Impact of adaptive licencing and adaptive access on Intellectual property and regulatory exclusivity right periods (D3.06)

Executive summary

The conceptual framework of Medicines Adaptive Pathways to Patients (MAPPs) has its basis in fostering access to novel beneficial treatments for the right patient groups at the earliest appropriate time in the product life-span in a sustainable fashion. Embedded in the MAPPs concept are key facets of products getting to the market earlier and in initially small defined (sub) population, with an emerging evidence base supporting a positive benefit: risk and indication expansion. This creates uncertainty for medicine developers as to how this adaptive development and access impacts on intellectual property (“IP”) and regulatory exclusivity right (“RER”) periods. Activities of the D3.06 working group have been to map both the key legal impacts and additional key perceptual impacts that adaptive pathways and adaptive access has on IP and RER periods. The term RER encompasses regulatory data protection (“RDP”) and orphan market exclusivity (“OME”).

A broad review of the rules governing IP and RER as they are today, and with respect to MAPPs, was undertaken in the context of the following 4 scenarios deemed likely to occur with MAPPs: (i) Stand-alone MA (i.e. single indication only); (ii) MA with subsequent indications with the same compound, i.e. indication 1, subsequently followed by indication 2; (iii) MA under exceptional circumstances or conditional approval that subsequently gets approved for ‘full’ MA; and (iv) MA (full, conditional, or exceptional MA) that subsequently is revoked / suspended from a regulatory perspective. Any direct legal impact of MAPPs were assessed along with an exploration of several perceptual issues pertaining to the incentives of adopting and using MAPPs from an IP and RDP perspective.

No legal blocks were found for the 4 above scenarios. Within the current EU framework, current incentives are generally supportive of MAPPs, yet uncertainty remains as to how to best protect exclusivity periods from erosion (particularly in subsequent indications) and how a definitive economic case for MAPPs could be realized and accepted.  For example, earlier to market (<5 years after the patent filing) will mean that there can be no supplementary protection certificate (SPC), thus the benefit of earlier to market might be offset by the loss of incentive in development of other indications. With regard to orphan market exclusivity (OME) protection, the OME is an indication specific exclusivity right, and a medicinal product can obtain multiple orphan designations, provided that these designations concern different orphan conditions. Thus the incentives for OME (and other incentives) will require ever more nuanced consideration under MAPPs.

The current review of EU incentives/exclusivity rights and the practical economics of so-called cross label use (i.e. generic products being approved with a reduced label compared to their reference product due to specific patent protection (or RER) of certain indications whereas these generic products nevertheless are prescribed and reimbursed for this protected indication) could negatively impact MAPPs. Cross label use across Member States could also be exacerbated under MAPPs.

There was a strong desire to maintain the current EU legal frameworks for IP and RER – MAPPs could operate effectively within in it. However, if in the future, the EU legislative framework is re-opened for amendments it is vital that MAPPs concept is considered adequately alongside other existing instruments (e.g. conditional marketing authorisation).