Nouvelle définition de l’évidence au Canada

Le 6 novembre 2008, la Cour suprême a publié son jugement dans l’affaire Apotex Inc. c. Sanofi-Synthelabo Canada Inc. [2008 CSC 61].

Le concept d’évidence, qui est au coeur de cette affaire, a été reformulée par la Cour. Elle conclue que l’examen portant sur l’évidence n’est pas bien servi par une application rigide d’un seul et même critère dans toutes les circonstances.

La Cour conclue que la démarche énoncée dans l’arrêt britanique Windsurfing est utile dans le cadre d’un examen portant sur l’évidence.

La démarche à quatre volets adoptée par la Cour est la suivante :

1. a) Identifier la « personne versée dans l’art »; b) Déterminer les connaissances générales courantes pertinentes de cette personne;
2. Définir l’idée originale de Ia revendication en cause, au besoin par voie d’interprétation;
3. Recenser les différences, s’il en est, entre ce qui ferait partie de l’« état de la technique » et l’idée originale qui sous-tend la revendication ou son interprétation;
4. Abstraction faite de toute connaissance de l’invention revendiquée, ces différences constituent-elles des étapes évidentes pour la personne versée dans l’art ou dénotent-elles quelque inventivité?

La Cour a par ailleurs formulé une liste non exhaustive de facteurs à considérer dans l’évaluation du critère de l’«essai allant de soi» (“obvious to try”):

1. Est-il plus ou moins évident que l’essai sera fructueux? […];
2. Quels efforts – leur nature et leur ampleur – sont requis pour réaliser l’invention? […];
3. L’antériorité fournit-elle un motif pour rechercher la solution au problème qui sous-tend le brevet?

La Cour suprême a également considéré à la jurisprudence récente britannique pour énoncer quatre facteurs qui doivent être appliqués aux faits:

1. Le caractère réalisable est apprécié au regard du brevet antérieur dans son ensemble, mémoire descriptif et revendications compris. […];
2. La personne versée dans l’art peut faire appel à ses connaissances générales courantes pour compléter les données du brevet antérieur. […];
3. Le brevet antérieur doit contenir suffisamment de renseignements pour permettre l’exécution du brevet subséquent sans trop de difficulté. […];
4. Les erreurs ou omissions manifestes du brevet antérieur ne font pas obstacle au caractère réalisable lorsque des habilités et des connaissances raisonnables permettraient d’y remédier.

La cour a également précisé les critères pour l’évaluation d’un “double brevet” (double patenting”):

• Un brevet de sélection peut être obtenu par un demandeur qui n’est pas le propriétaire ou l’inventeur original du brevet de genre. Par conséquent, la «perpétuation» du monopole par un brevet de sélection ne serait pas applicable de façon générale.

[1] (…) In the context of chemical compounds, in general terms, a selection patent is one whose subject matter (compounds) is a fraction of a larger known class of compounds which was the subject matter of a prior patent.

[9] (…) if the selected compound is “novel” and “possess[es] a special property of an unexpected character”, the required “inventive” step would be satisfied (p. 321). At p. 322, Ma

Maugham J. stated that a selection patent “does not in its nature differ from any other patent”.

[10] While not exhaustively defining a selection patent, he set out (at pp. 322-23) three conditions that must be satisfied for a selection patent to be valid.

1. There must be a substantial advantage to be secured 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.

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.

[19] (…) A system of genus and selection patents is acceptable in principle, on the line of authority stemming from I. G. Farbenindustrie.

[31] (…) The compound made for the selection patent was only soundly predicted at the time of the genus patent. It was not made and its special advantages were not known. It is for those reasons that a patent should not be denied to the inventor who made and discovered the special advantages of the selection compound for the first time

[32] (…) If in reading the genus patent the special advantages of the invention of the selection patent are not disclosed, the genus patent does not anticipate the selection patent.

• “disclosure” and
• enablement.

Disclosure

When considering the role of the person skilled in the art in respect of disclosure, the skilled person is “taken to be trying to understand what the author of the description [in the prior patent] meant” (para. 32). At this stage, there is no room for trial and error or experimentation by the skilled person. He is simply reading the prior patent for the purposes of understanding it.

No trial and error is permitted. If in reading the genus patent the special advantages of the invention of the selection patent are not disclosed, the genus patent does not anticipate the selection patent.

Enablement

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.

In the field of chemical patents, originating or genus patents are based on the discovery of a new invention, namely, a reaction or compound, while selection patents are for compounds chosen from the compounds described in the originating patent. Selection patents do not differ in nature from any other patent, but in order to be valid, the selected compound must be novel and possess a substantial advantage to be secured or disadvantage to be avoided. [9-10] …

… for a successful anticipation claim, a two‑step approach should be adopted whereby the requirements of “prior disclosure” and “enablement” should be considered separately and proven.

No trial and error is permitted. If in reading the genus patent, there is no discovery of the special advantages of the selection patent, the genus patent does not anticipate the selection patent and the disclosure requirement to prove anticipation, as in this case, fails. For “enablement”, the person skilled in the art must have been able to perform the invention without undue burden. The question at this stage of the test is how much trial and error or experimentation is permitted. If an inventive step were required to get to the invention of the second patent, the specification of the first patent would not have provided enabling disclosure. The entire prior genus patent must provide enough information to allow a person skilled in the art to perform or make the selected subsequently claimed invention without “undue burden”. The skilled person may use his or her common general knowledge of the relevant art at the relevant time to supplement information contained in the prior genus patent and may conduct routine trials without being considered an undue burden, but prolonged or arduous trial and error experiments would not be considered routine….

Obviousness is largely concerned with how a skilled worker would have acted in the light of the prior art. An obviousness inquiry should follow a four‑step approach.

First, the notional “person skilled in the art” and that person’s relevant common general knowledge must be identified. Second, the inventive concept of the claim in question must be determined or construed. Third, the differences, if any, that exist between the matters cited as forming part of the “state of the art” and the inventive concept of the claim or the claim as construed must be identified. Fourth, a court must consider whether, viewed without any knowledge of the alleged invention as claimed, those differences constitute steps which would have been obvious to the person skilled in the art or whether they require any degree of inventiveness. [68,81] It is at this final step that the issue of “obvious to try” will arise and the nature of the invention in this case is such as to warrant this test. For a finding that an invention was “obvious to try”, there must be evidence to convince a judge on a balance of probabilities that it was more or less self‑evident to try to obtain the invention. Mere possibility that something might turn up is not enough.

Finally, the challenge to selection patents based on the ground of double patenting is not well‑founded. Strategies that attempt to extend the time limit of exclusivity of a patent may be contrary to the objectives of the Patent Act, depending on the circumstances, but a generalized concern about evergreening is not a justification for an attack on the doctrine of selection patents. A selection patent may be sought by a party other than the inventor or owner of the original genus patent so that evergreening does not arise. In addition, selection patents encourage improvements over the subject matter of the original genus patent because that selection does something better than or different from what was claimed in the genus patent.