News & Analysis as of

Patent Litigation Appeals Food and Drug Administration (FDA)

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

Sheppard Mullin Richter & Hampton LLP

Federal Circuit Upholds Rifaximin Patent Rulings, Affirms ANDA Approval Restrictions

In Salix Pharmaceuticals, Ltd. v. Norwich Pharmaceuticals, Inc. 2023-1952 (Fed. Cir. April 11, 2024), this case involves appellate review of a district court’s findings regarding patent obviousness and infringement in...more

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

2023 ITC Section 337 Year in Review: Analysis & Trends: The Public Interest Impact – Considerations from AliveCor and Masimo

The year 2023 was marked by two landmark Commission determinations resulting in exclusion orders and cease and desist orders against a popular consumer wearable—the Apple Watch. both investigations focused on health...more

Sheppard Mullin Richter & Hampton LLP

Federal Circuit Evaluates Impact of the Final Written Decision (FWD) in a Parallel Inter-Partes Review (IPR) on District Court’s...

In United Therapeutics Corp. v Liquidia Tech Inc., the Federal Circuit reviewed the district court’s decision on invalidity and infringement of two pharmaceutical patents and the impact of the Final Written Decision (FWD) in...more

McDermott Will & Emery

See Here: No Standing Based on Vague Future Plans or Adverse Priority Findings

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The US Court of Appeals for the Federal Circuit dismissed an appeal from a final written decision in an inter partes review (IPR) proceeding, finding that the petitioner lacked standing because it suffered no injury in fact....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

A&O Shearman

SCOTUS denies cert in skinny label appeal from the Federal Circuit

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On May 15, 2023, the Supreme Court of the United States denied Teva Pharmaceuticals USA, Inc.’s (“Teva”) petition for certiorari in Teva Pharmaceuticals USA, Inc. v. GlaxoSmithKline, LLC, ending a nearly nine-year court...more

McDermott Will & Emery

Patent Law Principles Apply to Claim Scope: Orange Book Delisting and Listing and Regulations

The US Court of Appeals for the Federal Circuit ordered that the only Orange Book patent asserted in a lawsuit must be delisted since its claims were directed to the computer-implemented distribution system and not a method...more

McDermott Will & Emery

Federal Circuit Divided on Whether Skinny Labeling Compliance Precludes Inducement or Supports Equitable Estoppel

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The US Court of Appeals for the Federal Circuit denied a generic drug manufacturer’s petition for en banc review of a panel opinion finding induced infringement liability despite the manufacturer’s adherence to skinny...more

McDermott Will & Emery

Federal Circuit Clarifies Venue in Hatch-Waxman Case

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Addressing venue in the context of a Hatch-Waxman case, the US Court of Appeals for the Federal Circuit explained that sending a paragraph IV notice letter to a company in the district is insufficient to establish venue....more

McDermott Will & Emery

Material Information Submitted to FDA but Withheld from PTO Gives Rise to Inequitable Conduct

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The US Court of Appeals for the Federal Circuit found prior art submitted to the US Food and Drug Administration (FDA), yet withheld from the US Patent & Trademark Office (PTO) during prosecution of an asserted patent,...more

Schwabe, Williamson & Wyatt PC

Latest Federal Court Cases - September 2021

Belcher Pharmaceuticals, LLC v. Hospira, Inc., Appeal No. 2020-1799 (Fed. Cir. Sept. 1, 2021) - In an appeal from the United States District Court for the District of Delaware, the Federal Circuit affirmed the district...more

Schwabe, Williamson & Wyatt PC

‎Latest Federal Court Cases - August 2021 #2

Our Case of the Week this week is a re-write of our Case of the Week on October 5, 2020. The case involves a drug that could be used for multiple therapeutic purposes. A patent covered use of the product for a specific...more

Harris Beach PLLC

Important 2020 Patent Law Decisions from the Court of Appeals for the Federal Circuit

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Whether you are pursuing patents on your new technology, thinking about bringing patent infringement litigation or defending patent infringement claims in court, knowing the important developments in patent law will help you...more

Goodwin

Federal Circuit Hears Argument Regarding the Denial of Genentech’s Motion to Preliminarily Enjoin Amgen’s Sales of Trastuzumab

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We previously reported on Genentech’s appeal of the district court’s denial of Genentech’s motion for a preliminary injunction against Amgen’s launch of trastuzumab. Today, a Federal Circuit panel (Judges Prost, Wallach, and...more

Schwabe, Williamson & Wyatt PC

Latest Federal Court Cases - December 2019 #4

PATENT CASE OF THE WEEK - Persion Pharms. LLC v. Alvogen Malta Operations Ltd., Appeal No. 2018-2361 (Fed. Cir. Dec. 27, 2019) - In this week’s Case of the Week, the Federal Circuit affirmed a district court judgment...more

Robins Kaplan LLP

INO Therapeutics LLC v. Praxair Distribution Inc.

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BUT FOR A CLERICAL ERROR TO BE ADDRESSED ON REMAND, THE FEDERAL CIRCUIT AFFIRMS FINDINGS OF INELIGIBLE SUBJECT MATTER AND NON-INFRINGEMENT. Case Name: INO Therapeutics LLC v. Praxair Distribution Inc., 2019 U.S. App. LEXIS...more

Smart & Biggar

2019 Mid-Year Highlights in Canadian Life Sciences IP

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Below are the major highlights in Canadian life sciences intellectual property and regulatory law that we have reported on in the first half of 2019....more

McDermott Will & Emery

Skepticism Does Not Need to Be Based on Impossibility

Addressing secondary considerations of non-obviousness, the US Court of Appeals for the Federal Circuit affirmed a Patent Trial and Appeal Board (PTAB) obviousness decision, finding that skepticism does not need to be...more

Akin Gump Strauss Hauer & Feld LLP

Federal Circuit: Skepticism of FDA Supports Finding of Nonobviousness and Patent Eligibility Not Within Scope of Appeal of an IPR

The Federal Circuit has affirmed a decision by the Patent Trial and Appeal Board finding nonobvious the claims of U.S. Patent No. 7,772,209 (the “’209 Patent”), which are directed to a method of treating cancer. The claims...more

Smart & Biggar

Rx IP Update - December 2018

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FCA overturns cefaclor damages decision on prejudgment interest issue, provides guidance on NIA defence - On November 23, 2018, the Federal Court of Appeal (FCA) allowed in part Apotex’s appeal of a decision awarding Eli...more

Jones Day

Supreme Court Hears Oral Arguments in Sandoz Inc. v. Amgen

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On April 26, 2017, the U.S. Supreme Court heard oral argument in Sandoz Inc. v. Amgen Inc. (Nos. 15-1039, 15-1195), on appeal from the Federal Circuit's July 21, 2015, opinion interpreting various provisions of the Biologics...more

Knobbe Martens

Supreme Court Grants Certiorari in Amgen v. Sandoz

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On January 13, 2017, the Supreme Court granted certiorari in Amgen v. Sandoz, 794. F.3d 1347 (Fed. Cir. 2015) and Sandoz v. Amgen, 773 F.3d 1274 (Fed. Cir. 2014), appealed from the Federal Circuit. The petitions involve the...more

Goodwin

BPCIA Litigation Roundup (Fall 2016)

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Below is our Fall 2016 update on the U.S. patent litigations concerning proposed or approved biosimilar products. For additional details, please consult our BPCIA Litigation Summary Chart or our previous quarterly update...more

McDermott Will & Emery

ANDA Update - Volume 2, Number 3

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On-Sale Bar Is No Bar for Selling Manufacturing Services to the Inventor - Addressing what constitutes an invalidating “sale” under § 102(b), the US Court of Appeals for the Federal Circuit sitting en banc affirmed the...more

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