Claims directed to plants or plant products (other than a plant variety) made by a process involving traditional breeding practices have been deemed to be patent eligible in Europe. Here, we report on two recent decisions of the Enlarged Board of Appeal of the EPO, ending several years of uncertainty for patentees in this area of technology. These decisions have broad implications for investors and innovators in the plant industry in Australia. We also provide a brief comparison with the Australian situation.
In Europe, there are two types of IP protection available for plant-related inventions: Plant Variety Rights (PVRs) and Patents.
In order to avoid any overlap in protection between these two IP regimes, the EPC specifically excludes plant varieties from patentability1. The EPC also requires that European patents shall not be granted in respect of “essentially biological processes for the production of plants”2. Questions regarding the scope of this exclusion were considered several years ago by the Enlarged Board of Appeal of the EPO (the “Enlarged Board”) in two cases: the so-called “Broccoli” and “Tomato” cases (G 2/07 and G 1/08, respectively).
Both the Broccoli and Tomato cases relate to patents3 which were granted and opposed by third parties on the basis that the claims were not patent eligible. In both cases, the patents describe traditional plant breeding methods for producing plants with desirable characteristics. For example, in the Broccoli patent, the claims granted relate to a method for the production of Brassica oleracea (broccoli, kale and related plants) with elevated levels of anticarcinogenic glucosinolates, and plants, and parts thereof made by that method. The methods claimed were defined in relation to conventional plant breeding steps which rely upon sexual crossing and selection of the resulting hybrids.
The Enlarged Board4 held that because the Broccoli and Tomato patents claimed methods involving conventional breeding techniques, the method claims fell within the exclusion of an “essentially biological processes for the production of plants”. The Board clarified that the use of additional technical steps before or after the breeding steps (for example, the use of molecular markers to assist in selection of relevant broccoli hybrids) would not render the claims patent eligible. The Enlarged Board also clarified that “genetic engineering techniques applied to plants” are patentable on the basis that such techniques differ considerably from traditional breeding techniques. For example, the transfer of a gene (or group of genes) encoding a single trait into a plant by genetic engineering is patentable.
In appealing the 2007 and 2008 decisions, the patentees of the Broccoli and Tomato patents deleted the method claims, limiting the remaining claims to product or product-by-process claims. Consequently, the debate shifted to whether the products produced by excluded processes were patentable.
Last week, the Enlarged Board concluded that plant product claims can be granted by the EPO. The decision includes the following key conclusions:
- the scope of the exclusion to patentability provided by the phrase “essentially biological processes for the production of plants” in Article 53(b) relates only to process claims and does not extend to plants or plant material such as plant parts (other than plant varieties);
- a product-by-process claim defining a plant or plant part is not deemed patent ineligible simply because that process defines an essentially biological process for the production of plants;
o the fact that the only method available at the filing date for generating the claimed subject matter is an essentially biological process for the production of plants does not render the claim patent ineligible; and
- it is irrelevant that the protection conferred by a product claim encompasses the generation of the claimed product by means of an essentially biological process for the production of plants.
In summary, the Enlarged Board considered that claims to a plant product can be granted, irrespective of whether the method used to produce such plants was itself subject to an exclusion under Article 53(b). In other words, claims directed to plants made by a process involving traditional breeding practices will be patent eligible. The exclusion still applies to plant varieties, but in the context of the Tomato and Broccoli cases, broader claims directed to any plant (or part thereof) made by the defined process will not be excluded from patent eligibility. The plant however, will still need to meet the requirements of being novel and inventive over the prior art.
Importantly, the decision of the Enlarged Board highlights two key differences between European and Australian patent law:
1. Dual protection in Australia
In Australia, plant varieties can be protected by a standard patent so long as the new plant variety meets the requirement for patentability. In addition, plant varieties can be protected in Australia under Plant Breeders Rights. Thus, in Australia, two IP regimes exist for the protection of plant varieties.
2. Scope of product-by-process claims
For European “product-by-process” claims, it is the product itself against which the patentability of the claim must be assessed (i.e., a product is not rendered novel merely by the fact that it is produced by means of a new process5). The process used to produce the product does not itself have to be distinctive over the prior art, and the scope of the claim extends to alternative methods for producing the same product.
This is in contradistinction from the situation in Australia where it is the process which must be novel and inventive in a product-by-process claim. As such in Australia, protection for a known product can be obtained if a novel and inventive method is defined for producing that product.
The decision of the Enlarged Board of Appeal has clarified that plants made by an excluded process are still eligible for patent protection, provided that the plants are not a plant variety. Despite being patent eligible, it remains to be seen whether the products claimed in the Broccoli and Tomato patents will satisfy the substantive requirements for patentability, including novelty, inventive step and if the specification is deemed to fully describe the invention.