• Sanofi’s Patent for Clopidogrel (PLAVIX) Found Valid and Infringed on Appeal; Apotex’s Appeal on Costs Moot
  • August 2, 2013
  • Law Firm: Borden Ladner Gervais LLP - Toronto Office
  • The Federal Court of Appeal has set aside the judgment of the Federal Court, and found that Canadian Patent No. 1,366,777 is valid, and infringed by Apotex. The matter has been sent back to the Federal Court to deal with the issue of remedies and to assess Sanofi’s costs.

    This is the same patent that had previously been the subject of a NOC proceeding and was appealed up to the Supreme Court of Canada, where it was found to be neither anticipated nor obvious (2008 SCC 61).

    Apotex subsequently commenced an action in the Federal Court seeking a declaration that the patent was invalid. Sanofi also commenced an infringement action, and the two proceedings were consolidated into one. The Trial Judge found the patent was infringed, but invalid for lack of utility on the basis that the promise of the patent had neither been demonstrated nor soundly predicted, as well as being obvious (2011 FC 1486).

    In overturning the Trial Judge, the Court of Appeal addressed the promise of the patent, obviousness and “obvious to try”, and the disclosure of the factual basis for sound prediction.

    The Court of Appeal clarified its earlier statements regarding the promise of the patent in Eli Lilly Canada Inc. v. Novopharm Ltd, 2010 FCA 197, stating that although the promise of the patent must be ascertained, it should not be taken to have assumed that every patent contains an explicit promise of a specific result. This is because there is no obligation on the part of the inventor to disclose the utility of his invention in the patent. If there is no explicit promise of a specific result, then a mere scintilla of utility will do.

    Furthermore, patent applications are often drafted to meet world-wide requirements, and so one must be cognizant that there may be statements made that are not applicable to Canadian law. For example, European applications will often contain statements regarding industrial application, and one must be careful not to treat each reference to a practical purpose as a promise of a specific result withinthe meaning of Consolboard:

    “Moreover, 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 [...]) and statements in respect of a claimed new process to make an old product to obtain a specific result [...] 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).”

    For obviousness, the Court of Appeal emphasized that the genus patent described multiple compounds that did not automatically point to clopidogrel. Also, while the methods of separating a racemate into its isomers are known, it does not follow that a person skilled in the art would necessarily apply them. Lastly, the actual conduct of the inventors was helpful in determining the relative obviousness of the invention:

    “Put another way, the distance between the common general knowledge and the inventive concept of the ‘777 Patent could not be bridged by routine experimentation since the results to be obtained were unknown. On the facts, this was confirmed by the fact that the inventors, who had more knowledge that the person of ordinary skill in the art, attempted to resolve a number of other compounds before finally trying PCR 4099.”

    In a concurring judgment, Gauthier JA distinguished between a situation where the invention is a new use and the situation in the present case where the invention is clopidogrel. Gauthier JA wrote that in such a case, the level of disclosure required for a sound prediction should be lower and in this case it was sufficient to state that some of the utility is based upon a prediction:

    “The clear indication in the [...] patent that use in humans was predicted as opposed to demonstrated should be sufficient at law to meet the test for sound prediction. Indeed, this is enough to enable the public to know that such practical application was not demonstrated at the time the patent application was filed. Therefore, the public would have the ability to challenge the monopoly based on whether it was granted on mere speculation, and determine whether the inventor in fact had the required factual basis and sound line of reasoning to support this statement at the relevant time.”

    As a result of this decision in favour of Sanofi, Apotex’s separate appeal on the issue of its costs was deemed to be moot (2013 FCA 187).