Federal Court Invalidates Olanzapine Patent: Selection Patents Revisited
On October 5, 2009, Justice O’Reilly of the Federal Court of Canada held in an infringement action, Eli Lilly Canada Inc v Novopharm Limited, 2009 FC 1018 (Lilly), that Canadian Patent No 2,041,113 (‘113 Patent) was not a valid selection patent.
The Lilly decision provides insight into the evidence required to establish or soundly predict a substantial and peculiar advantage on which a selection is based. The ‘113 Patent selected and claimed the schizophrenia drug olanzapine (ZYPREXA), inter alia, from a genus of compounds claimed in Canadian Patent No 1,075,687. The ‘113 Patent disclosed that olanzapine displayed certain surprising and unexpected clinical properties compared to other members of the genus, such as flumezapine and ethyl-olanzapine. The patent further stated that olanzapine showed marked superiority and a better side-effects profile over prior known anti-psychotic agents.
Lilly attempted to support the alleged clinical advantages of olanzapine; however, Justice O’Reilly held that the evidence did not establish any substantial and peculiar advantage of olanzapine, nor could it support a sound prediction of the disclosed advantages.
Justice O’Reilly’s analysis illuminated certain types of evidence the Court may find insufficient to support an advantage, and for a summary of those types of evidence and other aspects of the case, follow this link to a longer article on the Lilly case.
Summary and Article by: Michael Migus
