Food safety, security and nutrition are significant issues for today’s consumers. With increasing rates of obesity on the one hand, and food security issues associated with population growth, low incomes and global climate change on the other, the public has heightened awareness of the importance of availability, traceability, and nutritional content of food.
Modified Beneforte™ broccoli and Golden Rice are just two examples of modified crop species that are approved or being tested for human use. The improvement of crop species by genetic modification or modern breeding techniques remains a significant area of innovation, so it is important to consider how these developments can be protected.
Community plant variety rights (CPVRs) are available for the protection of individual plant varieties throughout the EU, provided these meet the required standards of being distinct, uniform, stable and new. Separately, European law requires that new plant varieties are registered on the National Listing before they can be marketed. Requirements for listing are similar to the requirements for CPVR protection (distinct, uniform, stable), and where a variety is covered by a CPVR, the right holder must consent to the registration.
Consistent with the limited exceptions to protection provided by IP rights generally, to ensure agricultural productivity is not adversely impacted by CPVRs farmers may use farm-saved seed of certain protected varieties on payment of a reasonable royalty to the right holder. Generally, CVPRs are useful protection for individual plant varieties ready for market, rather than for a plant characteristic that may be applicable across a range of plant types, or early stage technologies.
While individual plant varieties are excluded from patent protection, the European Patent Office (EPO) has confirmed that claims that encompass varieties can be patented. Also excluded from protection are “essentially biological processes for the production of plants”, and the scope of this exclusion was considered by the EPO’s Enlarged Board of Appeal (EBA) in 2010, in the Broccoli and Tomatoes cases.
The EBA concluded that methods that contain crossing and selection are in principle excluded from patentability, unless the crossing and selection steps contain within them a technical step “which introduces a trait into the genome or modifies a trait in the genome of the plant produced”.
In both cases, the methods (using selection by genetic markers or phenotype analysis) were excluded from patentability. The EBA indicated that methods applying “genetic engineering techniques” to plants were still patentable, but that “SMART (Selection with Markers and Advanced Reproductive Technologies) breeding” methods were excluded.
However, closer examination of the decision raises concerns about the extent of the exclusion. Methods are excluded if they “contain” crossing and selection steps, unless a technical step of modification is included “within” those crossing and selection steps (ie, not before), and the decision states that “claims should not, explicitly or implicitly, include the sexual crossing and selection process”.
So, on a strict interpretation, the decision may exclude even methods directed to improving a plant using genetic engineering if, as is likely to be the case in practice, achieving the desired plant includes a back- crossing and selection step, irrespective of whether that step is specified in the claim.
“Where gene transfer occurs from one variety into another without utilising a synthetic DNA construct, it is likely to be difficult to draft a valid claim that provides adequate protection.”
Furthermore, in both cases the resulting amended patents contained claims directed to the plants (or their products) produced by the excluded methods and the EBA is now asked whether claims to the plants themselves should also be excluded under the same provision. Allegations are made that by allowing such claims, essentially biological processes for their production are also indirectly protected. While exclusions to patentability are interpreted narrowly, and the exclusion refers only to processes, the EPO faces significant pressure to also exclude the products of such processes, from governmental and nongovernmental organisations.
Given these current uncertainties, we must consider alternative approaches in addition to claiming methods of producing plants and the resulting plants themselves in order to protect plant-related inventions effectively.
One possibility is to claim nucleic or amino acid sequences. This strategy may be appropriate for genetically modified plants containing exogenous DNA. However, difficulties remain for obtaining approval to market transgenic crops in Europe, and there is significant consumer opposition to genetically modified foods, so modern breeding techniques are the commercially favoured approach.
In such techniques, where gene transfer occurs from one variety into another without utilising a synthetic DNA construct, it is likely to be difficult to draft a valid claim that provides adequate protection, particularly where the exact nature of the genetic information that has been transferred is not known.
A note of caution when considering this approach comes from case C-428/08 (Monsanto Technology LLC v Cefetra BV and others), in which Monsanto attempted to enforce a claim to a nucleic acid construct. Monsanto was unable to prevent the import of processed soy meal into Europe because the nucleic acid present in the product was no longer capable of performing its function.
However, such claims to biological material should still be enforceable against unprocessed plant products, such as seeds, where the claimed material is able to replicate or perform its function in the product.
Claims to downstream products obtained from modified plants can also provide useful protection where the product is new as a result of the modification, such as having improved nutrient characteristics, for example a seed oil with increased levels of a particular fatty acid.
Similarly, claims directed to methods of preparation of these products using modified plants can be appropriate. Taking care to ensure that any claimed method (whether for producing a modified plant or for preparing a product from a modified plant) includes appropriate steps to attain the commercial product is key, to benefit from the protection that such process claims provide for the products directly obtained by the process.
Resolution of these uncertainties is expected to take some time while the EBA further considers the scope of the exclusion in the context of the patentability of plant products produced by essentially biological processes. Until then, applicants should aim to use a variety of the available claim types, providing a flexible approach to protecting their plant-related inventions.
This article has also been published in LSIPR