In this study we illuminate and discuss the most recent developments in respect of the interpretation of the “industrial application” requirement with respect to gene and protein related inventions in Europe.
The analysis will focus on the relevant provisions of the EPC and decisional practice from the European Patent Organisation (“EPO”), particularly decisions from the Technical Board of Appeal 3.3.08 (the “Board”). To get a glimpse of the national dimension, we will also look at the first patent judgment from the "new" UK Supreme Court, i.e. the groundbreaking decision in HGS v Eli Lilly, In the final discussion, we will elaborate on two issues in particular; (i) determine which types of qualities an invention should have in order to meet the industrial application requirement in the first place; and (ii) what type of evidence an applicant is expected to present in respect of (potential) applications at the date of filing to demonstrate a credible – or to use the terminology of the EPO – a plausible industrial application. In the final section of the article we shall also discuss various policy considerations relevant for the biotech industry and briefly refer to corresponding developments in the US.
Before going into the decisional practice of the EPO, we start out by providing a brief overview of the applicable regulatory framework. Even though the industrial application requirement is relatively straightforward on the face of the EPC, we believe that it makes sense to provide a more in-depth background, and maybe repetition for some readers, as to why the industrial application requirement raises particular concerns and questions in respect of biotech inventions.