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16 October 2017
In Bristol-Myers Squibb v Apotex,(1) the Federal Court of Appeal – in its first decision to consider the Supreme Court's landmark decision in AstraZeneca Canada Inc v Apotex Inc (Esomeprazole)(2) on the utility requirement(3) – overturned a finding of inutility made under the promise doctrine, with practical guidance for the requirement of a scintilla of utility.
Bristol-Myers Squibb sells the compound dasatinib as Sprycel, a drug used in the treatment of chronic myelogenous leukaemia. In a prohibition application under the Patented Medicines (Notice of Compliance) Regulations, Apotex alleged that a bare claim for the compound – Claim 27 of Canadian Patent 2,366,932 (the 932 patent) – was invalid due to a lack of utility.
Applying the promise doctrine analytical framework, before the release of Esomeprazole, the Federal Court found that there was an overarching promise in the 932 patent that dasatinib will "1) inhibit a Src-family [protein tyrosine kinase (PTK)]; 2) inhibit HER1 and HER2; and 3) be useful to treat a PTK-associated disorder or useful as anti-angiogenic agents". The Federal Court found that Bristol-Myers Squibb had data to prove the first of these claims, but not the second or third. The Federal Court thus concluded that Bristol-Myers Squibb had not met its burden to show that the entire overarching promised utility was either demonstrated or soundly predicted at the relevant date.
Following Esomeprazole, the Federal Court of Appeal reversed the Federal Court's decision. The court first noted that in Esomeprazole, the Supreme Court had unanimously abolished the promise doctrine. The court then applied the Supreme Court's two-step utility test.
First, in determining the claim's subject matter, the Federal Court of Appeal held that the subject matter of Claim 27 was merely the compound and not the potential therapeutic uses for dasatinib.
Second, in determining whether this subject matter was shown to be useful either by demonstration or sound prediction as of the filing date, the Federal Court of Appeal found that Bristol-Myers Squibb had demonstrated utility as it was conceded that it had demonstrated that dasatinib acted to inhibit Src-family PTKs.
As to the sort of discovery that will give rise to a scintilla of usefulness, the Federal Court of Appeal rejected Apotex's argument that the demonstration of "binding of dasatinib to certain isolated enzymes in a test tube" could not satisfy the utility requirement, holding as follows:
" I disagree. Establishing that a compound has the ability to inhibit a biological target implicated in disease is doubtlessly a useful discovery. Here, it was known as of the relevant date that enhanced activity of PTK was involved in many diseases, as stated in the specification and confirmed in the evidence of several of the experts. Thus, discovery of a substance that acted to inhibit certain PTKs represented an important advance and certainly meets the minimal utility requirements that are now applicable following the decision of the Supreme Court in Esomeprazole."
The Federal Court of Appeal set aside the judgment below in respect of the 932 patent and issued an order prohibiting issuance of a notice of compliance to Apotex for its dasatinib product until the patent's expiry.
The Federal Court of Appeal dismissed Bristol-Myers Squibb's appeal regarding a second patent, Canadian Patent 2,519,898, containing claims to the oral use of dasatinib for treatment of chronic myelogenous leukaemia and imatinib-resistant chronic myelogenous leukaemia. The court found no error in the Federal Court's finding that Apotex's obviousness allegation was justified.
For further information on this topic please contact Lynn Ing at Smart & Biggar/Fetherstonhaugh by telephone (+1 416 593 5514) or email (email@example.com). The Smart & Biggar/Fetherstonhaugh website can be accessed at www.smart-biggar.ca.
(1) 2017 FCA 190.
(2) 2017 SCC 36.
(3) For further details please see "Promise doctrine struck down and AstraZeneca's NEXIUM patent upheld as useful".
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