On October 24, 2014, Amgen initiated the first litigation under
the Biologics Price Competition and Innovation Act
("BPCIA"), asserting infringement of two patents. Over
the last two calendar years, Amgen, Biogen, Genentech, and
Regeneron have all filed BPCIA complaints (sometimes several)
asserting 20 or more patents. Does this reflect a trend of
Reference Product Sponsors ("RPS") asserting more patents
as they have gotten more experience with BPCIA litigation over the
last decade since Amgen filed the first BPCIA complaint asserting
just two patents?
To answer this question, we reviewed the complaints filed in all
54 BPCIA litigations monitored by the Big Molecule Watch blog and
tallied the number of patents asserted. On average, 17 patents were
asserted per BPCIA litigation, but that average does not appear to
be representative of the current trends. An average of 13 patents
were asserted in the 31 BPCIA complaints filed from 2014 through
2019, while an average of
