Experimental data required to support second medical use claims

摘要

The timing of filing a new patent application always requires a judgment call to be made between securing the earliest filing date and waiting to collect enough data to ensure the claims are fully supported and enabled across their scope. In addition, it is important to ensure that the application is drafted in such a way that it is suitable for filing in various jurisdictions. The case law we have considered for the sufficiency/enablement of second medical use claims in Europe, the USA and Australia makes it clear that experimental results should be included in the application at filing, and that the results must demonstrate that the claimed pharmaceutical product could be reasonably expected to treat the claimed indication.