News & Analysis as of

Patent Litigation Intellectual Property Protection FDA Approval

Robins Kaplan LLP

Pacira Pharms., Inc. v. eVenus Pharms. Labs., Inc. - Exparel® (bupivacaine)

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Case Name: Pacira Pharms., Inc. v. eVenus Pharms. Labs., Inc., Civ. No. 21-19829, 2024 WL 3812188 (D.N.J. Aug. 9, 2024) (Arleo, J.)....more

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Novartis Pharms. Corp. v. MSN Pharms. Inc. - Entresto® (sacubitril/valsartan)

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Case Name: Novartis Pharms. Corp. v. MSN Pharms. Inc., Civ. No. 20-MD-2930-RGA, 2024 WL 3756787 (D. Del. Aug. 12, 2024)....more

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Novartis Pharms. Corp. v. Hetero USA Inc. - Entresto® (sacubitril/valsartan)

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Case Name: Novartis Pharms. Corp. v. Hetero USA Inc., Civ. No. 20-md-2930-RGA, 2024 WL 3757086 (D. Del. Aug. 12, 2024)....more

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Teva Branded Pharm. Products R&D, Inc. v. Deva Holding A.S. - ProAir® HFA (albuterol sulfate)

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Case Name: Teva Branded Pharm. Products R&D, Inc. v. Deva Holding A.S., Civ. No. 24-4404 (SRC), 2024 WL 3966314 (D.N.J. Aug. 28, 2024) (Chesler, J.)....more

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Generically Speaking: A Hatch-Waxman Litigation Bulletin Second Quarter - New ANDA Cases

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This chart summarizes the case name, presiding judge, drug, and patents-at-issue in all federal district court cases that are filed pursuant to the Hatch-Waxman Act. It also includes the same information for proceedings...more

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Generically Speaking: A Hatch-Waxman Litigation Bulletin Second Quarter - Generic Launches

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This chart tracks the date, drug, reference-listed company, applicant, and indications of publicly available drug launches resulting from Abbreviated New Drug Applications and 505(b)(2) Applications....more

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Generically Speaking: A Hatch-Waxman Litigation Bulletin Second Quarter - ANDA Litigation Settlements

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This chart summarizes the case name, drug, patents-in-suit, and publicly available terms for reported settlements in federal district court cases that are filed pursuant to the Hatch-Waxman Act....more

Smart & Biggar

[Webinar] Cross-border IP strategies for IP owners and litigators - September 18th, 2:00 pm PDT

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Explore skinny labelling & obviousness in Canada and Australia - If you are an intellectual property (IP) owner, a litigator or an in-house legal professional managing IP litigation in multiple jurisdictions, don’t miss...more

Smart & Biggar

[Webinar] Cross-border IP strategies for IP owners and litigators - September 12th, 12:00 pm GMT

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Explore skinny labelling & obviousness in Canada and Australia - If you are an intellectual property (IP) owner, a litigator or an in-house legal professional managing IP litigation in multiple jurisdictions, don’t miss...more

Robins Kaplan LLP

Generically Speaking: A Hatch-Waxman Litigation Bulletin Second Quarter - ANDA Approvals

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This chart tracks the date, drug, reference-listed company, and applicant of Abbreviated New Drug Applications and 505(b)(2) Applications receiving final approval by the FDA....more

Fish & Richardson

Biologics and Biosimilars Landscape: IP, Policy, and Market Developments

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In this review, we discuss the most important recent developments in the biosimilars space, including new biosimilar approvals and launches, litigation under the Biologics Price Competition and Innovation Act (BPCIA),...more

Fitch, Even, Tabin & Flannery LLP

Calculating Patent Term Extension for FDA Delay: Original Patent or Reissue Patent Issue Date?

The Federal Circuit appeal in Merck Sharp & Dohme B.V., Merck Sharp & Dohme, LLC v. Aurobindo Pharma USA, Inc. et al., concerns whether patent term extension (PTE) for regulatory delay, in particular delay for FDA drug...more

American Conference Institute (ACI)

[Webinar] 3rd Annual Passport to Proficiency on the Essentials of Hatch-Waxman and BPCIA - October 10th - 26th, 1:00 pm EST

Gain a comprehensive understanding of Hatch-Waxman and BPCIA essentials, a critical competency for legal and business professionals in the biopharmaceutical arena. Attend ACI’s Hatch-Waxman and BPCIA Proficiency Series...more

Knobbe Martens

Navigating the Regulatory Landscape: FDA Approval and Patent Protection for Software as a Medical Device

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Software is increasingly used as a medical device, transforming the healthcare industry with the goal of improving patient outcomes. However, developing software as a medical device involves navigating complex and evolving...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

Wilson Sonsini Goodrich & Rosati

The Life Sciences Report – June 2022

Wilson Sonsini is pleased to present the latest edition of The Life Sciences Report. This issue features articles on the firm’s new Boulder office and recent Gateway to Colorado VC roadshow, a collaboration between Deloitte’s...more

Knobbe Martens

Federal Circuit Review - September 2021

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Arguments to the Patent Office That Contradict Information Submitted to the FDA Support an Inference of Deceptive Intent In Belcher Pharmaceuticals v. Hospira, Inc., Appeal No. 20-1799, the Federal Circuit held that a...more

Robins Kaplan LLP

ANDA Litigation Settlements - Summer 2021

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This chart summarizes the case name, drug, patents-in-suit, and publicly available terms for reported settlements in federal district court cases that are filed pursuant to the Hatch-Waxman Act....more

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ANDA Litigation Settlements - Spring 2021

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This chart summarizes the case name, drug, patents-in-suit, and publicly available terms for reported settlements in federal district court cases that are filed pursuant to the Hatch-Waxman Act....more

Kramer Levin Naftalis & Frankel LLP

Recent Updates on CAR T-Cell Therapy: FDA Approvals and Patent Litigation

On Feb. 5, 2021, the Food and Drug Administration (FDA) granted approval for a new CAR T-cell therapy, Breyanzi® (lisocabtagene maraleucel), to Juno Therapeutics, a subsidiary of Bristol-Myers Squibb (BMS). Breyanzi® is...more

Robins Kaplan LLP

ANDA Approvals - Winter 2021

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This chart tracks the date, drug, reference-listed company, and applicant of Abbreviated New Drug Applications and 505(b)(2) Applications receiving final approval by the FDA....more

Robins Kaplan LLP

Hatch-Waxman Venue Is Further Narrowed

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This week, the Federal Circuit issued an order finding that in cases brought under 35 U.S.C. § 271(e)(2)(A), infringement occurs for venue purposes only in districts where actions related to the submission of an Abbreviated...more

Kramer Levin Naftalis & Frankel LLP

CAR T-Cell Therapy Takes Off and Brings on Patent Litigation

CAR T-Cell therapy, a new biologic therapy, is taking off. As companies continue to develop this new and promising therapy, patent litigation inevitably follows.  ...more

Robins Kaplan LLP

ANDA Litigation Settlements - Fall 2019

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Please see full Chart below for more information....more

American Conference Institute (ACI)

[Event] Global Legal and Regulatory Summit On Biosimilars - December 3rd-4th, Munich, Germany

Legal, Regulatory and Commercial Perspectives on the International Biosimilars Marketplace - The Global Biosimilars market is expected to grow robustly. Market watchers anticipate that Europe in particular will experience...more

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