Teva and Apotex’s Allegations, that the GLEEVEC Patent Is Invalid, Are Not Justified

Teva and Apotex’s Allegations, that the GLEEVEC Patent Is Invalid, Are Not Justified

Novartis Pharmaceuticals Canada Inc.
v. Apotex Inc.
, 2013 FC
142

Novartis is the owner of Canadian
Patent No. 2,093,203 (the '203 Patent) covering imatinib mesylate, the active
ingredient in GLEEVEC. Teva and Apotex served Novartis with a Notice of
Allegation (NOA) with respect to the '203 Patent, in which they alleged that
all or certain claims of the '203 Patent are invalid. In response, Novartis
commenced an Application challenging the invalidity allegations of the NOAs.

The Court held that the allegations
of invalidity contained in the NOAs cannot be justified, relying on the Court’s
concurrent reasons in 2013 FC 141 dismissing Teva and Apotex’s impeachment
actions against the '203 Patent.

Moreover, the Court refused to decide whether Teva and Apotex’s NOAs
were invalid due to the fact that they initially chose in their Health Canada
filings to wait until the expiry of the ‘203 Patent, but subsequently changed
their position and alleged that the ‘203 was invalid.