In defence of gene patents
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Keywords: gene, patents, ethics, clearing house, patent pool
In defence of gene patents Emma Toumi Date received (in revised form): 18th November, 2002
Abstract For two years the Nuffield Council of Bioethics has scrutinised the pros and cons of gene patenting in the healthcare industry. The Council recently published its findings, saying that too many patents have been granted on gene sequences and, in future, gene patents ‘should be the exception rather than the rule’. The Council’s recommendations even go as far as to propose the discontinuance of monopoly rights on existing gene patents for certain applications such as diagnostic tools. The consequences of curtailing patent rights could have a deleterious effect on the healthcare industry where patents are essential for recovering the investment made in drug discovery. Furthermore, it could lead to a ‘dark age’ where the human gene sequences responsible for disease are kept secret by a minority of the industry players. In its defence, the patent system is a very sophisticated, self-correcting system with safeguards to protect society from unwarranted monopolies. Its purpose is to put every scientific advance into the public domain with the trade-off of a time-limited monopoly awarded to the proprietor.
THE IMPORTANCE OF GENE PATENTS IN THE HEALTHCARE INDUSTRY
Dr Emma Toumi McDermott, Will & Emery, 7 Bishopsgate, London EC2N 3AR, UK Tel: +44 (0) 20 7577 6900 Fax: +44 (0) 20 7577 6950 E-mail: [email protected]
The aim of the Nuffield Council on Bioethics’ (NCB) discussion paper on ‘The ethics of patenting DNA’, published in July 2002, was to examine the issues relating to genetics and intellectual property, particularly those that concern human healthcare and research related to healthcare. The protection of intellectual property rights in the healthcare industry is an important issue since this industry relies heavily on patents to recover the investment made on drug discovery. Furthermore, for fledgling biotechnology companies, not likely to see a profit on their balance sheets for years, patents are essential for attracting the venture capital required to keep them afloat. Any changes to the system that would compromise intellectual property rights could seriously jeopardise these industries. One of the greatest concerns for a pharmaceutical company is its product pipeline. Since it takes, on average, ten years for a drug to complete the regulatory process,1 and only one in ten compounds reach the marketplace,2 pharmaceutical companies require a constant stream of drugs at different stages of development in order to remain
profitable. The investment necessary to bring a pharmaceutical product to market has been estimated as £350m.1 The stream of drugs in the product pipeline ensures that the huge cost of drug development is paid for by a supply of patent-protected drugs which can make a healthy profit for a few years before the generic firms move in and undercut prices of drugs that are off-patent. However, there is trouble on the horizon: the volume
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