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Abbreviated New Drug Application (ANDA) Today's Popular Updates

Axinn, Veltrop & Harkrider LLP

Hatch-Waxman Overview

The Drug Price Competition and Patent Term Restoration Act of 1984, commonly known as the Hatch-Waxman Act, forms the current framework for the United States’ regulation of drug approvals. The law amended the Food, Drug, and...more

McDonnell Boehnen Hulbert & Berghoff LLP

FTC warns pharma companies it means business with its Orange Book listing policy

Last September, the Federal Trade Commission (FTC) promulgated a “policy statement” entitled “Statement Concerning Brand Drug Manufacturers’ Improper Listing of Patents in the Orange Book,” regarding the FTC’s allegations...more

Alston & Bird

Health Care Week in Review: CMS Issues Rules on FY 2025 Payment Rates; Medicaid Enrollment; and Short-Term, Limited Duration...

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Below is Alston & Bird’s Health Care Week in Review, which provides a synopsis of the latest news in health care regulations, notices, and guidance; federal legislation and congressional committee action; reports, studies,...more

Alston & Bird

Health Care Week In Review: Biden Administration Released FY2025 Budget; Bill Introduced to Make Telehealth Permanent

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Below is Alston & Bird’s Health Care Week in Review, which provides a synopsis of the latest news in health care regulations, notices, and guidance; federal legislation and congressional committee action; reports, studies,...more

Sheppard Mullin Richter & Hampton LLP

Federal Circuit Affirms Skinny Label Carve Outs

In H. Lundbeck A/S, et al. v. Lupin Ltd., et al., Nos. 2022-1194, 2022-1208, and 2022-1246 (December 7, 2023), the Federal Circuit held that generic pharmaceutical companies may continue to use skinny labels to avoid...more

Akin Gump Strauss Hauer & Feld LLP

President Biden's AI EO: Key Takeaways for Health Care & Life Sciences

Key Points - President Biden’s eagerly-awaited executive order (EO) on artificial intelligence (AI) tasks the Department of Health & Human Services (HHS) with promoting responsible AI innovation, development and use,...more

Fish & Richardson

District of Delaware Finds Non-Orange Book-Listed Patents Subject to the Same Pleading Standard as Listed Patents in ANDA...

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As part of the Hatch-Waxman Act, given the lack of information on the allegedly infringing product, courts have found that patentees can satisfy the pleading requirements of Twombly/Iqbal without having access to the accused...more

Haug Partners LLP

10 Years after Actavis, the Cases that Follow Tell a Story

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I. Introduction - No pharmaceutical antitrust decision has had more impact than the Supreme Court’s 2013 decision in Federal Trade Commission v. Actavis, a decision which officially defined the term “reverse payment...more

Robins Kaplan LLP

Sanofi-Aventis U.S. LLC v. Sandoz, Inc. Jevtana® (Cabazitaxel)

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Case Name: Sanofi-Aventis U.S. LLC v. Sandoz, Inc., No. 20-804-RGA, 2023 WL 4175334 (D. Del. June 26, 2023) (Andrews, J.) Drug Product and Patent(s)-in-Suit: Jevtana® (cabazitaxel); U.S. Patent No. 10,716,777 (“the ’777...more

Mintz - Intellectual Property Viewpoints

Can Enablement and Written Description Bars be Lower for Method-Of-Treatment Patent Claims?

Patent offices may reject a patent application with claims reciting using a composition to treat a disease, based on the requirement that the claimed treatment is not fully supported by the application. In the U.S., such...more

Alston & Bird

Health Care Week in Review: CMMI Model and IRA Part B Drug List

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Below is Alston & Bird’s Health Care Week in Review, which provides a synopsis of the latest news in health care regulations, notices, and guidance; federal legislation and congressional committee action; reports, studies,...more

Alston & Bird

Alston & Bird Health Care Week in Review - April 2022 #3

Alston & Bird on

Below is Alston & Bird’s Health Care Week in Review, which provides a synopsis of the latest news in health care regulations, notices, and guidance; federal legislation and congressional committee action; reports, studies,...more

Robins Kaplan LLP

GlaxoSmithKline LLC v. Teva Pharms. USA, Inc.

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Coreg® (carvedilol) - Case Name: GlaxoSmithKline LLC v. Teva Pharms. USA, Inc., No. 2018-1976, -2023 (Fed. Cir. Oct. 2, 2020) (Circuit Judges Prost, Newman, and Moore presiding; Opinion by Newman, J.; Dissent by Prost, C.J.)...more

White & Case LLP

FTC Publishes Annual MMA Report—Continues to Scrutinize Pharma Patent Settlements

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On December 3, 2020, the Federal Trade Commission (FTC) published its annual report on pharmaceutical patent settlements filed with the FTC under the Medicare Prescription Drug, Improvement, and Modernization Act of 2003...more

McDonnell Boehnen Hulbert & Berghoff LLP

Federal Trade Commission v. AbbVie Inc. (3d Cir. 2020)

The Federal Trade Commission carried out an (in)famous crusade against reverse payment (more provocatively, "pay for delay") settlements in ANDA litigation for almost a decade before eventually having the Supreme Court see...more

McDonnell Boehnen Hulbert & Berghoff LLP

GlaxoSmithKline LLC v. Teva Pharmaceuticals USA, Inc. (Fed. Cir. 2020)

What Quantum of Culpable Conduct Is Required for an ANDA Applicant to Induce Infringement? The back-and-forth, (almost) cat-and-mouse-like competition between branded innovator and generic drug makers sanctioned under the...more

King & Spalding

D.C. Circuit Concludes that Serial Periods of Exclusivity May Be Available Under the Orphan Drug Act

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On March 13, 2020, the U.S. Court of Appeals for the D.C. Circuit affirmed the D.C. District Court’s 2018 summary judgment ruling in favor of Eagle Pharmaceuticals and against the FDA, finding that (1) the Orphan Drug Act...more

Robins Kaplan LLP

Duke Univ. v. Akorn, Inc.

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THE COURT GRANTED PLAINTIFFS’ MOTION TO DISMISS DEFENDANT’S ANTITRUST AND PATENT MISUSE COUNTERCLAIMS AND RELATED AFFIRMATIVE DEFENSES. Case Name: Duke Univ. v. Akorn, Inc., Civ. No. 3:18-cv-14035-BRM-TJB, 2019 U.S. Dist....more

McDonnell Boehnen Hulbert & Berghoff LLP

Novartis Pharmaceuticals Corp. v. West-Ward Pharmaceuticals Int'l (Fed. Cir. 2019)

The Federal Circuit exhibited the current status of its obviousness jurisprudence in affirming the District Court's determination that the asserted claims of U.S. Patent No. 8,410,131 were obvious in a decision handed down...more

Fish & Richardson

Who Can Be A Defendant In Biosimilar Patent Litigation?

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Can a party that did not submit an abbreviated biologics license application or an abbreviated new drug application, but will market the biosimilar or generic product after U.S. Food and Drug Administration approval, be sued...more

Robins Kaplan LLP

Teva Pharms. USA, Inc. v. Sandoz Inc.

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Case Name: Teva Pharms. USA, Inc. v. Sandoz Inc. (In re Copaxone Consol. Cases), 906 F.3d 1013, Fed. Cir. No. 2017-1575, 2018 U.S. App. LEXIS 28751 (Fed. Cir. Oct. 12, 2018) (Circuit Judges Reyna, Bryson, and Stoll; Opinion...more

Holland & Knight LLP

The Government Shutdown and Its Effects on the FDA

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Note - On January 25, President Trump announced that the White House and congressional leaders in the House and Senate have reached an agreement to fund the government on a short-term continuing resolution (CR) through Feb....more

McDermott Will & Emery

Second Circuit Allows Class Action Suit Involving Diabetes Drug to Proceed

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Purchasers of Takeda Pharmaceuticals Company’s branded diabetes drug, ACTOS, filed an antitrust suit alleging that Takeda falsely described two patents to the US Food and Drug Association (FDA) and, as a result, delayed...more

Robins Kaplan LLP

GlaxoSmithKline LLC v. Teva Pharms. USA, Inc.

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Case Name: GlaxoSmithKline LLC v. Teva Pharms. USA, Inc., Civ. No. 14-878-LPS-CJB, 2016 U.S. Dist. LEXIS 94438 (D. Del. July 20, 2016) (Burke, M.J.) - Drug Product and Patent(s)-in-Suit: Coreg® (carvedilol); U.S....more

K&L Gates LLP

ANDA Filing May Subject a Pharmaceutical Company to Personal Jurisdiction in Patent Infringement Suits Anywhere in the U.S.

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On March 18, 2016, the Federal Circuit held that filing an abbreviated new drug application (“ANDA”) with the FDA for a generic drug product, and thus indicating an intention to sell that product in every state (including...more

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