Esomeprazole SCC AstraZeneca v Apotex, 2017 SCC 36. Abolished the “promise doctrine”. I am going to review the impact this decision has had on patent jurisprudence.

Esomeprazole SCC First, what did the SCC say? Utility is determined in two steps: 1. Determine subject matter of the claim. 2. Assess whether this subject matter is capable of a practical purpose. The promise doctrine developed by the Federal Courts is unsound and is inconsistent with the words and the scheme of the Patent Act. That said, how are we now to deal with the mischief overpromising?

Esomeprazole SCC [1] A disclosure which is not correct and full, or states an unsubstantiated use or operation the invention, may be found to fail to fulfill the requirements of s. 27(3). [2] An overly broad claim may be declared invalid; however, under the operation of s. 58 of the Patent Act, remaining valid claims can be given effect. [3] As well, this mischief may result in a patent being void under s. 53 of the Act, where overpromising in the specification amounts to an omission or addition that is “willfully made for the purpose of misleading”. How do we now address overpromising?

Apotex dasatanib In BMS v Apotex (dasatanib), Apotex was responding to BMS’ appeal from a decision dismissing its application for an order of prohibition. (2017 FCA 190) The appeal had been heard but had not yet been decided when Esomeprazole SCC was released. The Federal Court of Appeal permitted post-hearing submissions on the impact of Esomeprazole SCC. 2017 FCA 190 (dasatinib) Gleason J.A.

Apotex dasatanib On the application, Apotex had succeeded on the promise doctrine. Apotex now sought to alter its approach by arguing that the subject- matter of claim 27 of the patent in suit included the potential therapeutic uses of dasatanib. This argument was rejected by the Court, which held that the subject matter of the relevant claim was merely the compound itself. As dasatinib had been demonstrated to “to inhibit a biological target implicated in disease” the Court held that it was “doubtlessly a useful discovery”. 2017 FCA 190 (dasatinib) Gleason J.A.

BMS v Apotex Presumably following the guidance in Esomeprazole SCC, Apotex had also sought to argue that the patent was invalid for failing to meet the disclosure requirement under section 27(3) of the Patent Act. However, the Court refused to consider this argument because it had not been raised on the appeal. 2017 FCA 190 (dasatinib) Gleason J.A.

Apotex latanoprost Pleadings amendments - three types of amendments were sought. (2017 FC 951) First, the plea that in the hypothetical but- for world, Esomeprazole SCC would not have been applied and the result would as it had been prior to Esomeprazole SCC. 2017 FC 951 (latanoprost) Manson J.

Apotex latanoprost Second, insufficiency under section 27(3) of the Act. Third, overbreadth.

Apotex latanoprost Under the NOC Regs, Apotex’s allegations of invalidity had been found to be justified on the basis of the promise doctrine. Now, in the first set of amendments, Apotex sought to advance the plea that in the but-for world, the same result would obtain. This amendment was permitted. 2017 FC 951 (latanoprost) Manson J.

Apotex latanoprost Second, Apotex sought to plead that “[b]ecause the 132 Patent overpromises, it contains a disclosure that is not correct and full and it states an unsubstantiated use or operation of the purported invention, which constitutes a failure to fulfill the requirements of subsection 27(3)…” Sounds just like what the SCC said in Esomeprazole SCC. However, Apotex’s amendment was not allowed. 2017 FC 951 (latanoprost) Manson J.

Apotex latanoprost The Court held (¶52): “the impugned insufficiency plea does not stand a reasonable prospect of success.” It would seem, therefore, that the suggestion in Esomeprazole SCC that the mischief of overpromising might be dealt with under section 27(3) is not borne out. 2017 FC 951 (latanoprost) Manson J.

Apotex latanoprost Third, Apotex also sought to amend to plead overbreadth, specifically that there had been no demonstration or sound prediction of the advantage found in some of the patent claims. This was said to constitute the mischief of overpromising referred to by the SCC in Esomeprazole and to render the claims invalid for overbreadth. 2017 FC 951 (latanoprost) Manson J.

Apotex latanoprost Despite Pfizer’s argument that this was “an attempt to circumvent the reasoning of the SCC in Esomeprazole and improperly conflates overbreadth with utility”, the Court held that this plea stood “a reasonable prospect of success” and allowed the amendment. So, the mischief may possibly be addressed through a plea of overbreadth. 2017 FC 951 (latanoprost) Manson J.

Hospira methotrexate This decision (2018 FC 259) involves only a brief consideration of the issue:   [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. 2018 FC 259 (methotrexate) Phelan J.

Hospira methotrexate Are we to then understand that overpromising is not be raised in connection with a plea that the patent claims are overly broad? That is at least one interpretation of the passage we just saw. And didn’t the SCC give us “clear language” as to how to address the mischief of overpromising? 2018 FC 259 (methotrexate) Phelan J.

Retroactive Effect? In Teva v Lilly (olanzapine), Lilly’s appeal from the trial judgment of Teva’s section 8 claim was pending at the time that Esomeprazole SCC was released. (2018 FCA 53) Lilly sought and was granted leave to amend its Notice of Appeal, essentially to argue that Teva should be denied any damages because the relevant patent would not have been found valid if Esomeprazole SCC had been applied at the impeachment stage. 2018 FCA 53 (olanzapine) Laskin J.A.

Teva olanzapine Lilly was unsuccessful on the appeal, with the Court holding: [47] In my view things are not so simple. … it does not follow from the decision in AstraZeneca that Lilly’s patent would necessarily have been found to be valid if validity had been litigated after the decision was rendered. Parties shape their trial evidence and argument to the law as it exists at the time of trial. The evidence and argument before the trial judge in this case would inevitably have been different if AstraZeneca had been the governing law. 2018 FCA 53 (olanzapine) Laskin J.A.

Teva olanzapine And further noted (¶47): … the Supreme Court’s indication … that at least some of the concerns that animated the promise doctrine can better be dealt with as issues of sufficiency of disclosure. … Here, the FCA appears to be suggesting that overpromising might be addressed under sufficiency. 2018 FCA 53 (olanzapine) Laskin J.A.

Teva olanzapine After concluding that Lilly’s argument “depends on a finding of invalidity” the Court of Appeal observed that that was an issue “already decided” and declined to exercise its discretion not to apply issue estoppel. Lilly’s application for leave to appeal to the Supreme Court was dismissed yesterday. 2018 FCA 53 (olanzapine) Laskin J.A.

Apotex ramipril A decision from the Ontario Superior Court involving the ramipril patent. (2018 ONSC 903; rev’d 2018 ONCA 890) As in the last case, the defendants wanted to plead that following Esomeprazole SCC, the patent in suit would not have been invalidated. Without a finding of invalidity, Apotex could not recover damages in its claim under the Monopolies Act. 2018 ONSC 903 (ramipril) Dunphy J.

Apotex ramipril At the Superior Court the amendments were refused. However, that decision was overturned yesterday by the Court of Appeal for Ontario.

Apotex ramipril The OCA permitted the amendments, observing that it “will be up to the trial judge to determine whether that defence [that the patent in suit was valid, not invalid] will succeed.” Five reasons were given for departing from the decision in Teva olanzapine, which the OCA expressly considered. This was a rare instance that resulted in a foundational change to the law in this particular area. In my view, it is precisely the type of special circumstance where the principle of finality should yield to the justice of the case.  (¶36)

Where does this take us? It would seem that overpromising cannot currently be raised under section 27(3). As for overbreadth, more guidance may be required. It is unclear whether Esomeprazole SCC can be called upon to overturn existing judgments that invalidated patents.

Where does this take us? Never a dull moment in Canadian patent jurisprudence! Questions? Thank you.