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Articles 61 - 62 of 62
Full-Text Articles in Intellectual Property Law
Maintaining Incentives For Healthcare Innovation: A Response To The Ftc's Report On Follow-On Biologics, Christopher M. Holman
Maintaining Incentives For Healthcare Innovation: A Response To The Ftc's Report On Follow-On Biologics, Christopher M. Holman
Christopher M Holman
Congress is considering legislation that would create an abbreviated FDA approval process for follow-on biologics (FOBs), which proponents anticipate will promote competition and lower prices in the market for biologic drugs. In June of 2009 the FTC published a report on FOBs (“the FTC Report”), which attempts to forecast the nature of competition between innovator biologics and FOBs, and offers a number of substantive recommendations regarding specific provisions of the various FOB bills. In particular, the FTC Report concludes that there is essentially no justification for the inclusion of a substantial data exclusivity period (“DEP”) for innovators in pending FOB …
Of Mice And Men: Why An Anticommons Has Not Emerged In The Biotechnological Realm, Chester J. Shiu
Of Mice And Men: Why An Anticommons Has Not Emerged In The Biotechnological Realm, Chester J. Shiu
Chester J Shiu
In 1998 Michael Heller and Rebecca Eisenberg posited that excessive patenting of fundamental biomedical innovations might create a “tragedy of the anticommons.” A decade later, their dire predictions have not come to pass, an outcome which calls much of the legal scholarship on the topic into question. This Article proposes that legal commentators’ theoretical arguments have largely ignored two very important factors. First, the National Institutes of Health (NIH)—the single most important actor in the biomedical research industry—has played an active role in keeping the biomedical research domain open. In particular, regardless of what the current patent regime may theoretically …