David Yi

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Federal Court Notice on Use of Artificial Intelligence in Court Proceedings

Photo of Julia WonPhoto of Christopher A. GuerreiroPhoto of David YiBy Julia Won, Christopher A. Guerreiro and David Yi on Posted in Intellectual property
On December 20, 2023, the Federal Court (Court) published a notice on the use of artificial intelligence (AI) in proceedings (Notice) and interim principles and guidelines on the Court’s own use of AI (Policy). Notice mandates AI Declaration from litigants Declaration requirement. The Court now expects parties to proceedings before the Court to inform it, … Continue reading

The Ontario Superior Court dismisses a generic manufacturer’s claim for damages under section 8 of the PM(NOC) Regulations

Photo of William ChalmersPhoto of David YiPhoto of Pharma in Brief teamBy William Chalmers, David Yi and Pharma in Brief team on Posted in Damages, Intellectual property, Life sciences and healthcare
The Ontario Superior Court (ONSC) has dismissed a claim for damages under section 8 of the Patented Medicines (Notice of Compliance) Regulations (the Regulations) brought by Apotex Inc. (Apotex) for lost sales of its Apo-Atomoxetine product. The Court conducted a purposive interpretation of the Regulations and found that Apotex did not meet the statutory requirements … Continue reading

Supreme Court denies leave to appeal in generic Statute of Monopolies case

Photo of William ChalmersPhoto of Christopher A. GuerreiroPhoto of David YiBy William Chalmers, Christopher A. Guerreiro and David Yi on Posted in Damages, Intellectual property, Life sciences and healthcare
On April 27, 2023, the Supreme Court of Canada dismissed an application by Apotex Inc. and Apotex Pharmachem Inc. (Apotex) for leave to appeal from a decision of the Ontario Court of Appeal (ONCA), dismissing its claim for damages in the Ontario courts under the Statutes of Monopolies and other novel causes of action. In the Courts below, Apotex … Continue reading

ONCA Confirms Generics Limited to Section 8 Damages in the Face of an Innovator’s Legitimate Exercise of Rights under the PM(NOC) Regulations

Photo of David YiPhoto of Christopher A. GuerreiroPhoto of Pharma in Brief teamBy David Yi, Christopher A. Guerreiro and Pharma in Brief team on Posted in Damages, Intellectual property, Life sciences and healthcare, Pharmaceuticals and life sciences
On August 16, 2022, the Ontario Court of Appeal (ONCA) released its decision in Apotex Inc. v. Eli Lilly Canada Inc., 2022 ONCA 587.  The ONCA denied Apotex’s appeal of a lower court summary judgement decision that dismissed Apotex’s novel claims under the UK and Ontario Statutes of Monopolies, the Trademarks Act, and at common law (see … Continue reading

Pharma in Brief: The 2021 Year in Review

Photo of Kristin WallPhoto of William ChalmersPhoto of Christopher A. GuerreiroPhoto of David YiBy Kristin Wall, William Chalmers, Christopher A. Guerreiro and David Yi on Posted in Intellectual property, Life sciences and healthcare, Pharmaceuticals and life sciences
In this article, the Pharma in Brief team has curated and provided updates on the most significant topics we covered in 2021. Introduction In 2021, governments advanced major policy initiatives aimed at the COVID-19 pandemic and broader health priorities. These policy initiatives included reforms to the Patented Medicine Prices Review Board (PMPRB), the Patented Medicines … Continue reading

ONSC dismisses Apotex’s second monopolies action

Photo of Orestes PasparakisPhoto of Daniel DanielePhoto of David YiBy Orestes Pasparakis, Daniel Daniele and David Yi on Posted in Intellectual property, Life sciences and healthcare, Pharmaceuticals and life sciences
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

Proposed amendments to the PM(NOC) Regulations: Patents claiming different salt forms of medicinal ingredients eligible for inclusion on the Patent Register

Photo of David YiPhoto of Kristin WallPhoto of Pharma in Brief teamBy David Yi, Kristin Wall and Pharma in Brief team on Posted in Intellectual property, Life sciences and healthcare, Pharmaceuticals and life sciences
On April 23, 2021, Proposed PM(NOC) Amendments [1] were published in the Canada Gazette, Part I. These amendments permit patents claiming different forms of a medicinal ingredient (e.g., salt forms) to be listed on the patent register and are intended to balance Proposed FDR Amendments [2] published on March 30, 2019 which allow generic manufacturers … Continue reading

Ontario Superior Court summarily dismisses Apotex’s novel monetary claims under Statutes of Monopolies, Trademarks Act, and at common law

Photo of David YiPhoto of Pharma in Brief teamBy David Yi and Pharma in Brief team on Posted in Damages, Intellectual property, Life sciences and healthcare, Pharmaceuticals and life sciences
On March 8, 2021, the Ontario Superior Court granted summary judgment dismissing novel claims by Apotex under the UK and Ontario Statutes of Monopolies, the Trademarks Act, and at common law. It is the first decision on the merits of Apotex’s novel claims and arises in the context of litigation relating to Eli Lilly’s patented … Continue reading

Federal Court of Appeal upholds one of the last prohibition orders under the old PM(NOC) Regulations

Photo of Sarah PenningtonPhoto of David YiPhoto of Kristin WallBy Sarah Pennington, David Yi and Kristin Wall on Posted in Intellectual property, Life sciences and healthcare, Pharmaceuticals and life sciences
The Federal Court of Appeal has affirmed one of the last judgments granting a prohibition order under subsection 6(1) of the pre-September 2017 Patented Medicines (Notice of Compliance) Regulations (the PM(NOC) Regulations). The Court of Appeal upheld the prohibition order despite a decision in a subsequent action under the amended PM(NOC) Regulations finding that the … Continue reading

Federal Court determines that infringement action under PM(NOC) Regulations is not moot where trial proceeds after patent expiry

Photo of David YiPhoto of Pharma in Brief teamBy David Yi and Pharma in Brief team on Posted in Intellectual property, Life sciences and healthcare, Pharmaceuticals and life sciences
On May 22, 2020, the Federal Court granted a motion seeking an order that the issue of infringement in an action brought pursuant to section 6 of the Patented Medicines (Notice of Compliance) Regulations (Regulations) would not be moot notwithstanding that the trial was set to proceed after the expiry of the relevant patent. Background … Continue reading

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

Photo of Paul JorgensenPhoto of David YiPhoto of Daniel DanieleBy Paul Jorgensen, David Yi and Daniel Daniele on 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

Update: Expanded Federal Funding for Research and Innovation

Photo of David YiBy David Yi on Posted in Life sciences and healthcare, Pharmaceuticals and life sciences
As we reported in March, the Federal Government pledged $275 million to research relating to COVID-19. On April 23, 2020, an additional $1.1 billion in funding was announced and includes funding for: Research and Data: $114.9 million for research to accelerate the development, testing, and implementation of medical and social countermeasures to COVID-19. This will … Continue reading

Federal Court issues first decision on patent term restoration – Minister’s decision denying certificate of supplementary protection (CSP) is unreasonable

Photo of David YiPhoto of Kristin WallPhoto of Pharma in Brief teamBy David Yi, Kristin Wall and Pharma in Brief team on Posted in Intellectual property, Life sciences and healthcare, Pharmaceuticals and life sciences
On April 7, 2020, the Federal Court issued a decision in Canada’s first judicial review under the Patent Act and new Certificate of Supplementary Protection Regulations (CSP Regulations). It is the first decision issued under this regime, and also one of the first decisions to apply the Supreme Court of Canada’s new standard of review … Continue reading

Health Canada Provides Guidance on Regulation of Software as a Medical Device (SaMD)

Photo of Caroline HenriePhoto of David YiBy Caroline Henrie and David Yi on Posted in Life sciences and healthcare, Pharmaceuticals and life sciences
On December 18, 2019, Health Canada published a new Guidance Document Software as a Medical Device (SaMD): Definition and Classification (Guidance Document). The Guidance Document explains what products would be regulated as SaMD under the Food and Drugs Act (Act) and the Medical Devices Regulations (Regulations) as well as information on classification of SaMD. What … Continue reading

Federal Court reinstates damages decision concerning prejudgment interest

Photo of David YiPhoto of Pharma in Brief teamBy David Yi and Pharma in Brief team on Posted in Damages
The Federal Court has vindicated Lilly, reinstating a patent infringement damages decision that awarded Lilly prejudgment interest equal to its average annual rate of return during the interest earning period, on a compound basis. It found that Lilly’s real-world rate of return was convincing evidence of both what could have and what would have occurred … Continue reading

Competition Bureau issues statement regarding off-label use of vaccines

Photo of David YiPhoto of Pharma in Brief teamBy David Yi and Pharma in Brief team on Posted in Life sciences and healthcare, Pharmaceuticals and life sciences
The Competition Bureau (Bureau) recently conducted a preliminary investigation into possible competition concerns arising from a proposal to include a clause in a procurement contract that would restrict off-label use of a vaccine.  The Bureau concluded that there was no abuse of dominance as the provision was not included in the procurement contract; however, it … Continue reading

Competition Bureau publishes Final IP Enforcement Guidelines

Photo of David YiPhoto of Christopher A. GuerreiroPhoto of Brian R. DaleyBy David Yi, Christopher A. Guerreiro and Brian R. Daley on Posted in Intellectual property, Life sciences and healthcare, Pharmaceuticals and life sciences
On March 13, the Competition Bureau published a revised version of its IP Enforcement Guidelines (IPEGs). The IPEGs clarify the Bureau’s approach to conducting investigations of alleged anti-competitive activities that involve IP, including settlement of pharmaceutical patent litigation under the Patented Medicines (Notice of Compliance) Regulations (Regulations). The revised IPEGs replace the earlier 2016 version. … Continue reading

FCA Confirms Entirety of Inventors’ Conduct is Relevant in Obviousness Analysis and Upholds Inventiveness of Crystal Form Patent

Photo of David YiPhoto of Pharma in Brief teamBy David Yi and Pharma in Brief team on Posted in Intellectual property, Life sciences and healthcare, Pharmaceuticals and life sciences
The Federal Court of Appeal (“FCA”) upheld the validity of Canadian Patent 2,436,668 (“668 Patent”) which covers Form I ODV succinate (marketed as PRISTIQ) in two separate appeals by Apotex Inc. (“Apotex”) and Teva Canada Ltd (“Teva”), finding that the claims were novel and inventive. Obviousness The FCA began be reiterating key points of the … Continue reading

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

Photo of David YiPhoto of Pharma in Brief teamBy David Yi and Pharma in Brief team on Posted in Intellectual property, Life sciences and healthcare, Pharmaceuticals and life sciences
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

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

Photo of David YiPhoto of Pharma in Brief teamBy David Yi and Pharma in Brief team on Posted in Intellectual property, Pharmaceuticals and life sciences
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

Photo of David YiPhoto of Kristin WallPhoto of Pharma in Brief teamBy David Yi, Kristin Wall and Pharma in Brief team on Posted in Intellectual property, Pharmaceuticals and life sciences
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

Pharma in Brief – Federal Court dismisses application for a prohibition order regarding prasugrel hydrochloride under the old PM(NOC) Regulations

Photo of David YiPhoto of Pharma in Brief teamBy David Yi and Pharma in Brief team on Posted in Uncategorized
The Federal Court dismissed an application by Eli Lilly Canada Inc., Ube Industries, Ltd., and Daiichi Sankyo Company, Limited (the Applicants) seeking a prohibition order regarding Apotex’s generic version of Lilly’s EFFIENT® (prasugrel hydrochloride). While the Court rejected Apotex’s allegations of overbreadth, insufficiency, and non-patentable subject matter, it held that the claims were obvious. Background … Continue reading
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