Orphan Product Regulation/Market Exclusivity Protections

Clients are assisted in developing life cycle management strategies for their products. A number of product areas are subject to special inducements to encourage their development. These products include orphan drugs, humanitarian devices, veterinary drugs for minor uses or minor species, and minor use pesticides. A number of other products can have the same type of or different market incentives. Advice is also provided on developing the necessary submissions to take advantage of the incentives to market these types of products, including on the filing of designation requests, where necessary, and on protecting in court, any market incentives that have been obtained.