The Federal Court has decided two infringement actions concerning glatiramer acetate products under the Patented Medicines (Notice of Compliance) Regulations (the Regulations). The Court dismissed allegations of anticipation based upon "speculative" prior art and rejected an argument that there was insufficient disclosure to satisfy the test for sound prediction. However, the Court found one of the two patents in issue was invalid for obviousness. Injunctive relief was granted in respect of the other patent.

Background

Teva Canada Innovation and Teva Canada Limited (together, Teva) and Pharmascience Inc. (Pharmascience) market glatiramer acetate products in Canada for indications related to multiple sclerosis (MS). Teva's product, Copaxone®, is marketed in 20 mg and 40 mg strengths. Pharmascience obtained approval for a 20 mg strength of its product, Glatect®, in August 2017. This case concerns Pharmascience's Supplementary New Drug Submission (SNDS) to obtain approval for a 40 mg strength of Glatect®.

Teva argued that Glatect® 40 mg will infringe Canadian Patents No. 2,702,437 (the 437 Patent) and 2,760,802 (the 802 Patent), both of which are listed on the Patent Register against Copaxone® 40 mg. Pharmascience raised invalidity as a defence. The Court also considered whether Teva could rely on the Regulations to assert infringement by Glatect® 20 mg given that there are no patents listed against Copaxone® 20 mg on the Patent Register.

The 437 Patent: Asserted claims invalid for obviousness

Claims construction. The asserted claims of the 437 Patent relate to pharmaceutical compositions comprising glatiramer acetate for particular uses in a patient who has had a single clinical attack suggestive of MS (CIS patients) and meets certain other criteria specified in the claims.

Construction was complicated by the fact that two different sets of diagnostic criteria for MS were known as of the relevant date. Pharmascience argued that, based on one of the two sets of criteria, the claims could include patients who were diagnosed with MS after a single clinical attack. The Court disagreed. Emphasising the importance of the plain wording of the claims, the Court held that the claims only included patients who did not meet either set of diagnostic criteria for MS.

Anticipation. The Court found that the prior art documents cited by Pharmascience (Pinchasi 2007 and Karussis 2006) neither disclosed nor enabled the asserted claims of the 437 Patent.

Pinchasi 2007 is a patent application that related to relapsing-remitting MS (RRMS) patients-not CIS patients, as required by the relevant claim of the 437 Patent.

Karussis 2006 is a report of an International Working Group for Treatment Optimization in MS (the Karussis Working Group) that discussed prior and ongoing studies, and offered consensus statements on MS treatment. The Court held:

No disclosure. Karussis 2006 only disclosed the agreement of the Karussis Working Group that certain drug treatments, including glatiramer acetate, "should" work and "may be considered," and that "it is reasonable to propose early treatment"-there were no concrete data on the effectiveness of glatiramer acetate for treating CIS patients. The Court found that the statements in Karussis 2006 were "based on hypothesis and speculation, and not evidence-based."

The Court rejected Pharmascience's argument that, even if speculative, Karussis 2006 was anticipatory because performing the idea described in the art would result in infringement. Distinguishing two recent cases dealing with "speculative art" for anticipation, the Court noted that Karussis 2006 did not include a study protocol, nor did it describe testing or anticipated results.

The Court queried: "if Karussis 2006 is anticipatory art, what would prevent a group of experts in any field from having discussions and speculating on the positive outcome of a clinical trial in progress, developed and implemented by others, in order to later argue that their speculation that the trial in progress would be successful anticipated the claims of a patent that are based on such clinical trials?" Such an outcome would be inconsistent with the common law experimental use exemption. Thus, the Court held: "If a patent cannot be anticipated by its own clinical study, in my view, 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."

No enablement. The Court rejected Pharmascience's argument that the skilled person could have easily prescribed Copaxone® 20 mg for the claimed use, though off-label. Rather, the Court preferred expert evidence that CIS patients would not have been treated with a drug that was not approved due to the lack of evidence and untenable cost without coverage/reimbursement.

Obviousness. The Court found that the asserted claims of the 437 Patent were obvious. The difference between the prior art and the inventive concept was that the state of the art did not include clinical studies to demonstrate that glatiramer acetate was effective to delay the onset of MS in CIS patients, or to achieve the invention's other therapeutic benefits and outcomes. The Court held that while it was not self-evident that what was being tried ought to work, there was motive in the field and a lack of alternatives. The Court also held that, although clinical trials were not routine in that they required "planning, special expertise, funding and time," they were not "otherwise arduous."

Gillette Defence & Infringement. Pharmascience argued that Glatect® 40 mg will not infringe the 437 Patent because it merely practises the teachings of the prior art, which recognized that glatiramer acetate was known for the treatment of RRMS.

The Court held that the Gillette defence could not succeed because the prior art did not teach the use of glatiramer acetate for CIS patients, as required by the claims. A CIS patient is not a diagnosed MS (or RRMS) patient. Although the proposed Glatect® Product Monograph (PM) included an indication that the 20 mg strength could be used for RRMS and CIS patients, the 40 mg strength was indicated only for RRMS patients.

Although the Gillette Defence failed, the Court ultimately concluded there was no infringement of the 437 Patent's asserted claims as they were found invalid for obviousness.

Jurisdictional Issue. As a result of its finding on invalidity, the Court also refused to decide a jurisdictional issue about whether Teva could assert infringement of the 437 Patent under the Regulations in respect of Glatect® 20 mg.

As no patents were listed against Copaxone® 20 mg, Pharmascience had already obtained approval for Glatect® 20 mg. Later, the Regulations were triggered by Pharmascience's SNDS for Glatect® 40 mg, which used Copaxone® 40 mg as a reference product and required Pharmascience to address the 437 Patent. The 40 mg SNDS was described as a "line extension" to the already-approved Glatect® 20 mg product and included a combined PM addressing both strengths.

The jurisdictional issue arose because Teva tried to assert past and future infringement of the 437 Patent by the Glatect® 20 mg strength in addition to the 40 mg strength. Pharmascience argued that Teva did not have a reasonable cause of action under the Regulations in respect of the 20 mg strength. As we previously reported, the Glatect® 20 mg allegations were narrowed but not completely decided on two pre-trial motions. At trial, Teva argued that the proposed combined PM would "make additional changes to the 20 mg product" and that Glatect® 20 mg is "a drug that will be made, used, or sold" in accordance with the submission at issue.

The Court noted that, while it shared Pharmascience's overall view that the Regulations are a "complete regime," it did not need to decide the "more complex jurisdictional issue" in this case given its finding on obviousness.

The 802 Patent: Asserted claims valid and infringed

Claims construction. There was no dispute that the asserted claims of the 802 Patent "address 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."

Obviousness. The Court held that the asserted claims of the 802 Patent were not obvious. The skilled person would not have found all of the prior art cited by Pharmascience. Further, Pharmascience did not explain "how or why" these references would have been combined in a "mosaic" by the skilled person. Even if the skilled person had combined the references, it would not have been self-evident to try the 40 mg strength three times weekly or that it would work, and there were other possible solutions available in the art.

Inutility. The Court held that the asserted claims of the 802 Patent are not invalid for inutility. The Court found: "Although it was not known or obvious that 40 mg administered three times weekly would be an effective treatment for MS, in my view there is a sound prediction set out in the '802 Patent."

The Court considered the level of disclosure in the patent required for sound prediction. It held that the soundness of any line of reasoning is to be assessed from the perspective of a skilled person and whether or not they would accept the specification's logic and derive the patent's utility therefrom. The Court held that proper disclosure can be made with "a full, clear and exact description of the nature of the invention and the manner in which it can be practised."

The 802 Patent discloses the details (but not the results) of a Phase III study designed to examine the claimed dosing schedule. The 802 Patent also discloses the reasoning for the frequency and strength of its dosage, and points to other studies and trials for evidence of safety and efficacy. Reading this information together with the common general knowledge, the skilled person would have accepted the logic presented and expected at least a scintilla of utility.

Infringement. The Court found that Glatect® 40 mg, if approved and marketed in accordance with the SNDS and proposed PM, would infringe the asserted claims of the 802 Patent. The Court also held that Pharmascience would induce infringement through its proposed PM, which would be used by physicians to inform and guide their prescriptions. The Court granted Teva's request for injunctive relief.

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Teva Canada Innovation v. Pharmascience Inc., 2020 FC 1158

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