Janssen seeks leave to appeal to SCC regarding FCA decision upholding Minister of Health’s decisions relating to administrative drug submissions

As reported previously, on October 12, 2016, the Federal Court of Appeal allowed four appeals relating to decisions by the Minister of Health to issue a notice of compliance (NOC) to Teva for exemestane tablets (a generic version of Pfizer’s AROMASIN) and an NOC to Hospira for INFLECTRA, an infliximab powder for solution (a biosimilar of Janssen’s REMICADE). The FCA found that the Minister was reasonable in finding that these cross-referenced drug submissions did not trigger section 5 of the PMNOC Regulations absent early working. On December 9, 2016, Janssen filed an application with the Supreme Court of Canada for leave to appeal the FCA decision.

Teva Canada Limited v Pfizer Canada Inc et al, 2016 FCA 248
SCC Case No. 37342

Government of Canada extends deadlines for submissions regarding the Trans-Pacific Partnership

The House of Commons Standing Committee on International Trade has extended the deadline for submission of briefs by individuals and groups for the purpose of the Committee’s public consultation on the Trans-Pacific Partnership agreement until January 27, 2017: Notice from Standing Committee on International Trade. See our IP Update: Canada concludes negotiations on free trade agreement with Trans-Pacific Partners, which provides an overview of the intellectual property provisions, including specifically as they relate to pharmaceuticals.

Health Canada News

Heath Canada adopts new guidance for biosimilars. On November 14, 2016, Health Canada adopted Guidance Document: Information and Submission Requirements for Biosimilar Biologic Drugs, which replaces Guidance for Sponsors: Information and Submission Requirements for Subsequent Entry Biologics (SEBs), dated March 5, 2010. Health Canada now uses the term “biosimilar” instead of “subsequent entry biologic”. The new guidance document applies to all biologic drug submissions where the sponsor seeks authorization for sale based on demonstrated similarity to a previously approved biologic drug in order to present a reduced clinical and non-clinical package. Health Canada has also recently published a revised Fact Sheet: Biosimilars, which provides general information on biologic drugs, biosimilars, the applicable regulatory framework, and access to biosimilars.

Health Canada updates Product Monograph guidance. On December 9, 2016, Health Canada released revised versions of Part I: Heath Professional Information and Part II: Scientific Information of the Product Monograph (PM) guidance document. The revisions are intended to make health professional information easier to read and critical safety information easier to find in the Canadian Product Monograph. Beginning June 9, 2017, certain submissions for biologics, radiopharmaceuticals, and prescription pharmaceuticals will have to be filed in the revised format. Specifically, the 2016 format will be required for NDSs, as well as ANDSs and SANDs where the corresponding innovator PM is in the 2016 format.

CADTH Proposes Process for Assessment of Companion Diagnostics

The Canadian Agency for Drugs and Technologies in Health (CADTH) has invited stakeholders to provide comments and feedback on its proposed process for the assessment of companion diagnostics which is integrated through the Common Drug Review and pan-Canadian Oncology Drug Review programs. According to the CADTH’s Proposed Process for the Assessment of Companion Diagnostics, “[c]ompanion diagnostics are laboratory tests that aim to measure the expression of a specific biomarker … [and] guide optimal clinical management by identifying subpopulations of patients who are most likely to benefit from a given drug.” The proposed process would, among other things, include the CADTH evaluating a submitted drug and its associated companion diagnostic together, and would not delay the currently established timelines to complete a review or increase the current fees for reviewing a drug application. The CADTH proposal is anticipated to be implemented on or after April 3, 2017, and the deadline for stakeholders to submit comments and feedback is January 13, 2017.

Notice of Consultation
CADTH's Proposed Process for the Assessment of Companion Diagnostics

Court Decisions

Valeant’s application under PMNOC Regulations struck on interlocutory motion. Valeant’s prohibition application under the PMNOC Regulations in respect of metformin (Valeant’s GLUMETZA) was struck by a prothonotary of the Federal Court as an abuse of process upon a section 6(5)(b) motion brought by Apotex: Valeant Canada LP v Apotex Inc, 2016 FC 1359. On the motion, Apotex adduced expert opinion evidence that Valeant’s Patent No. 2,476,496 would not be infringed by Apotex’s proposed tablets. Valeant filed no evidence to the contrary and did not cross-examine Apotex’s expert but argued that it had a right to a hearing on the merits in the application.

The Court rejected Valeant’s arguments on a number of grounds, including because Valeant could not justify with evidence why the application should proceed, the onus was on Valeant to move the application forward, Valeant’s notice of application included only a bald allegation of infringement, the innovators’ right to a stay under the PMNOC Regulations was qualified, and Valeant had not met its burden to provide “some reasonable basis for bringing the application apart from the statement that it had a right to do so”.

Ontario Divisional Court denies Pfizer leave to appeal decision permitting Apotex’s unjust enrichment claim regarding sildenafil to proceed. As previously reported, Pfizer brought a motion to strike several of Apotex’s causes of action arising from Patent No. 2,163,446 (pertaining to sildenafil; Pfizer’s VIAGRA). The Motions Judge struck two of Apotex’s claims, but allowed those grounded in the Trademarks Act, unjust enrichment, nuisance, and conspiracy to proceed (2016 ONSC 4966). On November 18, 2016, Justice Nordheimer refused to grant Pfizer leave to appeal the Motion Judge’s order to the Divisional Court: Apotex Inc v Pfizer Ireland Pharmaceuticals, 2016 ONSC 7193.

New Court proceedings

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