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The SCC Sanofi Obviousness Test – Have the Courts Gone Wrong With the Inventive Concept?

As the Federal Court continues to interpret and apply the 2008 Sanofi SCC obviousness test (Apotex Inc. v. Sanofi-Synthelabo Canada Inc., 2008 SCC 61 (“Sanofi”)), one important step – defining the “inventive concept” – has not always been defined consistently. Inventive concept appears to have taken predominance over claim construction. Inventive concept is a pivotal issue for the court. It sets the bar for exactly what has to be obvious to try – ie. “self-evident” to work. As would be expected, a more complex/advanced inventive concept means an invention is more difficult to invalidate for obviousness. Equally, a broad/generalized inventive concept can mean a patent is easier to demonstrate as obvious (see for example the FCA’s criticism of the latter approach in Bridgeview Manufacturing Inc. v 931409 Alberta Ltd. 2010 FCA 188 at paras. 46, 55).

One of the difficulties with applying the 2008 Sanofi SCC test is that the Sanofi case dealt with a selection of one compound from a group (“a selection patent”) – where arguably special rules apply to the nature of the invention. (Although courts have consistently held the standard tests for validity apply, by definition the nature of a selection invention necessarily involves a “high” inventive concept involving improved properties over a prior group). Confusion arises when courts apply the identical inventive concept approach used for a selection patent, to a non-selection patent (as in the examples discussed below). Clarification from the FCA on this issue would be welcome.

Shortly after the Sanofi decision, the FCA in Laboratoires Servier v Apotex Inc., 2009 FCA 222 (“Perindopril FCA”) suggested (in finding a claim to a chemical compound perindopril – a non-selection patent – inventive and not obvious) that traditional construction may be the same as the “nature of the invention” and the new term “inventive concept” (compare paras. 58, 69 and 89). The FCA does not clearly explain how and why the inventive concept is different from claims construction – instead the FCA appears to suggest that in both concepts recourse may be had to the patent disclosure:

[58] Whirlpool Corp. v. Camco Inc., 2000 SCC 67 … decides that claims construction is antecedent to issues of both infringement and validity. It also stands for the proposition that purposive construction requires a court to have regard to the whole of the patent (including the claims and the disclosure) when ascertaining the nature of the invention. Indeed, several of the authorities cited in Apotex’s memorandum of fact and law illustrate the application of these principles. More recent authority indicates that the inventive concept need not be readily discernable from the claims, even in circumstances where construction of the claims is not in issue. A bare chemical formula may require recourse to the specification to determine the inventive concept of the claims …(Sanofi). [emphasis added]

Significantly, the Sanofi decision was released after the lower court perindopril decision and before the Perindopril FCA decision. The FCA (and the lower court) both found the “essential elements” related to the combination of specific structural components of the claimed chemical compound perindopril (paras. 77, 87). This is standard construction analysis.

At the same time, the FCA at para. 89 states that: “The inventive concept of the claim in question is found at paragraphs 125-133 and 206 of her [lower court’s] reasons.” [emphasis added] Notably at these paragraphs, the lower court simply conducts the standard claims construction analysis and analyzes its key question as “how should the claims be construed when a patentee claims only a portion of the compounds identified in the description” [emphasis added] (2008 FC 825 at para. 125).

Subsequently the FCA has followed the approach of Sanofi, and indicated the inventive concept does not always need to be identified/may not be different from plain purposive construction: “it will be sufficient to construe the patent if the inventive concept is not readily discernible from its claims” (Corlac v Weatherford 2011 FCA 228 at para. 69; refer also to Apotex v Lundbeck 2010 FCA 320 at para. 27, 90)

Unlike the approach in Perindopril FCA, the Federal Court has arguably “expanded” the inventive concept to import various features from the patent disclosure. In Allergan v. Apotex 2012 FC 767 (“Apotex brimonidine/timolol”) Justice Hughes considered the UK source of the “inventive concept” step where “One is trying to identify the essence of the claim in this exercise” (at para. 136). The same UK case law recognized the dangers of “unnecessary satellite debate[s]” regarding the inventive concept and issues beyond the claim.

So if a disagreement about the inventive concept of a claim starts getting too involved, the sensible way to proceed is to forget it and simply to work on the features of the claim…In yet other cases it is not even practical to try to identify a concept – a chemical class claim would often be a good example of this.

In Apotex brimonidine/timolol, the representative claim in issue was a combination formulation of two known medicines – brimonidine and timolol:

22. Topical use of a therapeutically effective amount of an ophthalmic pharmaceutical composition for the treatment of glaucoma or ocular hypertension wherein the amount of brimonidine is 0.2 percent by weight and the amount of timolol is, 0.5 percent by weight, and from 0.001% by weight to less than 0.01% by weight of benzalkonium chloride.

The Court (at para. 141) determined “it is permissible to go to the description in order to determine [the]… 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.” Following such an approach, the court identified a list of several “utilities” which were then subsequently included within the “inventive concept” (at para. 144):

  • the combination product in a single dose improves patient compliance
  • it contains brimonidine and timolol
  • which is effective
  • is safe
  • has increased stability
  • requires lower effective concentration of preservative than separate doses of each
  • has increased efficacy without increased concentration of brimonidine or timolol

Query whether such an approach is simply an application of the standard purposive construction of Whirlpool SCC which instructs the court to have regard to the whole of the patent, or a significant departure of such an approach. Notwithstanding the “long list” of inventive concepts, Mr. Justice Hughes found Allergan’s patent was obvious (para. 175). (A similar approach, albeit with a longer list under the inventive concept, was previously used in Allergan v. Sandoz 2011 FC 1316 regarding the same patent. Unlike Apotex brimonidine/timolol however, Allergan’s patent was upheld as not obvious, largely relating to the different evidence before the court).

It is apparent that even where there is no disagreement regarding claims construction, there may be very diverse positions on inventive concept. Although it is clear that the former is done antecedent to both infringement and validity, the latter is considered only as part of obviousness. Practically this may mean that a defendant may be found to infringe a claim to X (as construed), while at the same time may be unsuccessful in persuading the court that the same claim to X, with properties A, B and C (the inventive concept) is obvious. On its face there appears to be an inconsistency here that further jurisprudence over the next few years should clarify. Insight may also be obtained from the Canadian Patent Office who is in the process of finalizing a guidance document on inventive concept (the draft guidance specifically instructs that purposive construction is the first step in determining the inventive concept) (refer to http://www.cipo.ic.gc.ca/eic/site/cipointernet-internetopic.nsf/eng/wr03442.html ).

 

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Comments

  1. David Collier-Brown

    Looking at the terminology alone, it sounds a bit like “inventive concept” is being conflated with claims construction, while the words suggest something rather different. Were I to encounter the term inventive concept in informal discussion, I would normally think the speaker was striving to express an inverse to obviousness.

    Having it either inferred from the claims or related to the constructions of the claims seems to render it ambiguous.

    Instead, I’d expect that it should be considered a different concept, but one which can be clarified by a careful reading of the whole of the document, including the claims.

    It strikes me as quite reasonable to read the claims in order to help one understand what is unique and worthy about the invention. It’s rather similar to a worked example in mathematics or logic, where one is aided in understanding what’s important by example of how it would be applied. It’s a long stretch to say that the example or claims are the invention.

    I would hope to see a later case distinguish the inventive concept, possibly by showing its closer inverse relationship to obviousness.

    –dave (a philosopher, not a lawyer) c-b