Topic: Pharmaceuticals and life sciences

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Advertising Standards Canada introduces new advertising dispute procedure for resolving disputes between competitors 

Effective February 11, 2019, Advertising Standards Canada (Ad Standards Canada) will implement a new Advertising Dispute Procedure (the Procedure) to govern complaints between competitors for  alleged breaches of the Canadian Code of Advertising Standards (the Code). The new Procedure (formerly known as the Trade Disputes Procedure) is designed to further streamline the resolution process for … Continue reading

Top Headlines of 2018

Last year ushered in a number of changes to the Canadian pharmaceutical and life sciences sector. 2018 also served as a year to explore the impacts of major intellectual property decisions and regulatory changes from 2017 including the impact of the Supreme Court’s decision in NEXIUM striking down the Promise Doctrine and the implementation of … Continue reading

FCA Confirms that Non-Infringing Alternative Must be Legal and Objectively Economically Viable

The Federal Court of Appeal (“FCA”) confirmed that in assessing the availability of a non-infringing alternative (“NIA”) defence, the NIA must be legal and cannot infringe any patent, and its economic viability must be considered objectively. The FCA upheld an award for damages for patent infringement by the Federal Court (“FC”) but remitted the issue … Continue reading

Bill C-86 receives Royal Assent, bringing amendments across Canada’s IP statutes

Canada’s core IP statutes have been amended by Bill C-86, which received Royal Assent as the Budget Implementation Act, 2018, No. 2, SC 2018, c 27 on December 14, 2018. The final version of the legislation includes amendments to the Patent Act that are substantially identical to the version that received first reading 46 days … Continue reading

Two generics, one hearing: Federal Court orders common trial on patent validity issues in section 6 actions

The Federal Court has ordered that the trial of two actions brought under the post-CETA Patented Medicines (Notice of Compliance) Regulations (the Regulations), against two separate generics, be heard concurrently, on issues of invalidity. This decision highlights the Federal Court’s push to streamline section 6 actions. The court rejected the defendant Taro’s arguments that the … Continue reading

ONCA Permits Pleading Amendments Asserting Validity of Previously Invalidated Patent following Nexium Decision

This decision of the Ontario Court of Appeal (ONCA) arises in the context of a novel action brought by Apotex seeking damages for the delayed market entry of its generic version of Sanofi’s blockbuster ramipril drug. Apotex’s claims in this action are linked to the invalidity of Canadian Patent No. 1,341,206 (206 Patent). The 206 … Continue reading

Ontario Superior Court rejects Apotex attempts to revive the Promise Doctrine by dismissing motion for leave to amend, awards substantial indemnity costs

The Ontario Superior Court of Justice (ONSC) recently denied Apotex’s attempt to repackage the now defunct “promise of the patent” doctrine (the Promise Doctrine).  Apotex sought to amend its pleadings to reintroduce the Promise Doctrine under the guise of invalidity allegations of over-breadth, insufficiency, and willful misrepresentation pursuant to sections 27 and 53 of the … Continue reading

File-wrapper admissibility and other changes to the Patent Act are coming: what’s new for pharmaceutical patentees in Bill C-86

The federal government’s recent omnibus budget bill, Bill C-86 tabled October 29th, 2018, proposes significant changes to Canada’s IP laws. Division 7 of the Bill is intended to implement many aspects of the government’s IP strategy, announced in April 2018. The Bill targets the Patent Act, the Trade-marks Act, and Copyright Act; provides for a … Continue reading

New protections for biologics and other pharmaceuticals under the United States-Mexico-Canada Agreement (USMCA)

As we reported, Canada has joined a new trilateral trade deal called the United States-Mexico-Canada Agreement (USMCA). The USMCA contains important new protections for biologic and other pharmaceutical innovation. Chief among them, Canada will introduce an extended ten-year period of data protection for biologics and patent-term restoration (PTR) for delays in the patent office. The … Continue reading

Abbreviated New Drug Submissions will be posted on the Submissions Under Review List and other pre-market transparency initiatives

Health Canada recently published a notice outlining its phase III pre-market transparency initiatives for prescription drugs. Beginning October 1, 2018, Health Canada will publish a new list of abbreviated new drug submissions (ANDSs) on the Submissions Under Review (SUR) List, as well as publish Regulatory Decision Summaries (RDSs) for ANDSs, supplemental abbreviated new drug submissions … Continue reading

CETA Tracker: Update on CSPs

As we reported, on September 21, 2017 the Canada–European Union Comprehensive Economic and Trade Agreement Implementation Act and accompanying regulations came into force. The legislation provided key reforms to the Patent Act affecting the pharmaceutical industry, including up to two years of patent term restoration for patented pharmaceuticals under the Certificate of Supplementary Protection Regulations … Continue reading

Advisory Council on the Implementation of National Pharmacare – Consultation with Canadians

Advisory Council on the Implementation of National Pharmacare – Consultation with Canadians The Advisory Council on the Implementation of National Pharmacare (“Council”) is consulting with Canadians on the implementation of a national program to fund prescription drugs.  The consultation is open until September 28, 2018. The Council, which reports to the Minister of Health and … Continue reading

First motion for early patent dismissal fails to meet high burden under newly-amended PM(NOC) Regulations

On July 6, 2018, the Federal Court dismissed the first motion brought under section 6.08 of the newly-amended Patented Medicines (Notice of Compliance) Regulations (the Regulations). The Court’s public reasons were released July 30, 2018. The moving party, Amgen Canada Inc. (Amgen), was seeking an order dismissing the Plaintiffs’ action in respect of two of … Continue reading

Getting the Deal Through – Pharmaceutical Antitrust

Norton Rose Fulbright has published a new edition of Getting the Deal Through – Pharmaceutical Antitrust. This edition is an updated, thorough overview of the application of antitrust law to the pharmaceutical sector worldwide. The pharmaceutical sector remains a priority area for antitrust enforcement in most major jurisdictions, where enforcement agencies have been increasingly prone … Continue reading

Pan-Canadian Pharmaceutical Alliance (pCPA) releases draft brand process guidelines

On June 13, 2018, the pan-Canadian Pharmaceutical Alliance (pCPA) released its draft Brand Process Guidelines (Guidelines) for stakeholder feedback. As part of the consultation process, pCPA is planning a webinar for innovative manufacturers on June 22, 2018. The pCPA also released a Frequently Asked Questions (FAQ) document, and a Letter of Intent (LOI) template with … Continue reading

CETA Tracker: Update on section 6 actions under the Patented Medicines (Notice of Compliance) Regulations

As we reported, Canada implemented a single-track pharmaceutical patent litigation regime through amendments to the Patented Medicines (Notice of Compliance) Regulations (the Regulations) on September 21, 2017. Below, we provide an update on new actions and decisions under the amended Regulations. New actions under the amended Regulations Nearly seven months after the amended Regulations came … Continue reading

Standing Committee on Health releases report and recommendations on National Pharmacare

On April 18, 2018 the Standing Committee on Health tabled its report on national pharmacare entitled Pharmacare Now: Prescription Medicine Coverage for All Canadians. The Committee believes that the best way to move forward in establishing a universal single payer public prescription drug coverage program is by expanding the Canada Health Act to include prescription … Continue reading

ONCA upholds dismissal of summary judgment in lansoprazole s. 8 case

As we reported, Abbott Laboratories Limited, Takeda Pharmaceuticals Company Limited and Takeda Pharmaceuticals America Inc. sought dismissal of Apotex’s action for s. 8 damages in the Ontario Superior Court by summary judgment. The Ontario Court of Appeal (ONCA) affirmed the lower court’s finding that a real-world notice of non-compliance – withdrawal (NON-W) issued by Health … Continue reading

Top 10 Updates on Canadian Market Access, Exclusivity and Pricing Issues

Norton Rose Fulbright Canada LLP recently published an article on the “Top 10 Updates on Canadian Market Access, Exclusivity and Pricing Issues” for the Food and Drug Law Institute’s March/April 2018 issue of Update Magazine. The article contains an overview of some of the most pertinent changes in market access, exclusivity and pricing that have … Continue reading

Change in utility law not a factor in s. 8 damages

The Federal Court of Appeal (FCA) has refused to apply the “special circumstances” exception to issue estoppel in view of a change in law arising from the rejection of the “promise doctrine” in AstraZeneca Canada Inc v Apotex Inc, 2017 SCC 36 (NEXIUM, reported here). Noting any injustice to Lilly is “entirely commercial in nature” … Continue reading

CETA Tracker: Update on CSPs

As we reported, on September 21, 2017 the Canada–European Union Comprehensive Economic and Trade Agreement Implementation Act and accompanying regulations came into force. The legislation provided key reforms to the Patent Act affecting the pharmaceutical industry, including up to two years of patent term restoration for patented pharmaceuticals under the Certificate of Supplementary Protection Regulations … Continue reading

Health Canada releases a cost-benefit analysis survey for labelling changes of natural health products as part of the self-care product framework

Health Canada is conducting a cost-benefit analysis survey to gather information about the impact of its  proposed changes to the labels of Natural Health Products (NHPs). Interested stakeholders have until May 30, 2018, to complete the survey and provide any other comments. As we reported,  Health Canada is changing the way it regulates non-prescription drugs, … Continue reading

Section 8 liability offset by patent infringement in esomeprazole case

The Federal Court denied Apotex’s section 8 claim relating to esomeprazole on the basis that its product would have infringed a valid AstraZeneca patent. This aligns with a previous decision of the court that placed significant weight on patent infringement in the context of section 8 damages (reported here). There was no dispute that Apotex’s … Continue reading

CADTH releases updated guidelines for biosimilars

The CADTH Common Drug Review Procedure and Submission Guidelines for Biosimilars (Non-Cancer) and the CADTH pan-Canadian Oncology Drug Review Submission Guidelines for Biosimilars (Cancer) provide an overview of the Common Drug Review procedures and guidance to applicants for biosimilar submissions. The new guidelines are effective as of February 13, 2018. CADTH reports the following key … Continue reading
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