Biosimilars Handbook

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.

“Biosimilars will provide access to important therapies for patients who need them. Patients and the health care community can be confident that biosimilar products approved by the FDA meet the agency’s rigorous safety, efficacy and quality standards.”

Margaret Hamburg, M.D.
Former U.S. FDA Commissioner

The two companies go back and forth for several rounds, negotiating over the validity of the patents and their enforceability, until the final step—when the brand company has a last chance to assert additional patents after the biosimilar applicant has provided 180 days’ premarketing notice.

While the BPCIA outlines the patent dance as an avenue to resolve patent disputes, the process is voluntary. In June 2017, the Supreme Court issued a unanimous ruling that under federal law, biosimilar applicants can opt out of the patent dance—they cannot be enjoined to share their respective applications with the reference product sponsor. While reference product sponsors can still litigate possible patent disputes without seeing a product application, the Court’s ruling gives biosimilar applicants more control in choosing how and when to resolve patent disputes with a reference product sponsor.