Staking claims in the biotechnology Klondike

My first brush with intellectual property came through defending free data release from the human genome project. I was amazed at the tacit acceptance by some that this information could and should be privatized. The product was not an invention: a genome sequence is a clear-cut case of public domain material. People need a robust system for handling intellectual property, but patents have ambivalent effects. Patent protection stimulates some forms of creativity, and there are many winners. However, by stifling other forms of creativity, and by eroding the public domain, property rights create losers too. Patents are only one form of incentive, and most great scientific discoveries were made not for future claims to intellectual property rights, but for the fun and joy of exploration. The pressures to enclose the public domain are rife, reaching even into WHO--as we have seen in its policy over bird flu sequences, recently contested by Ilaria Capua. (W1) The value of patents is often argued through parallels between the growth of patenting and increasing prosperity. But proof of causality is missing. One can equally point to parallelisms between obesity and prosperity or between global warming and prosperity. However, nobody suggests that obesity or global warming are causes of prosperity, they are unwanted by-products. Undoubtedly, robust patents have an important part to play, but we should be cautious in giving them too much credit for industrial success. I was at one time persuaded that strong patents would stimulate a wide variety of pharmaceutical innovation across the genome, but the field is now awash with look-alike drugs focused on a small number of targets. Evidently markets, not patents, drive drug development. The success of the biotechnology industry in the United States should be seen in the context of this country having a very effective public domain system. It also has strong patent law, but drug discoveries are often rooted in the public domain. In general, the developing countries that have shown the fastest economic growth are those that retained relatively protected markets until they reached a position of strength. The same was the case for Europe and the USA a century ago. We must ensure that harmonization of international patent law does not become a way for developed countries to pull up the ladder. An obviously contentious subject is the patenting of life forms. The answer is straightforward if current criteria are used properly. A life form as it occurs in nature is not patentable because there is no inventive step. A captured life form is also not patentable, because the concept of caging is not novel, although a new and ingenious design of cage might be. A modified life form is patentable, but only as far as the actual modification is concerned. There is currently a big gap between those who want to patent entire micro-organisms, and people who fed that life should not be patented under any circumstances. Current patent practice has allowed excessively broad claims on the strength of a limited modification; cotton, for example. Neither of these extremes makes sense. To think about this wide gap of opinion, it helps to project forward to the time, probably during this century, when new life forms will be synthesized from scratch, Such life forms will be inventions, and therefore patentable. We shall understand them fully, so the mystical element will be gone, but even before that point it will be commonplace to modify life forms so extensively that their origins are unclear. Patenting of genes has been defended on the grounds that genes are novel chemical entities, subject to composition of matter patents. Unquestionably, a novel gene that had been synthesized from scratch, and served a useful purpose, could legitimately be considered in this way. In the future, such molecules will be commonplace, but at the moment patented genes do not meet this criterion. …