Daniel Daniele (CA)

Firm/Organization: Norton Rose Fulbright

Blogs: Consumer products law blog, Pharma in Brief, Social Media Law Bulletin

Latest Articles

Patent owner files its own pleading in a PM(NOC) action

By Colin Hyslop, Daniel Daniele (CA) & Brian R. Daley

January 29, 2020

The Federal Court granted leave to the United States of America (USA), in its capacity as co-owner of a patent, to file its own pleading in an action under s 6(1) of the Patented Medicines (Notice of Compliance) Regulations (PM(NOC) Regulations). The USA was permitted to respond to the defendant’s (Apotex Inc.) allegations of invalidity, including by making new and different allegations than those made by the plaintiff. Background This decision arose in the context…

Social Media Law Bulletin

Is court anonymization enough in the era of social media and big data?

By Daniel Daniele (CA)

December 12, 2019

In the age of social media, are court procedures enough to protect vulnerable parties subject to a publication ban? In a recent article, researchers at the University of Zurich were able to re-identify parties in 84% of judgments studied (the Zurich Study).…

Pharma in Brief

Stockpiling generic manufacturers may be liable for direct infringement of “composition for a use” claims

By William Chalmers & Daniel Daniele (CA)

November 7, 2019

The Federal Court has found that it is reasonably arguable that a claim for “a composition for use in the treatment of a disorder” may be directly infringed through the importation, manufacture and stockpiling of the composition. The Court distinguished these claims from pure “use of a composition for a treatment” claims, which can only be infringed by a generic manufacturer through inducing infringement. Background The Court’s decision concerns a pleadings amendment motion by Eli…

Pharma in Brief

Health Canada publishes new amendments to the Food and Drug Regulations and Medical Devices Regulations allowing for public release of clinical information in regulatory submissions

By Morgan Westgate, Daniel Daniele (CA) & Kristin Wall

March 25, 2019

On March 20, 2019, new amendments to both the Food and Drug Regulations (the Regulations) and the Medical Devices Regulations regarding the disclosure of clinical data were published in the Canada Gazette. These changes follow from the May 2017 release of Health Canada’s white paper – Public Release of Clinical Information in Drug Submissions and Medical Device Applications (which we have previously reported on here and here), and confirm Health Canada’s decision to…

Pharma in Brief

Health Canada rejects product-specific suffixes for biosimilars in favour of unique brand names

By Christopher A. Guerreiro, Daniel Daniele (CA) & Pharma in Brief team

February 24, 2019

Health Canada has decided that all biologic drugs, including biosimilars, will be identified by both their unique brand name and non-proprietary (common) name — without the addition of a product-specific suffix. The ability to distinguish between biologics with the same non-proprietary name is important for pharmacovigilance and to minimize inadvertent substitution of drugs that have not been deemed interchangeable. This policy statement was communicated in a Notice to Stakeholders, which outlines the following steps…

Pharma in Brief

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

By Kristin Wall & Daniel Daniele (CA)

February 4, 2019

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 advertising complaints between competitors. Key elements of the Procedure include: New pre-conditions for accepting a complaint. Ad Standards Canada will…

Daniel Daniele (CA)

Patent owner files its own pleading in a PM(NOC) action

Stockpiling generic manufacturers may be liable for direct infringement of “composition for a use” claims

Health Canada publishes new amendments to the Food and Drug Regulations and Medical Devices Regulations allowing for public release of clinical information in regulatory submissions

Health Canada rejects product-specific suffixes for biosimilars in favour of unique brand names

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

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