Pfizer Kicked When Down: Federal Court Provides Added Certainty that VIAGRA Patent is Now Invalid and Void

Published November 22nd, 2012

Apotex Inc. v. Pfizer Ireland Pharmaceuticals, 2012 FC 1339 (Zinn)

Summary – The Federal Court has followed the lead of the Supreme Court of Canada (“SCC”) and declared the VIAGRA patent “invalid” and “void”.  The Court found it had jurisdiction to consider Apotex’s impeachment action and motion for summary judgment.  The SCC’s prior finding of insufficient disclosure was a binding legal determination and dispositive of Apotex’s claim of invalidity.

Analysis – As reported here, the SCC recently held in Teva Canada Ltd. v. Pfizer Canada Inc., 2012 SCC 60 (“Teva”) that Pfizer’s Canadian Patent No. 2,163,446 (the “`446 Patent”) was invalid and void.  The `446 Patent contains a specific claim to the use of sildenafil (the active compound in VIAGRA) for the treatment of erectile dysfunction (“ED”).  The SCC found the `446 Patent failed to meet the statutory disclosure requirements because it did not identify “sildenafil” as the “one” compound that was stated as being effective in treating ED.

Pfizer filed a motion seeking to amend the SCC’s Judgment in Teva or alternatively for a re-hearing on the issue of remedy, on the basis that the SCC did not have jurisdiction to “invalidate” and “void” the `446 Patent.  As noted here, Teva resulted from a proceeding that arose under the Patented Medicines (Notice of Compliance) Regulations, in which the only issue was whether the allegation of invalidity of the `446 Patent was justified.

The present Federal Court decision arose from a parallel impeachment action brought by Apotex seeking a declaration of invalidity of the `446 Patent (“Apotex Action”).  The Apotex Action was scheduled to go to trial on November 26, 2012.  In view of Teva, both Apotex and Pfizer brought motions for summary judgment.  Apotex sought a declaration that the `446 Patent is invalid.  Pfizer moved for a dismissal of the Apotex Action on the basis that the Court lacked jurisdiction or in the alternative, for mootness.

With respect to jurisdiction, the Court held that if the SCC deletes its declaration that the `446 Patent is void from the Teva Judgment, the amendment would be made on the basis that it had no jurisdiction to make the declaration in the first place.  “If the declaration of invalidity was made without jurisdiction, then it is a nullity, it never happened.  If it never happened then there was never a loss of this Court’s jurisdiction to hear this action.” (para. 19)  This alone, in the Court’s view, was sufficient to deny the motion to dismiss for want of jurisdiction because it was not plain and obvious that the declaration of invalidity would be maintained in light of Pfizer’s motion to amend the Judgment in Teva.

Notwithstanding the SCC’s declaration of invalidity of the `446 Patent, the Court determined it retained jurisdiction to hear the Apotex Action.  Section 62 of the Patent Act makes it clear that a patent is voided by filing a certificate of the judgment in the Patent Office.  Since there was no evidence that such a certificate was filed, “the `446 Patent is not void and of no effect for the purposes of the Patent Act and accordingly, this Court retains jurisdiction to entertain this action”. (para. 26)

With respect to mootness, the Court accepted the Apotex Action was moot since Apotex has all that it seeks (its NOC and a declaration by the SCC that the `446 Patent is void).  At the same time, the Court recognized that, if the SCC amends its Judgment and removes the declaration of invalidity, the possibility of an action for infringement was not unlikely.  In the Court’s view, this alone was sufficient reason not to dismiss the action for mootness as it stated:

However, Pfizer’s motion to the Supreme Court, like the sword of Damocles, hangs over the head of Apotex.  Pfizer does not concede that Apotex is and will remain at liberty to produce and market its generic version of Viagra with no fear of suit from Pfizer. (para. 28)

The Court granted Apotex’s motion for summary judgment.  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 patent, and

3. whether the 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.”

The determination made by the SCC on these three questions, i.e., that the `446 Patent fails to meet the requirement of sufficient disclosure pursuant to subsection 27(3) of the Act, was held by the Court to be a binding legal determination.  This legal finding was dispositive of Apotex’s invalidity action regardless of whether the SCC granted Pfizer’s motion for a deletion of the declaration of invalidity.  In particular, the Court stated:

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. (para. 33)

The Court granted Apotex its costs of the action and the motions.

Practice Point – In our report on Teva, we questioned the effect of the SCC’s Judgment on Apotex’s patent impeachment action.  We now have our answer.  The Federal Court’s declaration of invalidity of the `446 Patent provides the parties and the public, including other generic drug manufacturers, with greater certainty that there is no longer a valid patent covering the use of sildenafil for treating ED.  However, even though the Court held “there can be no genuine issue for trial because no result is possible other than a finding that the `446 Patent is invalid”, this decision will be appealed to the Federal Court of Appeal.

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