Patents compensate an innovator for the efforts and resources invested into research and development. Because of the high development costs in the pharmaceutical industry, patents play a much greater role than in other industries. Based on their historical appearance in the market, active pharmaceutical ingredients can be grouped into at least four different classes, namely, small molecules, peptides, large biopharmaceutics, and nucleic acids. The term "patentability" means that an invention meets the substantial criteria set forth in the patent laws, including, in general, novelty and inventive step/non-obviousness. An appropriate patent lifecycle strategy reflects the different stages of a drug development process, plus new embodiments that represent second- or later-generation advancements of the said drug. In member states of EU, compound protection for an approved drug can be extended under Article 63(2) of the European Patent Convention (EPC) and Regulation (EC) 469/2009 by means of a Supplementary Protection Certificate (SPC).
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