Sir

The increasing emphasis of genomics in therapeutic and diagnostic research and development (R&D) suggests a continuing dominant role for the pharmaceutical industry in patenting human DNA. Here we present new data that challenge this broadly accepted trend by revealing that patenting activity of human DNA sequences by the US public sector is now approaching that of the private sector worldwide.

Figure 1
figure 1

Human DNA sequence patent applications published in 1995 – nationality and sector.

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We have used patents published after filing in order to reflect more recent R&D activity. Our methodology used the GENESEQ database (Derwent Ltd, UK) to analyse patents published in 1995 that included claims for human DNA sequences. (About two-thirds were Patent Convention Treaty applications, the remainder being European Patent Office, national applications and US Patent and Trademark Office.) Strikingly, the data reveal that 40 per cent of the 652 patents originated from public-sector institutions, mainly US universities and medical charitable foundations. This figure is remarkably high and double the estimate of public-sector patenting activity in the same area between 1984 and 1995 (S. M. Thomas et al. Nature 380 387-388; 1997).

Only half the patents were filed by the private sector. Approximately 50 per cent of the 157 companies involved were American, 21 per cent Japanese and 18 per cent from Europe (see figure). Despite the huge R&D spend of the worldd's multinationals (MNEs), they have been able to claim only 26 per cent of this patent total. The small US biotechnology companies have almost equal impact, accounting for 24 per cent. By contrast, the relatively immature European small and medium-sized enterprises (SMEs) account for only 3 per cent of the total.

The US multinationals have a relatively small stake in these patents. Paradoxically, Merck, with its commitment to public release of human expressed sequence tags, is the exception, having more than any other company. Only 8 per cent of the total belong to US multinationals, a mere third of the US SME fraction. Why are these large companies not more prominent? Many, particularly those in Europe, have strategic alliances with the small US genomics companies where the emphasis may well be on the multinational partner having an exclusive licence rather than ownership of a patent per se.The very recent increased patent filing activities of some multinationals will, moreover, be sufficiently represented in patent databases.

The largest single category is in the area of diagnostics. This is unsurprising as any gene sequence can be used to search for mutations in a particular gene. What is certain is that only a small proportion of these patents will actually be used. These data provide evidence of a realization on the part of public-sector scientists that patenting optimizes the chances of patients receiving benefits from their scientific research. US charities, universities and research institutes alike are filing for patents knowing that industry will not develop new treatments based on inventions without adequate intellectual property protection. We conclude that the increased rates of gene sequencing in a culture that lauds the entrepreneur are stimulating growth in patenting in both the US private andpublic sectors.