Are Plant Biotech Companies Misusing The Patent Law?

Niels Louwaars writes: Biotech companies, particularly those based in the United States consider that their patents on plant biotech inventions do not allow the use of the plants containing the invention as a source for further breeding, even if the invention has been eliminated in the plant variety resulting from this use.

The reach of the claims on biotechnology patents, combined with the limited extent of the research exemption in some jurisdictions, provide legal tools to restrict the use of plant varieties for further breeding. This use is, however, possible under the plant breeder’s rights systems that have dominated the breeding industry during the last decades.

Because the genetic background of plants that contain the patented invention is neither innovative nor novel, this cannot fall under the patent. The restriction on the use of the genetic background of patented plants in breeding should be considered a misuse of the patent law.

Plant Breeders’ Rights

Breeders have long protected their varieties by plant breeders’ rights (PBR) and have been using protected varieties under this regime for further breeding without restrictions to the exploitation of the resulting varieties. This is called the ‘breeder’s exemption’. Most PBR laws in the world are based on the International Convention for the Protection of New Varieties of Plants, the UPOV Convention. The breeder’s exemption in the various PBR systems is only restricted where the resulting variety is very similar to the existing, protected variety, in which case the breeder of the new, “essentially derived” variety needs a license from the breeder of the initial, protected variety for commercialisation.

The breeder’s exemption is based on the perception that

1. plant breeding is a cumulative operation, i.e., advances in breeding always build on previous work, initially on domestication of crops and farmers’ selection, and more recently on different levels of scientific breeding.
2. each new variety consists of a unique combination of known properties and crossings between varieties create new unique combinations. The PBR protection is limited to the variety as such and does not extend to these new combinations. It is thus not possible to protect all varieties with a particular novel trait under PBR.
3. it prevents the monopolisation of existing properties in plant species. Only the specific combinations newly created by plant breeders can be protected.
4. the advantage of the breeder of an innovative variety remains valid for 8 to 12 years, which is the time required in conventional plant breeding to release a new variety following a cross with the protected germplasm.

This “breeder’s exemption” is coming under pressure. Firstly, molecular techniques such as marker-assisted selection allow breeders to more efficiently and effectively use their competitor’s work. This is one of the reasons why some larger breeding companies have called for a moratorium on the use in breeding of, for example, 10 years following the release of a protected variety. The second challenge comes from the patent system.

The Challenge of Patents

The scope of protection in patents is determined by the claims as formulated by the applicant and granted by the patent office. Any unauthorized use of or act with the claimed invention or product is an infringement of the patent, including in some cases further breeding.

Almost all patent laws include a research exemption for others to learn from the invention. This is meant to allow society to gain from the disclosure of the invention in exchange for the exclusive rights that the law provides to the inventor.
Countries differ on the extent of the patent research exemption. An important issue is whether it concerns research “on” the invention or research “with” the invention. The research exemption in the United States, which is based on jurisprudence, is regarded as very narrow; it leaves only room to satisfy one’s philosophical curiosity.

The Intersection of Patents and Breeders’ Rights

The patent system applies to the plant breeding sector since the famous Chakrabarty and Hibberd cases in the United States and the subsequent adoption of the interpretation of patentability in the field of living organisms in other countries. This creates an interesting combination of rights, based on agricultural and industrial ‘cultures’.

Our analysis concentrates on the case where new traits can be identified, isolated and introduced in a useful genetic background to create a new crop variety through biotechnology or conventional breeding methods. In all cases, much effort and inventiveness is required to reach the intended goal and the invention may well fulfill the patenting requirements. The patented trait needs a carrier – a good plant variety – in order to have value in the market. We would like to compare this situation with a patented component fixed in a casing of a manufactured product, say, a computer.

In order to have adequate protection, the plants or plant cells into which the new trait is inserted are included in the patent claim. Individual varieties developed from those patented plants may be protected (as well) under PBR. In Europe, the patenting of plant varieties as such is not allowed but plants containing a patented invention can be claimed under the patent on that invention if the invention is not restricted to a particular plant variety. This makes it possible that more than one variety may fall under the patent protection of the trait.

The Scope of Protection in Plant Biotechnology Patents

The issue arising here is whether the original properties of the plant, its initial genetic constitution, called the “genetic background” (i.e., without the patented trait), fall under the patent of the introduced trait, and whether the use of the plant as such for further breeding can be restricted by this patent. The same applies for the product by process patents in biotechnology that claim a plant.

From a logic and legal point of view the answer is clearly no: if there is no patented invention in the plant there is no patent protection. The original plant without the invention is not part of the invention. So the original plant and its components fall only under the patent as long as the invention is in the plant. It is like with a computer: the outer frame may be protected by a model right, the inner parts by patents. Taking the patented parts out and replacing them by non-patented parts results in a device only protected by a model right.

Taking out the patented parts or elements in plants cannot simply be done by loosening the nuts and bolts, but, for example, by making a cross between the patented plant and a plant that does not contain these elements. After self-fertilization, plants with and without the patented elements may be selected. Selection of the latter allows the plant breeder to use the genetic background that does not contain patented elements and use this (under the breeder’s exemption) for further breeding.

However, making the first cross with a patented plant may be regarded as an infringement of the patent, even if this is done with the intention to use the genetic background and not at the patented elements. The prohibition of making such crosses precludes the access to the genetic background of the plant. We hold that this should not be the intention of any patent law and that such prohibition is therefore a misuse of the patent law. To avoid this misuse, France and Germany have introduced an exemption in their patent law that explicitly allows the use of varieties that fall under a patent claim for further breeding. If the resulting variety does not contain the patented trait, it can be commercialized without the consent of the patent holder according to this exemption. This approach maintains the genetic background in the public domain while observing the legitimate rights of the patent holder.

Free Use of Plant Genetics Lawful, Beneficial

From a perspective of progress and competition in plant breeding there are good reasons to make sure that all germplasm remains accessible for further breeding. There are also very good reasons to provide patent protection for innovative products and processes that may contribute to the development of better plant varieties in agriculture. The prohibition of the free use of the genetic background of plants that contain such patented components is both unlawful and not beneficial for the breeding industry. Claims to that extent should not be rewarded and interpretations of the research exemption with that effect should not be accepted.

Niels Louwaars is a research scientist at Wageningen University & Research Centre (Wageningen UR). Educated as a plant breeder, Louwaars worked in Sri Lanka and Uganda in seed programmes. Based on this field experience, he developed a research focus on the impact of national and subsequently international policies and regulations on the formal and farmers’ seed systems and their role in agricultural development. His current work within the Centre for Genetic Resources, The Netherlands (CGN) of Wageningen UR on seed laws, intellectual property rights and other rights systems over genetic resources is commissioned and published by various international public (World Bank, Food and Agriculture Organization) and civil society (GRAIN) organisations and by national governments. He has combined this task with various management roles in Wageningen UR, currently mainly on linkages with international research for development centres.