Case information

Intellectual property — Patents — Medicines — Utility — Sound prediction of utility — Obviousness — Whether sound prediction of utility and obviousness should be assessed on the same or different standards — Whether “proper disclosure” remains a requirement for sound prediction of utility and, if so, what is required to satisfy that requirement — Patented Medicines (Notice of Compliance) Regulations, SOR/93-133, s. 6(1).

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Teva Canada Innovation and Teva Canada Limited (together, “Teva”) initiated two patent infringement actions under s. 6(1) of the Patented Medicines (Notice of Compliance) Regulations, SOR/93-133. The patents — Canadian Patent Nos. 2,702,437 (“437 Patent”), entitled “Methods of Delaying the Onset of Clinically Definite Multiple Sclerosis”, and 2,760,802 (“802 Patent”), entitled “Low Frequency Glatiramer Acetate Therapy” — relate to Copaxone, a medication (glatiramer acetate) that treats multiple sclerosis. Only the validity of the 802 Patent is now in issue. It built on a previously known relapsing-remitting MS treatment: daily injections of 20mg of glatiramer acetate. The 802 Patent claimed an effective, low-frequency dosage schedule: 40mg of glatiramer acetate administered three times weekly, with a day between doses. The disclosure provided a detailed description of a multi-national, multicentre, randomized Phase III placebo-controlled study to assess the efficacy, safety and tolerability of the claimed dosage. Its design and its expected results were described, but, as the trial had not ended when the patent application was filed, its results were not set out. The parties agreed that the relevant date for construing the 802 Patent is its publication date, the relevant date for allegations of obviousness is the claim date (August 20, 2009) and the relevant date to assess its utility is the filing date (August 19, 2010).

Pharmascience submitted a Supplementary New Drug Submission in relation to a 40mg dosage of glatiramer acetate (Glatect 40mg) to be administered three times weekly, with a day between doses. It identified Copaxone 40mg as the reference product and submitted a product monograph for Galtect 40mg that was substantially identical to Teva’s Copaxone product monograph.

At trial, the 437 Patent was found to be invalid for obviousness and the infringement action (T-2182-18) with respect to it was dismissed, but the 802 Patent was found to be valid and the infringement action (T-2183-18) with respect to it was granted. The trial judge enjoined a variety of activities that would result in infringement of the 802 Patent. Pharmascience brought three appeals, and all three were dismissed in a single set of reasons.