News & Analysis as of

Judicial Review Prescription Drugs

Smart & Biggar

Health Canada must redetermine exemption requests for psilocybin (magic mushroom)-assisted psychotherapy training

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TheraPsil, a patient advocacy organization, and 73 healthcare practitioners (HCPs) have succeeded in the Federal Court of Appeal (FCA) to overturn the refusal of the Minister of Mental Health and Addictions and Associate...more

Goodwin

Third Circuit Affirms Rejection of AstraZeneca’s Challenges to IRA Drug Price Negotiation Program

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On May 8, 2025, the Court of Appeals for the Third Circuit affirmed the district court’s dismissal of AstraZeneca’s challenges to the Inflation Reduction Act’s Drug Price Negotiation Program and CMS’s Guidance implementing...more

Mintz - Health Care Viewpoints

Appeals Court Rejects AstraZeneca’s Challenge to Medicare Drug Price Negotiation Program

A federal appellate court has handed down the first appellate-level decision addressing the merits of drug manufacturers’ challenges to the Inflation Reduction Act of 2022's (IRA) Medicare Drug Negotiation Program...more

Quarles & Brady LLP

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

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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 confirms Janssen’s SPRAVATO not eligible for data protection

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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

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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

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

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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

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

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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

Rx IP Update - July 2019

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Federal Court of Appeal requires PMPRB to re-determine whether patent ‘pertains to’ Galderma’s DIFFERIN - On June 28, 2019, the Federal Court of Appeal granted the appeal of the Patented Medicine Prices Review Board (PMPRB...more

Smart & Biggar

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

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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

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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

Baker Donelson

Medicare 340B Drug Payment Policy Survives Legal Challenge; Hospitals Say, It's Not Over

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A federal court has handed CMS an initial legal victory enabling drastic cuts in Medicare Part B payment to take effect for separately payable drugs and biologicals purchased by hospitals under the 340B Drug Discount Program...more

Smart & Biggar

Rx IP Update - May 2017

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Federal Court of Appeal finds that Apotex did not fail to mitigate its damages in relation to Apo-Trazodone drug submission - On April 6, 2017, the Federal Court of Appeal overturned the Federal Court’s finding that...more

Smart & Biggar

Rx IP Update - February 2017

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Federal Court of Appeal rules on non-infringing alternatives and apportionment as defences to an accounting of profits from patent infringement - On February 2, 2017, the Federal Court of Appeal released a...more

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