New this morning: SCC decision approving selection patents, plus tests for anticipation and obviousness

Today was a hectic day at work. Not only have we just come off the madness of the three-day summer student recruitment period (meaning no one has done any legal work the last three days), but the Supreme Court of Canada released the highly-anticipated decision in Apotex v. Sanofi-Sythelabo. This case was closely watched because Apotex challenged the basic validity of all selection patents as a matter of law. Perhaps unsurprisingly, the Supreme Court affirmed selection patents in principle. However, the Court also went on to establish general tests for anticipation and obviousness that will apply to all Canadian patents.

In response, we quickly created and fired off a newsletter to our clients quickly outlining the case, and promising a more in-depth analysis to come. Here is the quick analysis.

This morning, the Supreme Court of Canada released a decision addressing the doctrine of selection patents and the tests for anticipation and
obviousness.

Selection patents are of considerable importance in Canadian patent law, particularly in the area of pharmaceuticals. This is the first decision of the Supreme Court to directly approve of selection patents. The Court’s statements on anticipation and obviousness also extend to all patents, selection or not.

Our preliminary analysis is that while Apotex lost this particular case, the Supreme Court has not given a green light to every selection patent. The validity of Canadian selection patents will very much depend on whether the claims are something special and inventive above the known prior art.

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

Procedural History:

Sanofi-Synthelabo Canada Inc. is the owner of Ca-nadian Patent No. 1,336,777 (the “777 Patent”). Sanofi had previously obtained Canadian Patent No. 1,194,875 (the “875 Patent” or the “genus patent’) which covered a large class of compounds useful in the treatment of coronary artery, peripheral vascular and cerebral vascular diseases. The 777 Patent covered a subclass of compounds that were previously disclosed in the 875 Patent, including clopidogrel bisulfate, a particular compound with properties superior to the compounds generally disclosed in the 875 Patent. Sanofi commenced NOC proceedings against Apotex, who wished to launch their own clopidogrel bisulfate product, and Sanofi won at the FC and FCA level on the basis that Apotex’ product would infringe Sanofi’s 777 patent. Apotex appealed to the SCC on the basis that this selection patent was invalid on the grounds of anticipation, obviousness and double patenting.

The Decision:

Justice Rothstein, writing for a unanimous court, dismissed Apotex’ appeal on all grounds.

The Court accepted selection patents in principle. Rothstein J. cited the UK In re I.G. Farbenindustrie case to find that a selection of compounds from those described in general terms and claimed in a fist or genus patent may be claimed in a second patent if:

1. There is a substantial advantage to be se-cured or disadvantage to be avoided by the use of the selected members;

2. The whole of the selected members (subject to “a few exceptions here and there”) possess the advantage in question; and

3. The selection must be in respect of a quality of a special character peculiar to the selected group. If further research revealed a small number of unselected compounds possessing the same advantage, that would not invalidate the selection patent. However, if research showed that a larger number of unselected compounds possessed the same advantage, the quality of the compound claimed in the selection patent would not be of a special character.

The Court emphasized that selection patents still must meet the standards of anticipation and obviousness.

Anticipation:

In order to determine whether a patent has been anticipated, a two-step approach should be taken. First, did the prior art disclose subject matter which, if performed, would necessarily (without trial and error) infringe the patent? Second, the person skilled in the art (PSITA) must be enabled by the prior art to perform the invention without undue bur-den. A question at the enablement stage is how much trial and error or experimentation is permitted.

In the case of selection patents, the Court interpreted the disclosure test as whether the first patent dis-closed the special advantages of the invention covered in the second patent. In the case at hand, the Court found that the 777 patent was not anticipated because the 875 Patent did not disclose the special advantages of clopidogrel bisulfate disclosed in the 777 Patent.

Obviousness:

The obviousness test adopted by the SCC followed a four-step approach derived from the UK case of Windsurfing International Inc. v. Tabur Marine (Great Britain) Ltd.

• First, the PSITA and his / her relevant general knowledge is determined.

• Second, the inventive concept of the claim in question is determined.

• Third, differences between the “state of the art” and the inventive concept of the claim must be identified.

• Fourth, the court decides whether the differences are obvious or would have required any degree of inventiveness.

The fourth step is done without any consideration of the alleged invention as claimed.

In the analysis of inventiveness, the court adopted an “obvious to try” approach in which routine experimentation does not make the patent inventive. Rather, some testing is explicitly permitted without rendering the invention non-obvious. The analysis requires looking at four factors:

(a) is it self-evident that what is being tried ought to work, and is the number of predictable solutions finite?

(b) how much effort is required to achieve the invention?

(c) is there a motive provided to find the solution the patent addresses?

(d) perhaps considering the evidence of the actual course of conduct (a long and expensive or short and inexpensive effort?) which resulted in the making of the invention.

However, Rothstein J. cautioned against over-application of the “obvious to try” test, writing that it is “not a panacea for alleged infringers.” Notably, the test is not a simple conclusion that if X is obvious to try, then X is obvious. Even if X is obvious to try, X may still be non-obvious if it succeeds only after difficult or expensive experimentation.

In this case, the Court found that the invention was not self-evident from the prior art, and most importantly that Sanofi had spent “millions of dollars and several years developing [the racemate] up to the point of preliminary human clinic trials” before the discovery that the invention of the 777 Patent was superior to other compounds disclosed in the 875 Patent. Therefore, the 777 Patent is not obvious.

Double patenting:

The Court found that there is no inherent conflict be-tween the doctrines of double patenting and selection patents. The SCC acknowledged that evergreening is problematic, but left that concern to be addressed through the tests for anticipation, obviousness and double patenting. The Court stated that there is a valid general concern about double patenting, but selection patents can play an impor-tant role in encouraging improvements over the original genus patent.

We will be completing a more fulsome analysis of the case in the coming days. In the meantime, please feel free to contact us.

Emily Kettel (Student-at-law)
Alexander Stack
Sara Zborovski

Gilbert's LLP