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Patents As with any applied science, the field of biotechnology is replete with invention and the development of proprietary (“owned”) technologies. The provision of adequate protection for these inventions is essential, given the often substantial cost of their development and the very considerable risk and investment needed to commercialize them. The continuing emergence of new pharmaceuticals, industrial processes/materials, and agricultural products from biotechnology would simply not happen without the incentive provided by the “competitive edge”. Patenting is the mechanism whereby that competitiveness is assured, thereby enabling an eventual return on the original investment.  The obvious involvement of life-processes in biotechnology inventions has frequently led to confusion and misunderstanding by opponents of biotechnology and those not involved in the field. Protestors have called for an end to patenting “life”, and it is apparent that some observers view patenting in biotechnology as a means for companies to claim ownership of naturally occurring entities such as plants, microbes, or genes. Such a perspective has no basis in reality. Patents protect inventions, and inventions by definition involve utility. Thus it is not possible to convince the U.S. Patent Office to issue a patent simply covering a newly discovered gene, microbial species, etc. without clear and demonstrable indication of the practical application for that discovery. And, when issued, the patent will cover that practical application, not the natural entity itself. Put simply, it is not sufficient merely to “discover”. One must also “invent”, i.e. demonstrate a practical application. This requirement for utility is just as true of patents protecting apparently simple entities such as genes as it is of those protecting inventions which represent complex assemblies and constructions. (The class of patents known as Plant Variety Protection might be thought of as an exception to this rule. However, the protected plant variety will again have been derived through inventive selection, identification, and/or breeding, with a specific application in mind, and it is that inventiveness directed at a stated application which, if unique, will secure the patent.)