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1host---
Hello everybody. My name is Peter Myschyshyn and I’ll be your host for this episode. This episodes script was created by Mike Myschyshyn on the 2012 SCC case of Teva Canada Ltd. v. Pfizer Canada Inc. This case is about patent law. Before we get started, I’d like to give a quick overview of what a patent is. A patent is granted for the disclosure of statutory eligible subject matter that is new, useful, and non-obvious. Proper disclosure of an eligible invention is the quid pro quo for the limited monopoly granted by a patent. Some of the components of a patent include the specification and the claims. The specification, which includes the claims, describes the invention, while the claims themselves define the scope of the legal protection granted by the patent. Courts will consider the specification, including the claims, in determining whether the patent satisfies the disclosure requirement. Now, onto the background of Teva v Pfizer: In 1994 Pfizer filed a patent application for the use of compounds of a general formula for the treatment of erectile dysfunction or ED. This application was accepted and resulted in Pfizer being issued Patent ‘446 in 1998. The claims were structured as “cascading claims”, with Claim 1 involving over 260 quintillion compounds, Claims 2 to 5 concerning progressively smaller groups of compounds, and, importantly, Claims 6 and 7 each relating to an individual compound. Claim 7 related to sildenafil, the active compound in Viagra. Importantly, nowhere in the patent application was it disclosed that the compound that works was found in Claim 7, or that the remaining compounds in the patent had not been found to be effective in treating ED. This became the fundamental issue at the SCC. Teva applied for a notice of compliance in order to produce a generic version of Viagra, alleging that Pfizer’s patent was invalid for insufficient disclosure, among other reasons. The trial judge, Justice Kelen, and the court of appeal held that Pfizer’s ‘446 Patent was not invalid for insufficient disclosure. The main issue at the SCC was whether Pfizer failed to properly disclose its invention when it obtained the patent for Viagra. The SCC unanimously found that Pfizer’s patent application did not satisfy the disclosure requirements of the Patent Act. Let’s listen to what the parties had to say.
<-- Example of a host script submission. If you are submiting audio files instead, provide the audio file name here, ex: host-clip1.mp31This is the order that the audio files will be concatenated.
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2host---
First up, Mr. Aitken representing the appelent, Teva:
2If you are not providing audio files, enter in text for the host to say. If you are providing audio files of yourself as the host, provide the name of the audio files, and optionally (recommended), the text you say.
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3hearing00:02:2400:02:48Teva: Submission (Mr. Aitken)
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4hearing00:03:1800:03:34Teva: Submission (Mr. Aitken)
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5hearing00:03:5400:04:05Teva: Submission (Mr. Aitken)
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6hearing00:04:5100:05:09Teva: Submission (Mr. Aitken)
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7host---Justice Abella has a question
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8hearing00:06:3300:07:42Question from Abella J
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9hearing00:09:3400:09:59Teva: Submission (Mr. Aitken)
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10hearing00:11:2200:11:39Teva: Submission (Mr. Aitken)
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11hearing00:22:2500:23:19Teva: Submission (Mr. Aitken)
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12host---A comment from justice LeBel
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13hearing00:23:48.500:24:19.5Comment from LeBel J
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14host---Justice Abella has a question
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15hearing00:25:07.500:25:33.5Question from Abella J
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16hearing00:26:0100:26:10Question from Abella J
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17hearing00:30:0600:30:55Teva: Submission (Mr. Aitken)
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18hearing00:31:3000:32:35Teva: Submission (Mr. Aitken)
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19hearing00:32:3600:32:54Teva: Submission (Mr. Aitken)
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20hearing00:33:5300:34:06Teva: Submission (Mr. Aitken)
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21hearing00:44:0100:44:23.2Question from Abella J
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22hearing00:44:43.500:45:44Teva: Submission (Mr. Aitken)
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23hearing00:50:5600:52:06Question from Abella J
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24host---
Closing remarks by Mr. Aitken, coundel for Teva
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25hearing01:00:5401:02:01Teva: Closing (Mr. Aitken)
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26host---
Mr. Shaughnessy, speaking for Pfizer, was promptly questioned by Justices Rothstein and LeBel, and Chief Justice McLachlin, respectively
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27hearing01:28:3701:28:57Question from Rothstein J
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28hearing01:30:52.201:31:01Question from LeBel J
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29hearing01:31:1201:31:34Question from LeBel J
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30hearing01:33:1001:34:31Question from McLachlin CJ
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31hearing01:37:1601:39:38.5Question from Rothstein J
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32hearing01:40:4401:41:30Question from Rothstein J
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33hearing01:41:5501:42:57.5Question from Rothstein J
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34host---
More questions from Justice Rothstein and commentary from Justices Abella and LeBel.
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35hearing01:43:2801:43:56Question from Rothstein J
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36hearing01:46:22.501:48:09
Question from Rothstein, LeBel, and Abella JJ
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37host---
Questions from Chief Justice McLachlin
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38hearing01:48:41.201:49:37.5Question from McLachlin CJ
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39hearing01:49:4801:51:38Question from McLachlin CJ
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40hearing01:52:2601:53:10.5
Pfizer: Submission (Mr. Shaughnessy)
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41host---
Question from Justice Rothstein and closing remarks from Mr. Shaughnessy, counsel for Pfizer
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42hearing01:57:00.701:57:39Question from Rothstein J
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43hearing02:02:12.502:03:09
Pfizer: Submission (Mr. Shaughnessy)
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44host---
Next are submissions from Mr. Bernstein, counsel for Pfizer, with questions from Chief Justice McLachlin and Justice Rothstein
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45hearing02:12:2402:13:17
Pfizer: Submission (Mr. Bernstein)
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46hearing02:14:5002:15:40.5
Pfizer: Submission (Mr. Bernstein)
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47host---A question from Justice LeBel
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48hearing02:16:01.502:17:08.2Question from LeBel J
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49host---
A question from Justice Rothstein and closing remarks from Mr. Bernstein, counsel for Pfizer.
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50hearing02:19:12.502:20:53.5Question from Rothstein J
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51hearing02:26:4002:27:11Pfizer: Closing (Mr. Bernstein)
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52host---
The hearing ended with closing remarks from Mr. Aitken, counsel for Teva.
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53hearing02:43:1402:43:42Teva: Submission (Mr. Aitken)
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54host---
In their decision, the SCC focused on whether the ’446 Patent met the disclosure requirements of section 27 (3) of the Patent Act. According to this section, the specification of an invention must correctly and fully describe the invention and its operation or use as contemplated by the inventor, and set out clearly, as to enable any person skilled in the art to make, construct, or use the invention. The SCC unanimously found that Pfizer’s patent application did not satisfy the disclosure requirements of the Patent Act. The court noted that the issue of sound prediction is a concept that becomes relevant only when an invention’s utility cannot actually be demonstrated by way of tests or experiments, but can nevertheless be successfully predicted. At the time the application was filed, sildenafil’s utility in treating ED had been demonstrated in Study 350. This took the invention out of the realm of sound prediction. The fact that Pfizer did not disclose that the tested compound was sildenafil goes to the issue of disclosure of the invention, not to that of disclosure of the invention’s utility. The SCC reaffirmed Consolboard Inc. v. MacMillan Bloedel Ltd. a 1981 SCC case that said in part that the nature of the invention must be disclosed and that the entire specification, including the claims, must be considered in determining the nature of the invention and whether disclosure was sufficient. The SCC also reaffirmed Pioneer Hi-Bred Ltd. v Canada a 1989 SCC case that said in part: Two conditions must be met to satisfy the requirement of disclosure. First, a patent must describe the invention and define the way it is produced or built, and second, the applicant must define the nature of the invention and describe how it is put into operation. A failure to meet the first condition would invalidate the application for ambiguity, while a failure to meet the second invalidates it for insufficiency. The SCC then turned their attention to what the invention in the ’446 Patent was. The court noted that section 58 of the Patent Act states that valid claims survive in the face of one or more invalid claims. Section 58 does not allow a court to consider the validity of a single claim (Claim 7 in this case) independently of the rest of the specification, even if the claim in question is the only one that may be valid. This section is engaged only after the validity analysis is carried out. In general, each claim of a patent should not be construed as a separate invention, however, it is possible for each claim in a patent to disclose a separate invention. In this case, the court decided that the use of sildenafil and the other compounds for the treatment of ED comprised one inventive concept as indicated by evidence such as the lack of the plural word “inventions” in the ’446 Patent and no divisional applications made by Pfizer. In terms of disclosure, although the ’446 Patent included the statement that “one of the especially preferred compounds induces penile erection in impotent males”, the specification did not indicate that sildenafil was the effective compound, that Claim 7 contained the compound that works, or that the remaining compounds in the patent had been found not to be effective in treating ED”. The disclosure in the specification would not have enabled the public “to make the same successful use of the invention as the inventor could at the time of his application”, because even if a skilled reader could have narrowed the effective compound down to the ones in Claim 6 and Claim 7, further testing would have been required to determine which of those two compounds was actually effective in treating ED. As the trial judge stated, “the skilled reader must undertake a minor research project to determine which claim is the true invention”. Thus, the SCC held that the disclosure of the ’446 Patent was insufficient and not in compliance with section 27(3) of the Patent Act. Therefore, Teva established its allegation that the ’446 Patent is not valid.
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