Will you, won’t you, will you join the dance?

When Congress enacted the Biologics Price Competition and Innovation Act (BPCIA) in 2009 to create an abbreviated pathway for biosimilar product approval, it included complicated provisions for resolving patent infringement disputes. In March this year, the US Food and Drug Administration (FDA) approved the first biosimilar product, and the US Court of Appeals for the Federal Circuit then had to decide whether those provisions are mandatory or optional.

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