FCA Dismisses Apotex Appeal to have the Promise Doctrine Extended

FCA Dismisses Apotex Appeal to have the Promise Doctrine Extended

Apotex Inc v Pfizer Canada Inc2014 FCA 250

The Federal Court of Appeal dismissed two appeals brought by Mylan Pharmaceuticals and Apotex Inc. (appellants) against Pfizer Canada Inc. and G.D. Searle & Co. (respondents). [1] The appellants argued that the Federal Court judge in each respective Federal Court case (2014 FC 83 [the Mylan decision], 2014 FC 314, [the Apotex decision]) erred when he held that the patent on celocoxib, Canadian Patent No. 2,177,576 (the ‘576 Patent), did not promise certain specified results. [2] The Court rejected the arguments of the appellants that, in light of the alleged promises made, the ‘576 Patent lacked utility in respect of treating inflammation in humans, in reducing side effects, in preventing colorectal cancer, and further rejected the argument on insufficient disclosure, and the arguments of abuse of process, comity, and stare decisis, which posited that the Court was bound by previous constructions of the ‘576 Patent made in the Federal Court and Federal Court of Appeal.

In dismissing each of these arguments, the Court made several comments on the law of the promise of the patent.

Although Pfizer was ultimately successful on the appeal, the Court rejected Pfizer’s argument that new law was developed with respect to the promise of the patent in Sanofi-Aventis v Apotex Inc, 2013 FCA 186 [Plavix FCA] (Leave to Appeal to SCC granted January 30, 2014, 35562, discontinued by Apotex, November 3, 2014).[68] The Court held that the analogy that was made in Plavix FCA that went towards the level of explicitness required for a statement in a patent to be considered a promise (that a promise must be supported by language “at least as clear and unambiguous as that used to establish the advantages of the selection over the compounds of a genus patent”) [67] to be not new law but merely an application of a long established legal approach. [68]

The Court rejected Apotex’s sweeping argument that any given promise in the patent must be construed as overarching to all of the patent’s claims. [86,87] The Court acknowledged that some promises may extend to each of the patent’s claims, but that there is no case law to support the assertion that every promise must extend to each of the patent’s claims. [87]

The Court also reiterated that the promise of the patent rule should favour saving an invention rather than invalidating it where there is ambiguity, [67] and that the construction will favour the patentee where it can reasonably be read by the skilled person as excluding this promise. [66]

Promise of Utility in Treating Inflammation in Humans [70-73]

The Court rejected Apotex’s argument that the ‘576 patent promised utility in treating inflammation, and that this promise also extended to humans, [70] which was a promise that was not upheld since as of the filing date the utility could be only demonstrated to reduce inflammation in rats. [34] The Court did not refer to a specific claim or a specific passage from the specification when addressing this argument, but notes that the ‘576 Patent speaks of treatment of a “subject”, which, according to Apotex, must be understood to include humans since the disorders that the invented compounds are claimed to treat are suffered by humans, some exclusively by humans. [35]

In dismissing the argument, the Court stated that while assertions of results or advantages in a patent’s claims will generally be seen as a promise of utility, Apotex failed to demonstrate how any of the claims in the ‘576 patent describe use in humans as a particular advantage of the claimed compounds, [71] even when read in light of Plavix FCA. [72] The Court must have thought this answer was sufficient, since it did not address the point made by Apotex that the disorders that the invented compounds are claimed to treat some disorders that are exclusive to humans.

Promise of Utility in Reducing Side Effects [74-84]

The Court rejected several arguments by the appellants that attacked the alleged promised utility in reducing side effects.

Firstly, the Court found no justification in the appellant’s argument that the Federal Court judge erred in holding that a promise must be explicitly stated in a patent’s claims. Pointing to para 70 of the Mylan decision and para 36 of the Apotex decision, the Court found no such assertion by the Federal Court Judge. [77] Neither of these references discuss passages of the ‘576 Patent directly, but each include the quote from Fournier Pharma Inc v Canada (Health), 2012 FC 741: “a utility not expressed in the claim portion of the specification ‘[…] should be presumed to be a mere statement of advantage unless the inventor clearly and unequivocally states that it is part of the promised utility.’”

Secondly, the Court rejected Mylan’s argument that the ‘576 Patent must be construed to include elevated COX-2 selectivity that is “distinctly higher” than existing NSAIDs, since the Federal Court judge in the Apotex decision “appears to have recognized as much”. [78] The Court found that no such recognition by the Federal Court judge occurred. [79]

Thirdly, the Court rejected Apotex’s argument that the Federal Court judge “blindly” adopted expert opinion that the patent should not be read to be making a distinction between “common” side effects and “harmful” side effects. [81] On the Court’s interpretation, the Federal Court judge was only using the expert opinion to support his view. [82]

Fourthly, the Court rejected Apotex’s argument that a distinction should be made between statements in the ‘576 Patent about “less equivocal side effects” and “more equivocal side effects”. [83] The Court rejected this distinction has having no grounding in any of the expert evidence. [84]

Utility in Preventing Colorectal Cancer [85-89]

The Court rejected Apotex’s argument that any given promise in the patent must be construed as overarching to all of the patent’s claims, [86,87] and further that the promise of preventing colorectal cancer must be construed as a promise overarching all of the patent’s claims. [89] The Court acknowledged that some promises may extend to each of the patent’s claims, but that there is no case law to support the assertion that every promise must extend to each of the patent’s claims. [87] Further, the Court agreed with the respondent that the promise of utility in preventing colorectal cancer is limited, if it exists at all, to Claim 16 of the ‘576 Patent. [86, 88] Claim 16 is presented below:

16. Use of a compound according to any of claims 1 to 7, including those as excluded in Claim 1 by the provisos except those wherein R2 and R3 are both hydrido, for preparing a medicament for the prevention of colorectal cancer in a subject.

Insufficiency of Disclosure [90 – 92]

Apotex further argued insufficient disclosure, claiming that the respondent concealed the “true invention” among compounds it knew not to be useful. [90] The Court, thinking this argument was likely an “afterthought” following the decision in Teva Canada Ltd v Pfizer Canada Inc, 2012 SCC 60, rejected the argument on the procedural basis that the argument was not contained in Apotex’s notice of allegation. [92]

Abuse of Process [94 – 108]

Apotex and Mylan argued that it would be an abuse of process to dispute whether the ‘576 Patent promised reduced side effects since Hughes J in Novopharm FC had already conceded that the reduced side effects were necessary to the utility of the claimed invention. [94] The Court declined to overturn the Federal Court judge’s dismissal of this argument since it was not arrived at on the basis of an improper principle or wrongful exercise of discretion. [96]

Apotex argued that a patentee cannot “elevate the ‘inventive concept’ to support non-obviousness and then read down the promised utility”. [98] The Court rejected these arguments based on lack of precedential authority, since the only authority applies against a patentee taking two different positions within a single proceeding, which is not the case here. [99]

Apotex further argued that the respondent cannot take “fundamentally inconsistent positions” in different proceedings in respect of the same patent, citing Apotex Inc v AstraZeneca Canada Inc, 2012 FC 559 [Omeprazole FC]. [98] The Court rejected the argument, interpreting Omeprazole FC to not be so broad, [100] being limited to where the innovator took one position to avail itself of a stay, and then another position when the generic sought to be compensated for being subject to that stay. [102]

Apotex argued that Pfizer cannot relitigate the lack of utility issues already decided in GD Searle & Co v Novopharm Ltd, 2007 FCA 173 [Novopharm FCA] , a caseto which it was a party, by bringing additional evidence that it chose not to adduce in the earlier proceedings. [98] The Court found this allegation not to accord with the facts, since firstly, Pfizer was only refusing to abide by an earlier concession, not providing additional evidence, and secondly, Pfizer was successful in the dispute when it was disposed of in Novopharm FCA. [107]

Stare Decisis and Comity [109-118]

Mylan also argued that the Federal Court’s conclusions in Novopharm FCA and GD Searle & Co v Novopharm Ltd, 2007 FC 81 [Novopharm FC] on the construction of the ‘576 Patent were binding on the Federal Court before this appeal by stare decisis and comity (horizontal stare decisis) unless it can articulate cogent reasons for its departure. [112,113] The Court rejected the argument, stating that comity is not binding, [115] and that the construction of the ‘576 Patent in Novopharm FCA was not part of the ratio decidendi of that case. [117]

Commentary

This case goes towards clarifying the law on the promise doctrine in Canada. Firstly, the Court rejected Apotex’s sweeping claim that any given promise in the patent must be construed as overarching to all of the patent’s claims. Secondly, the Court rejected Pfizer’s argument that new law was developed in Sanofi-Aventis v Apotex Inc, 2013 FCA 186 where it was stated that a promise must be supported by language “at least as clear and unambiguous as that used to establish the advantages of the selection over the compounds of a genus patent”. The Court found this to be entirely consistent with the established law.

It is interesting to note that leave to appeal to the Supreme Court of Canada was granted in Sanofi-Aventis v Apotex Inc, 2013 FCA 186 (35562) on January 30, 2014, but Apotex discontinued the appeal on November 3 2014, four days after the release of this decision. The factums of the appellant Apotex, the respondent Sanofi-Aventis, and those of the interveners, argue a broad range of issues, but the promise doctrine appears to be where a significant amount of argument is directed.

What’s more, Apotex had argued in its reply factum at para 33 that “This Court’s articulation of the promise doctrine has always addressed the promised utility as a singular concept that pervades the entire patent, including all of the claims.” However, any notion that the discontinuance of the appeal to the SCC was influenced by the release of this decision is cautioned since the argument at para 33 does not appear to be a pivotal argument of Apotex. Furthermore, the analogy from the FCA comparing the language in a promise of a patent to the language of a selection patent does not seem to appear in any factum for the appeal to the SCC. Still, one wonders whether this judgment impacted Apotex’s decision to discontinue its appeal to the SCC.

Leave to appeal to the SCC for 2014 FCA 250 was dismissed.