Biologics do not go through the Hatch-Waxman ANDA process; they have their own statute and their own litigation choreography. The Biologics Price Competition and Innovation Act amended 42 U.S.C. 262 to create an abbreviated approval pathway for “biosimilar” products and, alongside it, a structured patent dispute procedure that practitioners call the patent dance. The starting definition matters. The statute provides that a product is “biosimilar” when, among other things, “the biological product is highly similar to the reference product notwithstanding minor differences in clinically inactive components” and “there are no clinically meaningful differences between the biological product and the reference product.” The “reference product” is the original biologic licensed under subsection (a) against which the biosimilar is compared.

Because biologics are large, complex molecules made in living systems, the statute could not simply import the small-molecule generic rules. Instead, 42 U.S.C. 262(l) builds a sequenced information exchange between the biosimilar applicant — referred to as the subsection (k) applicant — and the reference product sponsor. The exchange is designed to let the two sides identify and sort the relevant patents in stages before any infringement suit, rather than litigating everything at once. That staged structure is what gives the patent dance its name.

"...(A) that the biological product is highly similar to the reference product notwithstanding minor differences in clinically inactive components; and (B) there are no clinically meaningful differences between the biological product and the reference product..."— 42 U.S.C. 262(i) (BPCIA), source

How does the patent dance actually proceed?

The first step belongs to the biosimilar applicant. The statute provides that “Not later than 20 days after the Secretary notifies the subsection (k) applicant that the application has been accepted for review,” the applicant shall provide the reference product sponsor with a copy of its application and information describing how the biological product is manufactured. This early disclosure of the application and manufacturing process is a defining feature of the BPCIA process — it gives the reference sponsor the technical detail needed to assess which of its patents the biosimilar might implicate. From there, the statute lays out successive exchanges: the sponsor provides a list of patents it believes could be asserted, the applicant responds with its positions on validity, enforceability, and infringement, and the parties work to narrow the patents that will actually be litigated.

The dance also governs timing and sequencing of the litigation that follows. The parties negotiate over which patents proceed to an immediate first phase of suit, and the statute provides a mechanism for a later phase tied to the biosimilar's planned commercial marketing. Separately, the applicant must give the reference sponsor notice of commercial marketing before launching, which sets up the window in which the sponsor may seek a preliminary injunction on patents reserved for the second phase. The overall effect is to convert what could be sprawling, all-at-once patent litigation into an ordered, information-driven process.

One feature that distinguishes the BPCIA process is that several of its steps are, by their terms, optional in a way that has been heavily litigated. The Supreme Court has addressed whether a biosimilar applicant must engage in the 262(l) exchange at all, and how the notice-of-commercial-marketing requirement operates relative to FDA licensure. The practical upshot for a docket-watcher is that not every biosimilar dispute follows the full dance in the same order: an applicant may decline to provide its application under 262(l)(2), which changes the reference sponsor's available remedies and the way patents get surfaced. Reading a given matter therefore requires checking which steps the applicant actually elected, not assuming the entire sequence ran. The statutory text supplies the menu of steps; the parties' choices within it determine the shape of the litigation.

How it differs from the Hatch-Waxman ANDA process

The contrast with small-molecule generics is structural. In the Hatch-Waxman world, a generic applicant files Orange Book patent certifications — including the Paragraph IV invalid-or-not-infringed certification — and a Paragraph IV filing can trigger a 30-month stay of approval. The BPCIA has no Orange Book and no Paragraph IV certification; instead, the patent identification happens through the 262(l) information exchange between the two companies, and the disputed patents are surfaced and narrowed by that private, staged process rather than by a public listing. Biologics also carry their own data-exclusivity period under the BPCIA, distinct from the exclusivities in the small-molecule scheme.

For litigators and licensing professionals, the practical point is that biosimilar patent strategy lives inside 42 U.S.C. 262(l), not inside the ANDA statute. The defined terms — highly similar, no clinically meaningful differences, reference product, subsection (k) applicant — and the staged disclosures and patent lists are the moving parts. Reading a biosimilar dispute correctly means tracking where the parties are in that sequence: whether the application and manufacturing information have been exchanged, which patents have been listed, which have been narrowed for the first phase, and whether commercial-marketing notice has been given.

It is also worth situating the patent dance within the BPCIA's broader exclusivity structure, because the two interact. A reference biologic receives a period of data exclusivity under 42 U.S.C. 262(k)(7), during which the FDA will not approve a biosimilar relying on the reference product's data, with a defined window before a biosimilar application can even be submitted. That regulatory clock runs independently of the patent dance: a biosimilar can clear the data-exclusivity period and still face patents surfaced through the 262(l) exchange, or it can navigate the patent exchange while the exclusivity period is still running. A complete picture of when a biosimilar can actually launch therefore requires reading the patent position established through the dance alongside the statutory exclusivity timeline, since either can be the binding constraint depending on the molecule.

This article describes the statutory framework; it is not legal advice, and the posture of any specific biosimilar dispute depends on the exchanges, lists, and suits in that matter's record.