Janssen Inc. v. Celltrion Healthcare Co., Ltd., 2016 FC 651

Drug: infliximab

Celltrion brought a motion pursuant to s. 6(5)(b) of the Patented Medicines (Notice of Compliance) Regulation (the NOC Regulations) to have the application dismissed. The Prothonotary granted that order. Janssen appealed, and also requested that the stay in the Prothonotary's Order be varied to provide for appeals to be exhausted. The Court affirmed the Prothonotary's dismissal of the proceeding and refused to grant a stay on any terms.

Celltrion's initial application for a NOC requested approval for both rheumatoid arthritis, ankylosing spondylitis, psoriac arthritis and plaque psoriasis (the RA indications) and various forms of inflammatory bowel disease (the IBD indications). This NDS was filed before one of Janssen's patents was issued. Thus, Celltrion did not have to address it pursuant to the NOC Regulations. The RA indications were approved, but the IBD indications were not. Celltrion filed a Supplementary NDS for the IBD indications, and was required by Health Canada to address the patent, which had then been issued, and was listed on the Patent Register.

The Court held that where a patent claims a particular use of a drug, that use must be compared with the intended use by the generic company, and not just the drug. In this case, the patent claimed the use for the RA indications. Celltrion's submission was for the IBD indications. Thus, the Court held that plainly and simply, Janssen's application was scandalous, frivolous, vexatious and an abuse of process. The Court considered the evidence on the motion and held that it was insufficient to conclude there was any basis for a finding of infringement.

The Court considered whether if the first person's case is fairly arguable it should be permitted to go to hearing, and held that applications under the NOC Regulations "have become, quite literally, a nightmare for the parties and the Court. ... Therefore, unlike many other types of summary applications, there is a good incentive to determine whether the case is appropriate for early disposition provided that early disposition is clearly established as appropriate. The Court should not incentivize such applications as routine." (para. 36) The Court held that Janssen's arguments were not destined to succeed, and dismissal of the application was the appropriate remedy. The Court also held that a stay of an order dismissing an application is not available.