The Federal Court of Appeal (FCA) has held that the sale of a single dose of a patented multi-dose regimen does not provide an implied license to use the entire patented dosing regimen. As a result, it is possible to infringe a dosing regimen patent by combining a first dose sourced from the patentee with other doses sourced from an unlicensed third party. Likewise, a third party may induce infringement by selling an unlicensed dose to be used in a combination with other doses obtained from the patentee.
Janssen markets INVEGA SUSTENNA® (paliperidone palmitate) for the treatment of schizophrenia and related disorders. Janssen’s Canadian Patent No. 2,655,335 (335 Patent) teaches a dosing regimen. Patients are to receive a first and second loading dose followed by maintenance doses at specific concentrations on specific days. A 75 mg equivalent (mg-eq.) dose is provided to non-renally impaired patients as the maintenance doses, and to renally impaired patients as the second loading dose. The 75 mg-eq. dose is an essential element of the claims of the 335 Patent.
Pharmascience Inc. (PMS) sought a Notice of Compliance to market a generic version of INVEGA SUSTENNA® (the PMS Product) that specifically excluded a 75 mg-eq. dose. Janssen commenced an infringement action under section 6 of the Patented Medicines (Notice of Compliance) Regulations. PMS brought an unsuccessful motion for summary trial (see here). The Federal Court (FC) found that PMS would infringe the 335 Patent by inducing use of the PMS Product together with the 75 mg-eq. dose supplied by Janssen. PMS appealed to the FCA.
Implied licence did not grant to component
On appeal, PMS argued that use of the PMS Product in combination with Janssen’s 75 mg-eq. dose would not infringe the 335 Patent on the basis of an implied licence. According to PMS, this implied licence permits Janssen’s customers to use the 75 mg-eq. dose in any way they choose, including in the claimed dosing regimen with other doses obtained from PMS. As a result of the implied licence, there would be no direct infringement of the 335 Patent and – by extension – no inducement by PMS to infringe the patent.
The FCA rejected PMS’s argument. The FCA agreed that that the sale of a patented article without restriction generally includes the right to use that article as the purchaser pleases. However, the context of the transaction is relevant. The Court held:
There appears to be no reason to conclude that either Janssen or its customers (a prescribing physician or a patient) would have understood that the purchase of paliperidone palmitate in a single dose from Janssen would include an implied licence to use the entire dosing regimen of the product in combination with other doses obtained from unlicensed sources, to practise the invention of the 335 Patent. It is difficult to accept that there could be such an implied licence in circumstances where neither the supposed licensor nor the supposed licensee would have understood such a licence to exist.
Pharmascience decision at para 21
The FCA contrasted this with cases where an implied licence existed because the sale of the entire combination had occurred, or where the parties’ intended use of the component at the time of sale contemplated its use in the patented combination.
In the absence of an implied licence, users of Janssen’s 75 mg-eq. dose with the PMS Product would directly infringe the 335 Patent. This activity satisfies the first prong of the test for induced infringement. As a result, the FCA dismissed PMS’s appeal.
Update on parallel litigation
In parallel litigation, the FCA also rejected an appeal from the finding that Apotex would induce infringement of the 335 Patent with its proposed generic version of INVEGA SUSTENNA®. Similar to PMS, Apotex had sought to exclude the 75 mg-eq. dose from its offering. Apotex argued that it would not exercise sufficient influence to meet the second prong of the test for induced infringement. The FCA disagreed, holding:
The main weakness of this argument is that it depends on there being a requirement that prescribing practices of physicians be altered because of Apotex’s activities. In fact, this is not necessary. What is required is that the ultimate act of direct infringement occur because of Apotex’s activities.
Apotex decision at para 23
The FCA held that this influence requirement could be satisfied if prescribing physicians continued their existing practice of using the invention of the 335 Patent, but switched from Janssen’s product to the unlicensed Apotex product.
As we recently reported, multiple generic companies have been unsuccessful in their attempts to market generic versions of INVEGA SUSTENNA®:
- In the PMS trial related to invalidity, the 335 Patent was found to be valid. PMS appealed and the FCA decision remains under reserve.
- As we previously reported, Apotex’s challenge to the validity of the 335 Patent was found by the FCA to be an abuse of process (see here).
- As we previously reported, Teva Canada Limited’s (Teva) proposed product was found by the FC to directly infringe certain claims of the 335 Patent; and the 335 Patent was valid (see here). Teva’s appeal to the FCA was unsuccessful (see here). Janssen’s appeal regarding induced infringement was successful.
Links to decisions:
Pharmascience Inc. v. Janssen Inc., 2024 FCA 10
Apotex Inc. v. Janssen Inc., 2024 FCA 9