Block Me Not: How 'Essential' are Patented Genes?
42 Pages Posted: 7 Nov 2006
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 prior to finding solutions, we need to revisit a fairly basic question: Is there a blocking or restricted access issue in the first place? A key determinant of this issue often is: How essential is a patented gene? This paper shows that not all gene patents are absolutely essential but that in many cases, viable substitutes do exist. By computing the essentiality of such patents on a case by case basis, one can determine the existence and extent of blocking. This paper uses the essential facilities doctrine under competition/antitrust law to draw out a framework for computing essentiality.
Keywords: gene patents, blocking, compulsory licensing, essential facilities doctrine, amgen epo
JEL Classification: K00, K19
Suggested Citation: Suggested Citation