Supplementary Protection Certificates (SPCs) and Data Exclusivity are essential tools for extending the patent life and market exclusivity covering pharmaceutical and biological therapies beyond the standard patent term and help offset regulatory delays.
SPCs can extend the protection of a patented therapeutic product by up to five years, with additional extensions available for medicines that have undergone paediatric testing. These extensions are crucial for maximising the return on investment in drug development and continue to ensure that bringing these innovative treatments to market remains financially viable.
Data exclusivity provides a period during which the data submitted by the original manufacturer to obtain marketing approval cannot be used by generic manufacturers to gain approval for their own versions of the drug. In the EU and UK, new medicinal products benefit from eight years of data exclusivity, followed by two years of market exclusivity. In the EU and UK, orphan drugs treating rare diseases generally benefit from longer exclusivity – although this can be further extended for drugs including a paediatric investigation plan (PIP).
This protection is vital for safeguarding the proprietary clinical data and research that underpin new drug approvals, thereby encouraging continued innovation and investment in innovative drugs.
Withers & Rogers can advise clients on how best to leverage SPCs and data exclusivity so as to maximise protection for pharmaceutical and biological therapies.
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