Title

Block Me Not: Are Patented Genes 'Essential Facilities'?

Abstract

The biopharmaceutical industry is characterized by the ‘cumulative innovation’ paradigm, wherein the discovery of a gene sequence is only the first step. In order to convert such sequence information into viable products, tests and cures for genetic conditions and diseases, vast amounts of additional time, effort and money have to be spent. It is feared that patents over upstream gene sequences may ‘block’ further downstream research and consequently adversely impact drug discovery, as many diseases today are known to have genetic origins.

This ‘blocking’ or ‘restricted access’ issue has been the subject of several important papers and a wide array of solutions have been suggested. However not many authors have suggested looking to the ‘doctrine of essential facilities’ as a potential solution. This doctrine stipulates that in certain circumstances, a monopolist in control of an ‘essential facility’ (gene sequences) can be ordered to grant access to its facility to others who may then go on to identify useful products/services.

Even amongst the few authors that have suggested an application of this doctrine, the treatment has been sparse¾none of them have focussed on the most fundamental aspect of this doctrine, namely the concept of ‘essentiality’ or ‘indispensability’. Consequently, this paper seeks to fill this gap by asking: ‘how essential is a patented gene?’ The paper will demonstrate that although it is difficult to invent around patented genes, it is not impossible-viable substitutes do exist. To this extent, not all patented genes would quality as ‘essential’ for the purposes of the application of the essential facilities doctrine.

The paper concludes by noting that an antitrust remedy cannot be a panacea to resolve the blocking or restricted access issue for all time to come. Rather, if the blocking issue becomes pervasive, it may be more prudent to devise a more focussed remedy.

Disciplines

Intellectual Property Law | Internet Law

Date of this Version

April 2005