After the Phase 3 FM57 study indicated the value and efficacy of MED3000 (a formulation developed specifically for the treatment of ED) a new patent application was filed in December 2019 which has the potential, if successful, to extend protection of MED3000 until 2040. Aside from our current patent lawyers, Futura recently retained a specialist biotech IP and strategic advice company to assist in maximising the robustness of the MED3000 intellectual property.
MED2005's current patent protection runs until August 2028 in the USA and August 2025 in Europe. In addition EU rules grant a 10 year protection. Futura would benefit from a period of 8 years’ exclusivity during which data generated by Futura cannot be used for an MAA to support their application. In addition, no generic of the product may be marketed for 10 years after the first approval.
In August 2018 Futura filed a Patent Co-operation Treaty patent application which, if successful, could extend patent protection for MED2005 in many countries to 2038. The PCT filing will be moving into the National filing phase in Q1 2020 in line with standard processes. This phase sets out specific, nominated countries under the Patent Co-operation Treaty which, if successful, will provide patent coverage until 2037.