Janssen Inc v Celltrion Healthcare Co, Ltd, 2016 FC 525

Applications brought under the Patented Medicines (Notice of Compliance) Regulations (“the PM(NOC) Regulations”) are likely to be dismissed if it is plain and obvious that the applicant cannot succeed in showing a patent will be infringed.

In this case, the Federal Court (“FC”) granted Celltrion Healthcare Co. Ltd.’s (“Celltrion”) motion to strike Janssen Inc.’s (“Janssen”) application pursuant to section 6(5)(b) of the PM(NOC) Regulations. [45]

Application Found to be Clearly Futile

In January 2014, Celltrion received a Notice of Compliance (“NOC”) for its drug called INFLECTRA (infliximab) for use in the treatment of rheumatoid arthritis, ankylosing spondylitis, psoriatic arthritis and plaque psoriasis (“RA Indications”). [2] In 2015, Celltrion filed a Supplementary New Drug Submission (“SNDS”) seeking approval for additional uses for INFLECTRA in the treatment of diseases related to various forms of inflammatory bowel disease (“IBD Indications”). [5] The patent at issue in this case is the ‘630 Patent, which is listed on the Patent Register in connection with Janssen’s drug REMICADE® (infliximab). [4] Celltrion served Janssen with a Notice of Allegation (“NOA”) pursuant to the PM(NOC) Regulations alleging that none of the intended uses would infringe the ‘630 Patent. [6] Janssen responded by commencing an application for a prohibition order. [6]

Pursuant to section 6(5) of the PM(NOC) Regulations, the court may strike an application in whole or in part. [8] The FC noted that previous caselaw has described subsection 6(5)(b) as an extraordinary remedy that should only be granted when an application is clearly futile or it is plain and obvious that the application has no chance of success. [9] The FC further noted that the underlying premise of the PM(NOC) Regulations is to prevent infringement. [34] Upon reading the ‘630 Patent, the FC rejected Janssen’s argument that it required expert evidence in order to construe the claims. [37] The FC found that given a plain and ordinary construction, the claims relate only to RA Indications and do not in any way discuss IBD Indications. [37] Therefore, if Celltrion obtained an NOC for its SNDS, it could not infringe the claims of the ‘630 Patent. [37]