ABSTRACT

Intellectual property and medicine are institutional components of the knowledge economy. The institution of intellectual property is presented as a functional organic unity, but achieves that unity and presents as a public institution arguably without the consensus of the collective participants in the system. The cultural life of patents comprises not only the research culture that produces the resources of the institution of medicine, but also the ethical oversight for medicines. Research and development is one of the most critical concepts both in the modelling of investment and the appropriation of value in the pharmaceutical industry. Supplementary protection certificates are special kinds of intellectual property rights that are applied only in the fields of pharmaceuticals and plant protection, due to the particular requirements for clinical trials and regulatory approval in these areas of technology. The Food, Drug and Cosmetic Act provides for data exclusivity protection in the US under the authority of the Food and Drug Administration.