Thursday, November 15, 2012

Updated - Pfizer Seeks Amendment or Re-hearing of Supreme Court of Canada's Viagra Judgment

In the Teva v. Pfizer (“Viagra”) case, the Supreme Court of Canada on November 8, 2012 rendered a 7/0 judgment  that concluded as follows:
H. Remedy
[81] I have reached the conclusion that Patent ’446 does not comply with s. 27(3) of the Act. What is the appropriate remedy?
[82] The remedy for inadequate disclosure was stated by this Court in Pioneer Hi-Bred:
Canadian courts have stated in a number of cases the test to be applied in determining whether disclosure is complete. The applicant must disclose everything that is essential for the invention to function properly. To be complete, it must meet two conditions: it must describe the invention and define the way it is produced or built [citation omitted]. 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 description must be such as to enable a person skilled in the art or the field of the invention to produce it using only the instructions contained in the disclosure . . . . [Emphasis added; citation omitted; pp. 1637-38.]
[83] In the case at bar, Patent ’446 is insufficient, because a skilled reader having only the specification would not be able to put the invention into operation. Therefore, Patent ’446 is invalid.
[84] Although s. 27 does not specify a remedy for insufficient disclosure, the logical consequence of a failure to properly disclose the invention and how it works would be to deem the patent in question invalid. This flows from the quid pro quo principle underpinning the Act. If there is no quid — proper disclosure — then there can be no quo — exclusive monopoly rights.
[85] Pfizer, however, appears to argue that the patent cannot be deemed invalid, because Teva did not argue that s. 53 applies (R.F., at para. 82). Section 53 specifically states that a patent will be void if
any material allegation in the petition of the applicant in respect of the patent is untrue, or if the specification and drawings contain more or less than is necessary for obtaining the end for which they purport to be made, and the omission or addition is wilfully made for the purpose of misleading.
[86] Pfizer submits that Teva’s argument about “concealment” of the useful compound in the patent is a thinly veiled accusation of fraud, but that Teva has never alleged that Patent ’446 contravenes s. 53 (R.F., at para. 79). Further, Pfizer states that, “s. 27(3) . . . [was never] intended to address an allegation of deliberate deception” (R.F., at para. 80).
[87] There is a very simple response to Pfizer’s submissions on this point. Even if s. 53 was not raised and its requirements were not met, this does not mean that the disclosure was adequate for the purposes of s. 27(3). These provisions can be independent of each other, as is the case here. Although wilful intent to mislead has not been alleged or proven in this case, insufficient disclosure has been alleged and I have found that it has been made out. Therefore, in light of the remedy adopted in Pioneer Hi-Bred, Patent ’446 is invalid.
I. Other Submissions
[88] Pfizer and the intervener Canada’s Research-Based Pharmaceutical Companies argue that Teva’s submissions are incompatible with Canada’s international obligations, and more specifically with the Patent Cooperation Treaty, Can. T.S. 1990 No. 22, incorporated into Canadian law by the Intellectual Property Improvement Act, S.C. 1993, c. 15, s. 29(1). The essence of this argument is that Teva is advocating for an enhanced disclosure requirement which, Pfizer and the intervener says, is contrary to Canada’s obligations under the Treaty.
[89] There is no need to address this argument at length. Since, as I have already explained, this is not a case about sound prediction, the Court does not need to consider whether a claim of utility that is based on sound prediction would impose an “enhanced” disclosure obligation on the patentee or whether such an “enhanced” disclosure obligation — if one existed — would be contrary to the Treaty. Neither the parties nor the interveners argue that the disclosure requirements of s. 27(3) violate any international obligations. The only issue in this case is whether the disclosure requirements set out in s. 27 of the Act were met. This argument must therefore fail.
[90] Finally, I will note that the delay of 13 years between the filing of the patent and Teva’s challenge is inconsequential. As Nadon J.A. found in the reasons of the Federal Court of Appeal in this case, the relevant question is whether the disclosure was sufficient as of the date of filing. Consequently, the passage of time does not bar Teva’s challenge.
V. Conclusion
[91] I would therefore allow the appeal with costs and hold that Patent 2,163,446 is void.

Pfizer has filed a motion seeking to amend the judgment, or alternatively for a re-hearing by the Supreme Court of Canada on the basis, inter alia, that:
This Court accidentally granted a remedy in this appeal that exceeds its jurisdiction. In holding that Pfizer’s 446 Patent was invalid and void, this Court overlooked the legislative context in which the proceeding was brought, and that this Court did not have jurisdiction to issue a judgment invalidating Pfizer’s 446 Patent or declaring it void.

The Supreme Court Rules do provide for the possibility of amending a judgment or a re-hearing. I am unaware of any IP decision where there has been a re-hearing pursuant to Rule 76.  According to Henry Brown’s authoritative text on Supreme Court of Canada Practice, “Motions to amend under rule 81 may only be made to correct minor technical slips or errors in the judgment or pronouncement”.

Here is Pfizer’s Notice of Motion and Factum in support of the motion.


PS - in  a dramatic but predictable development, Justice Zinn in the Federal Court has just followed the SCC's ruling on the invalidity of the patent and went on to hold that:
[32] I reject the submission of Pfizer that the question of the sufficiency of disclosure in Teva was a mixed question of fact and law. I agree with Apotex that in Teva the sufficiency of the disclosure of the ‘446 Patent turned on three questions of law: (1) the determination of the invention or inventive concept of the patent, (2) the construction of the ‘446 Patent, and (3)
whether the ‘446 Patent, properly construed, permitted the person of skill in the art “to make the same successful use of the invention as the inventor could at the time of his application.”
[33] The determinations made by the Supreme Court on those three questions of law are binding on this Court. Its finding that Pfizer, in failing to disclose which of the many compounds named in the ‘446 Patent was effective in treating erectile dysfunction, had not properly or sufficiently disclosed its invention, is a finding that this Court must respect and follow. As a consequence, when, as here, the action seeks a declaration of the invalidity of the ‘446 Patent for insufficient disclosure, there can be no genuine issue for trial because no result is possible other than a finding that the ‘446 Patent is invalid. Accordingly, Apotex is entitled to summary judgment
 HT to Alan Macek - whose excellent blog IPPractice is a must.

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