We have all been confronted with the issue of patents and exclusivity for 505(b)(2) product development projects. Financial backers, VC’s, private equity are fixated on the ruggedness of patents – no patent = no money. Biomarin Pharmaceuticals made a presentation at the 2008 BIO conference to encourage others that patents are not always needed. The company representative stated that none of their 3 products had patent protection and that the company relied strictly on exclusivity. In the case of Kuvan, which has orphan exclusivity of 7 years, Biomarin used 3rd party literature to convince FDA to agree to a primary endpoint in their study.