Case information

Intellectual property — Patents — Medicines — Applicant seeking regulatory approval for its generic version of components of respondents’ patented combination dosage and administration regimen — Does the proposed appeal involve any question that, by reason of its public importance or the importance of any issue of law or any issue of mixed law and fact involved in that question, ought to be decided by this Honourable Court, or is, for any other reason, of such a nature or significance as to warrant decision by this Honourable Court?

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

Janssen Pharmaceutical N.V. is the registered owner of the 335 Patent, sold by Janssen Inc. in Canada (collectively, “Janssen”). The 335 Patent contains 63 claims relating to dosing regimens of long-acting paliperidone palmitate formulations for the treatment of schizophrenia and related disorders. The paliperidone palmitate is marketed under the brand name of Invega Sustenna in pre-filled syringes in dosage strengths of 50 mg, 75 mg, 100 mg and 150 mg.

Janssen brought an action under s. 6(1) of the Patented Medicines (Notice of Compliance) Regulations, SOR/93-133 seeking, inter alia, a declaration that the applicant, Apotex Inc., would infringe its 335 Patent if it were to make, use or sell its generic version of Janssen’s patented dosing and administration patent. Apotex brought a motion for a summary trial seeking dismissal of Janssen’s action on the basis that its generic product would not infringe the 335 Patent since it would not provide the 75 mg dose, which is an essential element of all of the claims of the 335 Patent. The summary trial judge issued a declaration that Apotex’s product would indirectly infringe the 335 Patent by inducing others to infringe through its product monograph. This decision was upheld on appeal.