Janssen initiated a patent infringement action pursuant to ss 6(1) of the PMNOC Regulations, relating to Canadian Patent No. 2,655,335, and Janssen’s INVEGA SUSTENNA® (paliperidone palmitate). Teva filed an ANDS with Health Canada seeking approval to sell its own paliperidone palmitate product in Canada. On Jan. 9, 2018, Teva served Janssen with a Notice of Allegation pursuant to the Regulations, and Janssen commenced this action.