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Supreme Court of Canada tightens obviousness standard

March 23, 2009
Post by Blog Staff

The Supreme Court of Canada recently made significant changes to its obviousness standard for patentability. The case addressed a dispute arising between the brand-name pharmaceutical manufacturer, Sanofi, and the Canadian generic manufacturer, Apotex. The decision by the Supreme Court of Canada brings its obviousness standard closer to the standard recently set forth by the U.S. Supreme Court in KSR v. Teleflex. However, the Canadian obviousness standard still appears to be less stringent than the U.S. obviousness standard. More on Apotex, Inc. v. Sanofi-Synthelavo Canada after the jump.

The patentability in Canada of the brand name pharmaceutical product Plavix® (an anticoagulation blood thinning agent) made by Sanofi was challenged in a suit brought by Apotex in its attempt to bring to market a generic version of the blockbuster drug. Apotex alleged that the patent covering Plavix® (Canadian Patent 1,336,777) was anticipated by, constituted double patenting and obviousness in light of an earlier patent obtained by Sanofi (Canadian Patent 1,194,875). The two patents are related in that the '875 patent described a broad class of compounds as a racemic mixture (involving optical isomers), whereas the '777 patent claimed one of the individual isomers in the mixture that is most effective in treating blood clots, as opposed to other isomer found to be toxic. This type of subsequent patent is often referred to as a "selection patent" as it selects a preferred compound from a previously disclosed class of compounds.

The Canadian Court upheld the patentability of selection patents, resulting in a very favorable ruling for pharmaceutical companies. The Court held that a selection can be patented from a previously disclosed class, provided that: (1) a substantial advantage is identified by the selection; (2) essentially all selected members demonstrate the advantage; and (3) the advantage is unique to the selected group. In addition, the Court ruled on the issue of anticipation, finding that the '777 patent was not anticipated by the '875 patent. The Court explained that a selection patent is only invalid according to anticipation if the earlier publication discloses the particular selected species and provides an enabling description of the specific species' production. The Court noted that such requirement is more than a mere disclosure of the compound itself, rather the special or preferred properties of the species must also be disclosed. The enablement requirement for the species product ensures that no undue experimentation is required to arrive at the selected species. Rather a person skilled in the art must be able to make and use the selected species according to the earlier publication. Finally, the Court turned to the issue of obviousness of the '777 patent in light of the '875 patent. First, the Court addressed the traditional standard for obviousness in Canada, as based on the case Beloit Canada Ltd. v. Valmet OY (1986):

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 claim date of invention, have come directly and without difficult to the solution taught by the patent it is a very difficult test to satisfy. (emphasis added).

This standard for obviousness often favored the patentability of subject matter, making it difficult for courts or patent examiners to determine an invention was unpatentable, so long as an inventor or skilled person could show at least "a scintilla of inventiveness." The Canadian Court moved in a different direction, adopting an approach more closely aligned with the standards set forth in U.S. patent law. Rather than showing "no scintilla of inventiveness" the Court requires a determination that prior art suggests it is "worth a try" to make the claimed invention. The Court noted that the "worth a try" requirement is more easily found in areas or fields where advances are typically achieved through experimentation.

Additionally, the Court set forth considerations to be applied in an obviousness determination. These include: whether a finite number of predictable solutions exist and whether what is being tried "ought to work", the degree of effort required to arrive at the invention (routing versus undue experimentation) and whether the prior art provided any motive to arrive at the solution of the claimed invention. Such considerations illustrate the Court's decision to introduce a stronger subjective element into the determination of obviousness. In applying the facts of the present case, the Court noted that the '875 patent did not disclose the beneficial properties of the precise isomer and did not distinguish the racemate and the two isomers comprising the racemate in terms relating to either its efficacy or toxicity. Moreover, there was no evidence provided in the '875 patent identifying the differences between the isomers, even though it is commonly known by skilled artisans that different isomers may have different characteristics and properties. Additionally, the Court noted that no preferred or selected method for separating the isomers of the original '875 patent were provided to arrive at the claimed invention of the '777 patent. This was bolstered by evidence presented that the inventors experimented for more than six months to separate and test isomers of the '777 patent. This change in the Canadian standard for obviousness puts Canada more in line with other major jurisdictions for patent law requirements for obviousness, including both the United States and Europe. The less rigid test for obviousness is predicted to result in increased numbers of inventions being rendered as obvious variations or obvious inventions. This decision is similar in many respects to the U.S. Supreme Court's decision in KSR v. Teleflex, which increased the threshold for showing the non-obviousness of an invention.In fact, the Canadian Court's decision recognized that both the U.S. and United Kingdom allow "obvious to try" analyses in determining obviousness. The Canadian Court explicitly referenced the KSR decision for this point and cited the need to have obviousness standards more closely in line with both the U.S. and the United Kingdom.

However, the Apotex decision does not appear to have brought the Canadian obviousness analysis to the same level as the test set forth by the U.S. Supreme Court in KSR. It still appears that it is slightly lessened hurdle to patentability in Canada than obviousness is in the U.S. This is a result of the Canadian Supreme Court not incorporating all of the obviousness principles from the KSR decision. For example, although the "obvious to try" rationale is appropriate under Apotex, the Court did not explore other rationales for obviousness (such as combinations of old elements according to known methods, yielding predictable results or substituting known elements to obtain predictable results, etc.) that were discussed in KSR.The Canadian obviousness standard is also less stringent in its application of the known problem or need that exists at the time of the invention. Under the

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