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.
- 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.
- 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.
- 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.
The preceding is intended as a timely update on Canadian intellectual property and technology law. The content is informational only and does not constitute legal or professional advice. To obtain such advice, please communicate with our offices directly.
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