Once a candidate drug has been identified and patented, the clock is ticking on the lifespan of patent protection. However, research and development does not stop there. Advances may be made in the development and selection of differing chiral or enantiomeric forms, of prodrugs or drug conjugates, of specific salts or solvates, or in the investigation of different polymorphic forms. The practicalities surrounding the patent protection of such different API forms are highly nuanced and vary considerably between jurisdictions. Here at Venner Shipley we are experienced in not only drafting and prosecuting such applications from a European perspective, but in managing portfolios on a worldwide basis and in liaising with businesses and overseas agents to finesse filing strategies and timings. We are also highly experienced in challenging the protection of such API forms, for example by opposition before the EPO. As such, we are well placed to advise in a manner that is most appropriate to the commercial need.
Moreover, we recognise that considerable investment is often made in the development and scale-up of processes for the manufacture of specific compounds, salts or polymorphs, or in the purification of such API forms. Patenting such processes and (if appropriate) resultant products can form a vital additional layer of protection to the originator, and a significant obstacle for generic companies to design around or overcome. At Venner Shipley we recognise this and are well versed to exploring the situation from both angles, providing drafting and prosecution services or FTO and opposition assistance as required.