Case information

Intellectual property — Patents — Validity — Lack of patentable subject matter — Method of medical treatment — Vendible product — Skill and judgment — Fixed or variable dosing regimen — Canadian Patent No. 2,655,335 teaches dosing regimen that includes first loading dose, second loading dose and monthly maintenance doses — Regimen incorporates dosing windows of +/- 2 days for the second loading dose and +/- 7 days for the maintenance doses — Whether patent is invalid in that it claims an unpatentable method of medical treatment.

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(SEALING ORDER) (CERTAIN INFORMATION NOT AVAILABLE TO THE PUBLIC)

Canadian Patent No. 2,655,335 (“’335 Patent”), which was issued to Janssen Pharmaceutica N.V. for INVEGA SUSTENNA, involves a suspension of paliperidone palmitate for the treatment of schizophrenia and related disorders. The ’335 Patent teaches a dosing regimen to achieve an optimum plasma concentration-time profile. Its claims have been construed in previous litigation and are not in issue: Janssen Inc. v. Teva Canada Ltd., 2020 FC 593,; Janssen Inc. v. Pharmascience Inc., 2022 FC 62, aff’d 2024 FCA 10 (“PMS Paliperidone”)). Its disclosure indicated that “[t]hose of ordinary skill in the art will understand that the maintenance dose may be [adjusted] up or down in view of patients condition (response to the medication and renal function)”.

Pharmascience Inc. has served two Notices of Allegation in respect of pms-PALIPERIDONE PALMITATE, its proposed generic version of INVEGA SUSTENNA. In 2020, Janssen’s infringement action related to Pharmascience’s Abbreviated New Drug Submission No. 236094 was discontinued on consent. Shortly thereafter, Pharmascience served a Notice of Allegation and Detailed Statement in respect of a different Abbreviated New Drug Submission — No. 244641 — seeking approval to market and sell doses of pms-PALIPERIDONE PALMITATE. Janssen again commenced an infringement action under s. 6(1) of the Patented Medicines (Notice of Compliance) Regulations, SOR/93-133. In that proceeding, Pharmascience moved for summary trial. It was found that if Pharmascience’s pms-PALIPERIDONE PALMITATE was made, constructed, used or sold as set out in the Abbreviated New Drug Submission, it would influence prescribers to prescribe the dosing regimen claimed in the ’335 Patent, leading to direct infringement: PMS Paliperidone. The defence of invalidity went forward, with Janssen seeking a declaration that Pharmascience would infringe the ’335 Patent if it were to make, use or sell pms-PALIPERIDONE PALMITATE in 50, 75, 100 and 150 mg doses.

The Federal Court found that the Patent was not invalid based on obviousness or for lack of patentable subject matter. The claims provided specified dosing regimens meant to produce a concentration of the medication within the therapeutic range. If a physician chose to use a dose other than that claimed, to stop treatment or to change therapies, they would no longer be practicing the claimed invention. The Court of Appeal dismissed Pharmascience’s appeal, finding that the use of the invention did not require the exercise of skill and judgment.