Wednesday, August 22, 2018

When Is it Permissible to Look at the Disclosure to Interpret the Claims?

Teva Canada Ltd v Janssen Inc 2018 FC 754 Locke J
            2,203,936 / 2,435,146 / 2,738,706 / bortezomib / VELCADE

Bortezomib is the API in a pharmaceutical product used for treating certain blood cancers [7]. The 936 patent claims the compound bortezomib [41], the 146 patent claims a specific formulation, namely the lyophilized mannitol ester of bortezomib [51], and the 706 patent claims a process for “large-scale” production of bortezomib. In prior NOC proceedings, Barnes J had held the 936 and 146 patents invalid for obviousness: 2015 FC 184 (discussed here), and 2015 FC 247 (here). Teva then brought an action for s 8 compensation and Janssen defended and counter-claimed on the basis that Teva had infringed the 936, 146 and 706 patents. Locke J held that the 936 and 146 patents were invalid for obviousness [208], [287] and that the 706 patent was not infringed [337], [341-42]. The s 8 action was therefore dismissed. Locke J’s decision turned on the facts. 

One legal issue of interest is that, as discussed here, there has been something of an ongoing debate as to whether recourse to the disclosure as an aid to construing the claims is always permissible, or is permissible only if the claims are ambiguous when read on their own. Locke J in particular has been concerned about this problem in prior decisions. On the one hand, it has been held that recourse to the disclosure is unnecessary where the words of the claim are plain and unambiguous, and in Mylan v Eli Lilly (CIALIS) 2016 FCA 119 [39] the FCA took that next step and held that “the judge erred in referring to the specification when construing the claims of the ‘377 patent. The rules of patent construction preclude reference to the specification when the claims are clear,” (my emphasis; and see similarly [43], cited by Locke J at [72]). On the other hand, the SCC said has a number of times that the claims must be construed in light of the specification as a whole, eg in Consolboard [1981] 1 SCR 504, at 520: “We must look to the whole of the disclosure and the claims to ascertain the nature of the invention and methods of its performance” (quoted at [75]). Locke J reviewed some of the relevant jurisprudence, noting the “potential for tension,” which he resolved by agreeing, at [74], with the assessment of Zinn J in Janssen-Ortho Inc v Novopharm Ltd 2010 FC 42 [115-116], [119 ].

In my view, with respect, the statement by the FCA in Mylan v Lilly that reference to the disclosure is impermissible when the claims are clear, is simply wrong. It is inconsistent with the statement by the SCC in Metalliflex [1961] SCR 117 , 122:

The claims, of course, must be construed with reference to the entire specifications, and the latter may therefore be considered in order to assist in apprehending and construing a claim, but the patentee may not be allowed to expand his monopoly specifically expressed in the claims "by borrowing this or that gloss from other parts of the specifications".

This statement was re-affirmed in Whirlpool 2000 SCC 67 [52], and is consistent with the passage from Consolboard quoted above. Similarly, in Minerals Separation [1950] SCR 36, 56, the SCC quoted with approval from the leading UKHL decision in EMI v Lissen (1939) 56 RPC 23 at 39, in which Lord Russell said

The claims must undoubtedly be read as part of the entire document and not as a separate document; but the forbidden field must be found in the language of the claims and not elsewhere.

The SCC in Minerals Separation then confirmed that “The claims then define and limit the ambit of the invention and may be read with the disclosure in the earlier part of the specification ‘in order to understand what the former says’.” (The above passage from Metalliflex was also quoted by Zinn J in Janssen-Ortho v Novopharm 2010 FC 42 and properly emphasized by Locke J in this case [74].)

The contrary rule, expressed by the FCA in Mylan v Eli Lilly, stems from a summary of the law provided by Urie JA in Procter & Gamble v Beecham 61 CPR(2d) 1, 11 (FCA):

In summary, the principles which I derive from the above-mentioned authorities as well as from others referred to in argument, to which further reference need not be made here, are that in construing the claims in a patent, recourse to the remainder of the specification is (a) permissible only to assist in understanding terms used in the claims; (b) unnecessary where the words of the claim are plain and unambiguous; and (c) improper to vary the scope or ambit of the claims.

It is (b) that has caused the problems. In itself, (b) is not strictly inconsistent with the SCC precedent, in that when the words of the claim are plain and unambiguous, reading them in light of the disclosure is unlikely to change much. But it is a short step from there to saying that it is impermissible to consider the disclosure except when the claims are unambiguous — a step which the FCA took in Mylan v Eli Lilly. Various problems ensue, such as whether it is permissible to look at the disclosure to decide whether the words of the claims are ambiguous.

What did Urie JA mean by part (b) of his summary statement? He began the discussion which led to that summary by citing the SCC in Minerals Separation as saying that the claims may be read with the disclosure, and then went on to quote from EMI v Lissen, which, as just noted, clearly endorses reading the entire specification to understand the claims. It seems that (b) was derived from the following passages in EMI, which are the only places in Urie JA’s review referring to “unambiguous” claims:

But I know of no canon or principle which will justify one in departing from the unambiguous and grammatical meaning of a claim and narrowing or extending its scope by reading into it words which are not in it;

If the patentee has done this 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.

Neither of these statements says that it is impermissible to read the disclosure to understand the claims, if the claims are plain and unambiguous. Rather, they both say that it is impermissible to use the disclosure to change the meaning of the claims. That, I suggest, is the real import of part (b) of Urie JA’s summary.

This view is consistent with Dableh v Ontario Hydro [1996] 3 FC 751 (FCA), which quoted Urie JA’s summary, as in Dableh the trial judge had in effect impermissibly restricted the scope of the claims to the specific embodiment of the invention set out in the description. Even in Mylan v Eli Lilly, the putative error was “of no consequence” [43].

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