Pharmacogenomics: Hope or Hype?

Much has been made of the potential for personalnot altruistic companies. Incyte Inc. alone holds US ised medicine, where a genomic screen of a patient patents on more than 350 genes and has an estimated could determine which drugs will work and be free of 6,500 applications pending with 10 more applied for side effects in an individual. Much of the hope based each week [3]. They hope to make profits out of gene on the fact that the sequencing of the human genome sequences either because they are able to patent the is going ahead at speed and maps of genetic markers sequences they describe or because other companies of individual variations in the form of single nucleowill pay them a licence to use the maps they produce tide polymorphisms (SNPs) are being produced for [4]. The distinction is important, because it is far the 100,000 or so genes that code for human beings. from clear that gene sequences should be patentable. ‘‘In the future, before a doctor prescribes a medicine, The validity of gene patents has not yet been tested in the doctor will take some blood, have it analysed at a court. A patent is a licence to charge for or protect nearby lab and identify which of, let’s say, 12 drugs intellectual property produced by a novel inventive are most likely to treat the patient effectively with step. The crucial argument is whether an expert minimal side effects.’’ So says Allen D. Roses, vice skilled in the field could have been able to predict the president and world-wide director of genetics reinvention. In the case of genetic sequencing the search at Glaxo-Wellcome, previously at Duke Unitechniques are common property, the ideas are widely versity [1]. If this is indeed the future it would not be touted, and it is more a case of a race to describe surprising if pharmaceutical companies would be rather than to invent. The sequences exist in nature attempting to describe and patent novel descriptions they have just not been described; it is as if Pasteur of phenotypes predictive of drug response. Yet this is were to patent what were later to be seen down a not what is happening. There are reliable reports that microscope; they were simply there waiting to be the major Pharma houses are joining forces in a codified and catalogued. If not patentable why are the non-profit venture to describe SNP maps for all the pharmaceutical companies wishing to invest in a major drug response regions of interest [2]. Is this a co-operative venture to describe SNP maps and why bout of corporate altruism, or is there more to the in a not-for-profit consortium; such behaviour is not thinking of corporate pharmaceuticals? commonly seen from this quarter. The public The US government has funded the Human pronouncements are that they wish consensus about Genome Project, the aim of which is to describe a the SNPs so that it does not descend to a war of complete and accurate DNA sequence of the human words such as ‘‘My SNPs are better than yours’’. genome. The SNPs which have received a lot of Although there may be a grain of truth in this, the recent interest are minor variants in DNA sequences answer might also lie in their doubts about the that can pick out variations between individuals and patentability of SNP sequences. They would prefer to which may, in some cases, carry subtle information get all SNP maps commonly acknowledged and on disease susceptibility or drug responsiveness. It is owned, widely accepted and not patented so that they this area that commercial interests have concentrated would not have costly licence fees or legal challenges on. France’s Genset SA and Millenium Pharmaceuto their use in the future. A pre-emptive strike against ticals Inc. and Incyte Pharmaceuticals Inc. of the US small up-start start-ups who might otherwise attempt have concentrated on describing the SNPs, with an to hold the majors to ransom over patent fees is what aim of patenting genetic regions of interest. These are the major players wish to achieve.