Second medical use: a regulatory perspective


Jackie Mulryne

Second medical use: a regulatory perspective

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Under close scrutiny by regulators, the rules around second medical use patents vary from country to country, explains Jackie Mulryne of Arnold & Porter.

As compound patents and regulatory data protection for medicinal products expire, pharmaceutical companies increasingly look to develop new uses for their products. This strategy usually involves filing second medical use patents to protect the invention and research investment.

As well as the complex patent landscape that surrounds such patents, and any extension to regulatory marketing protection that may be available, several regulatory and practical factors may impact how well second uses for existing products can be protected from immediate generic competition.

Regulatory background

When assessing a generic medicinal product, the competent authorities generally require the same information to appear in the summary of product characteristics (SmPC) and other product information of the generic medicine, as for the original, reference medicine.

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