Bristol-Myers Squibb Canada v. Apotex Inc., 2017 FC 296 Drug: dasatinib
The Court dismissed Bristol Myers Squibb's application for an order prohibiting the Minister from issuing an NOC to Apotex for its generic version of Sprycel®. The application related to two patents. Both patents, the ‘932 Patent and the ‘898 Patent, concern cyclic compounds (including dasatinib) and salts thereof, to methods of using such compounds in treating protein tyrosine kinase (PTK) associated disorders such as immunologic and oncologic disorders, and to pharmaceutical compositions containing such compounds.
With respect to the first patent, the Court found that Apotex's allegation of invalidity on the basis of inutility was justified. Contrary to the Applicants submissions, the Court concluded that there are clear references in the specification that support the view of an overarching promise for therapeutic utility against PTK-associated disorders, in addition to the specific therapeutic utilities disclosed in the use claims. The promised utility was not demonstrated, nor soundly predicted as of the relevant date.
With respect to the second patent, the Court found that Apotex's allegation of invalidity on the basis of obviousness and double patenting were justified. The invention in the asserted claims of the ‘898 Patent, is the oral use of the compound for the treatment of Chronic Myelogenous Leukemia (CML) and imatinib-resistant CML (imatinib was an earlier treatment for CML), respectively. The Court found it clear that, at the relevant time, there was significant motivation in the field of CML research to find an alternative therapy for treating CML and imatinib-resistant CML. Thus, the Court concluded that Apotex's allegation that it was more or less self-evident that trying to treat CML and imatinib-resistant CML with the compound ought to work is justified. The Court also found that Apotex's allegation that the nature of the work required to achieve the invention was routine was justified.
On the issue of double patenting, the parties argued over which date should be relevant to the double patenting analysis: the claim date of the first patent, the priority date of the second patent, or the publication date of the second patent. Only claim was at issue for this allegation, since the parties had agreed that if Apotex's allegation of obviousness for claim 1 was found to be justified, its allegation of obviousness-type double patenting for the same claim would also be justified.
The Court noted that if the relevant date was the first patent's filing date, then claim 3 would not be invalid for obviousness-type double patenting, because imatinib-resistant CML was not well known as of that date. However, if the relevant date was either of the two later dates, then the Court's finding that Apotex's allegation of obviousness for claim 3 was justified entails that claim 3 be invalid for obviousness-type double patenting. The Court agreed with the comments made by Justice Gleason in E li Lilly Canada Inc v Apotex Inc, 2015 FC 875, finding that the second patent's priority date was the appropriate date at which double patenting is to be analyzed. Therefore, Apotex's allegations of double patenting were justified for both claim 1 and claim 3 of the ‘898 Patent.