In
Apotex Pty Ltd v ICOS Corporation [2017] FCA 466, the
Federal Court has provided guidance regarding the level of
disclosure required by a patentee in order for a court to exercise
its discretion in allowing amendments to the specification during
court proceedings.
Eli Lilly and Company (Lilly) is the holding company of ICOS
Corporation (ICOS) and holds a number of patents worldwide that
relate to a compound known as tadalafil (a PDE5 inhibitor that is
useful in the treatment of erectile dysfunction).
As part of a Federal Court proceeding brought by Apotex relating
to the validity of AU 773666 (the "666 Patent", relating
to compositions containing tadalafil, including in micronised
particle sizes, and methods of treatment using such compositions)
and the AU 769946 (the "946 Patent", relating to
compositions containing particular daily dosages of tadalafil for
oral administration and methods of treatment using such dosages),
ICOS sought orders to amend the