The Supreme Court of Canada made some significant pronouncements on the Canadian law on the obviousness of patents in Apotex Inc. v. Sanofi-Synthelabo Canada Inc., 2008 SCC 61 ("Sanofi"). Following a consultation period on a proposed Practice Notice, the Canadian Intellectual Property Office ("CIPO") released a Practice Notice on obviousness on November 2, 2009, in response to the Sanofi decision.
At the outset, the Practice Notice acknowledges that claimed subject matter resulting from any degree of ingenuity will not be considered obvious. Indeed, Sanofi and many other Canadian court decisions have held that any degree (or a mere scintilla) of inventiveness is sufficient to establish non-obviousness.
In Sanofi, the Supreme Court introduced a four-step approach to obviousness, based on a test that originated in the United Kingdom. The test, which was established in Windsurfing International Inc. v. Tabur Marine (Great Britain) Ltd., [1985] R.P.C. 59 (C.A.) and was restated in Pozzoli SPA v. BDMO SA, [2007] EWCA Civ 588, prescribes the following steps:
- a) Identify the notional person skilled in the art;
b) Identify the relevant common general knowledge of that person; - Identify the inventive concept of the claim in question or, if that cannot readily be done, construe it;
- Identify what differences, if any, exist between the matter cited as forming part of the state of the art and the inventive concept of the claim or the claim as construed;
- Viewed without any knowledge of the alleged invention as claimed, do those differences constitute steps that would have been obvious to the person skilled in the art or do they require any degree of invention?
The Practice Notice states that steps 1 to 3 establish a context for the question at step 4 of whether a claimed invention is obvious. The Windsurfing/Pozzoli approach therefore ostensibly resembles the factual inquiries set out by the Supreme Court of the United States in Graham v. John Deere Co., 383 U.S. 1 (1966). However, unlike the Graham factual inquiries, the Windsurfing/Pozzoli approach introduces the term "inventive concept" into the obviousness analysis.
Inventive concept. The Practice Notice appears to suggest that an inventive concept must be identified and considered for all obviousness inquiries. However, the Supreme Court in Sanofi expressly stated that if the inventive concept cannot be readily identified, it is the claim as construed that must be compared to the state of the art.
The Practice Notice states that the "inventive concept" is to be determined not by comparison to prior art but rather by identifying a claimed solution to a problem that the inventors have set out to address. Therefore, an undue focus on inventive concept may inadvertently disregard some aspects of a claim by focusing on a portion or re-characterization of the claim that may be closer to the prior art than the claim as properly construed. It is respectfully hoped that any dispute between an Examiner and an applicant regarding the identification of the inventive concept of a claim will be accepted as sufficient to demonstrate that the inventive concept cannot be readily identified, resulting in an assessment of obviousness based upon the claim as construed under steps 2 to 4 of the Windsurfing approach adopted in Sanofi.
Test for obviousness. On the ultimate question at step 4 of whether a claimed invention is obvious, the Practice Notice states that no single expression of a test is likely to apply in all cases. Rather, the Practice Notice discusses several factors in determining whether a claimed invention is obvious.
The Practice Notice acknowledges that the test for obviousness from Beloit Canada Ltd. v. Valmet Oy (1986), 8 C.P.R. (3d) 289 (F.C.A.), may be relevant in certain circumstances. In Beloit, the Federal Court of Appeal stated:
The test for obviousness is not to ask what competent inventors did or would have done to solve the problem. Inventors are by definition inventive. The classical touchstone for obviousness is the technician skilled in the art but having no scintilla of inventiveness or imagination; a paragon of deduction and dexterity, wholly devoid of intuition; a triumph of the left hemisphere over the right. The question to be asked is whether this mythical creature (the man in the Clapham omnibus of patent law) would, in the light of the state of the art and of common general knowledge as at the claimed date of invention, have come directly and without difficulty to the solution taught by the patent. It is a very difficult test to satisfy.
Therefore, CIPO has indicated that this classic Canadian statement of obviousness remains relevant, at least in some circumstances.
Obvious to try. The Practice Notice also comments on "obvious-to-try" considerations that the Supreme Court introduced in Sanofi. Unlike the earlier proposed Practice Notice, the recently released Practice Notice acknowledges a threshold question of whether obvious-to-try considerations apply at all. Most notably, the Supreme Court held in Sanofi that obvious-to-try considerations may apply in fields where advances are often won by experimentation.
However, the Practice Notice identifies certain circumstances where CIPO will presume that obvious-to-try considerations apply, and the Practice Notice also states that CIPO considers the threshold question to be inherently addressed by the obvious-to-try test itself. Therefore, there may be disputes over whether obvious-to-try considerations have been raised in appropriate circumstances.
In Sanofi, the Supreme Court identified the following non-exhaustive factors that may apply in circumstances where obvious-to-try considerations are appropriate:
- Is it more or less self-evident that what is being tried ought to work? Are there a finite number of identified predictable solutions known to persons skilled in the art?
- What are the extent, nature and amount of effort required to achieve the invention? Are routine trials carried out, or is the experimentation prolonged and arduous such that the trials would not be considered routine?
- Is there a motive provided in the prior art to find the solution the patent addresses?
The Supreme Court also held that subjective experiences of the inventors may be relevant to whether a claimed invention was obvious to try.
The Practice Notice elaborates on some of these considerations but leaves some matters open for debate. For example, there may be disputes over whether the subjective experience of the inventors is relevant in prosecution.
Notional person skilled in the art. Step 1a of the Windsurfing/Pozzoli approach requires an identification of the notional person skilled in the art. However, it is unclear how Examiners will approach this matter. According to the Practice Notice, Examiners need not explicitly address the notional person in circumstances where the nature of the notional person does not appear to be debatable or determinative of the obviousness analysis. If the nature of the notional person does become the subject of debate, then it is not clear how Examiners will respond to such debate as CIPO may not be well-positioned to consider and weigh relevant evidence on the notional person.
Effect on pending applications. In the Practice Notice, CIPO has indicated that Examiners will not systematically revisit applications that were allowed before the Practice Notice was released. However, CIPO will apply the Practice Notice to all applications still subject to examination.
Overall, the Practice Notice represents a useful guide to CIPO's interpretation and application of the Sanofi decision. However, the ramifications of this new Practice Notice are unclear in a number of respects. It will be important for applicants to work with their Canadian patent agents to ensure that objections based on obviousness are appropriately addressed.