On January 6, 2021, the Federal Court issued its decision in two patent infringement actions pursuant to subsection 6(1) of the Patented Medicines (Notice of Compliance) Regulations involving Teva’s patents pertaining to the drug glatiramer acetate (Teva’s COPAXONE and Pharmascience’s GLATECT): Teva v Pharmascience, 2020 FC 1158. Justice Kane found Canadian Patent No. 2,702,437 (437 patent) invalid for obviousness while Canadian Patent No. 2,760,802 (802 patent) was found valid and infringed by Pharmascience if it proceeds to market its product.

COPAXONE 20 mg has been on the market since the mid-1990s for use in treating patients with relapsing-remitting multiple sclerosis (RRMS) and, in 2017, Pharmascience received a notice of compliance for GLATECT 20 mg for daily administration for this indication. COPAXONE 40 mg was approved in 2016 to be administered three times per week to treat patients with RRMS. Pharmascience sought approval for GLATECT 40 mg and was required to address both the 437 and 802 patents. The claims of the 437 patent, as construed by the Court, relate to the use of glatiramer acetate in treating patients who have had a single clinical attack suggestive of multiple sclerosis (MS) before a confirmed diagnosis of MS (known as clinically isolated syndrome (CIS)), and not including patients who have already met certain criteria for a diagnosis of MS. The claims of the 802 patent claim the use of 40 mg of glatiramer acetate, administered by subcutaneous injection three times per week (and with a day in between injections), for the treatment of patients with RRMS.

The Court found that the subject-matter of the 437 patent was not anticipated but was, however, obvious. The Court noted that finding the prior art publication to be anticipatory would be inconsistent with the objectives of the experimental use exemption, stating that “[i]f a patent cannot be anticipated by its own clinical study, […] it cannot be anticipated by the speculative recommendations of a group of experts who discuss the state of MS treatment, note the lack of evidence, and note that trials are underway.” Regarding the obviousness allegation, the Court identified the only difference between the state of the art and the subject-matter of the claims as clinical studies demonstrating that glatiramer acetate administered to CIS patients was effective in delaying the onset of MS or achieving other therapeutic benefits. The Court concluded that it was more or less self-evident to try to obtain the invention given that, among other considerations, it was more than a mere possibility the treatment would be effective since about 80% of CIS patients go on to develop MS and glatiramer acetate had been proven effective for RRMS.

With respect to the 802 patent, the Court rejected Pharmascience’s invalidity attacks and found sufficient evidence to support infringement. The Court found that the claims were not obvious since it was not self-evident to try 40 mg of glatiramer acetate three times weekly or that such dosage regimen would work, other possible solutions existed to address patient adherence, and there was no motivation to simultaneously increase the dose and reduce the frequency of administration since the increased dose had not been shown to be more effective. Regarding utility, the 802 patent disclosed details of a phase III clinical trial but Teva had no clinical data to support the claimed dosing regimen as of the filing date of the patent. Nevertheless, the Court found the utility was soundly predicted because the skilled person would expect at least a scintilla of utility to treat RRMS based on the disclosed details of the trial and its expected results and considering the common general knowledge. Lastly, the Court found that if Pharmascience’s GLATECT 40 mg is approved and marketed as proposed, Pharmascience will directly and indirectly infringe the 802 patent as its product is indicated for the same patient population, in the same dosage strength and with the same dosage regimen to achieve the same outcomes.

Pharmascience has appealed. Teva may appeal, as of right.