In Janssen Inc. v. Pharmascience Inc. 1, the Federal Court found that the mechanism of a summary trial was appropriate to determine patent infringement in a Patented Medicines (Notice of Compliance) Regulations action 2. The Court found that a generic manufacturer would, based on its product monograph, induce infringement of the impugned patent.
What you need to know
- Summary trial may provide an efficient method for determining narrow issues in a patent dispute. Here, the Court found that the summary procedure could be applied to an infringement claim even where it would not result in the determination of every issue.
- A party opposing (or responding to) a summary trial motion must put its best foot forward regarding the underlying claims. Although the party moving for summary trial has the onus of establishing that summary trial is an appropriate mode for resolution, once that has been established and the Court moves to consider the merits of the matter, the ordinary burden of proof of the underlying action applies.
- Indirect infringement, or inducement, remains a three-pronged test: 1) direct infringement by a third party; 2) influence of an inducer on a party to the point that the infringing act would not have occurred without the influence; and 3) the defendant-inducer knew that its influence would bring about the infringing act.
- The test for inducement can be met by analyzing the product monograph alone. This is true even when the inducer does not have any direct contact with the infringer. This can also be true when a product monograph does not explicitly direct a prescriber to implement a claimed treatment and a prescriber's skill is necessary in determining a patient's treatment.
The Plaintiffs, Janssen Inc. and Janssen Pharmaceutica N.V. (collectively, Janssen), own the 335 Patent, which claims certain dosing regimens for long-acting injectable paliperidone palmitate formulations for the treatment of schizophrenia and related disorders. Janssen sells its paliperidone palmitate formulation under the brand name INVEGA SUSTENNA®; the product monograph for INVEGA SUSTENNA® sets out dosing regimens that fall within the claims of the 335 Patent.
The defendant, Pharmascience Inc. (Pharmascience), filed an Abbreviated New Drug Submission (ANDS) for a generic version of INVEGA SUSTENNA®. It also served a Notice of Allegation and Detailed Statement alleging that the 335 Patent is invalid and would not be infringed by Pharmascience because its product and product monograph did not explicitly direct anyone to use the 335 Patent's dosing regimens and methods. In response to Pharmascience, Janssen brought an action for patent infringement alleging that Pharmascience's product would directly and/or indirectly infringe the 335 Patent.
Pharmascience brought a motion for summary trial of Janssen's infringement claim under the Federal Courts' Rules. (Pharmascience did not seek a determination of its allegation of patent invalidity at this stage).
Notably, this was not the first proceeding regarding the 335 Patent. Janssen had previously asserted infringement of various claims of the 335 Patent against Teva Canada Limited (Teva). In Janssen Inc. v. Teva Canada Limited 3, currently under appeal, the Federal Court found that Teva would not induce infringement of the 335 Patent because "the Teva [product monograph] recommends that the prescribing physician select the maintenance dose for patients with renal impairment based on individual patient characteristics" 4. In other words, it did not specifically direct any particular dosing regimen.
This was also not the only proceeding that has considered the 335 Patent under the summary trial procedure. In a parallel proceeding, Janssen asserted all claims of the 335 Patent against another manufacturer, Apotex Inc. In response to his actoin, Apotex brought a motion for summary trial to determine Janssen's infringement action. As with the Pharmascience case, in Janssen Inc. v. Apotex Inc. 5, the Federal Court found summary trial was appropriate, found Apotex would induce infringement based on its product monograph, and resolved the full action in Janssen's favour (Apotex did not allege invalidity). The Court's reasoning in Janssen Inc. v. Apotex Inc. largely followed the same principled reasons underlying its analysis in-and in one instance directly relied on-Janssen Inc. v. Pharmascience Inc. 6, and in both decisions the Court came to the same conclusion on the appropriateness of summary trial and inducement.
When is summary trial appropriate?
The test for summary trial
The Federal Court first set out the test for summary trial. It noted that it did not matter that Pharmascience's motion did not address all matters in dispute (i.e., infringement and validity), stating that "[s]ummary trial need not be reserved for cases where the summary trial will result in determination of every issue" 7. According to the Court, the key question for determining if summary trial is appropriate is "whether there is sufficient evidence for adjudication, regardless of the amounts involved, the complexities of the issues, and the existence of conflicting evidence" 8. The additional factors the Court will consider are 9:
- the complexity and urgency of the matter;
- any prejudice likely to arise by delay;
- the cost of taking the case forward to a conventional trial in relation to the amount involved;
- whether credibility is a crucial factor and the deponents of the conflicting affidavits have been cross-examined;
- whether the summary trial involves a substantial risk of wasting time and effort, and producing unnecessary complexity; and
- any other matters which may arise for consideration.
Summary trial was appropriate
The Federal Court found that the matter was appropriate to be decided by way of summary trial. It rejected Janssen's arguments that a summary trial was inappropriate while an appeal was outstanding in the Teva case, because the evidence in the two cases was different. The Court also emphasized the narrowness of the infringement issue, noting that "there is sufficient evidence for the adjudication of the issue put forward by the Parties and it is an appropriate proceeding for summary trial" 10. It found that conflicting evidence was not a bar to summary trial, nor was the fact that the matter was proceeding on a written record: "Cross-examinations of each expert and fact witness on their affidavit evidence have been conducted" and "[t]his Court has decided the appropriateness of summary judgment or summary trial on a written record and without viva voce evidence" 11.
When is indirect infringement found?
The Court usefully clarified that once a summary trial moves to the merits of the matter (i.e., infringement or validity), the burden and standard of proof of the underlying action applies 12. Here, Janssen bore the onus to prove that Pharmascience would infringe the 335 Patent on a balance of probabilities standard.
Janssen did not dispute Pharmascience's position that it would not infringe the 335 Patent because its ANDS did not seek approval for use of paliperidone palmitate at the claimed doses (that were an essential element of every claim of the 335 Patent). Therefore, only infringement by inducement (also known as indirect infringement), which occurs where a defendant induces or procures a third party to infringe a patent, was at issue.
Indirect infringement is determined on a three-pronged test: 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 defendant knew that its influence would bring about the infringing act 13.
Prong 1: Direct infringement
The first prong of the inducement test requires that the "act of infringement must have been completed by the direct infringer" (i.e., a prescriber or patient) 14. The Court concluded that this prong was met because prescribers of paliperidone palmitate would prescribe the drug to be used in accordance with the 335 Patent's claimed dosing regimen. Based on the expert evidence, the Court was convinced that Pharmascience's product monograph would influence prescribers (as a third party) to implement the claimed dosing regimen, even though Pharmascience would not be supplying the exact dosing amounts.
Prong 2: Inducement
The second prong of the inducement test requires that "the acts of infringement must be influenced by the acts of the alleged inducer to the point that, without the influence, direct infringement would not take place" 15. This is a "but for" test-a high bar that requires more than "encouragement to infringe", a "subtle reference" to the infringing use, or "attempting to induce others to infringe" 16. The Court found that this prong was met based on Pharmascience's product monograph. Although the decision itself is heavily redacted, it suggests that the experts agreed that the product monograph contained several recommendations to prescribers for use of the claimed dosage and administration regimen. Thus, on the facts of this case, the Court found that the exercise of a physician's skill in determining a patient's dosing regime was not a bar to finding that the acts of infringement would be influenced by Pharmascience 17.
Prong 3: Knowledge of influence
The third prong of the inducement test requires that the inducer have knowledge of its influence (i.e., its actions); this is not the same as having knowledge that the direct infringer's activity will be an infringement 18. It is not difficult to "meet the third prong of the test where the inducer created and distributed the product monograph which was the source of the influence" 19. The Court found that Pharmascience had knowledge of its influence because it was aware that its product monograph contained guidance on implementing the claimed dosage regime, notwithstanding that it does not supply the exact doses. As a result, indirect infringement was found and Janssen's action regarding Pharmascience's defences of alleged invalidity would proceed.
1 2022 FC 62. Please click the following link for a copy of the decision: https://decisions.fct-cf.gc.ca/fc-cf/decisions/en/item/519793/index.do.
3 2020 FC 593. Please click the following link for a copy of the decision: https://decisions.fct-cf.gc.ca/fc-cf/decisions/en/item/470492/index.do.
4 2022 FC 62, para. 18.
5 2022 FC 107. Please click the following link for a copy of the decision: https://decisions.fct-cf.gc.ca/fc-cf/decisions/en/item/520422/index.do.
6 2022 FC 107, para. 50.
7 2022 FC 62, para. 30, citing Federal Court Rules, SOR/98-106, r. 213.
8 2022 FC 62, para. 31, citing Federal Court Rules, SOR/98-106, r. 216(6).
9 2022 FC 62, para. 34, citing Federal Court Rules, SOR/98-106, r. 216(6).
10 2022 FC 62, para. 43-44.
11 2022 FC 62, para. 35.
12 2022 FC 62, para. 57.
13 2022 FC 62, para. 93.
14 2022 FC 62, para. 95.
15 2022 FC 62, para. 123.
16 2022 FC 62, para. 124.
17 2022 FC 62, para. 137.
18 2022 FC 62, para. 139.
19 2022 FC 62, para. 140.
The content of this article is intended to provide a general guide to the subject matter. Specialist advice should be sought about your specific circumstances.