Last week, a federal judge in Boston answered a question of
first impression arising under the patent dispute resolution
provisions of the Biological Price Competition and Innovation Act
("BPCIA"), a process commonly known as the "patent
dance." The BPCIA limits a patentee's damages to a
reasonable royalty if an infringement suit was filed more than 30
days after the end of the information-exchange process. Does this
limitation apply when the applicant has chosen not to complete the
various steps in the dance?
In Janssen v. Celltrion, Celltrion had moved for
summary judgment alleging that Janssen lacked standing due to a
failure to join all the owners of the patent. The patent is
directed to a manufacturing process that allegedly covers the
manufacture of the biosimilar product. In its decision, the court
provided guidance on whether, if the pending cases were dismissed
without prejudice for lack of standing and a new case were
thereafter brought, Janssen would be limited to a reasonable
royalty for any proven infringement.
In this case, the court ruled that Janssen could seek lost
profits, in addition to a reasonable royalty, because Celltrion did
not engage in the required "good-faith" negotiation to
develop a list of patents to be asserted in the first phase of
BPCIA litigation. The court's order emphasizes the importance
of complying with the BPCIA's patent dance, noting that
"the Biologics Act lays out a step-by-step process for
exchanging information and channeling litigation about patents
relevant to the application." The BPCIA further states
that the parties "shall" engage in "good-faith
negotiations" and "shall" engage in the specified
dispute resolution procedure if those negotiations fail. The court
construed "shall" to mean that "the alleged
infringer must comply with each step in the BPCIA process in order
to limit the patentee to a reasonable royalty if it does not sue
within 30 days of the end of that process." As the court
explained, it is only the patents that emerge from the prescribed
negotiation that "are subject to the reasonable royalty
The interpretation of "shall" in other provisions of
the BPCIA is currently the subject of separate litigation and much
debate. On April 26, 2017, the Supreme Court will hear arguments in
Amgen v. Sandoz on whether the term "shall
provide" is mandatory or optional in another BPCIA
information-exchange provision. Sandoz has argued that a biosimilar
applicant can choose to engage in the BPCIA's patent dispute
resolution procedures, but cannot be compelled to do so. The
Supreme Court will also construe a related provision of the BPCIA
to determine whether a biosimilar applicant is required, under all
circumstances, to give the sponsor a "notice of commercial
marketing" not later than 180 days before the applicant begins
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