We all are aware of the fact that role of genes is to code for proteins which are directly or indirectly responsible for all body activities of all living organisms. But as far as IP regimes all round the world are concerned it’s the gene patents which are being compared to a modern Pandora box. Astonishingly, proteins that are encoded by these genes do not seem to attract enough controversy in any economy.
Why would only genes be a problem for patent community and not proteins though both are products of nature and chemical entities? Also, why has this issue gained momentum now when we already have many gene sequence patents that have already completed their tenure and expired? I wish to explore these issues and current criticisms with the way of this article which is first in the series of articles which I will be posting on detailed analysis of gene patents in EU and US regimes through landmark decisions.
One basic difference that came into picture on comparing genes and proteins is that genes are little more than naked information and at present little goes beyond that. This clashes with the very jurisprudence of patenting which explicitly mentions the utility requirement. Also, a majority of debate over gene patenting has been at an anecdotal level or on a general platform, which makes the situation more complicated than it actually is. This is because concerns at this level are not very adequately analyzed.
Also, when biotechnology directive became a law in late 1990’s the regulations and laws surrounding gene patents became more stringent. This is one of the reasons of gene patents issue gaining weight these days as the applicants have to operate within a tighter legal regime. Also, the amount of information which would constitute prior art have also increased exponentially in last decade which has further complicated the issue. We also have to consider the fact that the first generation of gene patents is coming to an expiry level and most of the low hanging fruits have been already taken like gene encoding the proteins for known therapeutic value. As the technological advancement has been on a very fast pace in last 10 years the scope and spectrum of gene patents has also widened beyond the initial scope defined by traditional laws. An appropriate example will be that of SNP identification and identifying differences in different sequences.
All these factors are major contributors towards debate of gene patents, though this series of articles will focus on other issues and famous case studies of this field which would further throw light upon the issue.