The regulatory, patent and exclusivity issues as they relate to the animal health industry in the United States are complex and overlapping. Focusing in his article on drug development, Sam Al-Murrani of Babylon Bioconsulting explains how the multiple regulatory hoops to jump through and the seemingly unending costs associated with patenting a new product may appear to be a dark cloud at first; however, upon a more thorough and deliberate second look the same dark cloud may end up with a very prominent silver lining.