Many reference product sponsors ("RPSs") of biologic
products have sought extensive patent protection for their
manufacturing processes, and RPSs commonly assert those patents
against biosimilar manufacturers in Biologics Price Competition and
Innovation ("BPCIA") litigation. Disputes over the scope
of discovery for manufacturing information are therefore common and
have included RPSs seeking manufacturing information from
biosimilar manufacturers and biosimilar manufacturers seeking
discovery from RPSs and even third parties, as discussed below.
Manufacturing patents are frequently at issue in BPCIA
litigation. For example, about half of the 68 patents Genentech has
asserted in recent BPCIA litigations are directed to
manufacturing.1 About half of the 18 patents that
AbbVie has asserted in BPCIA litigation related to Humira® are
directed to manufacturing.2 And of the 6 patents asserted by
Janssen in the BPCIA context, 4 patents have been directed to
manufacturing.3
