Balancing Commercial Interests and Public Access to Human Genome Patents, Study Guides, Projects, Research of Introduction to Public Administration

Download Balancing Commercial Interests and Public Access to Human Genome Patents and more Study Guides, Projects, Research Introduction to Public Administration in PDF only on Docsity! 1 Patents for Biotechnology I believe there should be a balance between commercial interests of firms already heavily invested in R&D concerning the discovery of human genom and the interests of society as a whole. In fact, the mere fact of completion of “human genom maps”1 was a fruit of competition and collaboration of both private enterprises as well as state research centers (it cost the US taxpayers “some 3 billion dollars”2) - two companies in 2000 announced that they had finished sequencing most of human DNA: publicly funded Human Genom Project and privately sponsored Celera Genomics3. On the one hand, the patents are extremely important for private firms, they “are crucial to both present and future profitability”4, because they are the mechanisms through which companies can offset the costs of inventions (that on average account for as high as $ 500 million5). They can also prevent competitors from the access to important information, therefore enabling the firms to obtain the market share. Due to virtual absence in recent years of US history of “clear rules”6 concerning patenting of genom-related inventions, it is no surprise that most firms tried hard to get as many patents in the field as possible, ‘with broadest possible claims”7, thus achieving the competitive advantage over competitors in the future, trying in advance to match private marginal rate of return with the social marginal rate of return. On the other hand, such policies could inevitably result in monopolization of information, in restrictions for the society as a whole to use this resources (although only for a period of patent-life). This could become very dangerous precedents, as one that happened in the case of Aventis and Andrx generic-drug making companies8, when the 15 US states sued them, justifiably assuming that they consciously made prices for their drug significantly higher in order to offset losses from the soon –coming expiration date of the patent. Of cause, there is a lot of misunderstanding for what to consider “patentable”. My personal point of view is that the information on human genom itself should undoubtedly be hold in a public domain, with any person having the right of obtaining the access to it. Moreover, I totally agree with the idea of creating the “patents pools”9 that can benefit the Humanity as a whole as well as provoke more researches in the field (that would apparently make society better off in terms of avoiding diseases, developing the completely new types of medicines etc.). 1 Shulman, Seth, “Toward Sharing the Genome,” Technology Review, September/October 2000, pp. 61-67 2 ibid 3 Materials of seminar PPA 730-05 by Professor David Popp from 02. 20.03 4 “Protection racket,” The Economist, May 19, 2001, p. 58 5 ibid 6 Shulman, Seth, “Toward Sharing the Genome,” Technology Review, September/October 2000, pp. 61-67 7 ibid 8 “Protection racket,” The Economist, May 19, 2001, p. 58 9 Shulman, Seth, “Toward Sharing the Genome,” Technology Review, September/October 2000, pp. 61-67 2 But I am to believe William A. Hasetline that isolated sequences of DNA removed “from the natural context of human body”10 the and proteins that are expressed by them are in fact the human-made products that could and should be patented as long as they are in line with the necessary conditions for patents: novelty, non-obviousness, usefulness. In addition to these conditions, the director of the US Patent Office recently proposed all potential applicants for patents in a field of genetics to describe a “substancial, specific and credible” use for their gene11. And for such “patentable” inventions all the rules of patents should apply. Otherwise the private enterprises will have little if any financial incentive to conduct R&D in this sphere, and all scientific work will be done only in two bottom segments of the quadrant we discussed at the class of 02.18.2003, or will be conducted by some strange non-profit companies like Raelits or alike. So as an expert I would strongly recommend the EU to introduce easier patenting procedures for the genes matching the discussed above requirements. Potential changes for European firms and citizens: I. If European Parliament refuses to pass easier patenting requirements: 1.1 For firms: - the private-owned companies will have no incentives to invest as many as $500 million for any major inventions without receiving sufficient surplus revenue or even covering the R&D costs. The result would be that the whole European economy loses the competition to the US biotech without any significant chances for catching up. The firms would also lose billions of euro in terms of lost opportunities (because the R&D in the field of human genom and closely-related fields are thought to become the most beneficial spheres of capital investments); -state-owned enterprises would try to conduct biotech research and compete with the US, but without support from- and cooperation with the private sector I suppose the whole industry would not especially succeed. 1.2 For EU citizens: -the necessity to import some medications based on human-genom R&D from the USA; -additional work places are not created, “brain-draining” of the brightest EU scientists to the USA in search for wider research opportunities as well as for better payment conditions; - the economy as well as society lacks the significant amount of money (in different forms, for example – tax payments). 10 Haseltine, William A., “The Case for Gene Patents,” Technology Review, September/October 2000, pp. 59. 11 Shulman, Seth, “Toward Sharing the Genome,” Technology Review, September/October 2000, pp. 61-67