In Apotex Inc. v Shire LLC1, the Federal Court of Appeal upheld the validity of a patent on the basis that the inventive concept of the claims included not only the claimed compound but also its beneficial properties. The decision clarifies the distinction between claims construction, which is used to identify the scope of a patentee’s monopoly, and the inventive concept, which contributes to an analysis of whether a patent claim is non-obvious.

What you need to know

  • In patent law, the inventive concept continues to be a crucial step in the analysis of whether a claim in a patent is invalid because the invention claimed is obvious
  • The inventive concept analysis is distinct from claims construction. While a court may be able to identify the inventive concept of a claim based on the language of the claims alone, courts may also refer to the patent description to inform its analysis of inventive concept.

Apotex Inc. v Shire LLC

The inventive concept

In 2008, in its landmark patent law decision in Sanofi, the Supreme Court restated the test for obviousness, adopting the four-part test set out in the U.K. Windsurfing case2. Since then, a key step in the obviousness test requires a court to ask, “what is the inventive concept of the claim?” In Sanofi, the Court said little about how to do this. But in applying the test, the Court noted that the claim at issue claimed a “bare chemical formula” which “may not be sufficient to determine its inventiveness”. It therefore determined the inventive concept based on the description.

Since then, parties and courts alike have struggled to determine the inventive concept. A key issue in dispute has been when it is appropriate to resort to the description, and when the inventive concept should be construed based only on the claims. In 2017, the Federal Court of Appeal suggested the concept should be abandoned altogether, noting that “because “inventive concept” remains undefined, the search for it has brought considerable confusion into the law of obviousness”3. The Court explained that until the Supreme Court develops a “workable definition” of the inventive concept, simply focusing on the claims is more useful than “arguing about a distraction or engaging in an unnecessary satellite debate”4.

Clarity on the concept (of inventive concept)

In its recent decision in Apotex Inc. v. Shire LLC the Federal Court of Appeal confirmed that the inventive concept, “properly construed and applied” is a key part of the obviousness analysis. The case involved a patent claiming a medication for ADHD that reduced the potential for abuse relative to other formulations of a similar compound. Apotex had unsuccessfully challenged the validity of certain claims at trial. The central issue on appeal was on whether those claims were obvious and, in particular, whether the inventive concept aspect of the obviousness test ought to focus on the precise language of the claims alone, or whether the patent description should inform the analysis.

The Federal Court of Appeal’s analysis

The FCA upheld the trial judge’s decision. In doing so, it addressed some of the Court of Appeal’s previous concerns about the inventive concept, and set out three basic principles that govern the exercise for properly construing the inventive concept:

  • In some cases, the inventive concept can be identified from previously-conducted claims construction. Where this is not possible, the judge may refer to the patent specification to determine if it provides insight or clarification into the inventive concept of the claims at issue.
  • Construing the inventive concept is analytically distinct from claims construction. While the purpose of claims construction is to determine the scope of the claim, the obviousness analysis contributes to determining a claim’s validity.
  • The inventive concept of the claim(s) in issue must be determined on a claim-by-claim basis. Inventive concept is not “some generalized concept to be derived from the specification as a whole”. Its purpose is to help determine what, if anything, makes the claim, as constructed, inventive.

In this case, some of the claims of the patent were for bare chemical compounds. Thus, like the patent in Sanofi, the chemical formula claimed could not speak to inventiveness, and the Court turned to the patent specification inform the analysis. The Court of Appeal held that the trial judge correctly looked at the properties of the claimed compound (including its abuse resistance) as set out in the description, in determining the inventive concept.

The FCA noted that while the inventive concept is determined on a claim by claim basis, a single inventive concept—the “solution taught by the patent”—flows through a patent. Thus, while no claim may contain wording that conflicts with its inventive concept, different claims may have the same inventive concept. The FCA concluded that, from a practical perspective, “so long as the single common inventive concept is found to be non-obvious, the Court will typically not need to explicitly consider any amendments to it made by later claims”.

The decision adds clarity and provides a useful analytical framework for a key aspect of the obviousness analysis. It also confirms that, at least for now, the inventive concept is here to stay.

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1 2021 FCA 52

2 Apotex Inc. v. Sanofi-Synthelabo Canada Inc., 2008 SCC 61

3 Ciba Specialty Chemicals Water Treatments Limited v. SNF Inc., 2017 FCA 225 at para. 77

4 Ibid.

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This publication is a general discussion of certain legal and related developments and should not be relied upon as legal advice. If you require legal advice, we would be pleased to discuss the issues in this publication with you, in the context of your particular circumstances.

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