Apotex Inc v Allergan Inc / COMBIGAN (NOC) 2012 FCA 308 Noël JA: Stratas, Webb JJA aff’g for different reasons 2012 FC 767 Hughes J
2,440,764 – COMBIGAN – brimonidine / timolol
The decision of the FCA in Apotex / COMBIGAN provides an important clarification of the second step of the Windsurfing/ Pozzoli approach to obviousness by establishing that it is necessary to have reference to the entire specification in order to construe the inventive concept. Implicitly, the statement by Jacob LJ that if any difficulty arises in determining the inventive concept, it can simply be ignored in favour of a focus on the claim as construed, is not the law in Canada.
The second step of the Windsurfing/ Pozzoli approach to obviousness, as approved by the Supreme Court in Sanofi 2008 SCC 61, [67] is to “[i]dentify the inventive concept of the claim in question or if that cannot readily be done, construe it.” This raises two questions. How is the inventive concept to be determined? As Hughes J put it in the decision under appeal, “The question is whether the “inventive concept” is something different from the claim at issue, even when that claim has been construed by the Court. Is the Court to embark on two separate missions; one to construe the claim, the other to define the inventive concept?” [135] Secondly, why bother construing the inventive concept at all? Jacob LJ remarked in Pozzoli [2007] EWCA Civ 588 [19] that identification of the inventive concept “can develop into an unnecessary satellite debate” and in such cases “the sensible way to proceed is to forget it and simply to work on the features of the claim,” as “[i]n the end what matters is/are the difference(s) between what is claimed and the prior art.” In Actavis UK Ltd v Novartis AG [2010] EWCA Civ 82 [20] he remarked similarly that “[t]he "inventive concept" can be a distraction or helpful. It is a distraction almost as soon as there is an argument as to what it is. It is helpful when the parties are agreed as to what it is.”
These questions were at the heart of the COMBIGAN litigation. As discussed in yesterday’s post, in prior litigation in Sandoz / COMBIGAN (NOC) 2011 FC 1316 Crampton J had held the ‘764 patent to be non-obvious, while in the decision under appeal in Apotex / COMBIGAN, Hughes J held the claims in question to be obvious. The difference driving these divergent conclusions was in the construction of the inventive concept. COMBIGAN is Allergan’s brand name for a composition comprising two active ingredients, brimonidine and timolol, for the treatment of glaucoma. Those two ingredients had previously been used together, but this had been done concomitantly, with a waiting period between the administration of the two drugs. It turned out that the combination treatment had an improved safety profile as compared with the concomitant treatment, and the key question was whether this improved safety profile was part of the inventive concept: Crampton J held that it was, while Hughes J held that it was not. On appeal of Hughes J’s decision, the FCA Apotex / COMBIGAN agreed with Crampton J [58-60], and reversed Hughes J [75]. (A second question was whether this inventive concept was sufficient to render the invention non-obvious. Given his construction of the inventive concept, Hughes J did not address this question, while Crampton J, and the FCA in Apotex / COMBIGAN, reviewing Hughes J de novo, held that it did make the invention non-obvious. I will not discuss this second question in this post.)
The differing conclusions were driven by a differing views as to whether the patent as a whole should be considered in construing the inventive concept. In some circumstances it is undoubtedly necessary to consider the disclosure. As the Supreme Court pointed out in Sanofi at [77], in the case of claim to a chemical compound per se
[t]he inventive concept of the claims is not readily discernable from the claims themselves. A bare chemical formula in a patent claim may not be sufficient to determine its inventiveness. In such cases, I think it must be acceptable to read the specification in the patent to determine the inventive concept of the claims.
The question left open is whether “such cases” refers to any case in which the inventive concept of the claims is not readily discernable from the claims themselves, or to the more limited circumstances where the inventive concept is not clear from the claims because the claim is to a chemical compound. In Sandoz / COMBIGAN Crampton J adopted the former interpretation, saying that in cases where “‘the inventive concept of the claims is not readily discernible from the claims themselves,’ it is both necessary and permissible to look to the balance of the patent ‘to determine its inventiveness’” [51, emphasis added]. This is almost completely contrary to Jacob LJ’s advice that when there is a debate over the nature of the inventive concept, it should be ignored entirely in favour of a focus on the claims. According to Crampton J, the answer to Hughes J’s question, “Is the Court to embark on two separate missions; one to construe the claim, the other to define the inventive concept?” is an unequivocal yes: ascertaining the inventive concept is “necessarily done after claims construction had been completed, because the exercise of claim construction is antecedent to the assessment of issues concerning validity and infringement” [52, original emphasis]. In contrast, in Apotex / COMBIGAN, Hughes J adopted Jacob LJ’s view that the inventive concept is merely “a statement of what the claim, properly construed, says ‘stripped of unnecessary verbiage’” [137, quoting Pozzoli at [18]]. After discussion of some of the prior case-law, he stated that:
[141] where the claim is something that is only a chemical compound or compounds selected from a larger class, and the utility is not found in the claim, it is permissible to go to the description in order to determine that utility and combine that utility with what is said in the claim in order to determine the “inventive concept” for purposes of examining obviousness of the claim.
It is not entirely clear whether Hughes J was of the view that it was permissible to go to the description only in these circumstances. That is the implication of his approving reference to Jacob LJ’s views. But that is too narrow a reading of the case law. The case of per se compound claims illustrate most clearly than recourse to the disclosure is sometimes necessary to discern the inventive concept, but there is no reason in logic or in the prior case law to conclude that reference to the disclosure is permissible only in those exemplary cases.
Whether or not Hughes J intended his remarks in [141] to define a restrictive approach to the use of the disclosure in construing the inventive concept, on appeal in Apotex / COMBIGAN, the FCA pointed out at [57] that despite his quotation of Jacob LJ’s remarks, Hughes J did not actually adopt a restrictive approach focusing on the claims themselves. In this case the utility was stated in the claim, so Hughes J’s statement in [141] would imply that recourse should not be had to the disclosure, but Hughes J nonetheless construed the inventive concept in light of the promise of the patent, which he discerned from paragraph 1 of the disclosure [FC 113, 144].
Thus despite Hughes J’s statement of principle, the real difference between him and Crampton J was not whether it is permissible to have recourse to the disclosure, but only as to how the disclosure might be used. In coming to his conclusion as to the inventive concept, Hughes J first stated how he construed the claim [142], then he stated what he considered the promise of the patent to be [143], and finally he stated that the inventive concept is, in effect, that the claimed invention will deliver the promised results [145]. Hughes J’s construction of the promise of the patent, in turn, was based largely on para 1 of the disclosure [113]. In contrast, Crampton J construed the inventive concept by looking to the patent as a whole, including in particular Example II which disclosed the improved safety profile, and without reference to the promise of the patent.
The FCA held that Hughes J had been wrong to restrict his attention to para 1 of the disclosure [61], [62], and that nothing in the record [69], or the evidence [71], justified this limited focus:
In holding that the inventive concept is restricted to what is stated in paragraph 1 of the patent, the Federal Court judge read this paragraph in isolation. Claim construction must be conducted in light of the patent as a whole.
As the FCA pointed out, [72-73], this holistic approach is consistent with the FCA and SCC jurisprudence on claim construction, including the recent SCC decision in Pfizer / sildenafil 2012 SCC 60 [50]. (While the FCA did not provide more detail as to exactly how the inventive concept should be construed: I have suggested that the problem-and-solution approach used in the EPO might be helpful in this regard.) On this analysis, Hughes J’s focus on paragraph 1 of the disclosure to construe the promise is simply arbitrary.
Hughes J’s reference to Jacob LJ’s restrictive view of the role of the inventive concept, which focuses instead on the claims, might have provided a principled basis for a narrower construction, but, as noted, Hughes J did not in fact apply a claim focused approach. With due respect, this case illustrates that Jacob LJ was wrong to assert that the inventive concept can be ignored if any difficulty arises in construing it. The ‘764 patent is one more example showing that it is generally necessary to have recourse to the disclosure to construe the inventive concept, not only in the case of a per se compound claim. In the case of a use patent, the inventive concept may be the discovery that the compound is useful for a particular purpose (eg sildenafil), or, as in this case, it may be the discovery that the composition has surprising advantages when used for a particular purpose. The structure of the use claim itself will not tell us which of these possibilities is at play, yet the obviousness analysis will be very different in these two circumstances. The claim focused approach advocated by Jacob LJ is also unsound in principle. While the claims define the scope of the patent right, it is the information contained in the disclosure which is the quid pro quo for that monopoly: Consolboard [1981] 1 SCR 504 at 517. Consequently, it is the information in the disclosure which must be non-obvious in order to justify the monopoly.
There is another possible principled interpretation of Hughes J’s approach. As noted above, the approach actually used by Hughes J can summarized in general terms as being that the inventive concept is that the claimed invention will deliver the promised results [145]. So, while he did not say so expressly, this might be taken as implying that the inventive concept should be defined in terms of the promise of the patent. One might debate whether Hughes J had correctly identified the promise of the patent by focusing on para 1, but at least on this view his analysis was based on a principled focus on the promise of the patent, rather than an arbitrary focus on para 1 of the disclosure. The difficulty with this approach is that the promise of the patent is subjective, in the sense that it turns on the promise intended by the patentee, while obviousness must be determined objectively. A patentee may be wrong as to the true inventive concept of the invention, if for example she was unaware of some element of the prior art, and yet she may have nonetheless made an inventive contribution to the art sufficient to support at least some of her claims, even though it was not the contribution she had thought she was making. Thus, regardless of the merits of the promise of the patent doctrine as part of the law of utility (and I am not a fan), it cannot be part of the obviousness inquiry, as this would be inconsistent with the well established objective nature of the non-obviousness requirement.
In summary, the FCA decision in Apotex / COMBIGAN establishes or implies that
- it is necessary to construe the inventive concept of the claim in order to determine obviousness; contrary to Jacob LJ’s remarks in Pozzoli, it is not permissible to ignore the inventive concept and focus on the claim as construed if there is disagreement as to the nature of the inventive concept;
- the patent as a whole must be considered in construing the inventive concept;
- the inventive concept is not defined by the promise of the patent.
A final question. The FCA decision is limited to cases in which the inventive concept is not readily discernable from the claim itself [50], [57]. What if the inventive concept is apparently readily discernable from the claims, but a reading of the specification as a whole indicates a different inventive concept from that which is discernable from the claims? In my view, recourse to the disclosure is necessary even in such circumstances. This follows from the general principle that “[c]laim construction must be conducted in light of the patent as a whole.” If a claim specifies that a member is “vertical,” and the disclosure states that “vertical is defined to mean 90 degrees plus or minus 20 degrees,” it is necessary have recourse to the disclosure even though the claim itself might seem clear on its face. This is because the words of the claim cannot be properly understood without recourse to the specification as a whole: Pfizer / quinapril (NOC) 2007 FCA 209 [88]. We cannot say whether the meaning of a term in the claim is clear without looking to the specification to understand that meaning. The same is true in respect of the inventive concept.
No comments:
Post a Comment