FCA Upholds the Plavix Patent, Reverses Lower Court’s “Promise of Patent” and “Obvious to Try” Analyses

FCA Upholds the Plavix Patent, Reverses Lower Court’s “Promise of Patent” and “Obvious to Try” Analyses

Sanofi-Aventis v. Apotex Inc. – 2013 FCA 186

Per Pelletier J.A. (Noel J.A. concurring):

Apotex attempted to market a generic version of clopidogrel bisulfate (clopidogrel), sold by Sanofi under the name Plavix. Apotex applied for a Notice of Compliance. Sanofi responded by applying to the Federal Court for an order prohibiting the Minister from issuing the Notice of Compliance to Apotex. This application was successful (2005 FC 390), and appeals to the FCA (2006 FCA 421) and SCC (2008 SCC 61) were dismissed.

Apotex then initiated an action in the Federal Court seeking a declaration that Sanofi’s Canadian patent no. 1,336,777 (the ‘777 Patent) was invalid. Sanofi replied by commencing its own action, alleging that Apotex had infringed its patent by importing clopidogrel into Canada from Mexico and then exporting it from Canada for sale in other countries including the United States. [2] The Trial Court found that the ‘777 Patent was invalid for lack of utility on the basis that the promise of the patent had neither been demonstrated nor soundly predicted. In addition, the Trial Judge found that the invention described in the patent was obvious. The Trial Judge also found that Apotex had infringed the ‘777 Patent (2011 FC 1486). This is an appeal of that decision.

The Court reversed the trial decision, and held that the ‘777 Patent is neither lacking in utility nor obvious. Moreover, the Court agreed with the finding of infringement at trial, but modified some of the Trial Judge’s reasons relating to infringement.

Utility and Promise of the Patent

The Trial Judge erred in construing the patent as specifically promising a result when the invention was used in humans and then assessing the utility of the patent against that specific promise. Properly construed, the ‘777 Patent made no such promise. [71]

Not every patent has an explicit promise. There is no obligation on the part of the inventor to disclose the utility of his/her invention in the patent. [50]

The passages in the evidence that the Trial Judge relied on for his construction of the promise are all equivocal. [64] In addition, the Trial Judge “inferred from the fact that clopidogrel is to be administered by oral, rectal or parenteral administration that human use is contemplated. He drew the same inference from the use of the word ‘patient’ and from the phrase ‘the patent indicates that the dosage depends on the age of the patient and the severity of the disorder to be treated’. The Trial Judge was also influenced by the fact that the active ingredient is formulated into ‘tablets, capsules and other dosage forms that are useful for administration’. This exercise in the construction of a document, familiar as it is to lawyers, is an unreliable guide to the skilled person’s reading of such a document.” [65]

The Trial Judge “erred in law in reading into the ‘777 patent a promise for use in humans on the basis of inferences, in the absence of language at least as clear and unambiguous as that used to establish the advantages of the selection over the compounds of the genus patent.” [66] “The pharmaceutical industry’s interest of the invention obviously lay in its potential use in humans which the invention foreshadowed. The person skilled in the art would understand that in alluding to this possibility, the inventors were not promising that this result had been or would be achieved.” [67]

The Trial Judge further “reasoned that since the genus patent (the ‘875Patent) contained a reference to use in humans, the ‘777 Patent would fail as a selection patent unless an explicit promise for use in humans was also read into it.” [68] “This reasoning is problematic for at least two reasons. First and foremost, it is improper to construe a patent with an eye to its validity…The Trial Judge erred when he read into the patent a promise of use in humans in order to validate the patent as a selection patent, then used this promise in order to invalidate it for lack of utility.” [69]

Second, the unexpected advantage(s) disclosed by a selection patent “need not be an improvement on every aspect of the invention described in the genus patent, though it may be. It is sufficient that it is a new and useful improvement on some aspect of that invention.” [70] The “Trial Judge found that the ‘777 Patent described the advantages of the compound of the ‘777 Patent over the compounds of the ‘875 Patent, and that the inventor was able to demonstrate the existence of those advantages as of the date of the filing of the patent application. On that basis, the ‘777 Patent is a valid selection patent when measured against the genus patent, the ‘875 Patent, regardless of the fact that it makes no promise for use in humans.” [70]


The Trial Judge erred in finding that the invention of the ‘777 Patent was obvious.

The Court examined the evidence before the Trial Judge and found that he was in exactly the same position as the Supreme Court when it decided Sanofi, where obviousness of the ‘777 Patent was also at issue. In Sanofi the key factor in the “obvious to try” analysis was the lack of knowledge of the properties of the enantiomers of the compounds of the ‘875 Patent, including the racemate from which clopidogrel was obtained, and not the difficulty in separating the racemates covered by the ‘875 genus Patent. The Supreme Court held, largely based on that absence of knowledge, that it was not obvious to try to resolve the racemate, or any other compound, so as to obtain the enantiomer having those advantageous properties.

The Court held that given that the Trial Judge applied the test for obviousness set out in Sanofi, and given that he applied it to the same material facts as the Supreme Court, he ought to have come to the same conclusion. His error lay in failing to recognize that the unknown nature of the properties of the enantiomers was fatal to the “obvious to try” analysis. [81]


The Trial Judge came to the correct conclusion, though in the case of the limitation defence, perhaps for the wrong reasons.

In order for section 39(1) of the Federal Courts Act to apply, all the elements of the cause of action must have occurred in the same province:

39. (1) Except as expressly provided by any other Act, the laws relating to prescription and the limitation of actions in force in a province between subject and subject apply to any proceedings in the Federal Court of Appeal or the Federal Court in respect of any cause of action arising in that province.

(2) A proceeding in the Federal Court of Appeal or the Federal Court in respect of a cause of action arising otherwise than in a province shall be taken within six years after the cause of action arose.

Damages are not an element of the cause of action of patent infringement. “[I]t is not necessary to prove that the patent holder has suffered a loss of some kind in order to succeed in an action for patent infringement.” [108] To the extent Apotex v. Pfizer, 2004 FC 190, states the contrary, it was incorrectly decided. [106]

“[T]he essential aspect of importation and exportation is the movement of goods into or out of Canada. Since a patent confers monopoly rights across Canada, the movement of goods across provincial boundaries is not an infringement of the patent. The port at which goods enter or leave the country is not determinative of the place where the cause of action arose since it is the movement of goods into or out of Canada which is the act of infringement.” [110]

“Canada is indivisible for the purposes of importation and exportation of infringing goods. Goods are imported or exported when they enter or leave Canada, regardless of the port of entry or departure. To that extent, the infringing acts of importing and exporting clopidogrel took place other than in a province so that subsection 39(2) of the Federal Courts Act applies.” [112]

Per Gauthier J.A. (concurring)

Gauthier J.A. explained some of the circumstances that may lead to Canadian patent applications including statements addressing utility, given that such statement are not required in Canadian law. He cautioned that “when Canadian applications are filed on the basis of European applications…it is useful to know that under European Union patent law, an invention must be capable of industrial application, which is a wide concept. Because of this, European applications will often contain some statements in that respect. In this context, and considering that no such requirement exists in our law, one must be careful not to treat each reference to a practical purpose as a promise of a specific result within the meaning of Consolboard.” [125]

Gauthier J.A. further stated that “statements of or references to a specific result in a claim, which are part of the specification as expressly noted in Consolboard (such as one dealing with a new use/new utility (See AZT…)) and statements in respect of a claimed new process to make an old product to obtain a specific result (See, for example, Re Alsop's Patent (1907), 24 R.P.C. 733) ought to be distinguished from expressly qualified statements as to what practical applications can be expected to flow from the demonstrated properties and advantages of a new product (such as the new compound in this case).” [126]

Gauthier J.A. found that it would be difficult, if not impossible, to construe the following statement in the ‘777 patent as a promise (i.e., effectively, a guarantee) that any specific result will be achieved in humans:

…the medicine of the invention can be usefully administered in the treatment and prevention of platelet disorders due to extracorporeal blood circuits or the consequence of complications in artheroma.

The word “can” must mean that, as a pro-drug, clopidogrel has the prerequisite inhibitory properties before ingestion (i.e., the power) to allow a practical application to occur in humans; it is “potentially capable of” such application. [129]

Gauthier J.A. highlighted the seriousness of criticism that (as raised by Prof. Siebrasse)  AZT does not provide a “proper basis for the heightened level of disclosure applied in recent case law, especially in cases where no use or specific result is referred to in claims where the inventor defines the invention for which he is seeking a monopoly, or where a specific advantage/utility is required to support the right to claim a particular invention (selection).” [132]

“In contradistinction with the situation in AZT, where the invention claimed was the new use/utility and thus the quid pro quo for the grant of the monopoly was a full disclosure in respect of such utility, the public here received all the information necessary to make and use clopidogrel, the invention claimed in the ‘777 Patent. The Trial Judge found, and this is no longer challenged, that the advantages necessary to make the selection inventive and thus justify the grant of a monopoly on clopidogrel were fully and properly described and demonstrated in the patent.” [134] “In such a case, the level of disclosure required by law should be lower.” [135]


This case recognises the importance of not being slavish to a particular doctrine, such as the promise doctrine, and instead looking at the underlying benefit to the public that is found in the disclosure. Indeed in some cases the promise is key to the invention as disclosed and claimed. In other circumstances, such as this case, it's not.