In an action by Apotex for compensation from Sanofi and Schering under the Ontario Statute of Monopolies, U.K. Statute of Monopolies and the Trade-marks Act, the Ontario Court of Appeal has overturned a motion judge’s decision denying Sanofi and Schering leave to amend their defences to plead the Supreme Court of Canada’s decision in AstraZeneca Canada Inc. v Apotex Inc., 2017 SCC 36 [AstraZeneca]: Apotex Inc. v Schering Corporation, 2018 ONCA 890.

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Save the date: Life Sciences Regulatory Webinar 

(formal invitation to follow)

We previously reported on proposed amendments to the Patented Medicines Regulations released on December 2, 2017. The originally proposed coming into force date was January 1, 2019. However, in its October 2018 Newsletter, the Patented Medicine Prices Review Board provides an update on Guideline Reform associated with the proposed amendments, noting that “a January 2019 implementation date for the Regulations now appears to be unlikely.”

Supreme Court of Canada Leave Applications

By Tierney GB Deluzio

Supreme Court of Canada denies Eli Lilly leave to appeal in olanzapine section 8 damages action. On November 8, 2018, Eli Lilly was denied leave to appeal (docket No. 38077) the Federal Court of Appeal (FCA)'s decision (reported here) which affirmed the trial decision awarding more than $70 million to Teva under section 8 of the Patented Medicines (Notice of Compliance) Regulations in respect of olanzapine (Eli Lilly's ZYPREXA). The FCA granted Teva's cross-appeal seeking to add to its recovery lost pipefill sales and an adjustment to account for an under-reporting of sales in the data relied on by both parties' experts.

Supreme Court of Canada denies Teva leave to appeal in levofloxacin damages assessment. On November 8, 2018, Teva was denied leave to appeal (docket No. 38033) the FCA's decision (reported here) which affirmed the trial judge's quantification of damages (close to $19 million) from infringement of Janssen's patent for levofloxacin (LEVAQUIN). The FCA found that the Federal Court did not err in constructing the hypothetical world, and that the Federal Court's factual findings were open to it on the evidence.

Apotex seeks leave in judicial review of Health Canada decision regarding Indian facilities. As previously reported, the FCA dismissed Apotex's appeal of a judicial review decision of the Therapeutic Products Directorate (TPD) which required Apotex to submit additional information concerning products manufactured or tested in Apotex's facilities in India. The FCA found that the Federal Court made no reviewable error in its conclusion that the TPD's decision was not improperly motivated. On October 1, 2018, Apotex applied for leave to appeal (docket No. 38336).

In October 2018, the Canadian Agency for Drugs and Technologies in Health (CADTH) issued an interesting Environmental Scan on International Policies on the Appropriate Use of Biosimilar Drugs (Report). This Report outlines some of the post-market policies and factors in jurisdictions outside Canada (U.S., U.K., Norway, Germany, Netherlands, France, Finland, Australia and New Zealand) impacting market uptake. The analysis was grouped under the categories of (a) interchangeability, switching and substitution; (b) supply side policies (relating to drug pricing, procurement and pharmacy reimbursement and practices); and (c) prescribing incentives.

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On October 16, 2018, Prothonotary Tabib ordered that common validity issues in actions relating to Biogen’s fampridine (FAMPYRA) against Taro and Apotex are to be heard concurrently: Biogen v Taro; Biogen v Apotex, 2018 FC 1034. Biogen’s actions against Taro and Apotex under the PMNOC Regulations had been commenced on June 15, 2018 and July 24, 2018, respectively (see our prior article, Amended PMNOC Regulations: First Anniversary Update). Biogen and Apotex consented to having the invalidity issues heard concurrently. Taro did not, due to its concern that it could lose the commercial advantage of being first on the market.

Prothonotary Tabib concluded that having the common invalidity issues heard together would be the most efficient use of the Court and parties’ time and resources, and would achieve the just, most efficient and least expensive determination of the issues. She further concluded that Taro would not suffer prejudice: even though Taro was the first generic to serve a notice of allegation, this does not guarantee that Taro would be first on the market, even if the trials were heard separately. Further, only common issues will be heard together, and the remainder of the issues in Apotex’s action would be heard at a later date, such that a judgment in Taro’s action could be issued before Apotex’s action concludes. Thus, she ordered that the common invalidity issues in the Taro and Apotex actions be heard concurrently in March 2020, with the remainder of the issues in Apotex’s action to be heard in April 2020.

A Federal Court Order has issued on a motion to strike brought by Sandoz in four actions relating to infringement of rituximab patents. The Court’s treatment of the novel claims by Roche may be of interest to litigants under the current scheme of the PMNOC Regulations.

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PMNOC Proceedings

rivaroxaban (XARELTO): Bayer v Teva

lenalidomide (REVLIMID): Celgene v Apotex

ticagrelor (BRILINTA): AstraZeneca v Taro

silodosin (RAPAFLO): Allergan v Sandoz and Kissei

Canadian IP Impact Case of the Year 
AstraZeneca v Apotex (NEXIUM)
LMG Life Sciences

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