The session will provide a comprehensive strategic focus on up-to-date regulatory and IP matters including;
1) Regulatory Strategy
- Engaging with regulators early in development to enhance the probability of regulatory success
- Incentives offering short term financial gains and long term impact e.g. orphan drug designation; EMA's PRIME scheme and UK's Innovative Licensing and Access Pathway (ILAP including the Innovation Passport) for priority medicines; the UK's Early Access to Medicines Scheme (EAMS) including the Promising Innovative Medicine (PIM) designation.
2) Intellectual Property
- An introduction to the supplementary protection certificate system for extending patent protection for pharmaceutical inventions
- Tips to make sure your portfolio is in good shape for securing SPCs. Regulatory approval is a lengthy process and often, by the time a pharmaceutical product is approved, the patent which covers it will be well into its 20-year term. Will it be possible to extend your patent, when the time comes? Is your portfolio SPC-ready? Several things can be done whilst your patent portfolio is at an early stage that can maximise your chances of securing an SPC.
Carole Pugh, Managing Director of EUDRAC Ltd
Amanda Simons, Partner, European and UK Patent Attorney at J A Kemp