Judge Sleet of the U.S. District Court for the District of
Delaware has dismissed Genentech's complaint against Amgen for
allegedly failing to comply with the the Biologics Price
Competition and Innovation Act (BPCIA), but the Avastin biosimilar
patent dance still may go on. Judge Sleet dismissed the
complaint without prejudice and gave Genentech 45 days to
amend its complaint. Perhaps more importantly, the clock still may
be running against Genentech to make the next move in the patent
dance.
Genentech's Patent Dance Complaint
As explained in
this article, this case arose from Amgen's November 2016
aBLA for a biosimilar version of Genentech's Avastin®
(bevacizumab) product, which Genentech describes as it
"best-selling cancer drug." However, Genentech's
complaint was not for patent infringement, but rather alleged that
Amgen failed to comply with the information exchange requirements
of the "patent dance" provisions of the BPCIA.
Although Amgen provided a copy
