Summary

Keywords

Intellectual property — Patents — Proper framework for assessing whether claimed invention monopolizes unpatentable method of medical treatment.

Summary

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

Janssen Inc., and Janssen Pharmaceutica N.V. (collectively, “Janssen”), sought a declaration that Pharmascience Inc. would infringe Canadian Patent No. 2,655,335 if it were to make, use or sell its generic version of Janssen’s patented medicine, a suspension of paliperidone palmitate, known commercially as INVEGA SUSTENNA, in 50, 75, 100 and 150 mg doses. The Patent makes 63 claims, and teaches a regimen to achieve an optimum plasma concentration-time profile: a first loading dose administered in the deltoid muscle on the first day, a second loading dose administered the same way on the eighth day, then monthly maintenance doses thereafter, administered in either the deltoid or gluteal muscle. The dosages differ for renally-impaired patients and other patients, and the regimen incorporates “dosing windows” of +/- 2 days for the second loading dose and +/- 7 days for the maintenance doses. The Patent’s disclosure indicated that the maintenance dose could be titrated (adjusted) up or down depending on the patient.

In earlier proceedings, it was found that Pharmascience’s pms-PALIPERIDONE PALMITATE made, constructed, used or sold as set out in ANDS No. 244641, would influence prescribers to prescribe the claimed dosing regimen, leading to direct infringement of the Patent: Janssen Inc. v. Pharmascience Inc., 2022 FC 62. The defence of invalidity went forward and is now in issue.

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.

Lower Court Rulings