The question of how to formulate a drug is often demanding, requiring a trade-off between various requirements such as bioavailability, stability and processability. The choice of excipients, the way in which an API is formulated for a given use and the method of manufacturing a dosage form can all give rise to patentable subject matter. A specific formulation may be vital to the commercial success of a drug, yet obtaining adequate protection may not be straightforward, not least due to the multi-functional nature of many excipients and the propensity for anticipatory disclosures by the time the formulation is developed. Our team is here to help. We routinely navigate this complex field, both drafting and prosecuting patent applications to maximise protection, and challenging protection attempted by others.
Moreover, as experts in the field of pharmaceutical formulation technology, we are also adept in recognising and protecting novel formulation excipients and techniques, serving companies and start-ups where it is this, rather than any specific API per se, that is the focus of their business. In such circumstances, we seek to work closely with inventors and scientific leaders within the business, to use our full breadth of experience in the field of formulation and pharmaceutical technology more widely, to efficiently maximise the value of any obtainable patent protection and to ensure the sustainability of the commercialisation strategy.