DE Under 3: What Federal Contractors Need to Know About OFCCP's New Audit Scheduling Letter
In Bayer Inc v Amgen Canada Inc, 2024 FC 1849, the Court granted a motion brought by Amgen for a declaration that Canadian Patent No. 3,007,276 (276 patent) was ineligible for inclusion on the Patent Register and that the...more
On November 15, 2024, the Office of Federal Contract Compliance Programs (OFCCP) published its Corporate Scheduling Announcement List (CSAL), identifying 2,000 establishments of federal supply and service contractors and...more
Navigating a compliance review (“audit”) with the Office of Federal Contract Compliance Programs (OFCCP) can be a complex and nerve-wracking experience for federal contractors. The process is often extensive, and the results...more
Federal Court of Appeal (FCA) dismisses appeal on finding of inducement: Apotex Inc v Janssen Inc, 2023 FCA 220 - Apotex appealed the trial decision, finding that Apo-Macitentan would infringe Canadian Patent No. 2,659,770...more
On August 30, 2023, the Small Business Administration (“SBA”) filed a “Notice of Compliance” in Ultima Services Corp. v. U.S. Dept. of Agriculture, et. al., Case No. 2:20-cv-00041, U.S. District Court for the Eastern District...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 previously reported, the Federal Court quashed a second decision by the Minister of Health (Minister) to issue a Notice of Compliance (NOC) to Médunik Canada (Médunik) for its amifampridine product, RUZURGI, following the...more
It’s here! OFCCP has finally released the long-awaited latest Courtesy Scheduling Announcement List. As a reminder this is the list of contractors and their establishments that have been selected for upcoming audit by the...more
The California Privacy Protection Agency (CPPA) recently released the draft proposed CCPA Regulations and draft initial statement of reasons. Importantly, these are draft regulations that are likely to be subject to extensive...more
The OFCCP has been very busy of late. On March 14, 2022, the Office of Federal Contract Compliance Programs issued Directive 2022-01, introducing new requirements for federal contractors’ mandated compensation system...more
On March 10, 2022, for the second time, the Federal Court set aside a decision by the Minister of Health (Minister) to issue Médunik Canada (Médunik) a Notice of Compliance (NOC) for its amifampridine product, RUZURGI,...more
The Federal Court released a pair of decisions in patent litigation relating to paliperidone palmitate (Janssen’s INVEGA SUSTENNA): Janssen Inc v Pharmascience, 2022 FC 62 and Janssen Inc v Apotex, 2022 FC 107. Pharmascience...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
As previously reported, Apotex sought leave to appeal a decision of the Federal Court of Appeal (2021 FCA 52) affirming a Federal Court decision finding that the claims of a patent relating to lisdexamfetamine (Shire’s...more
As previously reported, the Federal Court of Appeal dismissed Apotex’s appeal from a decision holding that the claims of a patent relating to lisdexamfetamine (Shire’s VYVANSE) were valid and prohibiting the Minister of...more
Update: On redetermination, Health Canada issued a new notice of compliance for RUZURGI on June 24, 2021. Catalyst and Kye have sought judicial review (Court File No T-1047-21). On May 31, 2021, the Federal Court quashed a...more
Update: Health Canada’s “Forward Regulatory Plan: 2023-2025” no longer lists the 2019 proposed amendments to the Food and Drug Regulations, “Regulations amending the Food and Drug Regulations (Improving Access to Generic...more
Update: On October 7, 2021, the Supreme Court of Canada denied Apotex’s leave to appeal (Apotex v Shire, Docket No. 39662). The Federal Court of Appeal (FCA) recently dismissed an appeal by Apotex from a decision of the...more
On September 30, 2020, the Federal Court dismissed an application by Catalyst Pharmaceuticals Inc (Catalyst) and KYE Pharmaceuticals Inc (KYE) (collectively, the applicants) for an interlocutory injunction to stay the...more
On October 29, 2020, Justice Manson of the Federal Court ordered the Minister of Health to issue a notice of compliance (NOC) to Fresenius Kabi for IDACIO (adalimumab), a biosimilar of AbbVie’s HUMIRA: Fresenius Kabi v...more
Don't rely on the initial list posted! The Office of Federal Contract Compliance Programs announced that it has posted a revised Corporate Scheduling Announcement List. The agency's statement was emailed this morning: On...more
On August 10, 2020, the Office of Federal Contract Compliance Programs (OFCCP) updated its website, including revamping the National Pre-Award Registry and the VEVRAA Hiring Benchmark Database. These new features provide...more
As previously reported, the Federal Court of Appeal (FCA) dismissed Millennium Pharmaceuticals and Janssen’s appeal from a decision granting Teva’s claim for compensation under section 8 of the Patented Medicines (Notice of...more
In an action commenced by Allergan against Apotex in respect of ulipristal (Allergan’s FIBRISTAL) under the Patent Medicines (Notice of Compliance) Regulations (PMNOC Regulations), an issue arose as to the appropriate...more
On October 29, 2019, the Federal Court issued its final decision under the pre-amended Patented Medicines (Notice of Compliance) Regulations: Janssen Inc v Apotex Inc, 2019 FC 1355. Justice Phelan granted Janssen’s...more