The Promise Doctrine Strikes Again

Published January 20th, 2012

Apotex v. Sanofi-Aventis, 2011 FC 1486 (clopidogrel – PLAVIX™)

This is the latest decision of a rather significant number of decisions released over the past year or so that have construed the promise of a Canadian patent.  The patent at issue in this case was Canadian Patent No. 1,336,777 (the “`777 Patent”), a selection patent that claims:  1) clopidogrel and its salts; 2) a process for making clopidogrel; and 3) compositions containing clopidogrel.  Clopidogrel and its salts were also encompassed by the claims in the genus patent, Canadian Patent No. 1,194,875 (the “`875 Patent”).  Clopidogrel is a pro-drug and an enantiomer of the racemic compound PCR 4099.

The `777 Patent is the same patent that was the subject of the decision of the Supreme Court of Canada (the “SCC”) in Apotex Inc. v. Sanofi-Synthelabo Canada Inc., 2008 SCC 61 (“Sanofi #1”), where the patent was held to be valid and the legal tests for anticipation and obviousness in Canada were modified.  Since proceedings brought under the Patented Medicines Notice of Compliance (NOC) Regulations (the “PMNOC Regulations”) are summary in nature, the decision in Sanofi #1 did not preclude the parties from subsequently initiating patent infringement and impeachment actions.

In the present decision, Apotex Inc. v. Sanofi-Aventis, 2011 FC 1486 (“Sanofi #2”), Justice Boivin of the Federal Court granted Apotex’s patent impeachment action and declared the `777 Patent invalid for lack of utility and for obviousness.  It is important to note that the utility of the `777 Patent was not an issue at play in Sanofi #1.  Although Justice Boivin found that Apotex infringed the `777 Patent, Sanofi’s related patent infringement action was held moot in view of the declaration of invalidity.  Sanofi has appealed this decision in Court File No. A-7-12.

Construction of the Invention and the Promise

Justice Boivin construed the invention of the `777 Patent to be “a compound which is useful in inhibiting platelet aggregation, has greater therapeutic effect and less toxicity than the other compounds of the `875 Patent, has the advantages of the salts (crystallize easily, not hygroscopic and sufficiently water-soluble) and the methods for obtaining that compound” (para. 140).

Justice Boivin also construed the promise of the `777 Patent to be “the use of the invention in humans” (paras. 174 and 367).  Justice Boivin arrived at this construction on the bases that:  1) the words “medicine”, “patient”, “pharmaceutical compositions”, “active pharmaceutical index” and “medicine of the invention” used in the `777 Patent illustrated that the promise of the `777 Patent is for use of the invention in humans (paras. 163 and 164); and 2) the genus `875 Patent promised use in humans (paras. 169 and 172) and it would be illogical, in this particular case, to allow a selection patent to promise less than the genus patent (para. 170).

Utility – Lack of Demonstration and Lack of Sound Prediction

In order to meet the requirements of utility in Canada, the utility of a claimed invention must either be demonstrated or be soundly predicted.  Demonstration of utility does not need to be disclosed in the patent [see Consolboard v. MacMillan Bloedel (Sask.) Ltd., 1 S.C.R. 504; Pfizer Canada Inc. v. Canada (Health), 2008 FCA 108 (atorvastatin calcium); and Novopharm Ltd. v. Pfizer Canada Inc., 2010 FCA 242 (sildenafil)].  On the contrary however, disclosure of both the factual basis and the sound line of reasoning of the sound prediction of utility must be disclosed in the patent itself (see Eli Lilly Canada Inc. v. Apotex Inc., 2008 FC 142 aff’d 2009 FCA 97 (raloxifene) and  Eli Lilly and Co. v. Teva Canada Ltd., 2011 FCA 220 (atomoxetine)].

On the issue of demonstration, Justice Boivin determined that the utility of the `777 Patent was not demonstrated in humans.  In particular, although some of the results of human study P-1062 were known before the February 8, 1988 filing date of the `777 Patent, it was determined that these early results did not provide sufficient information to demonstrate the utility of the `777 Patent in humans (paras. 348 and 349).  Justice Boivin was also not convinced that the co-inventor of the `777 Patent was informed of clopidogrel’s activity in humans before the filing date of the `777 Patent (paras. 350 to 356).

On the issue of sound prediction, Justice Boivin found that there was both a factual basis (para. 488) and a sound line of reasoning (para. 563) to support the prediction that the invention of the `777 Patent could be used in humans.  However, Justice Boivin found that the disclosure of the factual basis and the sound line of reasoning in the `777 Patent, i.e., the third part of the test for sound prediction as enunciated by the SCC in Apotex Inc. v. Wellcome Foundation Ltd., 2002 SCC 77 (AZT), was insufficient.  Justice Boivin arrived at this finding on the grounds that there was no reference or recognition in the `777 Patent to the following:  1) the work done on the earlier compound ticlopidine; 2) the work done on PCR 4099; 3) the multiple animal models used in the testing of PCR 4099; 4) the knowledge that PCR 4099 caused convulsions in baboons; and 5) the importance of the metabolism of the pro-drug clopidogrel (paras. 571 and 574 to 580).  In addition, Justice Boivin found that the progression from ticlopidine to PCR 4099, and finally to the `777 Patent, was essential for a sound prediction and that “it should be in the patent itself and not a couple of steps removed in a reference to another document” (para. 582; emphasis in original).  Accordingly, Justice Boivin held that the `777 Patent lacked sound prediction.

Obviousness – Obvious to Try

While Justice Boivin was not required to address the other asserted reasons for invalidity of the `777 Patent, he went on to analyze the issue of obviousness and, contrary to the decision of the SCC in Sanofi #1, held that the `777 Patent was “obvious to try” and therefore invalid (para. 784).  Justice Boivin arrived at an opposite conclusion mainly because he had the advantage of hearing the testimony of one of the inventors in support of undue experimentation.  Justice Boivin found the inventor’s testimony to be evasive and inconsistent and, it appeared that rather than taking months to separate the enantiomers after a series of failed experiments, as stated in his affidavit relied on by the SCC, success was straightforward once he had settled on the “classic” method.  The difference in the conclusions reached by Justice Boivin and the SCC highlight the difference between making a determination on affidavit evidence in a proceeding under the PMNOC Regulations and after hearing live testimony in an impeachment/infringement action.  Accordingly, Justice Boivin found that:  1) persons skilled in the art would have been directed towards the classic method to separate and that the method was routine (para. 709); and 2) there was motivation to separate the enantiomers of PCR 4099 at the relevant date, stating that in the mid 1980’s “there was a clear indication that the separation of enantiomers could be performed and it was therefore important to test for them” (para. 748).  In addition, with respect to the method of salt preparation, Justice Boivin found that it would have been clear to a person skilled in the art at the relevant date that it would work (para. 708).

Best Practices

In view of the continued application of the promise doctrine by Canadian Courts, it is important for Applicants to ensure that their patent application provides sufficient support for its promised utilities.  Applicants should include all available data and information in the application itself to ensure that it meets the requirements of a proper disclosure of the sound prediction for the promised utility. And, as we recently advised in our report on the olanzapine decision in Eli Lilly Canada Inc. v. Novopharm Ltd., 2011 FC 1288, Applicants must also be careful in selecting the language used in a patent application to describe the promised utility, ensuring not to set the bar higher than what can be supported by the disclosure.

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