Patent law in horticulture

Abstract

In November 2016, the EU Commission contradicted the European Patent Office´s (EPO) interpretation of Art. 53 lit. b EPC which excludes „essentially biological“ processes from patentability. The EPO´s Enlarged Board of Appeal decided in „Broccoli II/ Tomatoes II“ 2015 that product protection is not covered by the exclusion of processes. The EU Commission argues that this narrow interpretation violates the European Community´s (EU) Biotechnology Directive (Biotech-Dir). In turn, the European Patent Office stayed all similar procedures (Notice of 24.11.2016). A clarifying decision of the Administrative Council of the Board of Directors European Patent Organisation is expected for summer 2017.
While the facts of the cases „Broccoli II/ Tomatoes II“ concern marker assisted breeding only, the open question is if the novel interpretation affects the qualification of mutagenesis in general and modern breeding techniques, like CRISPR/Cas9, in particular. The author argues that the current practice of the EPO of broad and indiscriminate recognition of product-by-process - (pbp) and product claims is, under the novel interpretation rules, not in line with EU law. The objective of the exclusion in the light of the deliberations of the EU Parliament requires that no product protection (be it as direct claim or via indirect protection scope) is granted to plant material which is not distinguishable from existing plants. This rationale gives effect to the ethical and economic goals of Art. 4 of the Biotech Directive. It applies both to “native traits” as found in nature, and to potential mutants. The analysis differentiates between random mutagenesis (eventually captured by the patent exclusion) and targeted mutagenesis (patentable process claims without product protection).