News & Analysis as of

Hatch-Waxman

Venable LLP

Playing Chess and Ice Hockey Makes Me a Better Lawyer

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The foundational comic premise of walk-into-a-bar jokes is the underlying differences among the characters walking in. The three characters—in this case a chess player, a hockey player, and a patent litigator—may appear...more

A&O Shearman

Federal Circuit Provides Clarity On Proper Obviousness-Type Double Patenting References

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In Allergan USA, Inc. et al., v. MSN Laboratories Private Ltd., et al., the United States Court of Appeals for the Federal Circuit issued a precedential decision relating to obviousness-type double patenting (“ODP”) and...more

Neal, Gerber & Eisenberg LLP

Federal Circuit Weighs in Again on Obviousness-Type Double Patenting to Limit In re Cellect and Preserve PTA for First-Filed,...

Obviousness-type double patenting (ODP), a judicially-created ground of patent invalidity, has become the subject of intense interest after the Federal Circuit issued two decisions refining the application of the doctrine in...more

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

Fish & Richardson

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

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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

Fish & Richardson

Preparing Your Company for Hatch-Waxman

Fish & Richardson on

The Hatch-Waxman Act regulates the relationship between branded and generic drugmakers and attempts to strike a balance between two competing policy interests — encouraging pioneering drug development and facilitating market...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

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

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

Proskauer - Minding Your Business

The Broad Impact of Edwards v. Meril on the Safe Harbor Provision

The Federal Circuit’s decision in Edwards Lifesciences Corp. v. Meril Life Sciences Pvt. Ltd., has garnered significant attention, especially concerning the application of the “safe harbor” provision under 35 U.S.C. §...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

Robins Kaplan LLP

Pharmacyclics LLC v. Alvogen Pine Brook LLC - Imbruvica® (Ibrutinib)

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Case Name: Pharmacyclics LLC v. Alvogen Pine Brook LLC, Civ. No. 19-434-CFC, 2024 WL 1885677 (D. Del. Apr. 30, 2024) (Connolly, J.) - Drug Product and Patent(s)-in-Suit: Imbruvica® (ibrutinib); U.S. Patents Nos. 8,008,309...more

Robins Kaplan LLP

Teva Branded Pharm. Products R&D, Inc. v. Amneal Pharms. of NY, LLC - ProAir® HFA (Albuterol Sulfate)

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Case Name: Teva Branded Pharm. Products R&D, Inc. v. Amneal Pharms. of NY, LLC, Civ. No. 23-20964 (SRC), 2024 WL 2923018 (D.N.J. June 10, 2024) (Chesler, J.)....more

Robins Kaplan LLP

Janssen Pharms., Inc. v. Tolmar, Inc. - Invega Sustenna® (Paliperidone Palmitate)

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Case Name: Janssen Pharms., Inc. v. Tolmar, Inc., Civ. No. 21-1784-WCB, 2024 WL 2972832 (D. Del. June 13, 2024) (Bryson, J.) - Drug Product and Patent(s)-in-Suit: Invega Sustenna® (paliperidone palmitate); U.S. Patent No....more

Robins Kaplan LLP

Janssen Pharms., Inc. v. Teva Pharms. USA, Inc. - Invega Sustenna® (Paliperidone Palmitate)

Robins Kaplan LLP on

Case Name: Janssen Pharms., Inc. v. Teva Pharms. USA, Inc., No. 2022-1258, 2022-1307, 2024 WL 1355733 (Fed. Cir. Apr. 1, 2024) (Circuit Judges Dyk, Prost, and Hughes presiding; Opinion by Prost, J.) (Appeal from D.N.J.,...more

Robins Kaplan LLP

Salix Pharms., Ltd. v. Norwich Pharms. Inc. - Xifaxan® (Rifaximin)

Robins Kaplan LLP on

Case Name: Salix Pharms., Ltd. v. Norwich Pharms. Inc., No. 2022-2153, 2023-1952, 2024 WL 1561195 (Fed. Cir. Apr. 11, 2024) (Circuit Judges Lourie, Chen, and Cunningham presiding; Opinion by Lourie, J.; Dissenting-in-part...more

Robins Kaplan LLP

Amarin Pharma, Inc. v. Hikma Pharms. USA Inc. - Vascepa® (Icosapent Ethyl)

Robins Kaplan LLP on

Case Name: Amarin Pharma, Inc. v. Hikma Pharms. USA Inc., No. 2023-1169, 2024 WL 3152087 (Fed. Cir. June 25, 2024) (Circuit Judges Moore, Lourie, and Albright presiding; Opinion by Lourie, J.) (Appeal from D. Del., Andrews,...more

Polsinelli

Federal Circuit Clarifies Rules for Skinny Labeling for Generics and Biosimilar Companies

Polsinelli on

Last week, the Federal Circuit decided Amarin Pharma, Inc. v. Hikma Pharmaceuticals USA Inc., 23-1169 (Fed. Cir. June 25, 2024), a case that spotlighted the issues of skinny labeling and induced infringement for generic...more

Jones Day

Federal Circuit Revives Induced Infringement Claims Despite "Skinny Label" Carve-Out

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The Situation: The Hatch-Waxman Act allows generic drug manufacturers to "carve out" a brand's patented indications from their proposed labeling. Generic manufacturers often rely on these so-called "skinny labels" to try to...more

Haug Partners LLP

FTC Opens Investigation for Orange Book Listing of Medical Device Patents After Teva v. Amneal in District of New Jersey

Haug Partners LLP on

Summary - On June 10, 2024, the District Court for the District of New Jersey ordered Teva to delist five patents from the Orange Book for ProAir® HFA (albuterol sulfate) Inhalation Aerosol. The patents were directed to...more

A&O Shearman

New Jersey District Court Orders Delisting Of Teva Inhaler Patents From The Orange Book

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On June 10, 2024, Judge Stanley R. Chesler of the United States District Court for the District of New Jersey granted the Amneal defendants’ motion for partial judgment on their counterclaims in a Hatch-Waxman dispute, and...more

MoFo Life Sciences

USPTO Seeks Input On Experimental Use Exception To Patent Infringement And Possible Legislative Action

MoFo Life Sciences on

On June 28, 2024, the United States Patent and Trademark Office (USPTO) issued a Notice requesting public comments on the current state of the common law experimental use exception to patent infringement and whether Congress...more

Axinn, Veltrop & Harkrider LLP

More Skinny-Label Drama or Just Your "Run-Of-The-Mill" Induced Infringement Case?

The Federal Circuit's recently issued decision in the Amarin/Hikma case continues the drama around skinny labeling for generic and biosimilar products, but the panel certainly went out of its way to couch its analysis as an...more

Fenwick & West LLP

New Jersey Federal Court Weighs in on Orange Book Patent Listings

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In recent months, the issue of whether certain patents are appropriately listed in the Food and Drug Administration (FDA) Orange Book, associated with the Hatch-Waxman Act, has garnered the attention of the Federal Trade...more

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