Prothonotary's Dismissal of a PM(NOC) application pursuant to s. 6(5)(b) upheld on appeal
Janssen Inc. v. Celltrion Healthcare Co., Ltd., 2016 FC 651
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.
Order of Prohibition Granted in respect of Compound Patent but Refused in respect of Patent Relating to Salt
Bristol-Myers Squibb Canada Co v. Teva Canada Limited, 2016 FC 580
This is an application under the Patented Medicines (Notice of Compliance) Regulations related to two patents. The first patent (the '840 Patent) claims the commercial compound, atazanavir, and the second patent (the '736 Patent) claims a particular salt. The Court found that the allegations in respect of the '840 Patent were not justified, but the allegations in respect of the '736 Patent were justified.
With respect to the '840 Patent, two allegations were pursued at the hearing, namely obviousness and anticipation. For the purposes of obviousness, the parties disagreed about whether a portion of an Australian patent application was publically available as of the relevant date. The Court found that Teva had not demonstrated that the particular pages that it relied on were available and were not added at a later date. The parties also disagreed as to whether a letter to the European Patent Office was available to the public as of the relevant date. The Court noted that there was little evidence that the letter was available to the public, the letter was written in German and no translation was provided, and it was not cited in the Notice of Allegation (NOA). The Court construed the inventive concept of the ‘840 Patent and noted that it can be different to the construction of the claims. The Court preferred the evidence of BMS' expert and found that Teva's expert conducted a results-driven, hindsight analysis. After considering the evidence, the Court found that this allegation was not justified. With respect to anticipation, the Court rejected Teva's interpretation of the term "arylakly", and concluded that atazanavir does not fall within the genus of the compounds claimed in another patent. The Court determined that even if the genus patent did include atazanavir, following the patent would not inevitably result in atazanavir. An Order of prohibition was granted.
With respect to the '736 Patent, this patent claims the bisulfate salt of atazanavir. The Court considered an issue of construction and preferred BMS' construction. Teva alleged that the '736 Patent was obvious in light of the '840 Patent. The Court accepted that it would have been more or less self-evident to a person skilled in the art that improving the solubility of atazanavir ought to improve its bioavailability. Further, it was not inventive to make salts to try to improve the solubility of atazanavir. The Court distinguished the Court of Appeal decision relating to PLAVIX where "in light of the lack of information regarding the properties of the enantiomers of the PCR 4099 racemate, the POSITA would have no motivation to single out and try to resolve the racemate. In contrast, when confronted with the limited bioavailability of the free base of atazanavir in this case, the skilled person would have had every reason to try making salts of atazanavir in order to improve its solubility and bioavailability. It was therefore obvious to try." The Court therefore found the allegation of obviousness to be justified and the application relating to the '736 Patent was dismissed.
Other Industry News
The PMPRB has published a Guidelines Modernization Discussion Paper in the first phase of major consultations to modernize its legal framework. The consultation is open until October 24, 2016.
Health Canada has published a Draft Guidance Document — Cancellation of a Drug Identification Number (DIN) and Notification of the Discontinuation of Sales. The consultation period is open until September 28, 2016.
Health Canada has published a Notice — Validation rules for regulatory transactions submitted to Health Canada in the electronic Common Technical Document (eCTD) format.