Barriers to Patient Access: Patent Litigation
The BPCIA created not only an approval pathway for biosimilars, but also a mechanism for resolving patent disputes between brand drug companies and biosimilar manufacturers. This complex, multi-step process is known as the biosimilar “patent dance.”
Some brand biologic manufacturers have been using the court system and complex biosimilar patent dance litigation to keep their competitors off the market. These brand manufacturer efforts to create a so-called “litigation backlog” are succeeding—as of November 2018, only 16 FDA-approved biosimilars are approved for use in the U.S. and of those, only 4 are marketed to patients. Despite FDA approval, patent litigation from brand biologic manufacturers is stalling biosimilar entry to the market.
As outlined in the BPCIA, the patent dance begins when the biosimilar applicant shares its biosimilar application with the reference product sponsor. Then, two companies exchange lists of patents that may be infringed by the biosimilar and patents that could be licensed to the biosimilar applicant.