Topic: Pharmaceuticals and life sciences

Subscribe to Pharmaceuticals and life sciences RSS feed

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

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

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

Ontario legislation requiring disclosure of payments to physicians receives Royal Assent

By Ian Trimble and Sara Zborovski on December 13, 2017 Posted in Life sciences and healthcare, Pharmaceuticals and life sciences

On December 12, 2017, Bill 160 passed third reading and received Royal Assent. Included in Bill 160 is the Health Sector Payment Transparency Act (the “Act”). This Act will come into force at a later date to be determined by the government. The stated purpose of the Act is to require the reporting of information … Continue reading

PMPRB responds to proposed amendments to the Patented Medicines Regulations with Guidelines Scoping Paper

By Christopher A. Guerreiro and Kristin Wall on December 12, 2017 Posted in Intellectual property, Pharmaceuticals and life sciences

On Monday, December 11, 2017, the Patented Medicine Prices Review Board (PMPRB) released a scoping paper providing a high-level overview of how a new, risk-based approach to its mandate could function under revised Guidelines following forthcoming amendments to the Patented Medicines Regulations. This previews an official consultation on a revised set of proposed Guidelines that … Continue reading

PAAB Announces New Code of Advertising Acceptance

By Ian Trimble and Sara Zborovski on December 7, 2017 Posted in Life sciences and healthcare, Pharmaceuticals and life sciences

The Pharmaceutical Advertising Advisory Board (PAAB) has announced an updated Code of Advertising Acceptance (Code). The new Code will be implemented beginning on January 1, 2018. The primary change is to the Code’s format. It will only be available online and will allow keyword searching and filtering code provisions by core principle. Other changes include … Continue reading

Amendments to the Patented Medicines Regulations are coming: Health Canada proposes new powers for the PMPRB to lower prices of patented medicines in Canada

By Christopher A. Guerreiro and Kristin Wall on December 3, 2017 Posted in Intellectual property, Pharmaceuticals and life sciences

On Friday, December 1, 2017, the government revealed proposed amendments to the Patented Medicines Regulations (the Regulations) conferring new powers on the Patented Medicine Prices Review Board (PMPRB) and setting the stage for revised Guidelines from the Board. Interested stakeholders have until February 14, 2018 to provide comments to the government. A definitive version of … Continue reading