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Federal Court finds Minister of Health’s refusal to grant CSP based on the “Timely Submission Requirement” unreasonable

SUMMARY The Federal Court has granted Merck Canada Inc.’s (Merck) application for judicial review of a decision of the Minister of Health (Minister) denying a Certificate of Supplementary Protection (CSP) for Canadian Patent No. 2,670,892 (892 Patent) and the drug BELSOMRA (suvorexant). BACKGROUND A CSP provides patent-like rights and is intended to compensate patentees for … Continue reading

Overview of IP Law In Canada – The Intellectual Property Review, 10th Edition

The recently published Tenth Edition of the Intellectual Property Review (the Review) includes a Canadian chapter. Readers are invited to learn more on the various forms of IP protection available in Canada, and highlights of important changes in Canadian IP law over the past year. The chapter was authored by members of the Pharma in Brief team. The … Continue reading

Federal Court of Appeal Restores Suspension Period

On April 21, 2021, the Federal Court of Appeal (FCA) announced that it will restore the Suspension Period by default for all new matters and begin reinstating the Suspension Period on existing matters by removing them from its Selected Files List. Selected Files As previously reported in June 2020 (June 2020 Update), the FCA began … Continue reading

Canada amends CSP Regulations, adding UK to list of “timely submission requirement” countries

Canada has added the UK to the list of countries that must be considered for the “timely submission requirement” in an application for a Certificate of Supplementary Protection (CSP). The change was implemented by an amendment to the CSP Regulations that came into force on January 6, 2021. Impact on “timely submission requirement” CSP eligibility … Continue reading

Federal Courts update guidance on COVID-19

The Federal Court of Appeal (FCA) provided updated guidance for resuming hearings starting September 1, 2020 and clarified the effect of the federal Time Limits and Other Periods Act (COVID-19) on timelines for commencing and conducting litigation in the FCA. Both the FCA and the Federal Court confirmed that all Practice Directions, judgments, orders and … Continue reading

Federal Courts begin to phase out the Suspension Period

On June 11, 2020 the Federal Court (FC) and Federal Court of Appeal (FCA) published updated notices to gradually phase out the Suspension Period, which had previously been extended to June 15, 2020. Federal Court The FC’s June 11, 2020 Practice Direction and Order (Updated Order), amends its previous Practice Directions, which, subject to the … Continue reading

Ontario lifts recommendation to limit prescription dispensing to 30 days’ supply

We previously reported on the Ontario government’s efforts to manage the risk of drug shortages in the early days of the pandemic. Those efforts included a recommendation that pharmacies dispense no more than a 30-days’ supply of medication to patients under the Ontario Drug Benefit (ODB) program. Because the policy resulted in additional dispensing fees … Continue reading

Federal Courts Extend Suspension Periods to June 15

The Federal Court of Appeal (FCA) and the Federal Court (FC) have extended their Suspension Periods to June 15, 2020. Federal Court of Appeal On May 28, 2020, the FCA issued a Notice to the Parties and the Profession extending the Suspension Period to June 15, 2020. Federal Court On May 29, 2020, the FC issued … Continue reading

Health Canada collaborates with international partners to address pandemic

Health Canada recently published a notice to industry detailing its collaborations with international partners during the COVID-19 pandemic. These cooperative efforts aim to ensure that Canadians’ health product needs are being met quickly and effectively during the outbreak, and that Canada’s policies and regulatory strategies are consistent with those in force around the world. Collaboration … Continue reading

Health Canada amends regulations to permit distribution of OTC and NHP samples to general public

Health Canada has finalized amendments to the Food and Drug Regulations (FDR) and Natural Health Product Regulations (NHPR) to allow for the distribution of samples of non-prescription drugs (NPDs, or “over-the-counter” (OTC) drugs) and natural health products (NHPs) to a larger scope of healthcare professionals as well as the general public. Previously, the distribution of … Continue reading

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

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

Bill C-4: New CUSMA Implementation Act Introduced

On January 29, 2020, the Government introduced Bill C-4 to implement the Canada-United States-Mexico Agreement (CUSMA). The Bill, sponsored by Deputy Prime Minister Freeland, was read for the first time the same day. As we reported, the previous Government’s CUSMA implementation bill (Bill C-100) died on the Order Paper as it was not passed into … Continue reading

Ontario implements regulatory changes to streamline drug formulary listing and reduce government payments to pharmacies

The Ontario Ministry of Health and Long-Term Care (the Ministry) has amended Regulations made under the Ontario Drug Benefit Act (ODBA) and the Ontario Drug Interchangeability and Dispensing Fee Act (DIDFA). The new Regulations are substantially similar to those originally proposed (as we reported). The intended effect of the amendments is to reduce technical requirements … Continue reading

Health Canada consulting on the contents of the Generic Submissions Under Review List

On January 7, 2019, Health Canada opened a consultation on whether to include the names of sponsor companies on the generic submissions under review list (GSUR) for Abbreviated New Drug Submissions (ANDSs). This type of information was recently added to the list of drug and health product submissions under review (SUR) that Health Canada has … Continue reading

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

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

Federal Court upholds patent validity and grants prohibition order against generic lisdexamfetamine in pre-CETA PM(NOC) application

The Federal Court dismissed Apotex’s action to invalidate the claims of Canadian Patent No. 2,527,646 (the 646 Patent), which was consolidated with Shire’s application to prohibit the Minister of Health from issuing a Notice of Compliance for Apotex’s generic version of VYVANSE® (lisdexamfetamine). Shire’s counterclaim for infringement in the action was dismissed but the Court … Continue reading

FCA upholds damage award based on Teva’s infringing sales of levofloxacin

The Federal Court of Appeal has upheld the Federal Court’s order that Teva Canada Limited pay Janssen Inc. (Janssen Canada) and Janssen Pharmaceuticals, Inc. (Janssen US) over $18 million for infringing sales of levofloxacin (reported here). The Court of Appeal’s decision addresses standing, mitigation, market reconstruction, and how freely a trial judge can swing the … Continue reading
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