Nouveau test d’anticipation de brevets de l’affaire Sanofi, analysé par la Cour fédérale

C’est une des premières décisions du juge Hughes en brevets suite à l’affaire Sanofi – une affaire de NOC avec contestation de validité du brevet (nouveauté seulement).

 

 

 

http://decisions.fct-cf.gc.ca/en/2008/2008fc1359/2008fc1359.html(malheureusement, il n’y avait de considération du test de l’évidence vu que le brevet était jugé invalide comme étant anticipé)

Voir paragraphes 65 et suivants pour son appréciation du nouveau test de nouveauté:

c) Anticipation

i) Legal Test

[65] The law as to anticipation was very recently reviewed and restated by the Supreme Court of Canada in Sanofi, supra, particularly at paragraphs 18 to 50. That Court at paragraphs 20 to 22 reviewed the legal test for anticipation used by the Trial Judge namely “that the exact invention has already been made and publicly disclosed”. This test, the Supreme Court wrote at paragraph 23, was overstated:

23

For the reasons that follow, and in light of recent jurisprudence, I am of the respectful opinion that the applications judge overstated the stringency of the test for anticipation that the “exact invention” has already been made and publicly disclosed.

[66] The Supreme Court discussed with approval at paragraph 24 to 37 the decision of the House of Lords in the Synthon case, supra. Two separate requirements are necessary for there to be anticipation, prior disclosure and enablement.

[67] Prior disclosure means that the prior patent (publication, use or other disclosure) must disclose subject matter which, if performed, would necessarily result in infringement of the patent (claim at issue). The person skilled in the art looking at the disclosure must be taken to be trying to understand what the prior patent (or other disclosure) meant. There is no room for trial and error, the prior art is simply to be read for the purposes of understanding.

[68] The second requirement is that of enablement which means that the person skilled in the art would have been able to perform what had been disclosed. At this stage the person skilled in the art is assumed to be willing to make trial and error experiments to get it to work. The Supreme Court at paragraph 37 of Sanofi summarized a non-exhaustive list of factors that may be applied in the consideration of enablement:

37

Drawing from this jurisprudence, I am of the opinion that the following factors should normally be considered. The list is not exhaustive. The factors will apply in accordance with the evidence in each case.

1. Enablement is to be assessed having regard to the prior patent as a whole including the specification and the claims. There is no reason to limit what the skilled person may consider in the prior patent in order to discover how to perform or make the invention of the subsequent patent. The entire prior patent constitutes prior art.

2. The skilled person may use his or her common general knowledge to supplement information contained in the prior patent. Common general knowledge means knowledge generally known by persons skilled in the relevant art at the relevant time.

3. The prior patent must provide enough information to allow the subsequently claimed invention to be performed without undue burden. When considering whether there is undue burden, the nature of the invention must be taken into account. For example, if the invention takes place in a field of technology in which trials and experiments are generally carried out, the threshold for undue burden will tend to be higher than in circumstances in which less effort is normal. If inventive steps are required, the prior art will not be considered as enabling. However, routine trials are acceptable and would not be considered undue burden. But experiments or trials and errors are not to be prolonged even in fields of technology in which trials and experiments are generally carried out. No time limits on exercises of energy can be laid down; however, prolonged or arduous trial and error would not be considered routine.

4. Obvious errors or omissions in the prior patent will not prevent enablement if reasonable skill and knowledge in the art could readily correct the error or find what was omitted.

[69] To this analysis by the Supreme Court should be added comments by Floyd J. of the English Chancery Court, Patents Division, in a recently decided case, June 30, 2008, Actavis UK Limited v. Janssen Pharmaceutica N.V., [2008] EWHC 1422 (Pat). He was applying the law established in Synthon, supra. He was considering an argument to the effect that the prior art must disclose something that, if carried out, must “inevitably result” in what is claimed in the patent at issue and, if there was any room for doubt, then there is no anticipation. Floyd J. rejected that argument, the Court, he held, is required to consider the evidence on the normal civil burden of “balance of probabilities” and not on a “quasi-criminal standard”. He wrote at paragraph 85:

85. Is that finding good enough for an inevitable result? The legal requirement is that this feature of the claim be the inevitable result of carrying out the prior teaching. Does that mean that if there is something other possibility, even a fairly remote one, that some other result would follow, I should conclude the result is not inevitable? Or am I concerned to establish what, on the balance of probabilities would in fact occur? In my judgment, it is the latter approach which is correct. The inevitable result test does not require proof of individual facts to a quasi-criminal standard. It may be impossible to establish the relevant technical facts to that standard. It is another matter if the evidence establishes that sometimes one result will follow and sometimes another, depending on what conditions are used. But there is nothing of that kind suggested here. It is simply a question of what occurs in fact.

[70] Adding to this point regard should be had to the recent decision of the Supreme Court of Canada in F.H. v. McDougall, 2008 SCC 53 where Rothstein J. for the Court stated at paragraph 40 that in civil proceedings there is only one standard of proof, the balance of probabilities. At paragraph 40, the Court says:

40

Like the House of Lords, I think it is time to say, once and for all in Canada, that there is only one civil standard of proof at common law and that is proof on a balance of probabilities. Of course, context is all important and a judge should not be unmindful, where appropriate, of inherent probabilities or improbabilities or the seriousness of the allegations or consequences. However, these considerations do not change the standard of proof. I am of the respectful opinion that the alternatives I have listed above should be rejected for the reasons that follow.

[71] A further legal consideration arises in cases such as the present. What is the situation where, in practicing the prior art a particular substance was present and doing what it always has done but that substance was not recognized as such or as doing that particular thing. As Floyd J. said at paragraph 99 of Actavis, supra:

99. In my judgement, merely explaining the mechanism which underlies a use already described in the prior art cannot, without more, give rise to novelty.

[72] It is useful in this regard to have regard to an earlier decision given by Lord Hoffman in the House of Lords in Merrell Dow Pharmaceuticals Inc. v. H.N. Norton & Co. Ltd., [1996] R.P.C. 76. The issue in that case was whether a claimed pharmaceutical had been previously disclosed by use. The previous use was by way of metabolism in the human body, that is, a related but different pharmaceutical composition was swallowed but, in the liver it changed to some extent. It was “metabolized” and became the chemical claimed in the patent at issue. Nobody had conducted an analysis however at any previous time as to what if anything was happening in the liver. The “metabolite” itself had not been previously identified. Lord Hoffman held that there was sufficient anticipation to invalidate the claimed invention. In doing so, he relied on a case in the European Patent Office which held that a patent claiming a process for making flavour concentrates from vegetable or animal substances by extraction with fat solvents under pressure in the presence of water was anticipated by old cookbook recipes for pressure cooking chicken or stews. Nobody knew that flavour concentrates were being extracted but it was being done, hence the claim was anticipated. As he said at page 90 lines 8 and 9 “if the recipe which inevitably produces the substance is part of the state of the art, so is the substance“. Later at the same page 90, at lines 49 to 52 he said:

The fact that they would not have been able to describe the chemical reaction in these terms does not mean that they were not working the invention. Whether or not a person is working a product invention is an objective fact independent of what he knows or thinks about what he is doing.

[73] Following that quoted portion, Lord Hoffman at the end of page 90 and over to page 91 considered the situation where a patent claimed a use for the product. If the claimed use is different than the old use of the undetected but nonetheless present product, then the claimed use may not have been anticipated. But, if the old use is the same as the claimed use, the claim is anticipated. He wrote:

The position may be different when the invention is a use for a product; in such a case, a person may only be working the invention when he is using it for the patented purpose: see the discussion of the MOBIL/Friction reducing additive case in the next section). The Amazonian Indian who treats himself with powdered bark for fever is using quinine, even if he thinks that the reason why the treatment is effective is that the tree is favoured by the Gods. The teachings of his traditional medicine contain enough information to enable him to do exactly what a scientist in the forest would have done if he wanted to treat a fever but had no supplies of quinine sulphate. The volunteers in the clinical trials who took terfenadine were doing exactly what they would have done if they had attended Merrell Dow’s Strasbourg symposium and decided to try making the acid metabolite in their livers by ingesting terfenadine.

[74] Lord Hoffman further addressed this point in Synthon, supra, at paragraph 22:

22. If I may summarise the effect of these two well-known statements, the matter relied upon as prior art must disclose subject-matter which, if performed, would necessarily result in an infringement of the patent. That may be because the prior art discloses the same invention. In that case there will be no question that performance of the earlier invention would infringe and usually it will be apparent to someone who is aware of both the prior art and the patent that it will do so. But patent infringement does not require that one should be aware that one is infringing: “whether or not a person is working [an] … invention is an objective fact independent of what he knows or thinks about what he is doing”: Merrell Dow Pharmaceuticals Inc v H N Norton & Co Ltd [1996] RPC 76, 90. It follows that, whether or not it would be apparent to anyone at the time, whenever subject-matter described in the prior disclosure is capable of being performed and is such that, if performed, it must result in the patent being infringed, the disclosure condition is satisfied. The flag has been planted, even though the author or maker of the prior art was not aware that he was doing so.

[75] To summarise the legal requirements for anticipation as they apply to the circumstances of this case:

1. For there to be anticipation there must be both disclosure and enablement of the claimed invention.

2. The disclosure does not have to be an “exact description” of the claimed invention. The disclosure must be sufficient so that when read by a person skilled in the art willing to understand what is being said, it can be understood without trial and error.

3. If there is sufficient disclosure, what is disclosed must enable a person skilled in the art to carry out what is disclosed. A certain amount of trial and error experimentation of a kind normally expected may be carried out.

4. The disclosure when carried out may be done without a person necessarily recognizing what is present or what is happening.

5. If the claimed invention is directed to a use different from that previously disclosed and enabled then such claimed use is not anticipated. However if the claimed use is the same as the previously disclosed and enabled use, then there is anticipation.

6. The Court is required to make its determinations as to disclosure and enablement on the usual civil burden of balance and probabilities, and not to any more exacting standard such as quasi-criminal.

7. If a person carrying out the prior disclosure would infringe the claim then the claim is anticipated.

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