The Federal Court has confirmed that issues of infringement, including by inducement, may be decided by summary trial in an infringement action under the Patented Medicines (Notice of Compliance) Regulations (the Regulations). The Court rejected the Defendant’s attempt to avoid infringement based on the scope of its abbreviated new drug submission and product monograph (PM).
This subsection 6(1) infringement action concerns Canadian Patent 2,655,335 (335 Patent), which claims a set of dosing regimens of long-acting injectable paliperidone palmitate (paliperidone) formulations for the treatment of schizophrenia and related disorders. The 335 Patent is owned by Janssen Pharmaceutica NV and listed on the Patent Register against INVEGA SUSTENNA®, which is marketed in Canada by Janssen Inc. (collectively, the Plaintiffs). This case concerns a submission for a generic version of INVEGA SUSTENNA® filed by the Defendant, Pharmascience Inc. (the PMS Product).
As we reported, the 335 Patent was the subject of a second subsection 6(1) action decided under the PM(NOC) Regulations. In that case, Manson J. held that Teva Canada Limited (Teva) would directly infringe certain claims of the 335 Patent, but rejected the argument that it would induce infringement of any of the claims. That judgment is under appeal.
In this case, the dispute centred on the Defendant’s argument that it “deliberately and knowingly” did not seek approval for certain pre-filled syringes of paliperidone palmitate. The Defendant argued that as a result an essential element of every claim of the 335 Patent (as construed in the prior Teva proceeding) was missing and the action for infringement must fail. The Defendant moved to have the issue of infringement determined on summary trial. The Defendant also pleaded invalidity defences that were not raised on the motion for summary trial.
Summary trial appropriate
If the Court is satisfied that there is sufficient evidence for adjudication, regardless of the amounts involved, the complexities of the issues, and the existence of conflicting evidence, the Court may grant summary judgment, unless it would be unjust to do so.
The Plaintiffs challenged the appropriateness of a summary trial on three bases: 1) the appeal of the Teva action involving the 335 Patent was pending, the outcome of which may answer questions of law also raised in this case on inducement, 2) there were issues of conflicting expert evidence and credibility, and 3) they would be prejudiced by the absence of full discovery on issues central to this motion within the Defendant’s knowledge.
The Court rejected the Plaintiffs’ arguments and found that there was sufficient evidence to adjudicate the patent infringement issue summarily. The Court further noted that the issue raised in this motion was narrow and any issues of expert credibility and conflicting evidence could be determined on the written record.
No burden-shifting on summary trial
The Court held that on a motion for summary trial, the burden of proof is the same as in the action as a whole. The Court noted that there has been conflicting jurisprudence on this issue in the past and sought to clarify the law for future cases.
As a result, the Plaintiffs bore the burden of proving their infringement allegations on a balance of probabilities, even though the motion for summary trial was brought by the Defendant. Equally, the Defendant was expected to put its best foot forward in respect of non-infringement and would bear the burden of establishing any affirmative defence.
Inducement found on the facts
The Court held that the Defendant’s PM would induce infringement of the 335 Patent, despite its attempts to carve out certain statements from its PM. The Court was satisfied that the three-pronged test for inducement was satisfied:
- Direct infringement by third-party physicians. The evidence showed that physicians prescribing paliperidone would implement the claimed dosing regimen, even though certain aspects of the regimen would not be supplied by the Defendant. The Court relied on the fact that the Defendant would seek to have the PMS Product declared interchangeable with INVEGA SUSTENNA®, and that the PMS Product would be used in combination with INVEGA SUSTENNA® based on the PM.
- Defendant’s inducement to infringe. The evidence showed that at least some physicians will be influenced to infringe by Pharmascience’s PM, which includes recommendations to use the dosing regimen claimed in the 335 Patent. Although all experts agreed that the ultimate dosing decision is based upon the prescribing physician’s skill and judgment, the Court rejected the argument that this was determinative: it was sufficient that some prescribers would be influenced.
- Knowledge of influence. The evidence showed that the Defendant was aware its PM contained guidance on implementing the claimed dosage regimen, notwithstanding that it would not supply certain aspects of that regimen and does not market its products.
The Court dismissed the Defendant’s motion and held that the PMS Product would infringe the claims of the 335 Patent. Accordingly, the action will proceed to trial with respect to the pleaded defences of invalidity only.
Link to decision:
Janssen Inc. v Pharmascience Inc., 2022 FC 62