Rival Biologics Bills May Determine No. Of Patent Suits

Law360, New York (March 20, 2009, 12:00 AM EDT) -- Competing bills have come out seeking to create a regulatory pathway for the U.S. Food and Drug Administration to approve follow-on versions of biologic drugs – with key differences that will likely spur or decrease patent litigation, experts say.

A bill introduced by Rep. Henry Waxman, D-Calif., would stick close to the existing regulatory scheme for approving generic pharmaceutical drugs and give incentives to follow-on companies to challenge patents held by innovator firms, while a rival measure proposed by Rep. Anna G. Eshoo, D-Calif., would lengthen...
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