Case:

Eli Lilly Canada Inc. et al. v. Novopharm Limited (Federal Court)

DRUG:

ZYPREXA® (olanzapine)

Nature of Case:

Patent Infringement Action Successful Party:Novopharm Limited

Date of Decision:

October 1, 2009 (non-confidential reasons dated October 8, 2009)  

Summary:

On October 1, 2009, Justice O'Reilly of the Federal Court held that Canadian Patent No. 2,041,113 ("113 Patent") was an invalid selection patent on the basis that the advantages of olanzapine in comparison to a previously disclosed genus and other anti-psychotics was not soundly predictable at the Canadian filing date.

The '113 Patent contained claims to olanzapine, inter alia. The subject-matter of the '113 Patent was selected from a previously disclosed class of compounds that was protected by Canadian Patent No. 1,075,687 (the '687 Patent). Olanzapine was broadly covered by the '687 Patent, but was not specifically claimed or exemplified. The '113 Patent disclosed that olanzapine displays certain surprising and unexpected properties compared to flumazapine and other related compounds. The '113 Patent also stated that in clinical situations, olanzapine shows marked superiority and a better side-effects profile than prior known anti-psychotic agents. At the filing date, Lilly had the results of healthy volunteer studies, preliminary results from clinical trials, and a six-month study in dogs. The '113 Patent itself contained direct comparisons between olanzapine, ethyl olanzapine and flumazapine. The Court noted, however, that neither of the comparator drugs referenced in the patent had been used to treat schizophrenia or any other condition.

O'Reilly J. held that a selected compound is an invention and is separately patentable if the patentee can establish, as of the Canadian filing date, that the selection had a substantial and peculiar advantage over the previously patented family of compounds, or if that advantage could be soundly predicted. The selection patent must set out clearly what is better and different about the selected class member. Sufficient representative testing must be disclosed in the patent so that a person skilled in the art could predict that the surprising characteristic would not be expected to be found in a large number of other compounds in the genus.

O'Reilly J. held that the '113 Patent was not a valid selection, as none of the advantages of olanzapine described in the patent were known or soundly predictable at the Canadian filing date. In particular, there was no evidence of any factual basis for the assertion that olanzapine had advantages over the genus of compounds disclosed in the '687 Patent, or in comparison to other known anti-psychotic agents. The comparisons presented in the '113 Patent did not relate to the genus as a whole and the alleged advantages of olanzapine were "insubstantial". The '113 Patent was not a valid selection, as little was known about the "billions of other compounds in the genus that might have been equal to or better than olanzapine". The invention claimed in the '113 Patent was "neither obvious nor a genuine invention." Rather, it was a "compound that showed promise and, later, some of the early positive indications were borne out." The Court issued a declaration of invalidity and held that Novopharm is entitled to relief under section 8 of the Patented Medicines (Notice of Compliance) Regulations based on its prior success in litigation against Lilly pertaining to the '113 Patent.

LINK TO DECISION:

The reasons have not yet been posted on the Federal Court website - the citation will be 2009 FC 1018.