As previously reported, the Federal Court released a pair of decisions relating to paliperidone palmitate (Janssen’s INVEGA SUSTENNA), finding in a summary trial that each of Pharmascience and Apotex would induce infringement of Canadian Patent No. 2,655,335 (335 patent).
On January 12, 2024, the Federal Court of Appeal (FCA) dismissed both appeals: Apotex Inc v Janssen Inc, 2024 FCA 9 and Pharmascience Inc v Janssen Inc, 2024 FCA 10.
The 335 patent relates to dosing regimens for long-acting paliperidone palmitate depot formulations for treatment of schizophrenia. Both Pharmascience and Apotex’s non-infringement positions were premised on not seeking approval for the 75 mg strength syringe, which corresponded to the 75 mg-eq. dose – an essential element in each of the 335 patent claims.
Pharmascience and Apotex both appealed the Federal Court decisions which were based on the three “prong” test for inducement of infringement:
- 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.
Apotex Inc v Janssen Inc, 2024 FCA 9
Apotex appealed on the finding of inducement in the second prong of the test for inducement of infringement.
Apotex argued that a high threshold for influence is required by the second prong of the test for inducement: that the infringing act would not have occurred without the influence, which is a “but for” test. Apotex argued that its product monograph would be essentially a copy of the INVEGA SUSTENNA product monograph and prescribing practices would not change, therefore any influence on infringement could not meet this threshold.
The FCA rejected Apotex’s argument that prescribing practices of physicians must be altered because of Apotex’s activities. Even if the practices of prescribing physicians were to remain unchanged, activities by patients that had previously been non-infringing would be infringing once sourced from Apotex. The Federal Court concluded that such infringement would be influenced by Apotex to the point that, without the influence, direct infringement would not take place. The Federal Court relied on several instances in the Apotex product monograph, including in the recommended maintenance dose ranges, to support its finding of influence. Accordingly, the FCA held that the Federal Court was entitled to conclude that the second prong was met.
The FCA found that the Federal Court did not err in law, and that this was a factually suffused issue on which Apotex would have to establish a palpable and overriding error in the analysis. It was held that the Federal Court was entitled to draw inferences from the evidence, and there was evidence to support the conclusion that Apotex’s product monograph would give rise to the required influence.
Apotex also argued that the Federal Court lacked meaningful analysis of the second prong, which included factual inaccuracies. The FCA found that the Federal Court’s analysis in this regard was not insufficiently based in fact and law, and the inaccuracies appeared to be no more than a slip of the pen.
Pharmascience Inc v Janssen Inc, 2024 FCA 10
Pharmascience argued that the Federal Court erred in the first prong of the three-part test, in finding that direct infringement would result from use of its generic version of INVEGA SUSTENNA.
The claims of the 335 Patent relate to:
- a first “loading dose” on day 1 (150 mg-eq and 100 mg-eq for non-renally impaired patients and renally impaired patients respectively);
- a second “loading dose” on day 8 (150 mg-eq and 75 mg-eq for non-renally impaired patients and renally impaired patients respectively);
- monthly doses thereafter (75 mg-eq and 50 mg-eq for non-renally impaired patients and renally impaired patients respectively).
Pharmascience argued that it will not provide the 75 mg-eq dose, which will only be sourced from Janssen. Pharmascience argued that any activities using Pharmascience’s product that would fall within the scope of the 335 Patent claims would be licensed by Janssen, as they provide the 75 mg-eq dose for prescribing physicians/patients.
The FCA rejected Pharmascience’s argument. The Court distinguished previous cases, and stated that there appears to be no reason to conclude that Janssen or its customers would have understood that the purchase of paliperidone palmitate in a single dose from Janssen would include an implied license to use the entire dosing regimen of the product in combination with other products obtained from unlicensed sources. The FCA also concluded that the sale of a component of a combination invention is insufficient to grant an implied right to use the entire invention.
Pharmascience also argued that the Federal Court erred in finding infringement of claims directed to the balance of the claims, including prefilled syringes adapted for administration according to the claimed dosing regimens (i.e., claims beyond the use of a dosage form according to the claimed dosing regimens). The FCA rejected this argument, finding that these claims would be directly infringed by a physician or patient using Pharmascience’s product, with the 75 mg-eq doses sourced from Janssen, and that such infringement would be induced by Pharmascience.
Should you have any questions, please do not hesitate to contact a member of the Pharmaceutical Litigation Group.
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