Sens. Settle On 12-Year Exclusivity For Biologics

Law360, New York (July 14, 2009, 12:00 AM EDT) -- A U.S. Senate committee has agreed to a proposal that would offer biologic drug manufacturers 12 years of patent exclusivity before allowing competitors to seek regulatory approval to bring follow-on versions to market.

The Senate Committee for Health, Education, Labor and Pensions late Monday approved an amendment sponsored by Sens. Mike Enzi, R-Wyo., Orrin Hatch, R-Utah, and Kay Hagan, D-N.C., permitting biologic drug manufacturers a data exclusivity period of 12 years.

Committee members voted 16-7 in favor of the Hatch-Enzi-Hagan amendment, one of several proposals put...
To view the full article, register now.