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Subject Matter Of A Compound Claim Cannot Be Expanded Beyond What It States – FCA

On September 18, 2017,  the Federal Court of Appeal released its decision in BMS’ appeal of a decision dismissing its prohibition application in respect of dasatinib and Canadian Patent Nos. 2,366,932 and 2,519,898.

Decision Below

The 932 Patent, in particular claim 27, is a compound patent directed to dasatinib or its salts. Justice Manson had previously held that the specification of the 932 Patent contains an overarching promise that all compounds will inhibit both a Src-family PTK and HER1/HER2, and be therapeutically useful in treating a PTY-associated disorder or useful as anti-angiogenic agents. While the parties agreed that BMS has demonstrated that dasatinib was an Src inhibitor as of the relevant date, the Application Judge held that BMS has not demonstrated nor could it soundly predict HER1/HER2 inhibition or that the claimed compounds could be used to treat disorders or be used as anti-angiogenic compounds. As a result, Justice Manson held that Apotex allegation of lack of utility was justified.

The 898 Patent is generally directed to the oral use of dasatinib in the treatment of chronic myelogenous leukemia, including CML that is resistant to imatinib. Justice Manson had previously held that the claims of the 898 Patent were obvious in light of several pieces of prior art, including art that disclosed that compounds like dasatinib were effective in treating CML.  Applying the test for obviousness set out by the Supreme Court of Canada in Sanofi-Synthelabo, Justice Manson held that orally administered dasatinib to treat imatinib-resistant CML was obvious to try.

Utility

While BMS’ appeal was pending, the Supreme Court of Canada issued its decision in Esomeprazole which held that that the so-called “promise doctrine” was not properly part of the utility analysis (see our previous post, here). Rather, the proper approach for assessing utility is:

First, courts must identify the subject-matter of the invention as claimed in the patent.

Second, courts must ask whether that subject-matter is useful — is it capable of a practical purpose (i.e. an actual result)?

In determining the subject matter of the impugned claims, the Court, following Esomeprazole, held that the potential therapeutic use of dasatinib was not part of the subject matter of the claim. Rather, claim 27 was simply directed to dasatinib per se:

[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.

BMS’ demonstration that dasatinib was an inhibitor of Src kinases was a real world utility sufficient to meet the minimal utility requirement following Esomeprazole and the Court of Appeal accordingly held that the Application Judge’s finding of lack of utility of the 932 Patent could not stand:

[8] For the reasons set out below and in light of the Supreme Court of Canada’s decision in Esomeprazole, I believe that the Federal Court’s determination regarding the lack of utility of claim 27 in the 932 patent cannot stand and that, accordingly, this appeal must be granted in respect of the 932 patent.

Obviousness

On appeal, BMS raised a number of arguments, including that the applications Judge erred in law by applying the “obvious to try test” instead of the test for obviousness. The Court of Appeal held that its prior decision in Atazanavir does not stand for the proposition that obvious to try cannot be considered in inquiring into obviousness.

The Court of Appeal also rejected BMS’ argument that the Application judge had conflated the tests for obviousness and sound prediction. While a single paragraph in the reasons below did link the obvious to try and the utility analyses, this paragraph was not central to the Application Judge’s reasoning and the balance showed that he correctly applied the test from Sanofi-Synthelabo.

A copy of the Court of Appeal’s Reasons may be found here.