There is more than one way to extend data exclusivity periods

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In regulating the pharmaceutical industry, legislators have to balance a number of competing interests. First, they aim to offer rewards for the research and development that produces innovative new treatments, while also allowing generic competition that will bring down the overall cost of medicines. Furthermore, they must ensure that sufficient pre-clinical and clinical data are produced by pharmaceutical companies to demonstrate that drugs are safe and effective, while avoiding excessive, repetitive testing in humans beyond what is strictly necessary. This has led to the development of two layers of exclusivity in the pharmaceutical industry.

First is the patent system, including supplementary protection certificates and paediatric extensions, which allows the innovator company a monopoly in the market for a defined period. After that, generic competitors may enter the market, which should mean that prices will fall.

Second, the innovator company is allowed a period of data and marketing exclusivity. In order to avoid unnecessary repetitive testing in humans, a generic pharmaceutical company may refer to the pre-clinical and clinical data produced for an earlier reference product when it was authorised, provided it can demonstrate that its product is a ‘generic’ of the reference product. However, it may only do this after the expiry of the data exclusivity period…

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