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« Some (But Not All) Amendments Introduced in "Patent Reform" Bill | Main | Senate "Patent Reform" Bill (S. 515) Voted out of Judiciary Committee »

April 02, 2009

Comments

Rather than making reverse payment settlements illegal, it would be more effective to just revise the Hatch-Waxman Act to remove the incentive to enter into such settlements. Pharmaceutical patent holders generally enter pay-for-delay settlements with the first generic challenger because these settlements bottleneck the generic process by preventing FDA from approving later-filed ANDAs. The 180-day exclusivity forfeiture provisions allow the first-filer to hold on to his exclusivity even after entering a pay-for-delay settlement, so long as the settlement doesn’t stipulate anything about the patent being invalid or not infringed. A simple change to the Hatch-Waxman Act - having the first-filer forfeit their exclusivity period upon entering ANY settlement agreement with the patentee - would open the door to other generic challengers and disincentivize patentees from entering into such settlements in the first place.

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