News & Analysis as of

Apotex Patent Infringement

Smart & Biggar

FCA upholds inducement of infringement findings relating to paliperidone palmitate.

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As previously reported, the Federal Court released a pair of decisions relating to paliperidone palmitate (Janssen’s INVEGA SUSTENNA), finding in a summary trial that each of Pharmascience and Apotex would induce infringement...more

Robins Kaplan LLP

Sanofi-Aventis U.S. LLC v. Apotex Corp. Jevtana® (Cabazitaxel)

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Case Name: Sanofi-Aventis U.S. LLC v. Apotex Corp., C.A. No. 20-cv-804-RGA, 2022 WL 2643532 (D. Del. July 8, 2022) (Hall, J.)  Drug Product and Patent(s)-in-Suit: Jevtana® (cabazitaxel); U.S. Patents Nos. 8,927,592 (“the ’592...more

Smart & Biggar

Janssen succeeds on infringement against Apotex in macitentan combination patent case

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In a public decision dated July 6, 2022 in an action under the Patented Medicines (Notice of Compliance) Regulations, Justice Pallotta of the Federal Court found that Apotex would infringe Janssen’s patent relating to...more

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2021 Highlights in Canadian Life Sciences IP and Regulatory Law

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In the fall of 2021, the Rx IP Update team celebrated its 20thyear of monthly updates on Canadian life sciences IP and regulatory law. Below are highlights from our team’s 2021 updates...more

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PM(NOC) Regulations: Fourth year following major amendments

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September 21, 2021 marked the fourth anniversary of the significant amendments to the Patented Medicines (Notice of Compliance) Regulations (Regulations). This article provides an update on activities in the fourth year...more

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FCA upholds reconsideration decision maintaining $100M+ award against Apotex for cefaclor patent infringement

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Update: On September 28, 2021, Apotex applied to the Supreme Court of Canada for leave to appeal (Docket No. 39851).  On July 23, 2021, the Federal Court of Appeal (FCA) dismissed Apotex’s appeal of the Federal Court’s (FC)...more

Smart & Biggar

Federal Court of Appeal affirms prohibition order against Apotex regarding abiraterone

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As previously reported, in the final decision released under the pre-amended Patented Medicines (Notice of Compliance) Regulations (Regulations), the Federal Court granted a prohibition order relating to Canadian Patent No....more

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Federal Court of Appeal upholds Federal Court decision finding Shire’s VYVANSE patent valid

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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

Robins Kaplan LLP

Eli Lilly & Co. v. Apotex, Inc.

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Alimta® (pemetrexed disodium) - Case Name: Eli Lilly & Co. v. Apotex, Inc., No. 2020-1328, 2020 WL 7490251 (Fed. Cir. Dec. 21, 2020) (Circuit Judges Prost, Bryson, and Stoll presiding; Opinion by Stoll, J.) (Appeal from...more

Fish & Richardson

[Webinar] Life Sciences | 2020 Year in Review - January 27th, 1:30 pm - 2:30 pm ET

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2020 has been referred to as an unprecedented year for the world in so many ways—the pandemic, the California and Washington fires, the racial justice protests and calls to action—but that didn’t stop the Federal Circuit from...more

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Supreme Court denies leave in perindopril accounting of profits decision

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On September 24, 2020, the Supreme Court of Canada denied leave to Apotex (Docket No. 39172) with respect to a decision affirming the quantum of profits payable to the Plaintiffs ADIR and Servier for infringement of ADIR’S...more

Robins Kaplan LLP

H. Lundbeck A/S v. Apotex Inc.

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CONVERTING FROM A PIV CERTIFICATION TO A PIII CERTIFICATION DOES NOT RID THE DISTRICT COURT OF SUBJECT MATTER JURISDICTION, BUT IT DOES WARRANT GRANTING DEFENDANT’S MOTION FOR JUDGMENT ON THE PLEADINGS. Case Name: H....more

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Supreme Court of Canada Leave Applications - May 2020

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UPDATE: UPDATE: On December 10, 2020, the Supreme Court of Canada dismissed Pfizer’s application for leave to appeal (Docket No. 39150) (see article here). Pfizer seeks leave in pregabalin section 8 case As previously...more

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First decision under amended PMNOC Regulations: Federal Court finds Amgen’s filgrastim patent obvious

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UPDATE: On November 3, 2020, the Federal Court of Appeal dismissed Amgen’s appeal. See our article here. On April 16, 2020, Justice Southcott of the Federal Court issued the first decision under the amended Patented...more

Smart & Biggar

Federal Court of Appeal dismisses Apotex’s appeal of $61M profits award to Servier/ADIR for infringement of perindopril patent

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On March 11, 2020, the Federal Court of Appeal dismissed Apotex’s appeal of the Federal Court’s decision ordering Apotex to pay over $61M from an accounting of profits from Apotex’s infringement of ADIR’s perindopril patent...more

McDonnell Boehnen Hulbert & Berghoff LLP

Life Sciences Court Report - March 2020

About Life Sciences Court Report:  We will periodically report on recently filed biotech and pharma litigation. Allergan USA, Inc. v. Prollenium US Inc. 1-20-cv-00104; filed January 23, 2020 in the District Court of Delaware...more

Smart & Biggar

Federal Court maintains $100M+ award in cefaclor infringement damages reconsideration decision

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On November 20, 2019, the Federal Court (FC) issued its reconsideration decision on the quantum of damages owed by Apotex for its infringement of eight Eli Lilly process patents related to the antibiotic cefaclor:  Eli Lilly...more

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Federal Court rejects Apotex’s invalidity allegations on claims for use of abiraterone acetate in combination with prednisone

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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

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Amended PMNOC Regulations: Second Anniversary Update

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September 21, 2019 was the second anniversary of the coming into force of the amended Patented Medicines (Notice of Compliance) Regulations (Regulations) heralding significant changes to the landscape for pharmaceutical...more

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Rx IP Update - January 2019

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IN THIS ISSUE: -Abbott/Takeda permitted to plead that a third party’s patent would be infringed by alleged non-infringing alternative - PMPRB News: **PMPRB issues a Notice of Hearing for allegations of excessive...more

Goodwin

Biosimilar-Related Patent Litigation Updates

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Here are some recent developments in U.S. legal proceedings relating to biosimilars: On December 10, 2018, in the Southern District of Florida, Apotex filed a motion to dismiss the patent infringement complaint that Amgen...more

Smart & Biggar

2018 Highlights in Canadian Life Sciences IP

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In 2018 we reported on a number of developments in life sciences IP and regulatory law. Our most-read articles were: #1 a June update on biosimilars (authored by Urszula Wojtyra); #2 a “live” summary chart of Vanessa’s Law...more

Smart & Biggar

FCA overturns cefaclor damages decision on prejudgment interest issue, provides guidance on NIA defence

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On November 23, 2018, the Federal Court of Appeal (FCA) allowed in part Apotex’s appeal of a decision awarding Eli Lilly over $100 million for Apotex’s infringement of eight process patents related to the antibiotic cefaclor:...more

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Apotex not permitted to plead promise-based invalidity grounds in Ontario section 8 lansoprazole action

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This motion arose in the context of a section 8 action in which Apotex claims damages for delay in the issuance of its notice of compliance for its generic lansoprazole product (Takeda's PREVACID), due to prohibition...more

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Rx IP Update - August 2018

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Teva succeeds in section 8 bortezomib action; infringement counterclaim dismissed - On July 18, 2018, Justice Locke of the Federal Court granted Teva’s claim for compensation under section 8 of the Patented Medicines...more

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