Failure To Launch: The Patent Thicket Delay Of US Biosimilars

By Stacie Ropka, Ted Mathias and Chantelle Ankerman (October 9, 2019, 12:42 PM EDT) -- Biologics originators successfully argued that they required longer exclusivity periods without competition from follow-on products because patents covering the originators' products would not pose the same barriers to entry that patents provide for small molecule drugs.

Almost 10 years after enactment of the Biologics Price Competition and Innovation Act, it is clear that originators' concerns were overstated. Patent thickets remain an important obstacle to launching follow-on biologics and help explain why such launches in the U.S. lag behind those in Europe.

Patent thickets are providing originators with years of additional exclusivity.

There can be little doubt that bringing new pharmaceutical and...

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