A potential change in federal patent law for generic drugs could raise federal health care costs by $1.3 billion over the next decade, according to an estimate by the Congressional Budget Office.
Pharmaceutical companies, frustrated by challenges to their patents by generic drug companies, want Congress to require that those challenging drug patents do so in federal court, rather than through an expedited administrative process, Inter Partes Review (IPR).
The Wall Street Journal reports that while IPR challenges usually take between 15 to 18 months to decide, federal law requires the FDA to wait two-and-a-half years after a challenge in federal court to approve a generic drug. Pharmaceutical companies say IPR was never the intended system for settling drug patent disputes.
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