Bill Aims To Expand ANDA First Filer Exclusivity

Law360, New York (June 23, 2009, 12:00 AM EDT) -- Sen. Bill Nelson, D-Fla., has introduced legislation in the U.S. Senate to revise the Hatch-Waxman Act's definition of “first applicant” for abbreviated new drug application filers to give generic-drug makers challenging brand-name patents a shot at receiving 180-day market exclusivity.

The Drug Price Competition Act of 2009, introduced Monday, would preserve the 180-day exclusivity period currently granted to the first company to submit a successful ANDA application.

However, if passed, the bill would give companies who successfully litigate past patent roadblocks the opportunity to claim market...
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