The Whole Disclosure Must be Reviewed

Biogen Canada Inc v Pharmascience Inc 2022 FCA 143 Gauthier JA: Gleason, Rivoalen JJA affg Biogen Canada Inc v Taro Pharmaceuticals Inc 2020 FC 621 Manson J

            2,562,277 / fampidrine / FAMPYRA / NOC action

            FC Mosaic FC Anticipation FC Medical Treatment

There has been an on-going debate in the case law as to whether recourse to the disclosure is always permissible in claim construction, or is permissible only if the claim terms are ambiguous. In this decision, Gauthier JA has given us a clear and definitive answer (my emphasis):

[73] [T]he point of the [claim construction] analysis is to interpret and respect the inventors’ objective intention as manifested in the words he used. This is why the whole disclosure must be reviewed, even for words that would appear at first glance to be simple and unambiguous when reading only the claims. Indeed, one of the reasons for reviewing the disclosure is to determine whether the inventor actually defines particular words that could appear plain and simple even to a POSITA when reading only the claims.

Gauthier JA again emphasized the point

[71] Although the principles described by the Federal Court are not in dispute in this case, it is still important to reiterate that a patent’s description (also referred to as the disclosure) must be considered when construing claims.

And see [72] stating that “[p]urposive claim construction involves looking at words of the claims in context,” and the relevant context includes the description.

Moreover, Gauthier JA directly applied this principle in her analysis. The specific question was whether terms such as “for improving walking” incorporated a subjective assessment by the patient, or only a quantitatively measured improvement, as Manson J held [75]. While the FCA ultimately upheld Manson J’s claim construction on a deferential standard of review [142], this is not a case where the FCA affirmed the FC claim construction on a holistic appreciation and a deferential standard, perhaps glossing over some details. One of the appellant’s main arguments was that Manson J erred in construing certain contentious terms against what they considered to be conclusive evidence of agreement between the experts [77]. Gauthier JA consequently chose to go into considerable detail on claim construction to illustrate why it can be appropriate for a trial judge to reject expert evidence of how a skilled person would read a claim when that evidence is not supported by a proper application of the principles of purposive claim construction [86], [91]. (This case is also an excellent illustration of the principle that claim construction is a matter for the court.) Consequently, much of Gauthier JA’s discussion reflects the FCA’s own view as to the correct claim construction, not simply the application of a deferential standard of review.

Gauthier JA pointed out that the 277 patent expressly stated that all technical and scientific terms used have the same meanings as commonly understood by one of ordinary skill in the art, “[u]nless defined otherwise,” and indeed, certain specific expressions were given specific definitions [96]. Thus, Gauthier JA’s observation that one must review the disclosure “to determine whether the inventor actually defines particular words that could appear plain and simple” when reading only the claims was directly illustrated in this case. Similarly, she also noted the key contentious terms, namely “use for improving”, “use for increasing” or “use for reducing,” were common words that “[o]n their face . . . appear plain and simple” [82]. She nonetheless went on to consider the description at length [87]–[116], before reviewing the expert evidence and finally arriving at a conclusion on claim construction [142].

It is somewhat unfortunate that Gauthier JA did not refer to the debate over this point, but she cannot have been unaware of it. And this is not a situation where there was some clear and unambiguous statement from the FCA to the effect that recourse to the disclosure is impermissible unless the claim terms are ambiguous; rather, the debate has arisen because of a variety of ambiguous statements by the FCA: McHaffie J provided a thorough review of the cases in Guest Tek 2021 FC 276, discussed here. The point was also raised in Google v Sonos 2022 FC 1116 [40], released just a week after this decision. In that case, Zinn J reviewed the recent FC caselaw and agreed with McHaffie J that “[t]he exercise of construction must consider both the disclosure and the claims” [42]–[44]. Thus, there was already a consensus emerging at the FC level, which is consistent with the position stated by Gauthier JA. The key point is that recourse to the disclosure is always permissible, but “[t]he disclosure should not be used to enlarge or contract the scope of the claims, particularly through the addition of words or limitations not found in the claims” [42], quoting and agreeing with Guest Tek [47]. In the circumstances, I take it that Gauthier JA did not review the caselaw because she was of the view that the point was not sufficiently controversial to warrant it. In any event, given the very clear statement of principle, combined with its application to the facts, we can now take it as settled law that in carrying out claim construction, “the whole disclosure must be reviewed, even for words that would appear at first glance to be simple and unambiguous when reading only the claims.”

Obviousness

After affirmed Manson J’s holding on claim construction, the FCA went on to affirm on his finding that the asserted claims were invalid for obviousness [170]. In my post on Manson J’s decision on this issue, I suggested that his analysis was notable for making a mosaic of obscure prior art. This issue was not raised at the FCA. I’ll discuss it further in my upcoming post on Google v Sonos 2022 FC 1116, which raises the same issue.

Anticipation

Manson J also held the 277 patent invalid for anticipation, noting that the key anticipatory prior art “is similar to the allegedly anticipatory art in Hospira [2020 FCA 30]” [133]. As discussed here, I had several concerns regarding the implications of Hospira, as reflected in Manson J’s analysis. It is therefore noteworthy that Gauthier JA declined to address anticipation:

[172] As mentioned, there is no need to discuss the Federal Court’s findings in respect of anticipation, nor is this the proper case to address in obiter the question of how Hospira Healthcare Corporation v Kennedy Trust for Rheumatology Research, 2020 FCA 30 (Hospira) and the Federal Court’s conclusion on anticipation might have an impact on inventions requiring investments in large clinical trials, as briefly argued.

[173] That said, it is important to recall that nothing in these reasons or my conclusion that the appeal should be dismissed, should be understood as endorsing the conclusion of the Federal Court on anticipation. Also, neither this Court in Hospira nor the Federal Court intended to modify the well-established test enunciated in Sanofi (FC Decision at paras. 114-115).

Nor did Gauthier JA discuss Manson J’s holding that none of the asserted claims were invalid as covering unpatentable methods of medical treatment [FC 214], discussed here, as the issue was not raised before the FCA [33].