Topic: Uncategorized

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

By Morgan Westgate, Corey McClary and Kristin Wall on January 18, 2021 Posted in Uncategorized

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 is tied to both a patent and a medicinal ingredient contained in an approved drug. There are also certain timing requirements.

The “timely submission requirement” in paragraph 106(1)(f) of the Patent Act stipulates that the Canadian application for market authorization for the approved … Continue Reading

Federal Courts update guidance on COVID-19

By Jordana Sanft, Allyson Whyte Nowak, Judith Robinson and Brian R. Daley on September 10, 2020 Posted in Uncategorized

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 directions from both courts remain in full force and effect.

Resumption of in-person hearings

On September 1, 2020, the FCA issued a Notice to the Parties and Profession (Notice) confirming that three types of hearings will be held during the Court’s … Continue Reading

Federal Courts begin to phase out the Suspension Period

By Jordana Sanft, Allyson Whyte Nowak, Judith Robinson and Brian R. Daley on June 23, 2020 Posted in Uncategorized

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 amendments listed, continue to remain in force. The Updated Order provides for different procedures by region.

Ontario, Québec and the Territories

Suspension Period: Subject to the five exceptions listed in April 29^th practice direction, the Suspension Period is … Continue Reading

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

By John Greiss and Randy Sutton on June 17, 2020 Posted in Uncategorized

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 being charged to patients, the government took further regulatory action to ensure that patients would not be required to pay additional fees as a result of this policy.

On June 15th, 2020, the Drugs and Devices Division ended its recommendation that pharmacies dispense … Continue Reading

Federal Courts Extend Suspension Periods to June 15

By Jordana Sanft, Allyson Whyte Nowak, Judith Robinson and Brian R. Daley on June 2, 2020 Posted in Uncategorized

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 an updated Practice Direction and Order (FC Update), also extending the Suspension Period to June 15, 2020. Pursuant to the FC Update:

the Suspension Period is still subject to the five exceptions listed in the FC’s Practice Direction

Health Canada collaborates with international partners to address pandemic

By Sarah Pennington and Kristin Wall on May 7, 2020 Posted in Uncategorized

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 with International Regulators

International Coalition of Medicines Regulatory Authorities (ICMRA)

Health Canada is a member of the ICMRA, an entity made up of 29 regulatory authorities and with the World Health Organization (WHO) as an observer. ICMRA members work together … Continue Reading

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

By John Greiss and Randy Sutton on May 5, 2020 Posted in Life sciences and healthcare, Pharmaceuticals and life sciences, Uncategorized

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 these products was limited to physicians, dentists, veterinary surgeons and pharmacists. The regulatory amendments were made as part of Canada’s obligations under the Canada–United States–Mexico Agreement (CUSMA) and the passing of the CUSMA … Continue Reading

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

By Kassandra Shortt, Christopher A. Guerreiro, Kristin Wall and Judith Robinson on April 28, 2020 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 States was the final member country to complete its domestic ratification process, giving notice to Canada and Mexico on April 24, 2020. Canada and Mexico had provided notice on April 2 and 4, 2020, respectively.

Next step: Uniform Regulations

The CUSMA member countries … Continue Reading

Bill C-4: New CUSMA Implementation Act Introduced

By Caroline Henrie, Christopher A. Guerreiro and Kristin Wall on February 4, 2020 Posted in Uncategorized

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 law before the federal election in October of 2019. Subsequently, the Intellectual Property Chapter of the CUSMA was amended to remove extended data protection for biologics. Although Bill C-4 includes an amendment to the Food and Drugs Act that authorizes regulations to … Continue Reading

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

By William Chalmers and Kristin Wall on December 19, 2019 Posted in Uncategorized

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 for listing a product on the Ontario formulary and align policies with industry standards and other provinces.

The amendments

Key changes to the Regulations include:

Remove the requirement for the Drug Notification Form (DNF) from formulary drug submissions. A

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

By Christopher A. Guerreiro, Kristin Wall and Pharma in Brief team on January 27, 2019 Posted in Uncategorized

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 maintained since 2015.

Historically, the SUR list has been restricted to New Drug Submissions (NDSs) and Supplemental New Drugs Submissions (SNDSs). With respect to each of these submissions, the SUR list includes the medicinal ingredient, … Continue Reading

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

By Corey McClary, David Yi and Allyson Whyte Nowak on August 13, 2018 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

The claims of Canadian Patent No. 2,432,644 (the 644 Patent) relate to pharmaceutical compositions comprising prasugrel and aspirin. Prasugrel is a member of the thienopyridine family of compounds. The asserted claims of the patent claimed the use of prasugrel for simultaneous or … Continue Reading

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

By Jonathan Chong, Brian R. Daley and Jordana Sanft on July 16, 2018 Posted in Uncategorized

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 granted the prohibition order against the Minister.

Patent found to be valid

Amphetamines are used to treat attention deficit and hyperactivity disorder (ADHD), but are controlled substances because they can be abused for their euphoric effect. Abuse typically occurs when tablets … Continue Reading

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

By Paul Jorgensen, Judith Robinson and Allyson Whyte Nowak on February 14, 2018 Posted in Uncategorized

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 “broad axe” in quantifying damages.

Background

Since at least 1998, Janssen Canada has sold levofloxacin in Canada as LEVAQUIN®.

Teva sold its infringing Novo-levofloxacin in Canada from November 29, 2004, until October 17, 2006, when the Federal Court enjoined further … Continue Reading