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In June 2008, the UK Court of Appeal decided that a ‘second medical use’ claim can be patentable, even if the sole distinguishing feature of the claim is the new dosing regime or new dosage form. This brings the UK into line with common practice at the European Patent Office (EPO) and provides a fresh incentive to explore different delivery devices.
Although over 70 per cent of drugs are administered in tablet form, there is increasing interest in the inhaled route. The respiratory tract is an attractive delivery route as it does not subject drugs to the harsh conditions of the gastrointestinal tract; it is also non-invasive and convenient for the patient.
There are a number of delivery devices available including the nebuliser, pressurised metered dose inhaler (pMDI), dry powder inhaler (DPI), nasal spray and other novel delivery systems. For each of these, a different formulation of the drug is required to ensure that best performance is achieved, and this can also vary according to the device manufacturer as there are few ‘standard’ components in this industry.
With the new clarification, we anticipate an increase in companies looking at reformulating patented drugs for inhaled devices. However, whether it is a new chemical entity or an existing drug, a battery of tests are required to improve understanding of what will make the most stable and effective formulation. This early stage analysis falls into two broad categories: pre-formulation studies and accelerated feasibility testing. |
