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Biotechnology defined as the integration of natural and engineering sciences has led to a burst of industrial activities with large assets accrued in terms of wealth, new food sources and new medicines. The liabilities include environmental contamination and degradation of genomes. This leads to a proportion of decisions to be made, which involve or affect well being of other individuals of society at large, of the environment and quality of life at present and future generations. These decisions require a combination of technical knowledge (which gives alternatives) and a basing on ethical issues to make a choice. Biotech patenting has its own set of non-ethical but technical issues regarding subject matter for patenting and issues related to ownership of intellectual property while co-inventing, inventor/investor relations and informal channels of knowledge movement. Biotechnology and IP issues The massive growth in biotechnology can be attributed to the completion of the human genome project, the success of animal cloning, pharmaceutical research, and other notable advances which promise to further our standard of living. As a result of the scramble to gain proprietary rights over these advances, the biotechnology field has seen phenomenal growth in the number of biotechnology patents. Biotechnology inventions may include microbes, cell lines, tissue generation, antibody production, proteins, nucleic acids and transgenic multi-cellular organisms. These inventions differ from others because the subject matter of such advances may relate to self-replicating entities or life forms not existing in nature. As with other classes of technology, inventions in the field of biotechnology must be adequately protected to ensure continued innovation. Biological inventions possess properties that pose unique challenges to the patent system. Technical issues Under the intellectual property right system, society grants the inventor a limited monopoly over his/her invention for a stipulated period which after WTO is for 20 years from the date the patent application is filed. The patent allows the inventor the right to exclude all others from making, using, selling, offering for sale or importing the patented invention. In return, the public receives full disclosure of a new and useful invention that enters the public domain after the patent term expires. For an invention to be patentable, it must be The first issue that must be addressed is whether the biotechnology patent consists of patentable subject matter within the meaning described in the Act. Biotechnology patents usually fall within the article of manufacture or composition of matter categories. While patents may be obtained for DNA, proteins, antibodies, transgenic microorganisms, viruses, (plants and animals, in the US), those specifically excluded from the realm of patentable subject matter are laws of nature, mathematical and scientific formulas, abstract ideas, naturally occurring objects, and human life. Assuming the biotechnology invention consists of patentable subject matter, there are three statutory subject matters that the invention must meet. |
