This was the fifth trial decision to be rendered under the “amended” PM(NOC) Regulations. The plaintiff, Teva Canada Innovation (“Teva”), brought an action to prevent the defendant, Pharmascience Inc. (“PMS”), from selling a generic version of Copaxone (glatiramer acetate) capsules (“PMS Product”) for the treatment of multiple sclerosis (“MS”) until after the expiry of two patents: CA ‘437 (use patent) and CA ‘802 (dosing patent). The patentee, Yeda Research, was named as a necessary party pursuant to ss. 6(2) of the PM(NOC) Regulations, but it did not seek a remedy.
Following a thirteen-day trial, the Court held that CA ‘437 was invalid for obviousness, while CA ‘802 was valid and infringed. The Court made an order prohibiting PMS and its affiliated companies from “making, constructing, using, selling, offering for sale, marketing, having marketed, importing, exporting, distributing, having distributed, or otherwise infringing or inducing infringement” of CA ‘802.
The decision is very lengthy and turned largely on the facts and established legal principles. However, the Court’s comments about the disclosure requirement for anticipation (CA ‘437) is notable from a jurisprudential perspective.
The key issues in respect of CA ‘437 were construction, anticipation and obviousness.
Construction: It was common ground that the use of glatiramer acetate to treat MS was prior art. Teva argued that the claims of CA ‘437 are directed only to patients who have had one clinical attack and have not yet been diagnosed with MS. By contrast, PMS argued that the claims of CA ‘437, when properly interpreted, included both pre-MS and MS subjects and overlapped with the prior art. The Court rejected PMS’ proposed interpretation because it was “illogical”, “contrary to the plain wording of the claims”, “not supported by the evidence”, and “would pave the way for a successful Gillette defence and other bases of invalidity”. The Court rejected PMS’ argument that it is simply practicing the prior art.
"There is no disclosure for the purposes of anticipation where a prior use is experimental"
Anticipation: The Court held that the prior art (Karussis 2006) did not disclose “fully and exactly what the patent claims and would not lead the POSITA directly to the claimed subject matter” (475). Rather, Karussis 2006 was a “carefully worded opinion” prepared by a working group of physicians that did not provide “any evidence about the efficacy of glatiramer acetate”. The Court held that the skilled person would “draw distinctions between the statements that are based on evidence and those that are not”. The Court rejected PMS’ submission that “anticipation has never required the prior art to be evidence based” and held that “there is no disclosure for the purposes of anticipation where a prior use is experimental”.
Obviousness: The Court held that inventiveness would not have been required to bridge the gap between the state of the art (Karussis 2006 and other prior art cited by PMS) and the inventive concept, even though a clinical trial would have been required to establish its efficacy. Glatiramer acetate was well-known, available, and approved for the treatment of a related form of MS. There was a motivation to investigate the drug for use in patients who could not tolerate other therapies. Of note, no evidence from elicited from the inventors with respect to their course of conduct, but the Court did not draw an adverse inference as a result. The key issues in respect of CA ‘802 were obviousness, utility and infringement.
The Court held that inventive effort would have been required to move from the state of the art (glatiramer acetate 20 mg every other day) to the inventive concept (40 mg three times weekly).
The POSITA would rely on their expertise to read [the prior art] with a critical eye, make the distinction between small pilot studies, Phase II studies and Phase III studies, and know that some clinical studies are more reliable and informative than others.
Suggestions in publications arising from a pilot study would not have led the skilled person directly to the invention. There was no motivation to simultaneously increase the dose of glatiramer acetate and reduce its frequency of administration. The outcome of proceedings in foreign jurisdictions is not relevant when assessing obviousness.
Utility: PMS argued that the utility of the claimed invention had not been soundly predicted by the filing date. The Court relied on principles from the jurisprudence and held that the evidence did not support PMS’ allegation. The disclosure of the patent was “more than sufficient to permit the POSITA to put the subject-matter of the claims into practice”.
Infringement: The Court held that “PMS will infringe, directly and indirectly, [CA ‘802] because the [PMS Product] is indicated for the same patient population, in the same dosage strength and with the same dosage regimen to achieve the same outcomes.” (923)
PMS has filed an appeal from the judgment [A-315-20].