Viagra® Will No Longer Erect Alone

Viagra® Will No Longer Erect Alone - Federal Court Wastes No Time in Confirming the Invalidity of the Viagra® Patent While Supreme Court Decides Whether to Reconsider Its Decision

Jonathan Roch, November, 29, 2012

The patent for Viagra®, Pfizer’s sixth best selling medicine, was recently struck down by the Supreme Court of Canada in a unanimous 7-0 decision for failing to meet the statutory disclosure requirements. The patent had been in force since 1998 and had two years remaining of its term.

Given the context of the appeal to the Supreme Court (a proceeding commenced under the Patented Medicines Notice of Compliance (PMNOC) Regulations), the decision by the Supreme Court to declare the patent invalid surprised Canadian patent practitioners. As a result of this decision, not only Teva but any generic manufacturer that obtains a Notice of Compliance can immediately start selling generic versions of Viagra® to the Canadian market. As reported here by my colleague Dr. Suzanne Hof, Pfizer has petitioned the Supreme Court to reconsider its decision to invalidate the patent, asserting that the Court in the context of the NOC proceedings, lacked the jurisdiction to do so.

Pfizer’s comments with respect to the Supreme Court’s lack of jurisdiction have some merit. Given however that the lower courts in Canada must follow the Supreme Court’s findings with respect to the insufficiency of the Viagra® patent disclosure, the ultimate fate for the Viagra® patent will not change. This was the reasoning as adopted by the Federal Court in Apotex Inc. v. Pfizer Ireland Pharmaceuticals, released only twelve days after the Supreme Court’s decision was rendered, when it held that the only possible result for the Viagra® patent is a finding of invalidity. If Pfizer’s goal in requesting the Supreme Court to reconsider its decision was to extend its monopoly until the issue of validity had been dealt with by the Federal Court, this issue appears to be moot. Pfizer appears to have accepted its fate by slashing the price of its little blue pill from about $49 to about $37 bringing the cost in line with its generic competitors. The Supreme Court may still take this opportunity to shed some light on its decision in the context of the current legislative framework and/or recommend revisions to the current framework.

Supreme Courts Comments – Patent’s Lack of Disclosure
The patent at issue relates to the use of a class of compounds, which includes sildenafil (the active ingredient in Viagra®), to treat erectile dysfunction (“ED”). The main issue before the Supreme Court was whether the patent met the Patent Act’s disclosure requirements which state that the specification “correctly and fully describe the invention”. In overturning the findings of both the Federal Court and the Federal Court of Appeal, the Supreme Court held that, although sildenafil was one of nine especially preferred compounds listed in the patent and that there was testing establishing that one of these compounds was found to work to treat ED, the specification failed to meet the statutory disclosure requirements as it did not specifically identify sildenafil as the tested compound that was found to be effective. Given that the skilled reader would be required to conduct “a minor research project” to determine which of two preferred compounds was the compound that was found effective, the Supreme Court held that the patent failed to state in clear terms what the invention was and that “as a matter of policy and sound interpretation”, Pfizer should “not be allowed to 'game' the system” as they did. As a result, the Court concluded that the patent was invalid for failing to meeting the disclosure requirements.

Context of the Decision by the Supreme Court
The appeal before the Supreme Court was the result of a proceeding under the PMNOC Regulations to prevent the Canadian Minister of Health from issuing a Notice of Compliance (“NOC”) to Teva to produce a generic version of Viagra®.  Proceedings under the PMNOC Regulations are abbreviated proceedings and historically do not result in a general finding of invalidity. In such proceedings, the court(s) mandate is limited to an assessment of whether allegations of invalidity are justified in order to decide if the Minister of Health should be permitted to issue a Notice of Compliance. If a court finds that the allegations of invalidity are justified, as the Supreme Court did in this case, the expected remedy is to deny the patent owner’s prohibition order application thereby allowing the Minister of Health to grant the generic company a Notice of Compliance to produce a generic version of the patented medicine.  The generic company or any other party could elect to invalidate the patent in question by commencing a separate impeachment action or assert the invalidity of the patent in an infringement action.

Pfizer’s Request for Reconsideration or Re-Hearing
The day after its Viagra® patent was invalidated, Pfizer filed a motion to the Supreme Court seeking to amend the judgment pursuant to Rule 81 of the Supreme Court Rules (“the Rules”), or alternatively for a re-hearing on the issue of remedy pursuant to Rule 76 of the Rules. Both Rules 76 and 81 have been applied in very limited circumstances.

Pursuant to Rule 81 (the so-called “slip rule”), a party may motion the court to correct minor technical slips or errors in the judgment or pronouncement. In a Rule 81 motion, the judge may elect to dismiss the motion, amend the judgment or direct that a motion for a re-hearing be made to the Court in accordance with Rule 76. This author believes that it is highly unlikely that an important decision such as the invalidity of a patent would be treated as a minor slip or error.

Rule 76 motions are also of very narrow scope. They have been limited to exceptional cases involving “a failure of justice or an error regarding the nature of the issues”. These motions are done in writing unless the Court otherwise orders and the Supreme Court has full discretion as to the conduct of the hearing. Given that the context was a proceeding in which the ultimate validity of the patent was not in issue, this author believes that the Court may grant a Rule 76 re-hearing, to at a minimum further explain or clarify its decision in the context of the current legislative framework and/or suggest revisions to the current framework.

Supreme Court’s Findings Binding on Lower Courts
The determination by the Supreme Court in its reasons that the Viagra® patent fails to meet the statutory requirement of sufficient disclosure is a legal determination that would be binding on any lower court in Canada asked to deal with the validity of the Viagra® patent.

This legal reality was recognized by the Federal Court in Apotex Inc. v. Pfizer Ireland Pharmaceuticals, an impeachment proceeding by Apotex against the same Viagra® patent. Justice Zinn explains in his reasons, made twelve days after the Supreme Court’s decision, that the Supreme Court’s determinations with respect to the sufficiency of the disclosure of the Viagra® 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” and that the Supreme Court’s finding that Pfizer, in failing to disclose which of the many compounds named in the patent was effective in treating erectile dysfunction, had not properly or sufficiently disclosed its invention, is a finding that the Federal Court must respect and follow. Given that Apotex action was seeking a declaration of the invalidity of the Viagra® patent for insufficient disclosure, Justice Zinn held that there can be no genuine issue for trial as no result is possible other than a finding that the Viagra® patent is invalid.

For more information please contact Jonathan Roch