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Patents and Data Exclusivity: It Ain't Necessarily So

By Donald Zuhn, Kevin Noonan, Chris Singer, Sherri Oslick, and Jason Derry

By Kevin E. Noonan -- The most troublesome point of contention in the follow-in biologics (FOBs) debate has undoubtedly revolved around the term for data exclusivity. In a subject so complex, it may be understandable that there are differing views about the importance of data exclusivity, and whether this is "much ado about nothing" or a vitally-important part of any follow-on biologics regime. Whether the data exclusivity provisions are of almost supreme importance depends, in part, on the significance of patent protection in biologics and the extent of protection patenting can be expected to give biologic drugs. The Federal Trade...

Full post as published by Patent Docs on August 03, 2009 (boomark / email).