Critics Say Biologics Bill Doesn't Protect Innovators

Law360, New York (March 27, 2007, 12:00 AM EDT) -- Critics of legislation that would provide a pathway for copies of biologic drugs to make their way to the marketplace say the proposal allows no market exclusivity and unfairly tilts the advantage during patent litigation to generics manufacturers.

The Access to Life-Saving Medicine Act, co-sponsored by Rep. Henry Waxman, D-Calif., in the U.S. House of Representatives, has basically no intellectual property or data protection provisions analogous to those in the Hatch-Waxman Act, critics say.

Hatch-Waxman was the landmark legislation that created a pathway for generic drugs...
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