Published Online: Thursday, March 1, 2007

Officials from the Pharmaceutical Research and Manufacturers of America (PhRMA) warned Congress against passing legislation to curb authorized generics, arguing that such restrictions could cause drug patent litigation costs to skyrocket. Testifying before the Senate Judiciary Committee, PhRMA President Billy Tauzin maintained that many arrangements that result in the introduction of an authorized generic drug are implemented in an effort to resolve prolonged and costly patent litigation between the branded manufacturer and the generic challenger.

Noting that it is not uncommon for drug patent suits to stretch on for several years, Tauzin cited estimates that, for every dollar branded pharmaceutical companies spend on research and development, another 27 cents is spent defending patented drugs from litigation.

Proposed legislation preventing the use of authorized generics to settle drug patent disputes "would make settlements less likely and less efficient and would threaten both innovation and generic drug development," he warned Congress.

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