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Patent Litigation Janssen Pharmaceuticals Pharmaceutical Patents

Bradley Arant Boult Cummings LLP

Spring Has Sprung Obviousness Trends from the Federal Circuit

There have been only a few precedential decisions from the Federal Circuit related to obviousness since spring sprung. While these decisions have produced mixed results for the lower courts, clinical study protocols have held...more

Schwabe, Williamson & Wyatt PC

Latest Federal Court Cases - April 2024 #2

Janssen Pharms., Inc. et al. v. Teva Pharm. USA, Inc. et al., Appeal Nos. 2022-1258, -1307 (Fed. Cir. April 1, 2024) In this week’s Case of the Week, the Federal Circuit vacated-in-part a district court’s bench trial...more

Goodwin

Biocon Settles with Janssen, Securing U.S. Market Entry Date for Ustekinumab Biosimilar

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​​​​​​​On February 29, Biocon Biologics Ltd announced that it signed a settlement and license agreement with Janssen Biotech Inc. and Johnson & Johnson (“J&J”) regarding Bmab 1200, Biocon’s proposed biosimilar to STELARA....more

Goodwin

Formycon/Fresenius Kabi and Samsung Bioepis Settlements with J&J and Janssen Biotech regarding Ustekinumab

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On August 7, 2023, Formycon AG and Fresenius Kabi announced that they have reached a settlement with Johnson & Johnson (“J&J”) in the United States relating to FYB202, a proposed ustekinumab biosimilar to STELARA®, marketed...more

Goodwin

Janssen and Amgen Settle STELARA (Ustekinumab) BPCIA Litigation

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We previously reported on Janssen’s complaint alleging that Amgen’s filing of an aBLA for ustekinumab, a biosimilar of STELARA, infringes Amgen patents, and about Janssen seeking a preliminary injunction to block Amgen from...more

Goodwin

Janssen Files Redacted Public Version of Its Opening Brief in Support of Its Motion for Preliminary Injunction Against Amgen in...

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As we previously reported, on March 1, 2023, Janssen filed a motion for preliminary injunction in Janssen Biotech, Inc. v. Amgen Inc., C.A. No. 22-1549-MN, seeking to enjoin Amgen from the commercial manufacturing, sale, and...more

Goodwin

Janssen Seeks a Preliminary Injunction in BPCIA Ustekinumab Case Against Amgen

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On March 1, 2023, Janssen filed a motion for preliminary injunction in Janssen Biotech, Inc. v. Amgen Inc., C.A. No. 22-1549-MN, seeking to enjoin Amgen from the commercial manufacturing, sale, and offer for sale of ABP 654,...more

Goodwin

Janssen Files BPCIA Complaint Against Amgen Regarding Ustekinumab

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​​​​​​​On November 29, 2022, Janssen filed a BPCIA complaint in the District of Delaware against Amgen related to Amgen’s ustekinumb biosimilar ABP 654 of Janssen’s STELARA. This is Janssen’s first BPCIA case filed with...more

Smart & Biggar

Federal Court rejects trial of common issues and allows pleadings amendment re: supply disruptions in abiraterone acetate amended...

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As previously reported, the Federal Court found Janssen’s Canadian Patent No. 2,661,422 (“422 patent”) – which relates to treatment of prostate cancer in humans by co-administration of abiraterone acetate (marketed by Janssen...more

Smart & Biggar

Federal Court of Appeal upholds obviousness finding re: Janssen’s abiraterone acetate and prednisone combination therapy patent

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As previously reported, the Federal Court found Janssen’s Canadian Patent No. 2,661,422 (the 422 patent) invalid on the basis of obviousness and dismissed its actions against Apotex, Dr. Reddy’s Laboratories, and...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

Bradley Arant Boult Cummings LLP

Court Decision Means that Antibody Patenting Is Not Getting Easier

Patenting antibodies has long been challenging. Although most inventions can be patented based on their functionality, assuming the functionality is new and non-obvious, for antibodies and other biomolecules there is a higher...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

Smart & Biggar

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

Smart & Biggar

Federal Court upholds validity of Janssen’s paliperidone palmitate patent

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On May 5, 2020, Manson J. of the Federal Court issued the second decision on the merits under the amended Patented Medicines (Notice of Compliance Regulations). The Court upheld the validity of Janssen’s patent for...more

McDonnell Boehnen Hulbert & Berghoff LLP

PTAB Life Sciences Report - February 2020

About the PTAB Life Sciences Report:  We will periodically report on developments at the PTAB involving life sciences patents. Abbott Laboratories v. Edwards Lifesciences Corp. PTAB Petition:  IPR2020-00480; filed January...more

McDonnell Boehnen Hulbert & Berghoff LLP

Life Sciences Court Report - February 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...more

Smart & Biggar

Federal Court of Appeal confirms obviousness finding in section 8 bortezomib action against Teva

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As previously reported, the Federal Court granted Teva’s claim for compensation under section 8 of the Patented Medicines (Notice of Compliance) Regulations relating to Teva’s bortezomib product (Janssen markets bortezomib as...more

Smart & Biggar

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

Smart & Biggar

Rx IP Update - February 2019

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Orders of prohibition relating to polymorphic form patent for PRISTIQ upheld on appeal - As previously reported, the Federal Court, in a pair of decisions, granted orders prohibiting Apotex and Teva from marketing their...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

Goodwin

Judge Sets Trial Date in Janssen v. Celltrion Should Summary Judgment Be Denied

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As we reported here, in the patent dispute between Janssen and Defendants Celltrion and Hospira relating to Inflectra® (infliximab-dyyb), a biosimilar of Remicade®, there are multiple motions for summary judgment pending...more

Benesch

Federal Circuit Confirms That Continuation Patent Type May Not Be Retroactively Altered to Invoke Safe Harbor Provision

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In In re: Janssen Biotech, Inc., the Federal Circuit affirmed the Patent Trial and Appeal Board’s (“Board”) holding that, for the purposes of the safe harbor provision of 35 U.S.C. § 121, a patent owner of a...more

Goodwin

Scheduling Order Entered in Janssen v. Samsung Bioepis

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This morning, the district court in Janssen v. Samsung Bioepis, which concerns Samsung Bioepis’ Renflexis® (infliximab-abda) biosimilar product, entered a pretrial scheduling order. The scheduling order calls for, among other...more

McDonnell Boehnen Hulbert & Berghoff LLP

PTAB Life Sciences Report -- Part III

About the PTAB Life Sciences Report: Each month we will report on developments at the PTAB involving life sciences patents. Complex Innovations, LLC. v. AstraZeneca AB - PTAB Petition: IPR2017-00631; filed January 9,...more

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