Table of Contents
2. Marine biotechnology
2.1 1 Scientific background
2.2 Patent background
3. Patents on life forms
3.1 General concerns
3.2 Landmark cases
Major industries relating to inventions in marine biotechnology increasingly apply for patents. Most patents are applied for inventions that are derived from terrestrial biotechnology. However, it is recognized that marine biotechnology offers a high potential to yield inventions as well. Marine biotechnology can be divided into two main areas. First, development of commercially viable drugs obtained from marine bioprospecting and, second, development of marine genetically modified organisms for aquacultural and environmental purposes.
A patent means intellectual protection for an invention. Intellectual protection confers the exclusive right upon the patent holder to sell the right of utilization of the invention to interested parties. The selling of licenses provide one important way of receiving revenues for the research done for the invention. The prospect of potential revenues provide the incentive for investment into biotechnological research and subsequent patenting of inventions arising thereof.
The overall aim of this work is to illustrate the close interrelationship of science and law by using marine biotechnology and patents as an example.
Section two provides an overview on the scientific side of marine biotechnology. It will define marine biotechnology and investigate current advancements in marine biotechnology. Additionally, it roughly explains the international patent system governing inventions in the biotechnological area and provide examples on patents related to marine biotechnology.
Section three illustrates the criticism expressed against life form patents in marine as well as terrestrial biotechnology. It will describe the most important cases that have fueled controversial debates on life form patents until today.
2. Marine biotechnology
2.1 1 Scientific background
Biotechnology is any technology that uses biological systems, such as organisms, to make or modify products1. Biotechnology can be divided into two different technical fields. First, classical biotechnology or bioprocessing that uses physiological processes of microorganisms for the making of useful products2. Second, modern biotechnology which mainly includes recombinant DNA technology3. Biotechnological techniques are predominantly applied for the microbial production of pharmaceuticals4, for the creation of transgenic plants and animals5, and for bioremediation6. Most of these techniques derive their material, such as genes or proteins, from the terrestrial environment. However, it is recognized that the marine environment offers a high potential to yield material as well7.
For example, proteins derived from marine organisms show antibiotic8, anticancer9, antineurosuppressive10, aninflammatory11, antimalarial12, antivirial13, and antipain14 activities15. Transgenic approaches create fish with enhanced growth16, disease resistance17, and cold tolerance18. Marine bioremediation uses microorganisms capable of degradation of pollutants to clean up contaminated environments19. The work of Ananda Mohan Chakrabarty constitutes one of the major advancements in the field of marine bioremediation. Via bacterial recombination he created genetically improved microorganisms that have the ability of an increased rate of crude oil degradation20. These microorganisms are valued in oil industries and were also applied during the cleanup of beaches during the ExxonValdez oil spill in 198921.
2.2 Patent background
Patents are one form of intellectual property rights22 and are also regulated by the Trade Related Aspects of Intellectual Property Rights (TRIPs) Agreement23 by the World Trade Organization (WTO)24. A patent can be loosely defined as a grant by the state that provides exclusive rights for an invention25 provided that it is new, involves an inventive step, and is capable of industrial application26. Exclusive rights do not entail the right to practice the invention but provide protection by excluding third parties from using, making, and selling the invention27. Third parties must first purchase or otherwise obtain a license from the patent holder for practicing the invention28. The outlook of future benefits gained from the sale of licences provides the necessary incentive for undertaking expensive research for an invention29. However, the exlcusive right to sell licences is normally limited to a time period of 20 years from the date of filing the patent30. In return to the exclusive rights, patent holders are obliged to disclose the invention so that anybody skilled in the field can reproduce the invention31. Through disclosure of the invention knowledge is disseminated to the public with the aim to encourage innovation and further advancements in the field32.
1 One main definition is provided by Art. 2 of the Convention on Biological Diversity (CBD) stating that “biotechnology means any technological application that uses biological systems, living organisms, or derivatives thereof, to make of modify products or processes for specific use.” See also: Borém, A., F.R. Santos, and D.E. Bowen. 2003. Understanding Biotechnology. Prentice Hall, Upper Saddle River. 216 pp. And: Bains, W. 2004. Biotechnology from A to Z. Oxford University Press, Oxford. 413 pp.
2 For example, the microorganism yeast, Saccharomyces cerevisiae, feeds on sugar via fermentation. Useful byproducts of this process are ethanol important for alcoholic beverages and carbon dioxide which is used for the raising of dough.
3 Recombinant DNA technology, also known as genetic engineering, involves the technology of artificially cutting and extracting DNA segments of a source organism and inserting them into a host organism, thus creating new genetic combinations of interest. It marks the transition from simple use of biological characteristics for human purposes to the active modification of the genetic material for creating new biological traits. For the first experimental study see: Cohen, S.N., A.C.Y. Chang, H.W. Boyer, and R.B. Helling. 1973. Construction of Biologically Functional Bacterial Plasmids In Vitro. Proceedings of the National Academy of Sciences 70: 32404. They managed to produce the first genetically modified Escherichia coli bacterium by joining DNA fragments from different plasmid origins. For further fields of modern biotechnology see: Carstoiu, D., E.v. Dyck, B. Glenn, C. Littlehales, and A. Massey. 2007. Guide to Biotechnology. Biotechnology Industry Organization, Washington D.C. 140 pp.
4 Some microorganisms carry genes that express proteins highly valued for therapeutic purposes but that are hard to culture in amounts that allow commercial extraction of the desired protein. By recombinant DNA technology these genes can be cut and inserted into microorganisms that can be cultured more easily in large amounts. See: Dorkins, H.R. and K.E. Davies. 1985. Recombinant DNA technology in the clinical sciences. Trends in Biotechnology(3) 8:1959.
5 A transgenic organism carries genes from another organism, usually from another species, in order to exhibit certain desired characteristics such as enhanced growth or resistance against pathogens or physical influences.
6 Bioremediation is the use of biological systems, usually microorganisms, to clean a location from environmental pollutants via organic degradation.
7 Colwell, R.R. 2002. Fulfilling the promise of biotechnology. Biotechnology Advances 20:21528.
8 Gandhimathi, R., M. Arunkumar, J. Selvin, T. Thangavelu, S. Sivaramkrishnan, G.S. Kiran, S. Shanmughapriya, and K. Natarajaseenivasan. 2008. Antimicrobial potential of sponge associated marine actinomycetes. Journal of Medical Mycology 18(1):1622.
9 Simmons, T.L., E. Andrianasolo, K. McPhail, P. Flatt, and W.H. Gerwick. 2005. Marine natural products as anticancer drugs. Molecular Cancer Therapeutics 2(4):33342.
10 AntiHIV. Chang, L., N. Whittaker, and C. Bewley. 2003. Crambescidin 826 and Dehydrocrambine A: New polycyclic guanidine alkaloids from the marine sponge Monanchora sp. that inhibit HIV1 Fusion. Journal of Natural Products 66:14904.
11 Proksch, P., R.A. Edrada, and R. Ebel. 2002. Drugs from the seas – current status and microbiological implications. Applied Microbiological Biotechnology 59:12534.
12 Laurent, D., V. Julian, and A. Parenty. 2006. Antimalarial potential of xestoquinone, a protein kinase inhibitor isolated from a Vanuatu marine sponge Xestospongia sp. Bioorganic and Medicinal Chemistry 14: 447782.
13 Lee, CK., H.S. Kim, J.R. Nam, M.J. Lee, J.H. Yim, and H.K. Lee. 2008. Antiviral Effects of Sulfated Exopolysaccharide from the Marine Microalga Gyrodinium impudicum Strain KG03. Antiviral Research 78(2):59.
14 Prommer, E. 2006. Ziconotide: A new option for refractory pain. Drugs of Today 42: 36978.
15 Approximately 800 new marine compounds are found annually that have bioactivity. See: Blunt, J.W., B.R. Copp, W.P. Hu, M.H.G. Munro, P.T. Northcote, and M.R. Prinsep. 2007. Marine natural products. Natural Products Report 25:3594.
16 Cook, J.T., M.A. McNiven, G.F. Richardson, A.M. Sutterlin. 2000. Growth rate, body composition and feed digestibility/ conversion of growthenhanced transgenic Atlantic salmon (Salmo salar). Aquaculture 188:1522.
17 Hew, C. and G. Fletcher. 2001. The role of aquatic biotechnology in aquaculture. Aquaculture 197:191204.
18 Gong, Z., K. Ewart, Z. Hu, G. Fletcher, and C. Hew. 1996. Skin antifreeze protein genes of the winter flounder, Pleuronectes americanus, encode distinct and active polypeptides without the secretory signal and presequences. Journal of Biological Chemistry 271(8):410612.
19 Prince, R.C. 1997. Bioremediation of marine oil spills. Trends in Biotechnology 15(5):15860.
20 Certain species of Pseudonomas bacteria carry genes on their plasmids which code for enzymes that degrade and convert longchain hydrocarbons into energy. This enables the bacteria to thrive on oil substrates. Chakrabarty used various Pseudonomas species to combine their genes within one target species in order to enhance the rate of oil degradation. His technique does not involve recombinant DNA technology but applies conjugation typical to bacteria to transfer the desired genes and UV radiation to fuse the gene on the plasmids. See: Chakrabarty, A.M. 1973. Genetic fusion of incompatible plasmids in Pseudomonas. Proceedings of the Natural Academy of Sciences 70(6):16414. Chakrabarty, A.M., G. Chou, and I.C. Gunsalus. 1973. Genetic regulation of octane dissimilation plasmid in Pseudomonas. Proceedings of the Natural Academy of Sciences 70(4):113740.
21 Chakrabarty, A.M. 1985. Geneticallymanipulated microorganisms and their products in the oil service industries. Trends in Biotechnology 3(2):329. Harvey, S., I. Elashvili, J.J. Valdes, D. Kamely, and A.M. Chakrabarty. 1990. Enhanced removal of Exxon Valdez spilled oil from Alaskan gravel by a microbial surfactant. Biotechnology 8:22830.
22 Matsushita, M., T.J. Schoenbaum, and P.C. Mavroides. 2006. The World Trade Organization. Law, practice, and policy. Oxford University Press, Oxford. p. 699. The others are copyrights, trademarks, geographical indications, trade secrets, industrial designs, and layout designs of integrated circuits.
23 The TRIPs Agreement is an international treaty that builds on the frameworks of other agreements, such as the Paris and Berne Convention, and aims at the harmonization of intellectual property rights among member states (153 states). Therefore, Art. 3 lays down the principle of national treatment which obliges member states to grant no less favourable rights to foreign inventors compared to his own nationals. Still, an inventor has to apply for a patent in each state separately in order to establish exclusive rights for the invention in another country. Information retrieved from www.wto.org on August 19, 2008.
24 TRIPs Agreement Art. 2734.
25 Grubb, P.W. 2004. Patents for chemicals, pharmaceuticals and biotechnology. Oxford University Press, Oxford. p. 3. A patentable invention can be a new product (e.g., pharmaceuticals), the process or method that creates this product, new processes for existing products (e.g., a new method to produce penicillin), or new processes altogether (e.g., a new method to administer penicillin).
26 TRIPs Agreement Art. 27.1. Due to a request by the United States, these terms are synonymous with an invention to be novel, nonobvious, and useful. See U.S. Patent Law, Title 35, § 100 ff.
27 TRIPs Agreement Art. 28.1.
28 Id. Art. 28.2.
29 Especially development of inventions in marine biotechnology is an arduous and costly undertaking. For example, the chance to find a promising lead compound for drug development is 1 percent, the time it takes to develop a drug takes in average 14 years and may consume up to US $ 900,000,000. See: Hunt, B. and A. Vincent. 2006. Scale and sustainability of marine bioprospecting for pharmaceuticals. Ambio 35(2): 5764.
30 TRIPs Agreement Art. 33.
31 Id. Art. 29.1.
32 AsiaPacific Economic Cooperation (APEC). 2001. Intellectual property and biotechnology: A training handbook.