Patents for Biomedicinal Products

A patent is certainly the most adequate means to protect an invention, if a product derived from this invention can be developed and sold on the market within the foreseeable future and if one expects major financial revenues from this product. The expected revenues should be high enough to recoup the cost of product development and to justify the expense of obtaining and maintaining a patent. 

The majority of patented pharmaceuticals cannot recoup the cost of product development during the life-span of their patents (Prentis et al., 1988). Thus, patents do not guarantee high profits, but -depending on their quality- patents can significantly improve the chances of commercial success of innovative products. The quality of patents does not only depend on the quality of the research which led to the patented invention, but also on the quality of the patent application and a skilful patent strategy. 

As far as the subject allows, only the general principles will be outlined which apply to patents in the field of biomedical products, rather than dealing with specific cases (as the interpretation of their patentability changes with time). For practical reasons emphasis will be laid on the patent policies of the European Patent Organization (EPO) and of the USA, since these are most advanced in this field and strongly influence other countries policies. Patents are usually applied first in the USA in in EPO countries, as they represent major markets. Important deviations from the EPO s or USA s policies in other countries will be mentioned and summarized where necessary. Alternatives to patents will also be briefly discussed. 

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Under the general provisions of novelty, non-obviousness and utility/technical applicability the following examples of biological subject matter with biomedicinal applications may be considered as patentable. For products which also occur in nature, this applies to a form which is isolated from nature or changed from how they exist in nature. See also Table 9 for country-specific exclusions. 

This book is an attempt to summarize information on the fundamentals of pharmaceutical product development for modern biomedicinal products and to combine these with specific recommendations for effective planning and management of applied research and development projects. A reasonable selection of information was necessary to avoid confusions by too many details. This inevitably leads to omissions and simplifications, particularly on patent and registration issues. The reader should bear in mind that these sections are primarily intended to... 

Process patents contain methods to prepare substances. Possible examples in the context of biomedicines are, e.g. isolation or purification methods, cell culture techniques, attenuation schemes and other more directed genetic manipulations of microorganisms, cloning techniques, and expression techniques for recombinant polypeptides. Since process patents are usually admitted in countries where certain products cannot be patented (see Table 9), process claims are a possibility to protect inventions in these countries. 

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