The impact of the Supreme Court’s landmark ruling in AstraZeneca Canada Inc. v Apotex Inc., 2017 SCC 36 (NEXIUM decision) rejecting the “Promise Doctrine” is taking shape in the Federal Court. As we reported, the SCC held that the level of utility required of a Canadian patent is driven by the claims of the patent rather than the description, reversing years of jurisprudence. Recent decisions from the Federal Court of Appeal and the Federal Court have applied the NEXIUM decision. In addition, Apotex has brought a motion to the SCC to have certain issues remanded back to both the Federal Court of Appeal (FCA) and the Federal Court (FC).
FCA reverses lower court decision on utility in dasatinib case
As we reported, in a decision rendered before the NEXIUM decision, the FC dismissed Bristol-Myers Squibb’s (BMS) prohibition application relating to SPRYCEL® (dasatinib), finding that one of the patents had an overarching promise and lacked utility, and the other patent was “obvious to try.”
Post-NEXIUM, the FCA rejected the FC construction of an overarching promise for enzyme inhibition and therapeutic use. Applying the “fundamentally recast” approach to utility set out in the NEXIUM decision for the first time, the FCA first determined that the subject matter of the claim at issue – a “bare composition claim for dasatinib” – is the compound claimed, dasatinib. The FCA rejected Apotex’s assertion that the subject matter of the claim was “potential therapeutic uses for dasatinib,” as it would be an error to expand the subject matter beyond what the claim states.
The FCA then determined that, as of the filing date, BMS has demonstrated that dasatinib inhibited certain enzymes. This inhibition was referred to in the patent and confirmed by the evidence, and is “doubtlessly a useful discovery.”
The FCA therefore allowed BMS’s appeal relating to this patent and issued a prohibition order. The FCA upheld the lower court’s decision on obviousness relating to the other patent.
Prothonotary rules on pleadings amendments allegedly made in light of NEXIUM decision
In an action relating to lisdexamfetamine dimesylate, Apotex’s statement of claim in this action was filed before the NEXIUM decision and contained “extensive” allegations of inutility. Following the NEXIUM decision, Apotex moved to amend its claim on the basis of NEXIUM and Shire moved to strike all of Apotex’s allegations of inutility.
Prothonotary Tabib described Apotex’s amendments as “slipshod, inconsistent and confusing,” reflecting Apotex’s “refusal to come to terms with and embrace” the essence of the NEXIUM decision and a “fairly desperate attempt to shoehorn Apotex’s promise allegations into each and every ground of invalidity known to law.” However, she allowed many of the amendments, as they were merely a recasting of the existing allegations and did not introduce new facts.
Prothonotary Tabib did not allow Apotex’s amendments relating to s. 53 of the Patent Act. Section 53 allegations amount to an allegation of fraud and state of mind, and require full particulars. She inferred that Apotex had no reasonable basis for the allegations, as it had failed to plead any facts about “any particular state of mind or knowledge in any particular persons at any particular time,” and that is was therefore not in the interests of justice to allow these amendments.
Apotex brings motion to amend and remand in NEXIUM case
On August 29, 2017, Apotex brought a motion to the SCC to have the NEXIUM case remanded back to the FC to determine whether the “unfulfilled promises” found by the trial judge render the 653 patent invalid on the basis of insufficient disclosure, overbreadth and wilful misleading. Apotex claims that this is necessary as no court has ever considered the “promise” of improved therapeutic properties on any of these grounds.
Apotex has also asked for the case to be remanded back to the FCA on the issues of anticipation and obviousness, as the FCA did not consider these issues.
Bristol-Myers Squibb Canada Co. v Apotex Inc., 2017 FCA 190
Apotex Inc. v Shire LLC et al, 2017 FC 831