2,606,282 / bictegravir / BIKTARVY
The most significant aspect of this decision is the simple fact that Manson J granted a contested motion for a summary trial on a claim construction issue – essentially a Canadian version of a Markman hearing. ViiV had brought an action alleging that its 282 patent was infringed by Gilead’s bictegravir product, sold as BIKTARVY. Gilead responded with a motion for a summary trial, which Manson J granted despite ViiV’s objections and attempts to “derail” it [18]. This follows on last fall’s decision in Canmar Foods v TA Foods 2019 FC 1233 (see here and here), in which Manson J explained that for a decade after the FCA restricted the availability of summary trial in MacNeil Estate 2004 FCA 50, “summary judgment as a just, efficient and expeditious means to resolve disputes on a proportionate basis was lost” [45], until Hryniak v Mauldin, 2014 SCC 7 resulted in “a culture shift” that “opened the door for a more reasoned approach to the use of summary judgment motions” [46]. (The only other recent summary trial that I’m aware of is Cascade v Kinshofer 2016 FC 1117, but it was on consent.) It will be interesting to see whether other FC judges agree with Manson J’s view of the effect of Hryniak, and, when an appeal inevitably comes, whether the FCA agrees as well. (I must say it seems like a good idea to me, but procedure is not my area of expertise.) Manson J’s specific reasons for granting the motion on the facts of this case ([11]-[18]), will be of interest in future motions of this type, but since the discussion is brief and I don’t have anything to add, I won’t go through it.
Recourse to the disclosure in claim construction
The key substantive issue was the construction of a single claim term. The most interesting substantive point is that Manson J, after an extensive review of the case law, had recourse to the disclosure to construe the contested claim term, even though it appeared on its face “to be a clear and unambiguous term” [128]
All the claims at issue (Claim 1 is exemplary) [88], are claims to a class of compounds comprising Ring A.
Ring A is defined in the claim as an “optionally substituted heterocycle” [102]. The key issue — where the shoe pinches — is whether Ring A includes only fused and spiro rings, or also a bridged bicyclic ring, as is found in bictegravir.
Much of Manson J’s discussion concerned the proper approach to claim construction. As Manson J noted, the “[t]he law is clear that recourse to the disclosure is improper to vary the scope or ambit of the claims” [126], [136]. However, it is said that while recourse to the disclosure is “permissible to assist in understanding the terms used in the claims,” it is “unnecessary where the words of the claim are plain and unambiguous,” Dableh (1996) 68 CPR (3d) 129 (FCA) at 144 [126].
The tricky question is whether it is permissible to consult the specification as a whole only when the claims are ambiguous. What if the words of the claim appear to be clear when read in isolation, but when read in the context of the disclosure as a whole, it is apparent that they mean something different from what they “clearly” mean when read in isolation? Is it necessary to make a determination that the claims are ambiguous before recourse to the disclosure is permissible? A series of decisions have wrestled with this question.
I won’t go through Manson J’s review of the case law in detail, but I would highlight his conclusion:
[66] The common thread in all of these cases is that the court is to construe the claims
through the eyes of the POSITA in light of their CGK at the relevant date. Apart from the
patent specification, the only evidence the Court should consider to inform its analysis of
the claims is evidence of how the POSITA would understand the claims in light of his or
her relevant CGK in the context of the specification as a whole (Bombardier FCA [2018
FCA 172] at para 24).
In other words, the claims must be read in the context of the specification because the claims are part of the specification. This strikes me as clearly correct; I won’t say more as I’ve discussed the principles at length in other posts.
Manson J’s application of these principles to the facts is clear:
[128] While “optionally substituted heterocycle” as used in claim 1 appears on its face to
be a clear and unambiguous term, I accept that recourse to the disclosure is necessary to
understand the meaning given to these words by the inventors, and the intended scope of
this claim language.
This is a clear holding, applied on the facts, that it is permissible to have recourse to the disclosure to understand the claims, even if the claims appear to be clear when read in isolation.
Essentiality
I’ll conclude with a brief comment on the essentiality analysis. ViiV argued that if Manson J construed Ring A as being limited to spiro and fused structures only, it was necessary for the Court to go on to consider whether the bridged ring was an obvious variant. Manson J rejected this, saying
[167] In light of ViiV’s admission that Ring A, as an “optionally substituted
heterocycle,” is an essential feature of the invention, the Court does not accept that it
should now look at a variant of this essential feature. The Free World Trust [2000 SCC
66]variant analysis focuses on a claimed element of an invention, not some sub-element
or feature of the claimed element.
I’m not sure I agree with this. It is true that Free World Trust focused on what it described as “elements” but it’s not clear to me that the analysis turns on what particular aspect of the claim is identified as an “element.” The term “element” never even appears in earlier cases, such as JK Smit [1940] SCR 279 or Birmingham Sound [1956] RPC 232 (CA), that the SCC inWhirlpool 2000 SCC 67 [45], [47] identified as exemplifying the analysis. In any event, the point was not determinative, as Manson J went on to hold that in any event, ViiV had not met its burden of establishing that it would have been obvious to the POSITA at the publication date that bridged bicyclic Ring A structures would have no material effect on how the invention works” [168].
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