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Healthcare › Food and Drug Administration (FDA) › Hatch-Waxman

Robins Kaplan LLP

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

Robins Kaplan LLP

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

Robins Kaplan LLP

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

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

Array

eDiscovery and ANDA Litigation: Unique Timelines, Processes, and Workflows

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ANDA litigation is a high-stakes niche of pharmaceutical law that presents unique challenges not only for lawyers, but also for eDiscovery practitioners. Here’s why: under the Drug Price Competition and Patent Term...more

Knobbe Martens

The Federal Trade Commission Put Brand Drug Manufacturers on Notice About Improperly Listing Patents in the Orange Book and Then...

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The Federal Trade Commission (FTC) issued a policy statement on September 14, 2023, stating that “[b]rand drug manufacturers may be harming generic competition through the improper listing of patents in the Food and Drug...more

Foley Hoag LLP

Previewing Generic’s Skinny Label: Supreme Court to Rule on Teva’s Certiorari Petition

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The Supreme Court is expected to consider Teva’s pending petition for certiorari in the highly anticipated GlaxoSmithKline LLC v. Teva Pharms. USA, Inc. on May 11, 2023, a case that could carry enormous implications for the...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

Robins Kaplan LLP

Challenging Drug Patents: Does AIDS Healthcare Raise an “Actual Controversy”?

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Manufacturers who want to introduce generic drugs face a special delay and enjoy a corresponding special right to challenge patents on branded drugs based on the great compromise in the Hatch-Waxman Act. ...more

Polsinelli

Federal Circuit Delays Sandoz Biosimilar Launch

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In a closely-watched case between Amgen and Sandoz regarding the first biosimilar approved (Zarxio), the Federal Circuit interpreted key Biologics Price Competition and Innovation Act (BPCIA) provisions regarding Sandoz's...more

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