News & Analysis as of

Intellectual Property Litigation Hatch-Waxman Patent Infringement

Robins Kaplan LLP

New ANDA Cases

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Federal district court cases that are filed pursuant to the Hatch-Waxman Act - This chart summarizes the case name, presiding judge, drug, and patents-at-issue in all federal district court cases that are filed pursuant to...more

Robins Kaplan LLP

Taiho Pharma Co. v. MSN Labs Private Ltd.

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Lonsurf® (tipiracil) - Case Name: Taiho Pharma Co. v. MSN Labs Private Ltd., No. 19-2342-JLH (D. Del. Jan. 23, 2025) (Hall, J.)  Drug Product and Patent(s)-in-Suit: Lonsurf® (tipiracil); U.S. Patent No. 10,457,666 (“the ’666...more

Robins Kaplan LLP

ANDA Litigation Settlements - Winter 2024

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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

Cooley LLP

Precedential Federal Circuit Decision Overturns Lack of Written Description Based on Later-Discovered Technology

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On January 10, 2025, the US Court of Appeals for the Federal Circuit issued a precedential opinion in Novartis Pharmaceuticals Corp. v. Torrent Pharma Inc., reversing a lower court decision that claims of a Novartis patent...more

Akin Gump Strauss Hauer & Feld LLP

District Court: Factual Disputes Preclude Application of Safe Harbor to Gene Editing Technology at the Pleading Stage

The District of Delaware recently denied a motion to dismiss a patent infringement complaint involving gene editing technology that sought relief under the Safe Harbor Provision of the Hatch-Waxman Act. Specifically, the...more

Fish & Richardson

The Not-So-Safe Harbor for Research Tools: Lessons From the District of Delaware

Fish & Richardson on

In BlueAllele Corp. v. Intellia Therapeutics, Inc., 2024 U.S. Dist. Lexis 222094 (D. Del. Dec. 9, 2024)1, the District of Delaware addressed several issues relevant to the safe harbor defense in Hatch-Waxman litigation. ...more

American Conference Institute (ACI)

[Event] 20th Paragraph IV Disputes - April 25th - 26th, New York, NY

Hosted by American Conference Institute, the 20th Annual Paragraph IV Disputes & the 40th Anniversary of the Hatch-Waxman Act returns for another exciting year with curated programming that will take a retrospective look at...more

Venable LLP

[Ongoing Program] Life Sciences Series - Current Trends in ANDA Litigation - October 31st, 1:00 pm - 2:00 pm ET

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We are excited to announce Venable’s inaugural Life Sciences Webinar Series. This month-long series will explore the intricacies and latest developments that shape the life sciences industry. Join us as we hear from our...more

American Conference Institute (ACI)

[Event] 9th Annual Paragraph IV Disputes Master Symposium - October 24th - 25th, Chicago, IL

Each fall, leading pharmaceutical patent litigators for brand name and generic drug companies gather at the Paragraph IV Disputes Master Symposium in Chicago to receive up-to-the-minute information on the latest developments...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

Schwabe, Williamson & Wyatt PC

Latest Federal Court Cases - July 2023 #4

United Therapeutics Corporation v. Liquidia Technologies, Inc., Appeal Nos. 2022-2217, 2023-1021 (Fed. Cir. July 24, 2023) In the Federal Circuit’s only precedential patent case this week, the Court considered questions...more

American Conference Institute (ACI)

[Event] 18th Annual Paragraph IV Disputes - April 19th - 20th, New York, NY

Hosted by ACI, 18th Annual Paragraph IV Disputes Conference returns to New York City for another exciting year with curated programming that not only addresses the hot topics, but also puts them within the context of pre-suit...more

Sterne, Kessler, Goldstein & Fox P.L.L.C.

MarkIt to Market® - January 2023: Watching the Pot™

High Stakes: Hatch-Waxman Litigation Comes for Cannabis - GW Pharma, now a subsidiary of Jazz Pharmaceuticals, is no stranger to patent litigation. It previously found itself on the receiving end of a patent infringement...more

Sterne, Kessler, Goldstein & Fox P.L.L.C.

MarkIt to Market® - January 2023

Thank you for reading the January 2023 issue of Sterne Kessler's MarkIt to Market® newsletter. This month, we discuss an ongoing trademark dispute between the band OK Go and cereal company Post, how to stay vigilant about...more

American Conference Institute (ACI)

[Event] 17th Annual Paragraph IV Disputes Conference - April 26th - 27th, New York City, NY

Premier forum which shapes the law, policy, and proceedings of Paragraph IV Litigation is back to New York City on April 26-27! Pharmaceutical patent practitioners from across the globe attend this flagship conference to...more

Sterne, Kessler, Goldstein & Fox P.L.L.C.

2021 PTAB Year in Review: Analysis & Trends

[co-author: Jamie Dohopolski] Love it or hate it, ignore the USPTO Patent Trial and Appeal Board (PTAB) at your peril. The introduction of the PTAB as part of the America Invents Act over ten years ago has forever changed...more

American Conference Institute (ACI)

[Event] Paragraph IV Disputes Conference - November 9th - 10th, New York, NY

Join the conference that the “who’s who” of Hatch-Waxman litigators have designated as the forum which sets the standards for Paragraph IV practice. ACI’s Paragraph IV Litigation Conference is returning LIVE & IN-PERSON to...more

Robins Kaplan LLP

[Remote Event] Health Care Antitrust Under President Biden - What Health Care Companies May Expect By Way Of Antitrust Policy And...

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After a turbulent year that roiled the economy, and the health care sector more than most, the Democrats emerged with control of both the White House and Congress for the first time since 2014. Business leaders and in-house...more

American Conference Institute (ACI)

[Virtual Event] Paragraph IV Disputes - October 6-7, 8:00 am-6:00 pm EDT

For the past 13 years, leading pharmaceutical patent litigators for brand name and generic drug companies gather at the Paragraph IV Disputes conference to discuss, debate, and analyze the latest trends, judicial rulings and...more

McDermott Will & Emery

Declaratory Judgment of Non-Infringement of a Disclaimed Patent Warranted in Hatch-Waxman - Apotex Inc. v. Daiichi Sankyo, Inc.

Addressing the issue of subject matter jurisdiction in Hatch-Waxman litigation, the U.S. Court of Appeals for the Federal Circuit reversed a district court’s dismissal for lack of case or controversy of an action seeking...more

McDonnell Boehnen Hulbert & Berghoff LLP

Apotex Inc. v. Daiichi Sankyo, Inc. (Fed. Cir. 2015)

Can a Federal district court ever have subject-matter jurisdiction to hear a declaratory judgment action of non-infringement for a disclaimed patent? Of course, the Federal Circuit explained this week in the Apotex Inc. v....more

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