On October 12, 2016, the Federal Court of Appeal allowed four appeals relating to decisions by the Minister of Health to issue a notice of compliance (NOC) to Teva for exemestane tablets (a generic version of Pfizer’s AROMASIN) and an NOC to Hospira for INFLECTRA, an infliximab powder for solution (a biosimilar of Janssen’s REMICADE): Teva Canada Limited v Pfizer Canada Inc et al, 2016 FCA 248.

Both NOCs resulted from administrative drug submissions, which Health Canada defines as submissions that do not require scientific review. Teva cross-referenced its submission regarding exemestane to Generic Medical Partners (GMP)’s abbreviated new drug submission (ANDS) for an exemestane product. GMP served a notice of allegation on Pfizer, but as GMP does not sell products in Canada, Pfizer did not start a prohibition application. Health Canada then issued an NOC to GMP. Hospira cross-referenced its submission for infliximab powder to Celltrion’s new drug submission (NDS) (an NDS, rather than an ANDS, was necessary because infliximab is a biologic). At the time the Celltrion NDS was filed, no patents were listed on the Patent Register against REMICADE. The Teva and Hospira submissions contained no scientific data, and both certified that their product would be identical to the cross-referenced product except for the name and manufacturer of the product.

In April 2012, prior to the issuance of both NOCs, Health Canada modified its guidance regarding administration of the Patented Medicines (Notice of Compliance) Regulations (PMNOC Regulations). Section 5(1) of the PMNOC Regulations requires a “second person” (typically a generic drug manufacturer) whose submission for an NOC directly or indirectly compares its product to that of a “first person” (typically the innovative drug manufacturer) to address the patents listed on the Patent Register in association with the first person’s product. Under the revised guidance, Health Canada no longer required compliance with section 5 by licensees who obtain a licence from another generic company to market a drug that is identical to the drug produced by a licensor who has been issued an NOC; only the originating ANDS triggers section 5.

Pursuant to the amended guidance, the Minister found that neither Teva nor Hospira’s submission triggered section 5(1) of the PMNOC Regulations, such that the NOCs for their exemestane and infliximab products were issued without notice to Pfizer and Janssen.

Both Pfizer and Janssen filed applications for judicial review of the Minister’s decisions. With respect to Teva’s exemestane product, Gleason J. of the Federal Court found that the Minister had incorrectly interpreted the PMNOC Regulations and that her decision to issue the NOC to Teva ought to be set aside (as previously reported). With respect to Hospira’s infliximab powder product, Gleason J. set aside the Minister’s decision to issue the NOC to Hospira on consent of the parties, so that the resulting appeal could be heard together with the appeal relating to exemestane (previously reported).

Each appeal raised two issues: first, the standard of review applicable to the Minister’s decision to issue an NOC based on an administrative drug submission; and second, whether the Federal Court erred in finding that the Minister’s decisions ought to be set aside.

Based on the Minister’s expertise and the nature of the question, the Court found that such decisions ought to be reviewed on the standard of reasonableness. As the Minister was interpreting a statute closely connected to her function, the presumption that the decision was subject to reasonableness applied. The Court further found that the question was one of mixed fact and law, which the jurisprudence firmly establishes as subject to the reasonableness standard.

With respect to the merits of the decisions, the Court of Appeal indicated that it agreed with the Federal Court that there is more than one reasonable interpretation of section 5(1). Pursuant to the Supreme Court’s jurisprudence on the matter, section 5(1) of the PMNOC Regulations had to be read in light of subsection 55.2(4) of the Patent Act, which authorizes the enactment of regulations considered necessary for preventing patent infringement by a person who engages in the early working of a patented invention. The Court explained that in determining whether a given drug submission constitutes a “submission” for the purpose of section 5(1) of the PMNOC Regulations, the relevant question is whether the changes reflected in the drug submission give rise to a new or different basis for asserting that a particular product is infringing.

On the facts, no such basis existed. There was no evidence that either Teva or Hospira had “early worked” the relevant patented inventions in connection with their administrative submissions. Their submissions contained no data and both certified that the drug product was identical to the licensor’s excepted for the name and manufacturer of the product. It was therefore not unreasonable for the Minister to decline to confer the advantages of the PMNOC Regulations on Pfizer and Janssen. Any patent infringement by Teva or Hospira could be addressed in infringement proceedings.