. I won’t ignore IP because I think that creates a bigger problem in the future”. Signing MTAs is a common procedure in almost all crops. For example, in earlier interviews with barley and wheat breeders (Galushko 2008), it was stressed that the legal procedures such as MTAs are “...more established now and there are not many unregulated transfers of germplasm”. While they can help avoid some problems down the road and reduce the risk of misappropriation, there are a number of concerns surrounding MTAs. First, MTAs can restrict the freedom of universities to publish if the conditions of material transfer are such that the material provider has some ownership over the results of the research. The terms of the agreement may award the distributing party reach-through rights on any IP developed using technology covered by the MTA. As such, recipient breeders might avoid using the material in order to sidestep the appropriation of value of future discoveries (Galushko 2008, p. 135). Based upon this observation alone, it is evident that MTAs can stifle valuable research initiatives. Our interviews with flax breeders have not revealed any of these negative characteristics of MTAs. The only drawback of MTAs mentioned by the respondents was that they add another complex layer of bureaucracy. One breeder claimed: “What I found in the past is that MTA requirements or the whole legal documentation are different across institutions. You’ve got two different institutions, they have two different ways of wording it and then they got to agree on that. This slows the process down”. Another breeder supported the above observation by saying: “MTAs slow things down because they go through IP offices and everything then. It’s between organizations really that they go through not the breeders and that slows everything down”. Sharing of knowledge and research tools When queried, all respondents strongly agreed that knowledge or germplasm must be freely disseminated amongst researchers. Despite unanimity on this point, there are exceptions. One respondent indicated that he/she tends to withhold the research results for a period of time until after the results are published to primarily avoid the misappropriation of the results and possibly patenting and enclosure. None of the researchers agreed to the statement that ‘they tend to keep the research results secret if the invention is not patentable’.

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While the flow of research materials does not seem to have been hampered, over the past several years, collegiality and informality of exchange has evolved into formalized agreements and processes. As was indicated by one breeder: “...we don’t have that [informal] exchange anymore. I mean at one time breeders would just share if you say ‘well, you’re doing this, send me some of it’. It doesn’t happen anymore”. Sometimes breeders are only willing to share after they have achieved a certain outcome in their breeding programs, which would provide a competitive advantage even if the materials are shared with others: “Why I would give the material is that I know that I have such a head start on that material. It would take someone 10-12 years to get a variety out with that to begin with. So, I already have a 10-12 year advantage by the time I give it to someone. So, yes, breeders tend to say ‘yes’, we’d like to give our material more freely because we are dependent upon one another, but we also know that we’ve got a little bit of competitive advantage already because we’ve already worked with it”. Despite the appearance that the breeding world has become less cooperative and that flow of knowledge/research materials may, in fact, be somewhat hampered, the public breeders all impart a general ‘willingness to share’ philosophy. In public institutions the culture of exchange of research materials is supported by their mandate, while sharing by the private sector is primarily encouraged by flax being a small crop. Because the seed market is small there is no incentive for firms to invest large amounts of R&D funds to ensure self-sufficiency in research and firms can operate more efficiently if they cooperate with other researchers. One respondent has confirmed this by saying that: “The reality is that often, and I go back to flax being a small crop, there isn’t a lot of advantage in being very hardnosed about the IP in some of these things because we all benefit from it. For instance, I spoke to a calibration curve with Canadian Grain Commission. I know another one that came through private industry to us and they are quite willing for us to have that calibration curve so that we may do work within our breeding program in order to improve their situation because the varieties that they are going to receive are improving for a particular trait they are interested in. If they know that all the breeders are working towards that end or have the capacity to do that testing and improve their varieties they

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get a better product at the other end and they are happy. So, they are quite willing to give us that technology”. Another breeder asserted that collegiality is a feature of the private sector at least in Canada: “Flax breeders within Canada are very collegial and even a breeder from a private company invited me to come up and see his/her nurseries and talk to him/her. Because there are so few of us, there are limited resources, so we have to pool them together otherwise we can’t move forward”. Private firms are still more likely to enclose their technologies than public researchers. Public-private partnerships can be used as a tool by industry to obtain access to genetic material held in the public domain and to further ensure protection of intellectual properties coming out of private breeding programs. One breeder mentioned the case where he/she could not access certain material from a public institution because that institution was working in collaboration with the industry: “I have been denied materials and information around something that was developed by a public institution so that was certainly in the public domain. Well, I think in this case it was that they had signed a contract with a private company to do something and the private company wanted it kept secret”. When asked about secrecy in the flax breeding community (secrecy defined as ‘unwillingness of researchers to discuss their current research with others’) all of the respondents agreed that secrecy has increased over the last 5-10 years. Respondents with a more extensive history in breeding note this change suggesting that secrecy has increased significantly. The following quotes support this: “I just think we are a little more cautious. I think it is not that we are trying to prevent exchange or unwilling to it, it is just that I take a little bit more cautious approach to it... I am cautious as to what I say or how much I say...” and, “I would agree that secrecy has increased because of the surge of the biotechnology industry and the idea that you know if you make a discovery about a gene or another invention you can patent it”.

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Impact of stronger IP protection on research Compared to some other oil crops such as canola or soybeans where genetic engineering is extensively applied, application of biotechnology has been limited in flax. As a result, technologies utilized in flax breeding involve more traditional approaches that have been used in the public domain for decades. This breeding and research culture has minimized the impacts of IPRs on flax breeding. One breeder stated that: “[Flax] a small crop. If you look at the genomics and that sort of work that we are getting into now, we are just getting into that ... I don’t think we have been hindered because we just have not been in that area. I know that there are patents out there that may impact us, but they have not stopped us or hindered us in the past in that sense”. One concern about patents and public research is that public institutions very often do not have bargaining power to negotiate agreements with the private sector in order to protect the materials in their research programs. As a result, the research areas that would require protected IPs may be avoided, thus leading to under-research in some potentially promising areas. In order to limit the adverse effect of patents on subsequent innovative activity, patent laws in many countries explicitly incorporate research or experimental exemption. In Canada the patent law was amended in 1993 to include a statutory exemption stating that it is not an infringement to use a patented process or product for research purposes or for non-commercial purposes. Some observers have argued, however, that the research exemption is vaguely defined in the Canadian legislation as it is very difficult to draw a line between experimental and non-experimental use. Universities, for example, are engaged in the production of both basic knowledge and in plant varietal development. At some point, plant varieties have to be distributed to farmers, which is considered a commercialization process. This type of research activity no longer falls under ‘the use for research purposes only’, even if the university is not distributing the variety for revenue-generating purposes. In our earlier study of the wheat and canola sectors (Galushko 2008, p.143) it was revealed by the respondents that in order to reduce the risk of litigation, it is safer for the breeders to just assume that there is no research exemption and not use patented materials at all rather than refer to the ‘research exemption’ clause. In that study only 20% of the respondents referred to or acknowledged Canada’s ‘research exemption’ legislation. In this flax breeder survey, however, there seemed to be a general acknowledgement on the part of the respondents that the research exemption clause is working in Canada:

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“Well, patents could cause problems only if you were going to commercialize your research outputs, but as far as I know patented materials can be used for research purposes”. Another concern about patents is that they can influence the direction of public research. If patents are associated with more applied research and with increased revenue for the institution, public researchers might be encouraged to divert their efforts from basic research to applied research, thus undermining the long term knowledge base. We have not found any evidence that stronger IPRs have shifted research priorities and this is supported by the following quote: “I don’t know about shifting of research priorities. I think it is more exchange of information or germplasm. It was a far more cooperative world in the past”. Hindrances to varietal development in flax industry Summarizing the above, while stronger intellectual property rights seem to hamper research in some crops (Galushko 2008), the flax breeding industry in Canada has not witnessed the negative effects of IP protection. While the exchange of materials has become more formal and this can add to short delays in research projects, the respondents have all agreed that the current IP regime has not been a hindrance to varietal development. Nevertheless, some hindrances unrelated to IPRs do exist in the Canadian flax industry. An essential element in plant breeding is access to genetic material. Ex situ collections of flax worldwide are estimated to hold about 48,000 accessions, of which possibly 10,000 are unique (Diederichsen and Fu 2008). Approximately 27,437 accessions are maintained in 16 main European gene banks (Bulgaria, Czech Republic, Germany, Hungary, Italy, Latvia, Netherlands, Portugal, Romania, Russia, Sweden, Ukraine and others) with Russia holding the largest collection accounting for about 42% of total European flax germplasm (Pavelek 2003). A large part of the European collection is of European origin but it also includes accessions from the USA, Canada, Australia, Turkey, Japan, and several countries of North Africa. In Canada, flax genetic resources are maintained at the Canadian national seed genebank, Plant Gene resources of Canada (PGRC) located in Saskatoon, SK. While the PGRC collection is one of the largest in the world containing around 3252 accessions of Linum usitatissimum (flax), it only accounts for about 6.8% of flax accessions in ex situ collections worldwide (Diederichsen and Fu 2008). Therefore, flax breeders in Canada could gain from utilizing genetic diversity in collections outside of Canada. Some studies

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have shown that Canadian flax breeding programs have narrowed the genetic base over time (Fu et al. 2002). Broadening the germplasm base by introducing materials from foreign genepools is a prerequisite for maintaining a healthy breeding industry. In order to bring a genetic material from outside, certain rules laid out by the CFIA must be followed. As was mentioned by one flax breeder, the CFIA regulations regarding plants with novel traits (PNTs) hamper varietal development as they limit access of breeders to foreign collections: “I really haven’t seen limitations for most things that I work with. I do have a very strong opinion about plants with novel traits and I do feel that the way we have our legislation in Canada is problematic and creates some barriers... There are things that are surrounding our particular legislation of PNT that can tie our hands or make it more difficult for us to get through the process of developing varieties and releasing varieties to industry”. There are also concerns surrounding the definition of PNT in Canada. Genetically modified plants are considered as PNT both in Canada and in the rest of the world. In Canada, though mutation breeding would be considered as PNT, while in the rest of the world it is not. One breeder elaborated on this saying that: “...if I get a variety from the European Union for instance and use it within my crossing program I have to consider that the material coming out of the cross is a PNT, while in the rest of the world it is not”. It was suggested that the current PNT legislation in Canada can be a bigger problem for the private sector. Unlike universities and AAFC that do not market their seeds, individual companies are doing all their development and marketing of the seed. So: “...a PNT can create a real issue for them [private firms] very fast. It is also the amount of money that it would take if you were challenged that this may be a PNT and if you had to develop information in order to substantiate that it was not a PNT it could be fairly costly. The other aspect is that the current legislation has lumped everything such as GMOs, mutation, and traditional breeding all into the same boat. So, if I, say, market a flax variety to Europe that is a PNT according to the Canadian standards, the Europeans might think that this means a GMO, while it might not necessarily mean a GMO at all. But even if it’s not a

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GMO I may be cut off the European market because Canada defines PNTs differently from the rest of the world”. CONCLUSIONS This study has endeavoured to assess the impact of IPRs on the sharing of genetic materials/research tools in the flax breeding industry. Flax is a small crop with breeding efforts concentrated in Canada, France, Netherlands and Eastern Europe (Russia, Romania, Lithuania, Ukraine). The global flax breeding community is represented by a few small private companies (located primarily in Western Europe) and public institutions. Given a significant involvement of the public sector in flax breeding and a limited use of biotechnology, the flax IP landscape is not as complex as that in other oil crops such as canola and soybeans. Therefore, one would not expect IPRs to have had a significant impact on the flax breeding community. The interviews with the Canadian flax breeders confirm that developments in the area of IPRs have changed the informal nature of research materials exchange. Most material exchange is now fulfilled through MTAs that specify the rules for the use of the transferred material and ownership of the research results. MTAs do not generally impede the flow of genetic materials among breeders, however, they are claimed to add another layer of bureaucracy and make the exchange process more cumbersome and lengthy. There is evidence that stronger IPRs have contributed to increased secrecy in the sector, however, the current IP protection system is still perceived by the breeders as efficient in terms of knowledge dissemination. The responses of the flax breeders support the view that IP protection has not posed any threats to varietal development so far, although the flax breeding industry in Canada does face some non-IP related hindrances to variety development. One of the major hindrances to varietal development mentioned by the respondents is how plants with novel traits are defined in Canada. Canadian definition significantly differs from the rest of the world and by including mutagenesis-based breeding techniques into a PNT category it restricts access of the Canadian breeders to foreign genetic material. Additionally, it creates uncertainties when marketing Canadian crops to Europe where a PNT might be perceived as a GMO and therefore, might be refused access to the European market.

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