News & Analysis as of

Judicial Review Pharmaceutical Industry

Quarles & Brady LLP

It's (Apparently) Never Too Late Part II: DEA & Morris & Dickson Settle

Quarles & Brady LLP on

This week, DEA announced it has entered into a settlement agreement with Morris & Dickson Co., LLC (“Morris & Dickson”), resolving the protracted dispute born out of a May 2, 2018 Order to Show Cause (“OTSC”) and Immediate...more

Smart & Biggar

Federal Court of Appeal dismisses appeal relating to Minister of Health’s decision to disclose records pursuant to Access to...

Smart & Biggar on

On November 1, 2023, the Federal Court of Appeal (FCA) dismissed Actial’s appeal from an application for judicial review of the Minister of Health’s decision to disclose records pursuant to a request under the Access to...more

Smart & Biggar

May 1 deadline to seek leave to intervene in PMPRB SOLIRIS rehearing

Smart & Biggar on

As previously reported, the Federal Court of Appeal set aside the Federal Court’s decision dismissing Alexion’s application for judicial review and remitted the matter of whether Alexion’s SOLIRIS (eculizumab) was sold at an...more

Smart & Biggar

Federal Court sets aside decision by the Minister of Health to issue RUZURGI NOC for the second time

Smart & Biggar on

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

Smart & Biggar

Federal Court of Appeal confirms Janssen’s SPRAVATO not eligible for data protection

Smart & Biggar on

Update: On November 10, 2021, the Minister rejected Janssen’s second request for data protection for SPRAVATO, which was submitted following the coming into force of the Canada-United States-Mexico Agreement (CUSMA). The...more

Smart & Biggar

Federal Court quashes RUZURGI NOC and returns matter to the Minister of Health for redetermination

Smart & Biggar on

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

Smart & Biggar

Federal Court denies stay of decision issuing NOC for RUZURGI

Smart & Biggar on

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

Smart & Biggar

Alberta Court of Appeal dismisses Allergan’s appeal regarding interchangeability of LUMIGAN RC and VISTITAN

Smart & Biggar on

On January 29, 2021, the Alberta Court of Appeal dismissed Allergan’s appeal of a judicial review decision relating to the interchangeability of its glaucoma drug, LUMIGAN RC (0.01% bimatoprost), with a higher concentration...more

Smart & Biggar

2020 Highlights in Canadian Life Sciences IP and Regulatory Law

Smart & Biggar on

In 2020, Rx IP Update reported on a number of developments in Canadian life sciences IP and regulatory law. We review top developments below: Table of Contents 1. COVID-19: CIPO, Federal Courts, Health Canada 2. PMPRB:...more

Smart & Biggar

Innovators challenge final PMPRB Guidelines in new Federal Court application

Smart & Biggar on

On November 23, 2020, Innovative Medicines Canada (IMC) and a number of research-based pharmaceutical companies commenced an application for judicial review (T-1419-20) of the final Patented Medicine Prices Review Board...more

Smart & Biggar

Federal Court orders Minister of Health to issue NOC to Fresenius Kabi for its biosimilar IDACIO following filing of consent...

Smart & Biggar on

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

Smart & Biggar

Federal Court finds reasonable Health Canada’s decision that enantiomer of previously approved drug not entitled to data...

Smart & Biggar on

Update: On July 12, 2021, the Federal Court of Appeal dismissed Janssen’s appeal from Zinn J.’s decision: Janssen Inc v Attorney General of Canada (Minister of Health), 2021 FCA 137 (see article here). On September 18,...more

Smart & Biggar

Federal Court strikes price calculation provision of amendments to Patented Medicines Regulations

Smart & Biggar on

UPDATE: On September 10, 2020, the applicants (Innovative Medicines Canada and the company applicants) appealed Justice Manson’s decision (A-215-20). On September 21, 2020, the Attorney General of Canada cross-appealed. As...more

Smart & Biggar

Federal Court releases decision on validity of the Amending Regulations of the Patented Medicines Regulations

Smart & Biggar on

UPDATE: See July 15, 2020 article here describing the decision in more detail. On September 10, 2020, the applicants (Innovative Medicines Canada and the company applicants) appealed Justice Manson’s decision (A-215-20). On...more

White & Case LLP

California's New Reverse Payment Law Departs from Supreme Court Standard in FTC v. Actavis

White & Case LLP on

On October 7, 2019, California became the first state to enact legislation—Assembly Bill 824 ("AB 824")—rendering certain pharmaceutical patent litigation settlement agreements presumptively anticompetitive. This alert...more

Smart & Biggar

Innovators commence Court challenges regarding recent amendments to Patented Medicines Regulations

Smart & Biggar on

The amendments to the Patented Medicines Regulations (Regulations) published on August 21, 2019 have been the subject of two court challenges launched by groups of innovative pharmaceutical companies (22 companies in total)...more

Smart & Biggar

FCA upholds issuance of NON-W letter and cancellation of reconsideration process for Apotex omeprazole magnesium tablet ANDS

Smart & Biggar on

On April 24, 2019, the Federal Court of Appeal (FCA) affirmed the Federal Court’s (FC) dismissal of Apotex’s application for judicial review of a decision by the Minister of Health relating to its Apo-Omeprazole (omeprazole...more

Smart & Biggar

Rx IP Update - March 2019

Smart & Biggar on

Federal Court finds invalidity allegations relating to patent for metformin formulations not justified - On March 8, 2019, Justice Fothergill granted Valeant Canada’s application for an order prohibiting the Minister of...more

Polsinelli

Missouri Supreme Court Talc Decision Alters Landscape

Polsinelli on

On March 6, the Missouri Supreme Court declined to review the intermediate appellate court’s decision in Fox v. Johnson & Johnson, which vacated a $72 million talc verdict awarded in St. Louis City Court. ...more

Smart & Biggar

Rx IP Update - October 2017

Smart & Biggar on

Pfizer obtains orders of prohibition on polymorphic form patent - On September 22, the Federal Court, in a pair of decisions, granted Orders of prohibition under the Patented Medicines (Notice of Compliance) Regulations...more

Bennett Jones LLP

Open Court Principle Means No Secret Proceedings If They Would Directly Affect a Competitor's Rights

Bennett Jones LLP on

Equip: IP Litigation Case of the Week - Courts in Canada are presumed to be open and accessible to the public. Although a party’s commercial interests can be protected, a court will not grant a confidentiality order if...more

McDermott Will & Emery

Federal Court Rejects HHS Interpretation of 340B Program’s Orphan Drug Rule

McDermott Will & Emery on

On October 14, 2015, the United States District Court for the District of Columbia (the Court) issued a decision in Pharmaceutical Research and Manufacturers of America v. United States Department of Health and Human...more

22 Results
 / 
View per page
Page: of 1

"My best business intelligence, in one easy email…"

Your first step to building a free, personalized, morning email brief covering pertinent authors and topics on JD Supra:
*By using the service, you signify your acceptance of JD Supra's Privacy Policy.
- hide
- hide