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18 January 2010
In Apotex Inc v Sanofi-Synthelabo Canada Inc (2008 SCC 61) the Supreme Court of Canada made some significant pronouncements on the Canadian law regarding the obviousness of patents. Following a consultation period on a proposed practice notice, on November 2 2009 the Canadian Intellectual Property Office (CIPO) released a practice notice on obviousness 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 ( RPC 59 (CA)) and restated in Pozzoli SPA v BDMO SA ( EWCA Civ 588) prescribes the following steps:
The practice notice states that the first three steps establish a context for the question at the fourth step of whether a claimed invention is obvious. Therefore, the Windsurfing/Pozzoli approach ostensibly resembles the factual inquiries set out by the US Supreme Court in Graham v John Deere Co (383 US 1 (1966)). However, unlike the Graham factual inquiries, the Windsurfing/Pozzoli approach introduces the term 'inventive concept' into the obviousness analysis.
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 recharacterization 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 the second, third and fourth steps of the Windsurfing/Pozzoli approach adopted in Sanofi.
Test for obviousness
On the ultimate question at the fourth step 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 CPR (3d) 289 (FCA)) may be relevant in certain circumstances. In Beloit the Federal Court of Appeal stated that:
"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, the 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 the CIPO will presume that obvious-to-try considerations apply, and the practice notice also states that the 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 list of factors that may apply in circumstances where obvious-to-try considerations are appropriate:
The Supreme Court also held that the inventors' subjective experiences 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
The first part of the first step 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 the CIPO may not be well-positioned to consider and weigh relevant evidence on the notional person.
Effect on pending applications
In the practice notice, the CIPO has indicated that examiners will not systematically revisit applications that were allowed before the practice notice was released. However, the CIPO will apply the practice notice to all applications still subject to examination.
Overall, the practice notice represents a useful guide to the 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.
For further information on this topic please contact Jonas H Gifford or John W Knox at Smart & Biggar/Fetherstonhaugh by telephone (+1 604 682 7780), fax (+1 604 682 0274) or email (email@example.com or firstname.lastname@example.org).
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