News & Analysis as of

FDA Approval Patent Litigation

Robins Kaplan LLP

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

Robins Kaplan LLP on

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

Robins Kaplan LLP

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

Robins Kaplan LLP on

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

Venable LLP

Spotlight On: Biosimilar Litigations - September 2024

Venable LLP on

Biosimilar Litigations include litigations relating to biosimilar/follow-on products of CDER-listed reference products. Litigations between biosimilar applicants/manufacturers and reference product sponsors as well as...more

Fish & Richardson

The Final Word on an Alleged Infringer’s Intent in a Hatch-Waxman Safe Harbor Analysis

Fish & Richardson on

We have been monitoring the dispute between Edwards Lifesciences Corp. (“Edwards”) and Meril Life Sciences Pvt., Ltd. (“Meril”) before and after the initial Federal Circuit decision. The dispute focused on whether Meril’s...more

Fenwick & West LLP

Federal Circuit Reaffirms Scope of Safe Harbor Defense to Patent Infringement

Fenwick & West LLP on

In 2019, Edwards Lifesciences Corporation sued Meril Life Sciences Pvt. Ltd. for patent infringement in the Northern District of California, with Fenwick representing Meril in the district court case and the recent appellate...more

Robins Kaplan LLP

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

Robins Kaplan LLP on

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

Smart & Biggar on

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

Smart & Biggar on

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

Venable LLP

Regeneron Files BPCIA Complaint Against Sandoz’s EYLEA® Biosimilar Enzeevu™ Following FDA Approval

Venable LLP on

Regeneron filed an eighth BPCIA litigation (Case No. 2:24-cv-08760 (D.N.J.)) related to an EYLEA® (aflibercept) biosimilar, against Sandoz’s Enzeevu™ (aflibercept-abzv).  The Complaint alleges infringement of 46 of...more

Robins Kaplan LLP

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

Robins Kaplan LLP on

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

Venable LLP

Venable’s BiologicsHQ Monthly Injection - July 2024

Venable LLP on

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

Venable LLP

Venable’s BiologicsHQ Monthly Injection - June 2024

Venable LLP on

Venable’s BiologicsHQ Monthly Injection – June 2024...more

Venable LLP

Venable’s BiologicsHQ Monthly Injection - May 2024

Venable LLP on

Venable’s BiologicsHQ Monthly Injection - May 2024...more

WilmerHale

The Interplay: Key Decisions at the Intersection of Antitrust & Life Sciences - May 2024

WilmerHale on

Second Circuit Affirms “Pay for Delay” Dismissal:  On May 13, 2024, the Second Circuit affirmed dismissal of antitrust claims brought by wholesalers, retailers, and employee benefit funds that alleged they overpaid for the...more

Venable LLP

FDA Approves First Two Interchangeable EYLEA® Biosimilars – Biocon’s Yesafili™ (aflibercept-jbvf) and Samsung Bioepis’s Opuviz™...

Venable LLP on

On May 20, 2024, the FDA approved the first two interchangeable biosimilars of Regeneron’s EYLEA® (aflibercept) – Biocon Biologics and Mylan’s Yesafili™ (aflibercept-jbvf) and Samsung Bioepis’s Opuviz™ (aflibercept-yszy). ...more

Fish & Richardson

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

Fish & Richardson on

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

Venable LLP

The First Prolia® / Xgeva® Biosimilar Approvals in the U.S.

Venable LLP on

On March 5, 2024, the FDA approved Sandoz’s Jubbonti® and Wyost® (denosumab-bddz) as the first biosimilars of Amgen’s Prolia® and Xgeva® (denosumab). The launch date for these biosimilars has not been announced as Amgen and...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

Goodwin

Genentech and Biogen File Joint Stipulation of Dismissal in BPCIA Litigation Regarding Tocilizumab

Goodwin on

​​​​​​​As we previously reported, in July 2023 Genentech, Inc., Hoffmann-LaRoche, Inc., and Chugai Pharmaceutical Co., Ltd. (collectively, “Genentech”) filed BPCIA litigation against Biogen MA Inc. and Bio-Thera Solutions,...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

Knobbe Martens on

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

Wilson Sonsini Goodrich & Rosati

Federal Circuit Affirms Jazz Pharmaceutical's Risk Evaluation and Mitigation Strategy Patent Is Not Listable in Orange Book

On February 24, 2023, the Federal Circuit held that Jazz Pharmaceuticals, Inc. (Jazz) must delist U.S. Patent No. 8,731,963 (the ’963 Patent) from the U.S. Food and Drug Administration’s (FDA’s) “Orange Book” because the...more

Fish & Richardson

Biosimilars 2022 Year in Review

Fish & Richardson on

2022 heralded the next chapter for biosimilars in the United States, including U.S. Food and Drug Administration approval of biosimilars in new therapeutic areas, additional interchangeable designations, and litigation...more

Robins Kaplan LLP

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

Robins Kaplan LLP on

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

95 Results
 / 
View per page
Page: of 4

"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