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Intellectual property & regulatory

Efficient IP systems are balancing the interests of inventors and society, creating incentives for innovation and fostering the dissemination, integration and adoption of new technology. Syngenta advocates realistic, science-based regulatory frameworks that allow farmers access to safe and efficient agricultural technologies.

Intellectual property (IP) and patents

What is Syngenta’s position on intellectual property (IP)?

Intellectual property (IP) rights – especially patents – are enabling a functioning market economy in areas as critical as food security. They provide legal certainty to breeders who dedicate substantial resources to innovation over a long period of time. A reliable legal framework prevents market failure and sets the stage for business cases that generate products farmers need to provide the growing global population with sufficient, healthy and nutritious food.

Patents also foster knowledge sharing because an invention must be fully disclosed for a patent to be granted. Through this mandatory publication of the patent, patents are one of the best ways of promoting knowledge-sharing and speeding up innovation.

An efficient IP system needs to consider the interests of the inventor and society in finding the right balance between fostering innovations and providing access to information for others to innovate further. IP rights prevent market failure by creating an incentive and a fair return for the investment of the innovator through licensing. In this way, IP can be an instrument to foster the dissemination, integration, and adoption of new technology. Innovations in areas related to food and agriculture often combine contributions from many players. There is a collective responsibility to evolve the IP system from exclusion to inclusion and to access and fair benefit sharing. Licensing platforms are one way to achieve this objective.

Syngenta is owned by a Chinese company. Does this affect its IP policy?

No. Syngenta is a Swiss company. The majority of our global IP is owned by Swiss affiliates of Syngenta. 

ChemChina’s acquisition of Syngenta will not change our balanced approach to IP nor lower our standards for IP protection. We remain committed to expanding our initiatives on transparency and open IP.

What is Syngenta’s position on IP systems in China?

China has made substantial progress in the development of IP laws and IP enforcement over the last decades. China today is the world’s number one in patent filing and within the top-5 tier in examination quality. While the enforcement of IP rights needs further strengthening, the establishment of dedicated IP Courts in major cities constitutes a substantial improvement.

ChemChina’s ownership of Syngenta provides opportunities for accelerated improvement in IP protection in agriculture in China. Syngenta is supportive of China’s intention to further strengthen the rule of law and to develop an innovation-driven economy.

How is IP used to protect plant-related innovations and seed?

Innovation relating to plant and seed development includes both conventional breeding, modern breeding techniques and methods of genetic modification. Modern techniques to create genetically optimized crops require substantial investment and lengthy development programs. As the resulting high-tech products are easy to copy by simple propagation, robust IP systems are required to protect these investments.

There are two primary forms of IP protection for plant-related innovation:

  • Plant Variety Protection (PVP): PVP protects a new plant variety on the basis of the combination of all its phenotypical characteristics, and is suitable for varieties developed through traditional breeding. The term of a PVP differs between countries and depends on plant species, but is generally between 15 and 25 years. PVP rights have specific exceptions, for example the free use of the protected variety for further breeding, or the right for farmers to practice farm-save-seed (saving part of their harvest for use as seed in the next season).
  • Patents: Patents on plants are only available in a few countries. Patents protect inventions so they are better suited for new traits derived from technical processes such as genetic modification or marker assisted breeding. In contrast to PVP, a patent needs to describe the invention in a way that it can be reproduced by others. Patenting promotes knowledge-sharing. Patented plant-related innovations normally require substantial development time and research investments. A new genetically optimized plant can require 13 years development time and generate costs of up to $200m. Normally, a patent is filed at the very beginning of the development phase. This reduces effective protection after market launch substantially below the full term of 20 years, often to less than 10 years. Additionally, there are no compensating mechanisms for regulated plants like the “Supplementary Protection Certificates” (SPC) that are available for pharmaceuticals and crop protection chemicals in many countries.

Patents and PVP protect innovations in different ways: while PVP protects a plant variety as a whole but not its individual parts (e.g., a trait or gene), a patent protects new and innovative parts of a plant but generally not the plant as a whole.

Patents and PVP are not alternatives, but complementary systems. Both are needed and can generate synergies if they are well-aligned. Where this is the case (e.g. in the EU and in Switzerland), it makes no difference for a farmer whether a specific plant is protected by PVP or patents or both. A lack of alignment can lead to debates and legal uncertainty, particularly in the case of high-value crops such as GMOs (e.g. in Argentina, Brazil, and India).

Syngenta is in dialogue with stakeholders to further evolve the plant-related IP systems to ensure ongoing research and investment in crop plants. It is our view that a combination of industry-led solutions (e.g. licensing platforms) and a harmonized legal framework of patents and PVPs (e.g. as implemented in the EU and Switzerland) could provide sustainable solutions enabling benefits for all parties involved and help foster food security across the globe.

Are native trait products and products obtained from PBIs patentable?

’Native trait products’ refers to the transfer of genetic material from closely related or sexually compatible species in order to develop a desired trait, such as drought tolerance. These plants can be the result of technical processes such as marker assisted breeding.

‘Products obtained from Plant Breeding Innovations (PBIs)’ refers to deliberate and precise changes to the plants genome to develop a desired trait. PBI techniques help to overcome limitations of conventional breeding They can expedite what could have been developed as a native trait product. 
Native trait products and PBI products that are the result of reproducible technical processes should continue to be patentable, if they fulfill the normal requirements of patentability.

Should GMO regulation apply to all plants that are patentable?

No. Syngenta believes that products obtained from Plant Breeding Innovations (PBIs), if they do not contain foreign DNA, should not fall within the scope of GMO legislation. Regulators should evaluate the specific agricultural products based on their characteristics, not the technology used. Regulations, if needed, should be proportional to the risk, and science-based, focusing on the safety of the product. Every technology which complies with the patentability criteria (novelty, inventive step, industrial applicability and enabling disclosure) should be patentable. This is also true for PBIs and the products resulting therefrom.

What patents can be applied to crop protection products?

The development of new active ingredients for crop protection products can take more than 10 years and cost around $260 million. Protecting innovations through patents is essential to enable innovators to recoup this substantial investment. Inventions related to crop protection are not limited to active ingredients. They also include mixtures, formulation or more efficient production processes, which can add substantial value to farmers and mitigate risks such as development of resistance. The data submitted throughout the process to gain regulatory approval for a new product also has substantial value and requires adequate protection against unized use by competitors.

What is Syngenta’s view and contribution to patent transparency?

Patent transparency is straightforward for many products. However, if commercial seed material that unknowingly comprises a patented trait is used in breeding programs, this could lead to patent infringement by the new plant variety and the need of licenses to commercialize it.

Syngenta supports the efforts of the European Seed Association (ESA) to increase transparency and enable breeders to understand the use rights on existing varieties by providing a greater level of data and information. Syngenta has helped to develop the database PINTO, which provides patent information for plant varieties registered in the EU. This database is accessible to everyone.

 

Use and enforcement of intellectual property (IP)

Does Syngenta support provisions and initiatives enabling collaboration among plant breeders and innovators?

Syngenta supports a balanced research exception in patent laws, which allows others to do research on an invention to enable further improvement of the innovation and shorten innovation cycles.

Most patent systems contain a research exemption, which allows further improvement of the invention. In countries without research exemptions (the US, for example), Syngenta encourages researchers to enter into research license agreements to obtain additional, proprietary information and stewardship support. Such research agreements are used to ensure researchers abide by appropriate stewardship standards, to safeguard the confidentiality and IP of proprietary information and to secure the highest standards of sound science.

We undertake research projects with many universities and have thousands of research agreements with public sector institutions around the world. Our e-licensing initiative, TraitAbility, provides a facilitated way for researchers to access many biotechnology research tools – use is free of charge for non-profit institutes.

TraitAbility is one example of Syngenta initiatives to facilitate access to innovations in the plant and seed area to promote innovation lifecycles in an area critical to food security. Our initiatives follow the principle of “free access but not access for free”.

Syngenta was among the first companies to make genetic information freely available for humanitarian purposes, in the shape of the rice genome. Similarly, Syngenta supports the humanitarian initiative to make Golden Rice a reality. Syngenta, the Syngenta Foundation and both of Syngenta’s legacy companies provided financial support and other resources to the inventors of this technology for a period of time. While we have no commercial interest in Golden Rice whatsoever, we continue to assist the International Rice Research Institute (IRRI) for regulatory and stewardship aspects of the project.

What is farm-saved-seed?

Farm-saved seed (FSS) is the practice of farmers saving part of the harvest for use as seed in the following season - usually in open-pollinated crops such as soy, wheat and rice. We recognize the right of farmers to practice FSS within the limitations of the International Union for the Protection of new Varieties of Plants (UPOV) 1991 convention. This requires farmers to take into account the legitimate interests of the breeder. In practice, this should limit FSS practices to those crops where seed saving is a traditional practice and should require farmers to pay a reasonable license fee for FSS unless it is being used for private, non-commercial use.

Without proper controls and limitations, the extensive use of FSS could reduces incentives to invest in productivity improvements of open-pollinated crops, which are the basis for food and feed, especially in the area of genetically modified crops like soybean. Uncontrolled use of FSS can also lead to the spread of seed-borne diseases which can reduce yields.

Syngenta will not enforce its plant variety protection rights against subsistence farmers for private or non-commercial use.

Does Syngenta enforce plant-related IP rights in the Least Developed Countries (LDCs); is Syngenta offering humanitarian licensing?

We do not enforce patents in seeds or biotechnology in Least Developed Countries (LDCs) by subsistence farmers for private or non-commercial use.

Why does Syngenta combat counterfeit products?

Counterfeit products threaten the safety of our customers, farming communities, and the environment because they are not subject to the same level of research and testing as legally registered products available on the market. Counterfeiting and piracy discourage innovation and investment in product and market development. There are also negative impacts on employment, technology transfer and tax revenues associated with counterfeit products.

We investigate cases of counterfeiting and initiate legal action against counterfeiters where appropriate. To combat the distribution of counterfeit products, we have completed a comprehensive review of our product packaging to identify improvements. We are also introducing features such as holograms on packaging that are difficult to counterfeit.

By removing illegal products from the market, we increase customer confidence, help stakeholders stay safe, protect farmland and the environment, and secure our freedom to operate.

Licensing & Access and benefit sharing

What innovative licensing solutions for breeders and plant innovators does Syngenta offer?

As farmers face increasing challenges, we aim to find better ways of making our products and technologies more accessible to plant breeders and growers around the world and - together with others - develop solutions which increase the openness of the IP systems. By doing so we help ensure that companies, both large and small, can develop the diverse crop varieties required to grow more from less.

We recognize that obtaining licenses can be a lengthy and costly process, especially for small companies. Our e-licensing system TraitAbility is an efficient, facilitated licensing process that enables breeders, companies and public research institutes to access many of our most important plant-related innovations.

The use for research, breeding and development is free.

In addition, Syngenta is a founding member of the International Licensing Platform Vegetables (ILP) an open licensing platform (Patent Clearing House) for vegetable breeding traits and varieties, launched in November 2014. This platform facilitates the quick and efficient licensing of vegetable breeding traits under fair, reasonable and non-discriminatory terms, which are overseen by an independent expert committee. The ILP has broad support in the industry: the current members represent more than 60% of the vegetable seed market. Furthermore, approximately 60% of all patents – more than 200 patent families - are already accessible through the ILP. This makes the ILP the licensing platform with the highest industry participation in the life science industry.

What is Syngenta’s position on Access-and-Benefit-Sharing (ABS)?

Syngenta believes that access to genetic resources over the years has led to the development of products that have benefited society and biodiversity broadly.  We recognize that these benefits could be distributed globally in a more equitable manner that creates greater protection against the loss of biodiversity. As such, we support the development and implementation of rules that will facilitate both the access to genetic resources and more equitable sharing of benefits in way that leads to greater conservation and sustainable use of biodiversity.

We strongly object to any form of illegal bio-sourcing.

While we support and consider the principles behind the Convention on Biological Diversity (CBD), we are concerned that restrictive implementation of biodiversity laws in general, and the Nagoya Protocol on Access and Benefit Sharing in particular, will have deleterious ramifications on research, development and the realizing of benefits from the utilization of genetic resources. Restrictions that go beyond the principles laid out in the CBD would create very onerous conditions for breeders and therefore hamper efforts to conserve and sustainably utilize biodiversity. The resulting legal uncertainty could endanger the use of the full range of plant genetic diversity for much needed breeding progress.

Syngenta strongly supports the International Treaty on Plant Genetic Resources under the Food and Agriculture Organization (FAO) as a specialized ABS instrument in harmony with the CBD. We are committed to work with the Treaty and its stakeholders to further evolve and expand the Treaty towards a sustainable solution for all crops.

A mandatory disclosure in patents of the origin of biological material should be limited to what is necessary for the enablement of the invention. This is already a requirement in the present patent law and does not need further amendments.

Post-patent approach

What impact will post patent/generic GM products have on Syngenta?

Patents on the first generation of genetically modified (GM) events (e.g. Syngenta’s Bt11 and GA21) have already expired in many jurisdictions. To avoid potential trade disruptions and ensure that competition and innovation in the GM industry continues, stakeholder initiatives such as The AgAccord framework have established predictable and transparent mechanisms that provide for the transition of regulatory and stewardship responsibilities for agricultural biotechnology events after patent expiration.

Syngenta is committed to facilitate a seamless transition from proprietary to generic market under conditions that safeguard the long-term stewardship and durability of our products. We favor a product-by-product approach, rather than an approach that treats all products the same regardless of their functions, durability, regulatory status, and stewardship considerations. We will notify customer groups and the wider industry four years before we discontinue support for cultivation and import izations of products that are no longer covered by patents. If requested by parties interested in a generic use, we will engage our licensees three years prior to a patent expiring so that we can develop an agreed approach should they intend to continue working with the product after the patent has expired.

What is Syngenta's position on post patent/generic crop protection products?

Generic products make up around 30% of the global crop protection market by value. We welcome competition from generics but we believe that they must be subject to the same quality and safety standards as non-generic products. Our continuing innovation and product lifecycle management practices and our focus on the grower's needs help to stay competitive in an environment with generic products.