David Alli is a J.D. Law Candidate at Osgoode Hall Law School, and is taking the Patent Law course.
In 2008 the Supreme Court of Canada delivered a seminal decision in Apotex Inc. v. Sanofi- Synthelabo Canada Inc. et. al. (2008 SCC 61) [Sanofi] relating to Patents and the key factor of obviousness. The case dealt more broadly with the requirements for patent protection.
Advocating for Flexibility:
While Apotex lost the case, their position regarding Beloit’s restrictive nature in relation to “obviousness” was triumphant. Originally, Hugessen J.A. constructed patent law’s version of the reasonable person as a “technician skilled in the art […] having no scintilla of inventiveness or imagination” (Beloit Canada Ltd. v. Valmet OY (1986), 8 C.P.R. (3d) 289 (F.C.A) at. 294) [Beloit]. And the question to be asked was “whether this mythical creature […] 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” [Beloit at 294]. While this test is thorough, it does not allow enough room for innovation, which is a touchstone of patent law. In fact, some would consider Shore J.’s interpretation unrealistic and romanticized given the creative process that is involved with invention. As such, Justice Rothstein in Sanofi indicated that “I do not think that Hugessen J.A. in Beloit intended that the rather colourful description of obviousness that he coined to be applied in an acontextual manner applicable to all cases of claims” [Sanofi at para 62]. From this the court contends with adopting an “obvious to try” test, which has been accepted in both the United States and the United Kingdom. It appears that the restraints relating to obviousness are being loosened.
A spokesperson for the Canadian Generic Pharmaceutical Association (CGPA) stated that the Supreme Court in Sanofi “change[d] the law of both anticipation and obviousness, making the legal tests, particularly for obviousness more flexible and, possibly, easier for generic pharmaceutical manufactures to meet in other cases” (Eileen McDermott, “Canadian High Court Weighs in on Obviousness”, Managing Intellectual Property, December 2008, p.12).
May Not Be as Flexible as Perceived – Threshold to Use Test May be Ridged:
This newfound flexibility may be chilled with the caveat that the “obvious to try” test “might be appropriate” in areas where “advances are often won by experimentation” [Sanofi at para 68]. This raises two points to consider; one, the court says “might” which leaves discretion regarding when to use it. While this is naturally a necessary part of judicial practice, the flexibility may however just serve as a window dressing that is not utilized. As such, a more detailed analysis of caselaw would be required to track the situations of appropriateness. Second, the caveat raises the question about areas of innovation that do not necessarily require advances by experimentation. For example, would computer software development be covered by this test or is it mainly applicable to a pharmaceutical context? Does this mean that industries that are not characterized by experimentation cannot have factors like those found in the “obvious to try” test considered (such as the amount of work required to create an invention or the motives of the invention)? Nevertheless, it should be noted that as of right now, there is no concrete evidence that industries that are not characterized by experimentation are being denied this line of analysis in the courts.
This determination of the appropriateness is an additional hurdle that is not seen in the American counterpart to the “obvious to try” test in KSR International v. Teleflex (KSR International Co. v. Teleflex Inc., 127 S. Ct. 1727 (2007) [KSR], (Julian Ho, “Apotex v. Sanofi”, thecourt.ca) [Ho, court.ca]. The American court operates more effectively off the premise that “helpful insights…need not become ridged and mandatory formulas”, and it is this attitude that creates a legal framework that includes all industries, not just those that are experimentation focused.
Application of the “Obvious to Try” Test:
In Canada, the first of the considerations once the test is determined appropriate is to ask whether “it is more or less self-evident that what is being tried ought to work” [Sanofi at para 69]. While this consideration is relevant is does suggest that there may “only be a finding of ‘obvious to try’ if it was self evident that the solution would solve the intended problem” [Ho, court.ca]. This expectation that one must know the outcome is very onerous and may be applied rigidly. Whereas, the KSR case holds that “any need or problem in the field of endeavours at the time of invention […] can provide reason for combining the elements in the manner claimed” [KSR at 1732] [Ho, court.ca]. This indicates that the United States gives a broader application of the test that does not require robust foresight. Nevertheless, the Canadian courts do indicate that their list of considerations are not exhaustive [Sanofi at para 69], and that there is room for further inquiry.
Despite having a system that is less broad than the United States, the Sanofi- Synthelabo Canada case has clarified previously confusing aspects of the law and created a more flexible system.
One Response
If one were to read para. 68 of Sanofi on its own, it does appear ambiguous as to when the “obvious to try” test may be appropriate. As David pointed out, the court held that this test might be appropriate in inventions which require experimentation, leaving us to wonder what legal test we have for other inventions? However, upon reading the decision in full, I don’t believe that we are completely without guidance from Sanofi on this point.
In his summary of previous caselaw, Rothstein J. revisits the need to be case specific. At para. 57 of Sanofi, he quoted from US case law, that Kennedy J. in KSR v. Teleflex affirmed a “functional approach”, which requires the court to adopt a “broad inquiry” and to “look at any secondary considerations that would prove instructive”. He cites the current case law in UK, in the case of H.Lundbeck A/S v. Generics, that “the question of obviousness must be considered on the facts of each case.” (Sanofi, para. 59) He goes back to what Lord Diplock said in Johns-Manville: “I doubt whether there is any verbal formula which is appropriate to all classes of claims.” (Sanofi, para. 61). Furthermore, Rothstein J. held that KSR taught that “as in most matters in which a judge or jury is called upon to make a factual determination, rigid rules are inappropriate unless mandated by statute.” (Sanofi, para. 63).
With all the discussion on being functional and case specific, it is surprising we get any “test” to work with at all! To be helpful in this specific case which involved experimentation, Rothstein J. provided us with a multi-step approach to the obviousness inquiry. He is careful to use language of discretion, as in the phrase: “in such areas, there may be numerous interrelated variables with which to experiment.” (Sanofi, para. 68) Such discretionary language reminds us that the obviousness inquiry cannot be determined through any rigid tests! Rothstein J. cautions us that the factors in the “obvious to try” test are not exhaustive and applies “in accordance with the evidence in each case” (Sanofi, para. 68).
What about non-experimental alleged inventions? In those cases, one can rely on the fundamental test of obviousness (Sanofi, para. 67) where, if the inventive concept of the alleged invention would have been obvious, or “very plain” (Sanofi, para. 65) to a person skilled in the art, then, the alleged invention would be invalid for obviousness.
We all want the courts to come up with elegant, simple, easy to apply, one-size-fits-all legal tests which can be applied to facts. This would let everyone know just where the law is, and provides certainty. However, the nature of case law is such that analysis is applied specifically to the facts of the case at hand. What Rothstein J. has given us here in Sanofi isn’t so much a new legal test of obviousness which is intended to be applied universally, or indeed, even within only pharmaceutical cases. Rather, it is a clarification that the obviousness inquiry must be approached cautiously, having regard to the context of each case.
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