Canada’s Federal Court of Appeal Applies Supreme Court’s Utility Test for the First Time to Uphold Validity of BMS’ Dasatinib Patent

On September 18, 2017, Canada’s Federal Court of Appeal (FCA) released its decision in BMS v Apotex Inc, 2017 FCA 190, reversing the Federal Court’s (FC) decision (2017 FC 296) that held BMS’s dasatinib (SPRYCEL®) patent invalid for lacking a demonstration or sound prediction of utility as of the Canadian filing date. This case marked the FCA’s first application of the utility test recently provided by the Supreme Court of Canada (SCC) in AstraZeneca Canada Inc v Apotex Inc (AstraZeneca, 2017 SCC 36, previously reported in E-TIPS® Newsletter here).

In AstraZeneca, the SCC provided the following test to determine utility:

1. identify the subject-matter of the invention as claimed in the patent; and

2. ask whether that subject-matter is useful – is it capable of a practical purpose (an actual result).

The claim at issue recites the compound dasatinib. Applying SCC’s utility test, the FCA held that the subject-matter of the claim was merely the compound and that BMS had demonstrated that dasatinib had at least a scintilla of utility – acting to inhibit Src-family PTKs. FCA rejected Apotex’s argument that showing “the binding of dasatinib to certain isolated enzymes in a test tube … cannot satisfy the utility requirement” and held that “[e]stablishing a compound has the ability to inhibit a biological target implicated in disease is doubtlessly a useful discovery”.

The FCA therefore set aside the FC’s judgment in respect of BMS’ dasatinib patent. It also dismissed BMS’ invalidity appeal regarding its patent claiming the oral use of dasatinib for treatment of chronic myelogenous leukemia (CML) and imatinib-resistant CML (use patent). The FCA did not find that the FC made a palpable and overriding error in finding that Apotex’s obviousness allegation regarding BMS’ use patent was justified.

Summary By: Junyi Chen