Daniel Daniele

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ONSC dismisses Apotex’s second monopolies action

The Ontario Superior Court of Justice has released the second decision in a series of summary judgment motions relating to Apotex’s claims against innovative drug companies under various causes of action pursued above and beyond the section 8 damages regime in the Patented Medicines (Notice of Compliance) Regulations. In Apotex Inc. v. Pfizer Ireland Pharmaceuticals, … Continue reading

Federal Court of Appeal Upholds First Trial Judgment under New PM(NOC) Regulations

By Orestes Pasparakis, Daniel Daniele and Paul Jorgensen on November 18, 2020 Posted in Intellectual property, Life sciences and healthcare, Pharmaceuticals and life sciences

The Federal Court of Appeal has upheld the first trial judgment under the new Patented Medicines (Notice of Compliance) Regulations. In Amgen Inc v Pfizer Canada ULC, 2020 FCA 188, the Court dismissed Amgen’s appeal from the Federal Court’s decision declaring certain claims in Amgen’s Canadian Patent No. 1,341,537 (537 Patent) invalid for obviousness. The … Continue reading

Two PM(NOC) Actions Dismissed After Common Trial on Validity of Treatment Regimen Patent

By Paul Jorgensen, David Yi and Daniel Daniele on June 1, 2020 Posted in Intellectual property, Life sciences and healthcare, Pharmaceuticals and life sciences

The Federal Court has dismissed two infringement actions brought against defendants under subsection 6(1) of the Patented Medicines (Notice of Compliance) Regulations (Regulations), following a common trial on the validity of Canadian Patent No. 2,562,277 (277 Patent). The Court found that all the asserted claims – to uses for treating multiple sclerosis (MS) – were … Continue reading

First trial judgment under new PMNOC Regulations declares claims to biologic drug invalid

By Orestes Pasparakis, Paul Jorgensen and Daniel Daniele on April 21, 2020 Posted in Intellectual property, Life sciences and healthcare, Pharmaceuticals and life sciences

The Federal Court has released its first trial judgment in an action brought under the new Patented Medicines (Notice of Compliance) Regulations. In Amgen Inc v Pfizer Canada ULC, 2020 FC 522, the Court dismissed Amgen’s action and declared certain claims in Canadian Patent No. 1,341,537 (537 Patent) invalid for obviousness. The action related to … Continue reading

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

By Daniel Daniele, Brian R. Daley and Pharma in Brief team on January 29, 2020 Posted in Intellectual property, Life sciences and healthcare, Pharmaceuticals and life sciences

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, … Continue reading

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

By William Chalmers and Daniel Daniele on November 7, 2019 Posted in Intellectual property, Life sciences and healthcare, Pharmaceuticals and life sciences

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 … Continue reading

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 Daniel Daniele, Kristin Wall and Pharma in Brief team on March 25, 2019 Posted in Life sciences and healthcare, Pharmaceuticals and life sciences

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 … Continue reading

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

By Christopher A. Guerreiro, Daniel Daniele and Pharma in Brief team on February 24, 2019 Posted in Life sciences and healthcare, Pharmaceuticals and life sciences

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 … Continue reading

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

By Kristin Wall and Daniel Daniele on February 4, 2019 Posted in Pharmaceuticals and life sciences

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