Blog

VIAGRA patent not invalidated in prohibition application appeal

On June 4, 2013, the Supreme Court of Canada granted in part Pfizer’s application for a modification of its reasons of the judgment of the Court dated November 8, 2012. As previously reported here, the Supreme Court of Canada allowed Teva’s appeal of a judgment of the Federal Court of Appeal holding that Canadian Patent No. 2,163,446 is void for failure to comply with subsection 27(3) of the Patent Act.

A comparison of the original and amended paragraphs 83, 87 and 91 of the reasons of the judgment of the Court is provided below: 

 

Original Reasons

Amended Reasons

[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

[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, I find that the appellant has established its allegation under ss. 5(1)(b)(iii) and 5(3) of the Regulations that Patent ‘446 is not valid

[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.

[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 the light of the remedy in Pioneer Hi-Bred, as I mentioned above, I hold that Teva has established its allegation that Patent ‘446 is not valid.

[91] I would therefore allow the appeal with costs and hold that Patent 2,163,446 is void.

[91] Therefore, I would allow the appeal with costs in this Court and in the courts below and hold that Teva established its allegation that Patent 2,163,446 is not valid, and dismiss Pfizer’s application for an order of prohibition under s. 6(1) of the Regulations.

The formal Order was also amended to read as follows:

The appeal from the judgment of the Federal Court of Appeal, Number A-292-09, 2010 FCA 242, dated September 24,2010, heard on April 18, 2012, is allowed with costs and Teva having established its allegation that Patent No. 2,163,446 is not valid, the application of Pfizer for an order of prohibition under s. 55.2(4) of the Patent Act, R.S.C. 1985, c. P-4, and s. 6 of the Patent Medicines (Notice of Compliance) Regulations, SORJ93-133, is dismissed.

The court also granted Teva’s motion to amend the formal order to clarify that Teva was entitled to costs at the Supreme Court and in the courts below.

A copy of Supreme Court’s Order may be found here.

Teva was represented by David Aitken, Marcus Klee and IldIko Mehes.