The discovery of a brand new compound (or class of compounds) with useful biological properties opens up the possibility of obtaining what is arguably the most robust form of pharmaceutical patent protection – a patent for the drug product per se. Such a patent provides a monopoly over manufacture, sale and use of the drug for any medical use, including potential future uses which might be identified during the lifetime of the patent.
Our team of pharmaceutical chemistry specialists have extensive experience in the drafting, filing and prosecution of patents for NCEs. We can advise on strategic aspects such as when to file and issues relating to the provision of supporting data, as well as on substantive issues of patentability.
Within our chemistry team there is also a wealth of experience in synthetic organic chemistry, with many of our team having backgrounds in natural product synthesis or synthetic methodology.
A further aspect of pharmaceutical innovation is the development of synthetic routes to the drug compounds. The discovery of a new synthetic pathway may provide access to further new compounds, or it may be a step towards an optimised manufacturing route to an already-discovered drug. Patent protection for a validated (GMP) manufacturing process can be a further useful tool for innovators seeking to safeguard their investment.
For a number of on-market pharma products we have handled all aspects of worldwide patent prosecution on behalf of large multi-national pharma clients. We also have substantial expertise in freedom-to-operate searching and due diligence in this area.