Update: The Promise Doctrine And Utility Post Astrazeneca

Despite the collective sigh of relief uttered by patentees following the Supreme Court's apparent abolition of the promise doctrine in the AstraZeneca judgment rendered June 30, 2017, 1 some doubt remained as to how lower courts would apply the decision.

First, commentary by the court about the mischief of overpromising and potential consequences under sections 27(3) and 53 of the Patent Act, as well as for overly broad claims,2 led to arguments being advanced that the promise doctrine endured (albeit under different auspices). Second, in articulating the test for utility under section 2, the court set the standard at whether the subject matter of the claimed invention was "capable of a practical purpose (i.e. an actual result)", but then went on to say that a scintilla of utility will do, 3 arguably leaving some room for debate.

These issues have since been addressed in a number of cases. The Federal Court, Federal Court of Appeal and Ontario Superior Court of Justice have consistently refused to revive the promise doctrine and applied a scintilla of utility standard. Most recently in Hospira Healthcare Corp v Kennedy Trust for Rheumatology Research, Justice Phelan stated:

[257] The law has returned to the principle that utility is met if a "scintilla" of utility is demonstrated. ...

[258] Hospira attempts to import the discarded "promise" doctrine into insufficiency and overbreadth. Certainly AstraZeneca does not do so and it would be inconsistent to discard that doctrine only to have it resurface under another principle without clear language to do so.

Hospira and the other cases addressing these issues are presented and summarized below.

The Cases

Bristol-Meyers Squibb v. Apotex, 2017 FCA 190

In the first Post-AstraZeneca decision on patent utility, the Federal Court of Appeal elaborated on the meaning of a "mere scintilla" of utility and commented that this standard is a "minimal utility requirement." This case concerned the validity of Bristol-Meyers Squibb's (BMS) patent for its leukemia drug SPRYCEL® (dasatinib). The Federal Court previously held that BMS's patent lacked utility as BMS had not demonstrated or soundly predicted all of the promised utilities for one of the claims as of the relevant date. Justice Gleason, applying the new test for utility set out in AstraZeneca, held that utility was in fact demonstrated as of the relevant date, and overturned the Federal Court's decision.

On the first step of the test, Gleason J. identified the subject-matter of the invention as claimed as "merely the compound", rejecting Apotex's argument that the subject-matter was the potential therapeutic uses of the drug. On the second step, Gleason J. noted the "minimal utility requirement" set out by the Supreme Court, and found that dasatinib's ability to inhibit certain proteins constituted a scintilla of utility. Establishing that a compound has the ability to inhibit a biological target implicated in disease is a useful discovery (i.e. capable of a practical purpose). She expressly rejected Apotex's argument that the binding of dasatinib to isolated enzymes in a test tube could not satisfy the utility requirement, and found that BMS had demonstrated utility as of the relevant date:

[37] Insofar as concerns the first point, contrary to what Apotex asserts in its supplemental written submissions, the subject-matter of claim 27 of the 932 patent is not the potential therapeutic uses for dasatinib. Rather, the subject-matter of claim 27 is merely the compound, dasatinib, itself. This is all that claim 27 claims, and it is erroneous to expand the subject-matter of the claim beyond what it says. In Esomeprazole, the Supreme Court found the subject-matter of a similar compound claim to be simply the compound itself (Esomeprazole at para. 61). Thus, contrary to what Apotex says, the relevant subject-matter in issue is merely the compound, dasatinib.

[38] The second step of the requisite analysis involves determining whether BMS has...