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505(b)(2) – No patent, just exclusivity

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.