New scholarship by West Virginia University College of Law professor S. Sean Tu appears in Clinical Pharmacology & Therapeutics, a journal published by the American Society for Clinical Pharmacology & Therapeutics. The article is titled "Preserving Timely Generic Drug Competition with Legislation on “Skinny Labeling”. Professor Tu co-authored the work with Aaron S. Kesselheim of Brigham and Women’s Hospital and Harvard University.
From the abstract:
Patents prevent generic drug entry. Brand firms file new “method of use” patents for old drugs to prevent generic entry. Congress addressed this issue by creating the “skinny label” pathway, which allows generic firms to use the drug label to indicate that the old drug can only be used for non-patented uses. This pathway is now in jeopardy due to a recent court case. This paper outlines the issues and suggests possible legislative solutions.
Find more of of Professor Tu's scholarship on SSRN.