Topic: Pharmaceuticals and life sciences

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

By Jillian Hyslop, Kristin Wall and Sara Zborovski on October 14, 2018 Posted in Life sciences and healthcare, Pharmaceuticals and life sciences

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

By Jillian Hyslop and Kristin Wall on September 30, 2018 Posted in Pharmaceuticals and life sciences

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

By Ian Trimble, Sara Zborovski and Kristin Wall on July 31, 2018 Posted in Pharmaceuticals and life sciences

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

By Chelsea Nimmo, Paul Jorgensen, Kristin Wall and Jordana Sanft on July 30, 2018 Posted in Intellectual property, Pharmaceuticals and life sciences

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

By Kevin Ackhurst on July 19, 2018 Posted in Pharmaceuticals and life sciences

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

By Jillian Hyslop, Sara Zborovski and Kristin Wall on June 20, 2018 Posted in Life sciences and healthcare, Pharmaceuticals and life sciences

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

By Christopher A. Guerreiro, Kristin Wall, Jordana Sanft and Judith Robinson on April 30, 2018 Posted in Intellectual property, Pharmaceuticals and life sciences

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

By Ian Trimble, Sara Zborovski and Kristin Wall on April 29, 2018 Posted in Pharmaceuticals and life sciences

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

By David Yi, Allyson Whyte Nowak and Randy Sutton on April 19, 2018 Posted in Intellectual property, Pharmaceuticals and life sciences

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

By Jillian Hyslop, Ian Trimble and Sara Zborovski on April 16, 2018 Posted in Pharmaceuticals and life sciences

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

By David Yi, Louisa Pontrelli and Allyson Whyte Nowak on April 10, 2018 Posted in Intellectual property, Pharmaceuticals and life sciences

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

By Jonathan Chong and Kristin Wall on April 1, 2018 Posted in Intellectual property, Pharmaceuticals and life sciences

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

By Jillian Hyslop and Sara Zborovski on April 1, 2018 Posted in Pharmaceuticals and life sciences

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

By David Yi, Ben Wallwork and Allyson Whyte Nowak on March 27, 2018 Posted in Intellectual property, Pharmaceuticals and life sciences

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

By Chelsea Nimmo, Kristin Wall and Jordana Sanft on March 1, 2018 Posted in Life sciences and healthcare, Pharmaceuticals and life sciences

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

Federal Budget 2018 – the foundation for a national pharmacare program?

By Jillian Hyslop and Kristin Wall on February 28, 2018 Posted in Pharmaceuticals and life sciences

The Federal government tabled the 2018-2019 budget on February 27, 2018, which included an announcement of steps toward the creation of a national pharmacare program to cover the reimbursement of certain prescription medications. The government will create an Advisory Council on the Implementation of National Pharmacare, with the goal of starting a national dialogue on … Continue reading

FCA affirms that infringer does not have the right to elect remedy for infringement in drospirenone case

By Jonathan Chong, Kristin Wall and Allyson Whyte Nowak on February 20, 2018 Posted in Intellectual property, Pharmaceuticals and life sciences

Following the Federal Court’s decision that Bayer’s patent relating to YAZ and YASMIN (both containing drospirenone and ethinyl estradiol) was valid and infringed by Apotex and Cobalt, Apotex argued that it, rather than Bayer, should be entitled to elect between damages and an accounting of profits. As we reported, the court disagreed, and ordered that … Continue reading

Ontario Superior Court denies pleading amendments based on Supreme Court of Canada’s rejection of promise doctrine in ramipril damages action

By David Yi and Allyson Whyte Nowak on February 15, 2018 Posted in Intellectual property, Pharmaceuticals and life sciences

As we reported, Federal Court jurisprudence is being continually reshaped by the Supreme Court’s decision in AstraZeneca Canada Inc. v. Apotex Inc., 2017 SCC 36 (NEXIUM Decision). In Apotex v. Schering Corporation, 2018 ONSC 903, the Ontario Superior Court has now considered the impact of the NEXIUM Decision in the context of Apotex’s action for … Continue reading

Health Canada consultation on the naming of biologics including biosimilars

By Ian Trimble and Sara Zborovski on February 1, 2018 Posted in Pharmaceuticals and life sciences

On January 18, 2018, Health Canada and the Institute for Safe Medication Practices Canada opened a consultation on the naming of biologic drugs (including biosimilars) in Canada. As we reported, the US Food and Drug Administration began affixing a four-letter suffix to the generic name of biosimilar drugs, which is intended to facilitate pharmacovigilance and … Continue reading

Lower prices announced for commonly prescribed generic drugs

By Ian Trimble and Sara Zborovski on February 1, 2018 Posted in Pharmaceuticals and life sciences

On January 29, 2018, the pan-Canadian Pharmaceutical Alliance (pCPA) and the Canadian Generic Pharmaceutical Association issued a joint statement announcing that effective April 1, 2018, 20 commonly prescribed generic drugs will be further reduced to 10% of the cost of the reference brand product. The list of drugs reimbursed at 18% has also grown and … Continue reading

Top Headlines of 2017

By Jillian Hyslop, Kristin Wall and Jordana Sanft on January 1, 2018 Posted in Intellectual property, Pharmaceuticals and life sciences

Happy New Year from Pharma in Brief! Reflecting back on 2017, the only constant over the last year was change, with the implementation of CETA, the rejection of the Promise Doctrine and proposals for reform of various regulatory regimes. We have compiled our list of top headlines below. Major changes to regulatory framework for pharmaceutical … Continue reading

Federal Court of Appeal affirms that the Patent Act’s price control provisions over patented medicines were validly enacted

By Chelsea Nimmo, Christopher A. Guerreiro and Kristin Wall on December 17, 2017 Posted in Intellectual property, Pharmaceuticals and life sciences

The Federal Court of Appeal has reaffirmed the constitutionality of the excessive price provisions of the Patent Act that ground the jurisdiction of the Patented Medicine Prices Review Board (PMPRB) over patented medicines. Background In 2015, the PMPRB commenced a proceeding against Alexion alleging that the price of Alexion’s drug SOLIRIS® (eculizumab) was excessive. In … Continue reading

Supreme Court dismisses leave to appeal on damages against Health Canada for Apo-Trazodone

By Sofia Lopez Bancalari, Kristin Wall and Brian R. Daley on December 17, 2017 Posted in Pharmaceuticals and life sciences

On December 14, 2017, the Supreme Court dismissed Apotex’s application for leave to appeal the decision finding that Health Canada does not owe a duty of care to drug manufacturers in reviewing drug submissions. Case: Apotex Inc v Canada (Minister of Health) (SCC Docket: 37593) Drug: Apo-Trazodone Nature of case: Application for leave to appeal … Continue reading

CETA tracker: First CETA PM(NOC) action has been commenced in Federal Court

By Jordana Sanft, Kristin Wall and Judith Robinson on December 14, 2017 Posted in Intellectual property, Pharmaceuticals and life sciences

The first court action under the newly amended Patented Medicines (Notice of Compliance) Regulations (PM(NOC) Regulations) was commenced on December 11, 2017. Genentech, Inc. and Hoffmann-La Roche Limited v Amgen Canada Inc. (T-1921-17) addresses allegations of infringement with respect to Canadian Patent Nos. 2,376,596; 2,596,133; 2,407,556 and 2,540,547 and a biosimilar new drug submission for … Continue reading