Tuesday, July 10, 2012

Claim Ambiguity and Recourse to the Specification

Fournier Pharma Inc. v. Sandoz Canada Inc. 2012 FC 740, 2012 FC 741 Zinn J
NOC; fenofibrate; LIPIDIL EZ; 2,487,054 (2012 FC 740); 2,372,576 (2012 FC 741)

The separate decisions in Fournier / fenofibrate (NOC) concern the same drug but two different patents. In both cases Fournier failed to obtain an order of prohibition against Sandoz because it failed to established that Sandoz’ product would infringe. Both patents had a particle size limitation. The particle size of Sandoz’ product could have been determined by a standard method, yet neither party did so [740: 102 / 741: 87]. Zinn J refused to draw any adverse inference from Fournier’s failure to carry out the relevant test, because Sandoz could equally well have carried out the test itself [740: 132 / 741: 87]. But the burden in an NOC proceeding is on the patentee to show that the generic’s allegations are not justified, and the evidence which Fournier did advance was inadequate to establish infringement [740: 129 / 741: 91].

The main legal battleground in the case was claims construction. The claims were well-drafted, so that the specification generally supported a straightforward reading of the text of the claims, but one point of interest arose 2012 FC 741, dealing with the ‘576 patent. A central issue was Sandoz’ submission that the term “micronized” in the phrase “a micronized form having a particle size less than or equal to about 20 μm,” should be interpreted as excluding particles less than 1 μm in size. Sandoz introduced evidence drawing on the common general knowledge in support of that interpretation. Zinn J responded by pointing out that the phrase “in micronized form” was specifically defined in the specification [65], and “where an inventor specifically provides a definition of a phrase used in the patent, that definition must be the prime consideration when interpreting the phrase and not the meaning that may or may not be ascribed any particular word in the phrase so defined” [66]. This is consistent with the principle that the specification may “provide[] the dictionary by which the scope and effect of these terms [of the claim] is to be ascertained” (Western Electric Co. v. Baldwin International Radio, [1934] S.C.R. 570 at 593). It is also consistent with the broader principle that “[t]he claims, of course, must be construed with reference to the entire specifications.” (Metalliflex Ltd. v. Rodi & Wienenberger Aktiengesellschaft, [1961] S.C.R. 117, 122 quoted with approval per Binnie J. Free World Trust 2000 SCC 66 at [52]; see also Electric & Musical Industries v Lissen Ltd (1939) 56 RPC 23 at 39 (HL): “The claims must undoubtedly be read as part of the entire document, and not as a separate document.”)

Subsequently, in construing a different term from the claim, Sandoz submitted that "it is an error of law to construe the claims by reference to the embodiments illustrated and described in the disclosure of the patent" [75] citing s as its authority Dableh v Ontario Hydro, [1996] 3 FC 751 (CA), in which the Urie JA stated that

It is a matter of settled law that recourse to the disclosure portion of the specification is: (1) permissible to assist in understanding the terms used in the claims; (2) unnecessary where the words are plain and unambiguous; and (3) improper to vary the scope or ambit of the claims.

Zinn J avoided part (2) of this rule by finding ambiguity in the claim [76]. While there is nothing wrong with doing so, this approach avoids a more fundamental problem, which is that the “rule” in Dableh is inconsistent with the broader rule, just discussed, that the claims must construed with reference to the entire specification. Suppose, for example, that the term “micronized” had a very clear meaning in the art, which excluded powdered particles of less than 1 μm, and yet the patentee had explicitly defined “micronized” in the specification as including smaller particles. Should “micronized” be interpreted as excluding small particles, on the basis that the term is unambiguous and it is therefore impermissible to have recourse to the specification, or should it be interpreted as including such parrticles, on the principle that it is necessary to read the claims in light of the specification and the patentee is entitled to create its own dictionary?

It is necessary to read claims in context and the same is true of doctrine. The puzzle can be resolved by a contextual interpretation of Dableh. Urie JA himself certainly understood that recourse to the specification is always permissible: “From these general propositions it is next necessary to recall that the claims define the scope of the monopoly and may be read with the disclosure in the earlier part of the specification ‘in order to understand what the former says’” (Procter & Gamble Co. v. Beecham Canada Ltd. 61 C.P.R. (2d) 1 at 11 (FCA), cited by Urie JA in setting out the rule in Dableh). It appears that statement (2) was intended as a summary of the principle that “If the patentee has [defined the scope of the monopoly] in a claim the language of which is plain and unambiguous, it is not open to your Lordships to restrict or expand or qualify its scope by reference to the body of the specification” (EMI v Lissen at 41 quoted by Urie JA in Procter & Gamble Co. v. Calgon). This does not say that recourse cannot be had to the specification to interpret the claims; it says that recourse cannot be had to the specification to change the claims. Fortunately, the view that recourse to the specification is impermissible absent ambiguity has recently been rejected by the FCA in Pfizer Canada Inc. v. Apotex Inc 2007 FCA 209 at [88]:

Thus, according to Dr. Langer, it was wrong of Dr. Brenner to interpret claim 1 of the '615 patent in the light of the specification because claim 1 is clear and unambiguous. Hence, it is not proper to consider the specification. In my view, Dr. Langer's approach is incorrect. In Whirlpool, supra, Binnie J. at paragraphs 49(e) and 52 made it clear that claims were to be construed in light of the entire specification in order to enable the reader to properly understand the claim at issue, bearing in mind that the specification could not serve as a device to expand the patentee's monopoly.

The FCA continued to say that “it [is] often unsafe to conclude that a term in a claim was plain and unambiguous without having carefully reviewed the specification.” On its face this seems to allow some life to the rule that there must be some ambiguity rule before recourse can be had to the specification. But if the specification must be referred to in order to determine whether there is ambiguity, then there will be “ambiguity” in any case in which the specification affects the interpretation of the claims. We might as well simply say that it is always necessary to have recourse to the specification in interpreting the claims.

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