United States: Requirements, Benefits, And Possible Consequences Of Listing Patents In FDA's Orange Book

he Drug Price Competition and Patent Term Restoration Act of 1984 (the Hatch-Waxman Act) amended patent law and drug law to facilitate pharmaceutical development and encourage the marketing of generic pharmaceuticals. Pub. L. No. 98-417, 98 Stat. 1585 (amending 21 U.S.C. § 355); see also H.R. Rep. No. 98-857, pt. 1, at 1 (1984), reprinted in 1984 U.S.C.C.A.N. 2647, 2647.

http://www.mondaq.com/unitedstates/x/721074/Patent/Requirements%20Benefits%20and%20Possible%20Consequences%20of%20Listing%20Patents%20in%20FDAs%20Orange%20Book