Abstract

The advent and evolution of corticosteroid treatment strategies over the preceding decades means that asthma is now at least controllable for the majority of asthmatics. The main mode of action for corticosteroids is the inhibition of the nuclear factor-kappaB (NF-kappaB) pathway which dampens the pulmonary inflammatory response associated with asthma pathology. The effectiveness of these drugs and the growing market means that there is strong competitive pressure for pharmaceutical companies to improve, or at the very least maintain, their intellectual property position in corticosteroid treatments for asthma. The most notable feature of the intellectual property situation for inhaled corticosteroids is the impending expiry of a large raft of patents associated with many of the market leading drugs. As efficacy of inhaled drugs is intimately related to how effectively the drug is delivered to the lung, there are a variety of options available for patent protection, including protecting the drug formulation itself as well as various components of a compatible delivery device. In the absence of new corticosteroid chemistries, such approaches will provide extended intellectual property protection and assist in the maintenance of market share for many of the leading inhaled corticosteroids.

Keywords: Inhaled corticosteroids, asthma, patent, airway remodelling, glucocorticoid receptor, long acting β2 adrenoreceptor agonist