Philippe Ducor

Title: <<Open access>> aspects of DNA patenting

Patents are generally viewed as the opposite approach to open access. Indeed, because they provide exclusivity patents are valued in industries where developing a new product is costly and difficult, and copying it once developed is comparatively easy. The pharmaceutical/biotechnology industry is notorious for its appetite for all forms of exclusivity, including patents.

However, patents are not only about exclusivity. The underlying policy goal of the patent system is to strike a fine balance between (i) preserving the incentive of innovators (by providing exclusivity) and (ii) maximizing the use of the relevant technology within society (notably through exclusivity limitations and restrictive patentability requirements). The “fine balance” is particularly difficult to find for DNA patents, due notably to the dual nature – structural and informational – of DNA and the finite number of naturally-occurring human genes. As a result of the ongoing debate about DNA patenting and the European directive 98/44/EC, a number of European countries have implemented statutory provisions aiming to limit the exclusivity afforded by DNA patents. Although not a member of the EU (and not formally held by directive 98/44/EC), Switzerland has amended its patent law on several points relevant to DNA patents, such as: scope of DNA product patents (art. 8b and 8c Swiss Patent Statute =SPS), experimental use exemption (art. 9 al. 1 litt. b SPS), compulsory licensing for research tools (art. 40b SPS), compulsory licensing in case of anti-competitive behavior related to genetic diagnostics (art. 40c SPS).

In addition to exclusivity limitations, well understood patentability requirements may also play a role: not everything is patentable. In particular, realizations considered patentable a few years ago may be considered obvious and unpatentable today, notably in rapidly evolving fields such as genomics. In this respect, the recent reversal of US case law regarding obviousness of human DNA over the corresponding amino acid sequence is particularly relevant (In re Kubin, Fed. Cir. 2009).