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

Update: On January 12, 2024, the Federal Court of Appeal dismissed appeals of both Apotex and Pharmascience. 

The Federal Court released a pair of decisions in patent litigation relating to paliperidone palmitate (Janssen’s INVEGA SUSTENNA): Janssen Inc v Pharmascience, 2022 FC 62 and Janssen Inc v Apotex, 2022 FC 107. 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.

Canadian Patent No. 2,655,335 (335 patent) was previously held valid and infringed by Teva, as previously reported (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 1 and day 8 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?

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: (1) direct infringement by a third party; (2) the inducer influenced the third party to the point that the infringing act would not have occurred without the influence; and (3) the inducer knew that its influence would bring about the infringing act.

1. Direct infringement: the Court was satisfied that, on the evidence in each case, direct infringement will occur by prescribing physicians. The Court viewed each product monograph as a whole and found that each contained several instances that will influence a physician to prescribe the omitted dosing amount as part of the claimed dosing regimen, leading to direct infringement of the 335 patent.
2. 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 will be influenced by the acts of the alleged inducer, Apotex and Pharmascience, to the point that, without the influence, direct infringement will not take place.
3. 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 has knowledge of its influence.

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.

Should you have any questions, please do not hesitate to contact a member of the Pharmaceutical Litigation Group.

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