Introduction

At the start of the 1990s, gene patents were already well engrained in the field of biochemistry and cell biology. Typically, they were targeted at specific, well-described and credible applications, ranging from receptor proteins useful for drug entry to sweetening proteins to replace sugar. The advent of gene cloning per se, in the preceding two decades, had not made an impact as a dramatic departure from existing patent practice. The major onslaught of large-scale, high-throughput automated sequencing, however, precipitated an intense debate on intellectual property (IP) issues, associated with the identification of our genetic heritage. As early as 1991, HUGO organised an expert workshop on this topic in Munich. This led to a first ‘HUGO position statement on cDNA patents’ (1992), noting that patenting DNA segments of unknown function was unjustified as these were mere discoveries, and that this practice would stifle upstream research. It was proposed to restrict patents to genes or other DNA elements of which the function was elucidated.

The issue of gene patents materialised in earnest in the genome community in 1992, when J. Craig Venter, then employed by the US National Institute of Health (NIH), after internal NIH consideration and stimulated by its director Bernadine Healey, submitted patent applications for 2,000 so-called ESTs (expressed sequence tags, short randomly cloned cDNA segments), on the basis that if they would not be protected this might cause missed future commercialisation possibilities. The scientific community reacted with profound and widespread dismay.