Update: The Government of Canada announced an agreement with the Yukon ($9.5 million over four years). The agreement text is available in the updated National pharmacare bilateral agreements resource....more
We previously reported on Canada’s first-ever National Strategy for Drugs for Rare Diseases, which included up to $1.4 billion in funding for provinces and territories, to be negotiated through bilateral agreements. This...more
As we previously reported, JAMP sought leave to commence an application against Janssen under the abuse of dominance provisions of the Competition Act (the Act), relating to ustekinumab (Janssen’s STELARA and FINLIUS). This...more
After filing a new drug submission for its ustekinumab biosimilar PYZCHIVA (Janssen’s STELARA), Samsung commenced the underlying action against Janssen for impeachment of Canadian Patent No. 3,113,837. Janssen sought to add a...more
As previously reported, on February 29, 2024, the Minister of Health introduced Bill C-64, An Act respecting pharmacare (Pharmacare Act), which proposed the foundational principles for the first phase of national universal...more
Explore skinny labelling & obviousness in Canada and Australia -
If you are an intellectual property (IP) owner, a litigator or an in-house legal professional managing IP litigation in multiple jurisdictions, don’t miss...more
8/30/2024
/ Australia ,
Canada ,
Cross-Border ,
FDA Approval ,
Hatch-Waxman ,
Intellectual Property Litigation ,
Intellectual Property Protection ,
Litigation Strategies ,
Obviousness ,
Patent Applications ,
Patent Litigation ,
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Explore skinny labelling & obviousness in Canada and Australia -
If you are an intellectual property (IP) owner, a litigator or an in-house legal professional managing IP litigation in multiple jurisdictions, don’t miss...more
8/30/2024
/ Australia ,
Canada ,
Cross-Border ,
FDA Approval ,
Hatch-Waxman ,
Intellectual Property Litigation ,
Intellectual Property Protection ,
Litigation Strategies ,
Obviousness ,
Patent Applications ,
Patent Litigation ,
Patents ,
Pharmaceutical Industry ,
Pharmaceutical Patents ,
Webinars
On November 10, 2021, the Minister of Health refused to reassess its decision that Janssen’s esketamine hydrochloride product (SPRAVATO) was not an “innovative drug” and therefore not entitled to data protection. As...more
On February 7, 2024, the Federal Court dismissed Takeda’s action under subsection 6(1) of the Patented Medicines (Notice of Compliance) Regulations in relation to dexlansoprazole (Takeda’s DEXILANT). Justice Furlanetto...more
On May 26, 2023, the Minister of Health determined that Biosimilar Collaborations Ireland Limited was entitled to the benefit of section 5 of the Patented Medicines (Notice of Compliance) Regulations (Regulations), including...more
On November 2, 2023, the Federal Court dismissed The Winning Combination (TWC)’s application for judicial review of Health Canada’s decision to refuse a natural health product licence for Resolve, a smoking cessation aid:...more
On May 26, 2023, the Minister of Health issued a decision that Biosimilar Collaborations Ireland Limited (BCIL) was entitled to the benefit of a notice of allegation (NOA) served by the previous owner of a new drug submission...more
On August 3, 2023, the Canadian Agency for Drugs and Technologies in Health (CADTH) released its annual report. Highlights from 2022-2023 include...more
On March 30, 2023, the Ontario Superior Court of Justice dismissed Apotex’s claim under section 8 of the Patented Medicines (Notice of Compliance) Regulations (PMNOC Regulations) relating to Apo-Atomoxetine (Lilly’s...more
As we previously reported, the Ontario Court of Appeal affirmed the lower court’s decision dismissing Apotex’s claims against Eli Lilly under the Ontario and English Statutes of Monopolies, Trademarks Act, and common law...more
As previously reported, the Federal Court found Janssen’s Canadian Patent No. 2,661,422 (422 patent)—which relates to treatment of prostate cancer in humans by co-administration of abiraterone acetate (Janssen’s ZYTIGA) and...more
On March 22, 2023, the Minister of Health announced the first-ever National Strategy for Drugs for Rare Diseases. This strategy includes $1.5 billion invested to “increase access to, and affordability of, effective drugs for...more
Before approving Janssen’s esketamine hydrochloride product (SPRAVATO) on May 20, 2020, the Minister of Health determined that it was not an “innovative drug” as defined by section C.08.004.1(1) of the Food and Drug...more
On April 1, 2023, the fee for filing a Certificate of Supplementary Protection (CSP) will increase from $9,952 to $10,152 in accordance with subsection 9(1) of the Certificate of Supplementary Protection Regulations (Canada...more
As previously reported, the Federal Court found Janssen’s Canadian Patent No. 2,661,422 (422 patent) – which relates to treatment of prostate cancer in humans by co-administration of abiraterone acetate (Janssen’s ZYTIGA) and...more
As previously reported, the Federal Court found Janssen’s Canadian Patent No. 2,661,422 (“422 patent”) – which relates to treatment of prostate cancer in humans by co-administration of abiraterone acetate (marketed by Janssen...more
On March 8, 2021, the Ontario Superior Court of Justice dismissed Apotex’s claims against Eli Lilly (Lilly) under the Statute of Monopolies, Trademarks Act, and common law conspiracy relating to Canadian Patent No. 2,041,113...more
9/8/2022
/ Apotex ,
Appeals ,
Canada ,
Civil Conspiracy ,
Dismissals ,
Eli Lilly ,
Patent Act ,
Patent Invalidity ,
Patent Litigation ,
Patent Registration ,
Patents ,
PMNOC Regulations ,
Statute of Monopolies ,
Trademarks Act
On April 1, 2022, the fee for filing a Certificate of Supplementary Protection (CSP) will increase from $9,756 to $9,952 in accordance with subsection 9(1) of the Certificate of Supplementary Protection Regulations (Canada...more
On August 9, 2019, the Minister of Health denied Merck’s application for a Certificate of Supplementary Protection (CSP) for Canadian Patent No 2,670,892 relating to the drug suvorexant (Merck’s BELSOMRA). On September 29,...more
On July 31, 2021, the Minister of Health provided notice of proposed amendments to the Food and Drug Regulations and the Medical Devices Regulations. The amendments are planned for spring 2022 and are intended to modernize...more
10/4/2021
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Biologics ,
Canada ,
Comment Period ,
Drug Approvals ,
Food & Drug Regulations ,
Medical Devices ,
Minister of Health ,
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