Kevin Carson has a provocatively titled article — Intellectual Property Is Murder — looking at the likely impacts of data exclusivity requirements on drug applications in India that are a result of trade agreements with the European Union.
“Data exclusivity” means that clinical trials conducted before marketing by the company that originally produced the drug cannot be applied to meet government safety or efficacy requirements for the generic version. Each separate company that wants to market a generic version of a patented drug will first have to conduct its own clinical trials as a precondition. That directly contradicts one of the arguments commonly put forward by patent apologists — that patents are an antidote to trade secrets because they require openness as a condition of obtaining a patent.
“Data exclusivity” is a death sentence not only for those in India who can’t afford to pay tribute to the owners of state-granted patent monopolies, but also for the people of such countries as South Africa and Brazil, where the availability of cheap medicine for treating HIV depends on the output of India’s generic drug industry.
Carson also does a nice skewering of traditional big pharma justifications for patent protection of medication (although some of his arguments are a result less of patent protection than the unintended consequences of the drug approval process).