Patent Issues in Biotechnology


In both European and US law, biotechnological products may be patented if they fulfil the normal requirements of patent law that they are novel, nonobvious and useful for industry. In practice this means that biological molecules, including genes, that have been isolated from nature and are susceptible of industrial application are capable of protection, as are processes of isolating and purifying biological molecules.

Keywords: patents; discoveries; novelty; obviousness; utility; ethical aspects

Further Reading

Bently L and Sherman B (1998) The question of patenting life. In: Bently L and Maniatis S (eds) Intellectual Property and Ethics, pp. 111–125. London: Sweet & Maxwell.

Bently L and Sherman B (2001) Intellectual Property Law. Oxford, UK: Oxford University Press.

Bostyn S (1999) The patentability of genetic information carriers. Intellectual Property Quarterly 1: 1–36.

Coghlan A (2004) Europe revokes controversial gene patent. NewScientist 18(May): 25.

Cook T (2006) Patenting genes. In: Pugatch M (ed.) The Intellectual Property Debate. London: Edward Elgar.

Diamond v. Chakrabarty (1980) 447 U.S. 303.

Eisenberg R (1987) Proprietary rights and the norms of science in biotechnology research. Yale Law Journal 97: 177–231.

Eisenberg R (2000) Re‐examining the role of patents in appropriating the value of DNA sequences. Emory Law Journal 49: 783–800.

Holman M and Munzer S (2000) Intellectual property rights in genes and gene fragments: a registration solution for expressed sequence tags. Iowa Law Review 85: 735–848.

Jensen K and Murray F (2005) Intellectual property landscape of the human genome. Science 310(5746): 239–240.

Kamstra G et al. (2002) Patents on Biotechnological Inventions: The E.C. Directive. London: Sweet & Maxwell.

Llewelyn M (1994) Industrial applicability/utility and genetic engineering: current practices in Europe and the United States. European Intellectual Property Review 16: 473–480.

Parthasarathy S (2006) The patent is political: the consequences of patenting the BRCA genes in Britain. Community Genetics 2005 8: 235–242.

Straus J (1995) Patenting human genes in Europe. International Review of Industrial Property and Copyright Law 26: 920–950.

Wadman M (2001) Testing time for gene patent as Europe rebels. Nature 413(October): 443.

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Bently, Lionel, Sherman, Brad, and Hubicki, Stephen(Mar 2009) Patent Issues in Biotechnology. In: eLS. John Wiley & Sons Ltd, Chichester. [doi: 10.1002/9780470015902.a0005189.pub2]