Promise of the Patent Is to Be Found in the Claims

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

Zinn J’s Fournier / fenofibrate (NOC) decision turned primarily on claim construction and infringement, but hidden in the brief treatment of validity of the ‘576 patent there is a very important passage regarding the promise of the patent which deserves to be quoted in full (Zinn J’s emphasis):

[126] The Federal Court of Appeal in Eli Lilly Canada Inc v Novopharm Limited, 2010 FCA 197, citing Consolboard Inc v MacMillan Bloedel (Sask)Ltd, [1981] 1 SCR 504, stated at para 76 that “where the specification sets out an explicit ‘promise’, utility will be measured against that promise [emphasis added].” The promise of a patent, as that term is used in patent law, is nothing more than the utility the inventor claims for his invention. Where that promise – that claimed utility – is clearly and unequivocally expressed by the inventor in the claims of the patent, then that expression ought to be viewed as the promise of the patent. Any statement found elsewhere 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. The following from page 1 of the patent in AstraZeneca Canada Incv Apotex Inc, 2010 FC 714, is illustrative of such a statement found in the disclosure:

It is desirable to obtain compounds with improved pharmacokinetic and metabolic properties which will give an improved therapeutic profile such as a lower degree of interindividual variation. The present invention provides such compounds, which are novel salts of single enantiomers of omeprazole [emphasis added].

[127] The interpretation should be focused on the claims because an inventor is not obliged to claim a monopoly on everything new, ingenious, and useful disclosed in the specification. If, as here, the claims are certain and unambiguous in stating the promise, then the disclosure should not be examined microscopically to find additional promises that are outside the scope of the inventor’s claimed monopoly.

Consequently, Zinn J concluded at [128] that “I find, as stated in claim 1, that the promise of the patent is a “fenofibrate composition … having a dissolution of at least 10% in 5 minutes, 20% in 10 minutes, 50%in 20 minutes and 75% in 30 minutes” (my emphasis). As I have emphasized, this promise directly reflects the wording of the claim itself.

While Zinn J’s remarks are very clear and he has provided his own emphasis, almost the entire passage could be highlighted, so I will add some of my own:

Where that promise – that claimed utility – is clearly and unequivocally expressed by the inventor in the claims of the patent, then that expression ought to be viewed as the promise of the patent. Any statement found elsewhere 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. . . 

If, as here, the claims are certain and unambiguous in stating the promise, then the disclosure should not be examined microscopically to find additional promises that are outside the scope of the inventor’s claimed monopoly.

Zinn J’s focus on the claims is in sharp contrast with the trend of the recent Canadian cases, which is to extract the promise of the patent from a searching, sometimes “microscopic,” analysis of the disclosure. This is usually done in an ad hoc manner, though Rennie J in Astrazeneca / anastrozole (NOC) has recently used a more structured approach; but however it is done, the focus is almost always on finding a statement of the promise in the disclosure. One exception which proves the rule was Pfizer v Apotex / latanoprost (NOC) 2011 FCA 236, blogged here, in which the FCA interpreted the promise in light of the common general knowledge, without reference to the disclosure, much less the claims.

While Zinn J’s approach is a departure from recent Canadian trends, it is consistent with the English cases which developed the false promise doctrine. In Alsop’s Patent (1907) 24 RPC 733 at 753 (Ch), one of the leading cases on the promise of the patent, Parker J noted “the importance of drawing a distinction between what the patentee claims to have effected by the invention for which he claims protection [ie the promise of the patent], and a statement of the additional purposes to which the invention can be applied.” That is, not every statement of advantage in the specification is to be treated as a promise. Put another way, in order for validity to turn on a promise made in the specification, the promise must be “material” in the sense that it can be said that the patent was obtained on the strength of the promise: Alsop’s Patent, ibid, Raleigh Cycle Co Ltd v H Miller & Co Ltd, (1948) 65 RPC 141 at 162 (HL). This point seems to have been largely forgotten in recent Canadian case law, in which the disclosure is examined to extract a promise without regard to whether that promise is material. Zinn J’s approach amounts to a presumption that a promise is material only if it is found in the claims. This presumption is consistent with the general rule that the invention is defined by the claims, not by the specification. Consequently, it helps address one of the most problematic aspects of the false promise doctrine, which is that validity of the patent will often turn on a “microscopic” construction of the disclosure. This is a trap particularly when, as is normally the case, the patent was drafted in light of US and European law, which do not have a false promise doctrine.

Notwithstanding the FCA decision in Pfizer v Apotex / latanoprost (NOC), a few recent cases suggest that the FCA has recognized the need to put some bounds on the false promise doctrine by approving relatively moderate constructions of the promise (see here and here). The difficulty with relying on the trial judge to adopt a moderate approach to construction of the promise is that there may be considerable arbitrariness in the result, depending on how aggressive a particular judge chooses to be in construing the promise. The approach of Rennie J in Astrazeneca / anastrozole (NOC) (blogged here) is one attempt to provide a principled legal structure to the construction of the promise, and Zinn J’s approach is another. I prefer Zinn J’s approach for its focus on the claims, as opposed to Rennie J’s approach, in which the focus remains on the disclosure. In any event, it is gratifying to see the Federal Court grapple directly with the legal structure of this problematic doctrine.