Summary Trial under the PM(NOC) Regulations: Janssen's INVEGA SUSTENNA patent is infringed

4 minute read
24 January 2022

Since 2019, the Court has seen a steady stream of motions for summary judgement or summary trial in the context of patent infringement actions. Justice Manson's newly issued decision in Janssen v Pharmascience, 2022 FC 62 continues along the same current. However, this new decision is noteworthy as being the first summary trial decision on infringement in a pharma case under the Patented Medicines (Notice of Compliance) Regulations.

In the underlying action, Janssen asserts infringement of Canadian Patent No. 2,655,335 (the "335 Patent") against Pharmascience. The 335 Patent relates to dosing regimens of long-acting injectable paliperidone palmitate formulations for the treatment of schizophrenia and related disorders. The 335 Patent is listed on the Patent Register in respect of Janssen's INVEGA SUSTENNA®.

This decision arose from Pharmascience's motion to resolve the proceeding by way of summary trial on non-infringement. Pharmascience's motion was not successful, and Justice Manson found that Pharmascience does in fact infringe by inducement.

While Janssen was ultimately successful on the summary trial, it argued against the summary trial format. Janssen raised issues such as a pending appeal in a case involving the same patent (Janssen v Teva, 2020 FC 593, discussed below), conflicting expert evidence and credibility, and alleged prejudice due to incomplete discovery (though some discovery had taken place). Unpersuaded by these arguments, Justice Manson concluded that this issue was appropriate for summary trial as there was sufficient evidence for adjudication and any issues of credibility or conflicting evidence could be determined on the written record.

Justice Manson then addressed an unresolved issue in the jurisprudence – who bears the burden on the merits of the issue(s) raised in a motion for summary trial? For example, if an accused infringer brings a motion for summary trial, does the accused infringer bear the burden of establishing non-infringement? Or does the usual burden apply, where the patentee bears this burden?

After reviewing the jurisprudence, Justice Manson concluded that the burden is on the moving party to demonstrate that a summary trial is appropriate. If the Court finds summary trial to be appropriate, then the usual burden and onus of proof applies for the underlying issues. On this motion, Pharmascience had the burden of proving that the summary trial was appropriate (and did so successfully), then the burden shifted to Janssen to prove infringement on a balance of probabilities.

In the context of this discussion, Justice Manson reiterated the requirement for parties to "put its best foot forward" on motions for summary disposition. Evidence and arguments on the issue put up for summary disposition should not be saved for a later day.

Justice Manson's substantive analysis of induced infringement is also of note for the pharma industry. Janssen only argued infringement by inducement. While the decision is heavily redacted, Justice Manson appears to have found induced infringement based largely, if not exclusively, on Pharmascience's proposed Product Monograph.

A declaration of infringement was therefore issued. Janssen's action will now proceed only on the defences of alleged invalidity.

As noted above, this case is not the first time Janssen asserted the 335 Patent under the Regulations, nor is it the first time Justice Manson heard infringement arguments in relation to this patent. In Janssen v Teva, 2020 FC 593, Justice Manson concluded that Teva's proposed paliperidone palmitate product would directly infringe, but not induce infringement, of the 335 Patent. That decision is under appeal. The Court's past experience with the 335 Patent presumably helped to streamline this motion for summary trial.

Should you have any specific questions about this article or would like to discuss it further, you can contact the authors or a member of our Life Sciences Group.

NOT LEGAL ADVICE. Information made available on this website in any form is for information purposes only. It is not, and should not be taken as, legal advice. You should not rely on, or take or fail to take any action based upon this information. Never disregard professional legal advice or delay in seeking legal advice because of something you have read on this website. Gowling WLG professionals will be pleased to discuss resolutions to specific legal concerns you may have.

Related   Life Sciences, Patents