Federal Court holds summary trial appropriate, Apotex and Pharmascience will induce infringement of paliperidone palmitate patent

Introduction
Facts
Decision
Comment

Introduction

The Federal Court has released a pair of decisions in patent litigation relating to paliperidone palmitate (Janssen's Invega Sustenna):

• Janssen Inc v Pharmascience;(1) and
• Janssen Inc v Apotex.(2)

Pharmascience and Apotex each brought a motion for summary trial, seeking to dismiss Janssen's actions for patent infringement pursuant to the Patented Medicines (Notice of Compliance) Regulations. The Court agreed that summary trial was appropriate in both cases, but ruled against Pharmascience and Apotex, finding that both would induce infringement.

Facts

Canadian Patent No. 2,655,335 (the 335 patent) was previously held valid and infringed by Teva (appeal decision currently pending). The 335 patent relates to dosing regimens for long-acting paliperidone palmitate depot formulations for treatment of schizophrenia. The 335 patent includes claims for a dosing regimen, in which paliperidone is administrated on day one and day eight at specified doses into the deltoid muscle, followed by a "maintenance dose" comprising a specified dose of paliperidone injected into the gluteal or deltoid muscle, administered monthly thereafter.

The substantive question (portions redacted as being confidential) as framed in the Pharmascience case was:

[43] The only issue for determination on this motion is whether, by not seeking approval for [redacted] as part of the dosing regimen in their ANDS and product monograph, Pharmascience cannot and does not infringe any of the claims in the 355 Patent.

And in the Apotex case:

[28]… should Janssen's infringement action be dismissed because Apotex is not seeking approval for [redacted] of the APO Product, or, conversely, should Janssen's infringement action be allowed because the product monograph for the APO Product will induce infringement of the 335 Patent?

Decision

The Court found that Janssen had met its burden and established that Pharmascience and Apotex would induce infringement of the 335 patent, based on the three "prong" test for inducement:

• direct infringement by a third party;
• the inducer influenced the third party to the point that the infringing act would not have occurred without the influence; and
• the inducer knew that its influence would bring about the infringing act.

Direct infringement
The Court was satisfied that, on the evidence in each case, direct infringement would occur by prescribing physicians. The Court viewed each product monograph as a whole and found that each contained several instances that would influence a physician to prescribe the omitted dosing amount as part of the claimed dosing regimen, leading to direct infringement of the 335 patent.

Inducement
The Court found that when considered as a whole, each product monograph includes recommendations to prescribers for use of the claimed dosage regimen. The Court concluded that notwithstanding the exercise of skill and judgment by prescribing physicians in selecting the dosing regimen for patients, the evidence established that acts of infringement would be influenced by the acts of the alleged inducer, Apotex and Pharmascience, to the point that, without the influence, direct infringement would not take place.

Knowledge of influence
The Court found that the third prong of the test was met: each of Pharmascience and Apotex was aware that its product monograph contained guidance on implementing the claimed dosing regimen, and therefore each had knowledge of its influence.

Comment

In the Pharmascience case, the Court therefore declared that Pharmascience would infringe the claims of the 335 patent. The action will proceed to trial on Pharmascience's pleaded defences of invalidity only; the trial is scheduled for July 2022.

In the Apotex case, the Court granted a declaration of infringement as well as an injunction against Apotex. The summary trial disposed of the whole action as Apotex had not defended the action on the basis of patent invalidity. Apotex has appealed.

For further information on this topic please contact Urszula Wojtyra at Smart & Biggar by telephone (+1 416 593 5514) or email ([email protected]). The Smart & Biggar website can be accessed at www.smartbiggar.ca.

Endnotes

(1) 2022 FC 62.

(2) 2022 FC 107.