As discussed in the November 9, 2012 post, Supreme Court Invalidates Pfizer’s Blockbuster VIAGRA® Patent, the Supreme Court of Canada struck down Pfizer’s blockbuster VIAGRA® patent (the “‘446 Patent”) on the basis of insufficient disclosure: see Teva Canada Ltd. v. Pfizer Canada Inc., 2012 SCC 60.

In a curious twist, the SCC declared the ‘446 Patent “void”, despite the case being brought under the Patented Medicines (Notice of Compliance) Regulations (“PM(NOC) Regulations”). However, on June 4, 2013, the SCC granted Pfizer’s rare Rule 76/81 Motion, varying this controversial aspect of its judgment to clarify that it had found Teva’s invalidity allegation justified, as opposed to declaring the ‘466 Patent invalid: see Supreme Court of Canada’s Order on Motion to Vary Pronouncement / Order, and for Re-Hearing dated June 04, 2013.

Importantly, any confusion and worry caused by the SCC’s original judgment as to whether patents can be suddenly voided by the Federal Court under the scheme of the PM(NOC) Regulations is now over.

Pfizer’s story highlights an important distinction that all patentees of pharmaceutical products need to be aware of.

PM(NOC) Regulations vs. Patent Act

The scope and purpose of applications brought under the PM(NOC) Regulations differ from patent actions brought under the Patent Act. So do the remedies available under each.

Applications brought under the PM(NOC) Regulations are intended to be summary in nature (decided within two years), and confined to administrative purposes. The Court’s scope in adjudicating patent infringement and invalidity is limited to determining whether the allegations made are “justified” or not. Where a “second person” (typically a generic manufacturer) has addressed all relevant patents pertaining to a specific drug, and the Court finds its allegations justified, the Minister of Health is free to issue the requested Notice of Compliance (subject to regulatory approval issues), paving way for generic product entry into the Canadian marketplace.

In contrast, patent actions brought under the Patent Act involve full-blown trials, with parties entitled to a full ambit of procedural rights including discovery, and viva voce evidence (i.e. live trial witnesses). In this context, the Court is free to impeach a patent (i.e. declare invalid and void), or make a declaration as to infringement.

The VIAGRA® Saga Continues

Unfortunately for Pfizer, the effect of the SCC’s amendment does not serve to “un-void” their ‘446 patent.

This is because a patent impeachment action brought by Apotex Inc. (another generic) on the VIAGRA® patent was concurrently proceeding while the Supreme Court was hearing Teva’s appeal under the PM(NOC) Regulations.

On November 20, 2012, the Honourable Justice Zinn granted Apotex’s motion for summary judgment declaring the ‘446 Patent void in light of the SCC’s judgment: see Apotex Inc v Pfizer Ireland Pharmaceuticals, 2012 FC 1339. The Court specifically considered the possibility of Pfizer’s success on the amendment motion before the SCC, but found nonetheless that the Supreme Court’s ruling on insufficiency was a legal determination that was binding on the Federal Court.

Pfizer’s appeal of Justice Zinn’s decision is slated to be heard by the Federal Court of Appeal later this year. In the mean-time, the VIAGRA® patent remains void and unenforceable in Canada.