The recent decision by the Supreme Court of Canada in Teva Canada Limited v Pfizer Canada Inc, 2012 SCC 60 (sildenafil, VIAGRA), as reported in an IP Update on November 8, 2012, continues to reverberate through the patent world. In particular, the finding that the ‘446 patent is “void” has generated a flurry of activity in the Supreme Court and Federal Court.
Supreme Court: '446 patent is “void” and “invalid.” In ruling against Pfizer, the Supreme Court found that the ‘446 patent failed to meet the disclosure requirements laid down by the Patent Act. As a result, the Court allowed the appeal and concluded that the “appropriate remedy” for inadequate disclosure was that the patent was “invalid” and “void” [at ¶82, 83, 87, 91].
While the decision to allow the appeal is understandable in view of the reasons, the remedy of voiding the patent is curious given the genesis of the appeal.
In particular, the proceeding arose under the Patented Medicines (Notice of Compliance) Regulations (“Regulations”). The issue in the proceedings below was whether the Minister of Health may issue a notice of compliance (NOC; marketing approval) to Teva for generic sildenafil. The validity of the ‘446 patent per se was not in issue (nor could it be in proceedings under the Regulations).
This distinction between whether an allegation of invalidity is justified and invalidity per se, while subtle, is material since the Federal courts have repeatedly affirmed that parties continue to enjoy the ability to litigate patent issues in actions, independent of proceedings under the Regulations. A finding that the ‘446 patent is invalid would be directly contrary to settled jurisprudence.
Pfizer request for rehearing. In response to the ruling that the ‘446 patent is “void,” Pfizer has asked the Supreme Court to amend the judgment or have a rehearing on remedy. The request is solely directed to the invalidity ruling. Pfizer is not challenging the substance of the Court’s reasoning.
Perhaps unsurprisingly, Teva is opposing the motion, with the support of the Canadian Generic Pharmaceutical Association, arguing that the Court has jurisdiction to void the patent. The motion remains pending.
The consequences of the Court declining to amend the judgment are potentially dire. Generic manufacturers likely will argue that the Federal Court has jurisdiction to invalidate patents in proceedings under the Regulations. Patentees will have little choice but to initiate actions for declarations of validity in order to benefit from the safeguards provided by an action, including oral testimony at trial.
Given that the ability of the Court to invalidate patents under the Regulations was not argued during the appeal, the ruling appears to be a purely inadvertent slip. In Apotex v Sanofi-Synthelabo Canada, 2008 SCC 61, another decision under the Regulations, the Court repeatedly considered whether allegations of invalidity were justified rather than whether the patent was valid.
Federal Court: VIAGRA patent invalid. In a ruling on November 20, 2012, Justice Zinn of the Federal Court — relying on Teva v Pfizer — granted summary judgment, declaring that the ‘446 patent is invalid and void: Apotex Inc v Pfizer Ireland Pharmaceuticals, 2012 FC 1339. The motion was brought in an impeachment action that was scheduled for trial later this year. In the same ruling, Justice Zinn rejected a motion by Pfizer seeking dismissal of the proceeding for want of jurisdiction.
Pfizer motion. Pfizer argued that the invalidity finding in Teva v Pfizer meant that no patent remained in issue between the parties and accordingly that the Court did not have jurisdiction to hear the action. In the alternative, Pfizer argued that the issue was moot.
The Court rejected Pfizer’s arguments on loss of jurisdiction. While acknowledging that the action was moot (as Apotex had received an NOC and the Supreme Court has declared the patent void), the Court elected to hear the summary judgment motion. The Court expressed concern over Pfizer’s motion to alter the Supreme Court judgment and the potential uncertainty that might otherwise exist around the sale of Apotex’s sildenafil product.
Apotex motion for summary judgment. On the merits of the motion, the Court construed the Supreme Court’s decision as a “legal determination” that is binding on the Federal Court even if Pfizer succeeds on the motion to amend the judgment. The Court ruled that sufficiency 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.’”
This reasoning seems at odds with the decision of the Supreme Court. In particular, the Supreme Court expressly considered what Pfizer actually invented (see ¶72). Moreover, the complaint was in part that Pfizer obscured the true invention (sildenafil) by having claims to two individual compounds when only one compound had utility. Presumably, if Pfizer could establish utility for the second individually claimed compound, any concealment argument would have considerably less force. In any event, the sufficiency analysis does not appear to have been a pure question of law.
Despite the Supreme Court’s judgment, the Federal Court judge went on to declare that the ‘446 patent is invalid and void, noting the possibility that the Supreme Court could set aside its declaration of invalidity.
As a final note, in an earlier decision in the same action issued on November 8, 2012, Justice Zinn declined to decide before trial or at the outset of trial the question of whether Apotex lacked standing to impeach certain claims of the ‘446 patent, having regard to Pfizer’s covenant not to sue Apotex for infringement of such claims: 2012 FC 1301.