Biotech drugs: Preserve incentives for investment in these drugs
To preserve existing incentives for investment and innovation,
the Pathway for Biosimilars Act provides a data exclusivity
period equivalent to patent protections for small molecules. The
Congressional Budget Office has determined that 11.5 years is
the average length of time that drugs are marketed under patent.
In other words, innovative drugs and biologics typically stay on
the market for about 12 years before facing competition.  My
legislation proposes allowing competitors access to this data
and a shortcut into the market, but also preserves the existing
incentives for innovators by maintaining a 12-year period of
concurrent data protection as a “backstop” to existing patent
protections. The bill also sets forth a process to resolve all
patent litigation prior to launch of biosimilars, providing the
opportunity to resolve important intellectual property issues
and certainty to all parties without market disruptions. Unlike
any othe