Chapter 8: Contrasting European and US Patent Laws: Issues for the Pharmaceutical Industry

Contrasting european and US patent laws: Issues for the pharmaceutical industry Patents have become the lifeblood of the biopharmaceutical industry, which depends heavily on intellectual property (IP) protection (especially patents and trade secrets) to justify and support its investment in R&D. Without IP protection, generic drug companies could develop products that match the physical and chemical specifications of innovator products and behave in a comparable manner and enter the market within only a few years of the introduction of a new drug product. Such a short period of exclusivity would not give developers of new molecular entities enough time to recoup their investments in R&D. In addition to supporting laws protecting patents, most industrialized nations also recognize the importance of protecting data generated from preclinical and clinical studies. Both Europe and the United States provide periods of data or marketing exclusivity for such data. An effective IP system must provide ...

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