Kassandra Shortt

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CADTH convenes Advisory Panel on a pan-Canadian prescription drug list

Photo of Kassandra ShorttPhoto of Kristin WallBy Kassandra Shortt and Kristin Wall on Posted in Life sciences and healthcare, Pharmaceuticals and life sciences
CADTH has convened a pan-Canadian Advisory Panel on a Framework for a Prescription Drug List (the Panel). The Panel will provide recommendations on developing a potential pan-Canadian prescription drug list (or formulary). Stakeholder consultations are scheduled to take place in the fall and winter of 2021, leading to a final public report setting out the … Continue reading

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

Photo of Orestes PasparakisPhoto of Mark DavisPhoto of Daniel DanielePhoto of Paul JorgensenPhoto of Kassandra ShorttBy Orestes Pasparakis, Mark Davis, Daniel Daniele, Paul Jorgensen and Kassandra Shortt on 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

NOC issued after Federal Court overturns Minister’s decision on effective date of consent letter under the PM(NOC) Regulations

Photo of Kassandra ShorttPhoto of Christopher A. GuerreiroBy Kassandra Shortt and Christopher A. Guerreiro on Posted in Intellectual property, Life sciences and healthcare, Pharmaceuticals and life sciences
On October 29, 2020, the Federal Court ordered the Minister of Health to immediately issue a notice of compliance (NOC) for a biosimilar drug following a dispute about the effective date of a consent letter under the Patented Medicines (Notice of Compliance) Regulations (the Regulations). The Court held the Minister acted unreasonably in refusing to … Continue reading

“New NAFTA” to take effect July 1, 2020: USA completes domestic ratification of CUSMA

Photo of Kassandra ShorttPhoto of Christopher A. GuerreiroPhoto of Kristin WallPhoto of Judith RobinsonBy Kassandra Shortt, Christopher A. Guerreiro, Kristin Wall and Judith Robinson on Posted in Uncategorized
Canada, the United States, and Mexico have each completed the domestic processes necessary to bring the Canada-United States-Mexico Agreement (CUSMA, also known as USMCA or New NAFTA) into effect. CUSMA will come into force on July 1, 2020, the first day of the third month after it was ratified by each member country. The United … Continue reading

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

Photo of Orestes PasparakisPhoto of Paul JorgensenPhoto of Kassandra ShorttPhoto of Daniel DanielePhoto of Mark DavisBy Orestes Pasparakis, Paul Jorgensen, Kassandra Shortt, Daniel Daniele and Mark Davis on 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

Canada completes domestic ratification of CUSMA

Photo of Kassandra ShorttPhoto of Christopher A. GuerreiroPhoto of Kristin WallBy Kassandra Shortt, Christopher A. Guerreiro and Kristin Wall on Posted in Intellectual property, Life sciences and healthcare, Pharmaceuticals and life sciences
Canada has completed domestic ratification of the Canada-United States-Mexico Agreement (CUSMA, also referred to as USMCA or new NAFTA). As we reported, Canada introduced Bill C-4 to implement CUSMA on January 29, 2020 and it received royal assent as the Canada-United States-Mexico Agreement Implementation Act (CUSMA Implementation Act) on March 13, 2020. No coming-into-force date … Continue reading

Amended CUSMA no longer extends data protection for biologics

Photo of Kassandra ShorttPhoto of Christopher A. GuerreiroPhoto of Kristin WallBy Kassandra Shortt, Christopher A. Guerreiro and Kristin Wall on Posted in Intellectual property, Life sciences and healthcare, Pharmaceuticals and life sciences
On December 10, 2019, Canada, the United States, and Mexico agreed to amend the Canada-United States-Mexico Agreement (CUSMA, also referred to as USMCA) as the trade agreement proceeds toward ratification in each country. Among other changes, the amended CUSMA no longer requires Canada to extend data protection for biologics to 10 years from the 8 years … Continue reading

Patent Act Infringement Actions Cannot be Joined to PM(NOC) Infringement Actions During NOC Prohibition Period

Photo of Kassandra ShorttPhoto of Christopher A. GuerreiroBy Kassandra Shortt and Christopher A. Guerreiro on Posted in Intellectual property, Life sciences and healthcare, Pharmaceuticals and life sciences
The Federal Court recently confirmed that an infringement action under the Patent Act cannot be joined with an infringement action under the Patented Medicines (Notice of Compliance) Regulations (the Regulations) while the Regulations prohibit the Minister from granting a NOC. The Court stated that an infringement action under the Patent Act could instead be brought in … Continue reading

CUSMA Implementation Bill Introduced

Photo of Kassandra ShorttPhoto of Christopher A. GuerreiroPhoto of Kristin WallBy Kassandra Shortt, Christopher A. Guerreiro and Kristin Wall on Posted in Intellectual property, Life sciences and healthcare, Pharmaceuticals and life sciences
On May 29, 2019, the federal government introduced Bill C‑100 to implement the new trilateral trade deal known as the Canada-United States-Mexico Agreement (CUSMA, also referred to as USMCA), making Canada the first of the three member countries to introduce legislation that would ratify the treaty. CUSMA provides more protections for biologic and innovative pharmaceuticals … Continue reading

Federal Court of Appeal affirms cancellation of reconsideration of ANDS for Apo-omeprazole

Photo of Kassandra ShorttPhoto of Judith RobinsonBy Kassandra Shortt and Judith Robinson on Posted in Intellectual property, Life sciences and healthcare, Pharmaceuticals and life sciences
The Federal Court of Appeal has dismissed an appeal by Apotex Inc. (Apotex) in its unsuccessful application for judicial review of a decision by the Minister of Health (the Minister) to cancel the reconsideration of approval for Apo-omeprazole. Background As we reported, the Minister revoked Apotex’s Notice of Compliance (NOC) for Apo-omeprazole and declined to … Continue reading

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

Photo of Kassandra ShorttPhoto of David YiPhoto of Allyson Whyte NowakBy Kassandra Shortt, David Yi and Allyson Whyte Nowak 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
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