News & Analysis as of

Inter Partes Review (IPR) Proceeding Patent Infringement Abbreviated New Drug Application (ANDA)

WilmerHale

Federal Circuit Patent Watch: FDA Filing Can Create Personal Jurisdiction; “Compelling” Arguments that Reverse Doctrine of...

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Precedential and Key Federal Circuit Opinions - STEUBEN FOODS, INC. v. SHIBUYA HOPPMANN CORPORATION [OPINION] (2023-1790, 1/24/2025) (Moore, Hughes, Cunningham) - Moore, Chief J. The Court reversed the district...more

Schwabe, Williamson & Wyatt PC

Latest Federal Court Cases - December 2024 #3

CloudofChange, LLC v. NCR Corp., Appeal No. 2023-1111 (Fed. Cir. Dec. 18, 2024) In our Case of the Week, the Federal Circuit addressed the question of divided infringement in the context of system claims. In its...more

Sheppard Mullin Richter & Hampton LLP

2023 Federal Circuit Case Summaries

We are excited to share Sheppard Mullin’s inaugural quarterly report on key Federal Circuit decisions. The Spring 2023 Quarterly Report provides summaries of most key patent law-related decisions from January 1, 2023 to March...more

Knobbe Martens

Federal Circuit Review - November 2021

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Venue and Pleading Infringement in Hatch-Waxman Litigation Turn on Location and Identity of ANDA Filer - In Celgene Corp. v. Mylan Pharm. et al., Appeal No. 21-1154, the Federal Circuit held that in Hatch-Waxman...more

Schwabe, Williamson & Wyatt PC

Latest Federal Court Cases - November 2021

University of Strathclyde v. Clear-Vu Lighting LLC, Appeal No. 2021-2243 (Fed. Cir. Nov. 4, 2021) - In this week’s Case of the Week, the Federal Circuit reversed an inter partes review decision finding claims directed to...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

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

Federal Circuit Appeals from the PTAB and ITC: Summaries of Key 2020 Decisions: Amneal Pharm. LLC v. Almirall, LLC, 960 F.3d 1368...

Abbreviated new drug (ANDA) applicant Amneal petitioned for an inter partes review (IPR) of Almirall’s patent listed in the Food and Drug Administration’s (FDA) Orange Book for a prescription drug to treat acne. Almirall...more

Schwabe, Williamson & Wyatt PC

Latest Federal Court Cases - January 2020

PATENT CASE OF THE WEEK - Amgen Inc. v. Amneal Pharmaceuticals LLC, et al., Appeal Nos. 2018-2414, et al. (Fed. Cir. Jan. 7, 2020) - In this appeal from Markman and summary judgment opinions by the district court in a...more

Schwabe, Williamson & Wyatt PC

Latest Federal Court Cases - October 2019 #3

PATENT CASE OF THE WEEK - HZNP Medicines LLC v. Actavis Laboratories UT, Inc., Appeal Nos. 2017-2149, et al. (Fed. Cir. Oct. 10, 2019) - In a lengthy decision following a bench trial, the Court addressed a matter of...more

McDonnell Boehnen Hulbert & Berghoff LLP

Dr. Falk Pharma GmbH v. Generico, LLC (Fed. Cir. 2019) - July 2019

The interplay (or perhaps utilization) of inter partes review (IPR) in ANDA litigation was illustrated by the Federal Circuit in last month's Dr. Falk Pharma GmbH v. Generico, LLC nonprecedential decision....more

Schwabe, Williamson & Wyatt PC

Latest Federal Court Cases - May 2019 #3

PATENT CASE OF THE WEEK - AVX Corporation v. Presidio Components, Inc., Appeal No. 2018-1106 (Fed. Cir. May 13, 2019) - Following an inter partes review upholding the patentability of certain challenged claims, the...more

Knobbe Martens

Federal Circuit Review - February 2019

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PTAB May Invalidate Claims on Reconsideration Based on Grounds Raised in the Institution Decision that Were Not Originally Instituted - In AC Technologies S.A., V. Amazon.Com, Inc., Blizzard Entertainment, Inc., Appeal No....more

McDermott Will & Emery

ANDA Applicant Has Standing to Appeal IPR Decision, Even with Only Paragraph III Certification

The US Court of Appeals for the Federal Circuit found that a failed inter partes review (IPR) petitioner that maintained a Paragraph III certification had sufficient standing to appeal an adverse decision, but affirmed the...more

Akin Gump Strauss Hauer & Feld LLP

Federal Circuit Decision Clarifies When an ANDA Filer May Appeal an Adverse IPR Ruling

In Amerigen Pharmaceuticals Limited v. UCB Pharma GmbH, generic drug manufacturer Amerigen appealed a decision of the Patent Trial & Appeal Board finding UCB’s patent to certain chemical derivatives of diphenylpropylamines...more

Jones Day

PTAB Upholds GILENYA™ Method of Treatment Patent, Prompting New ANDA Litigation

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In Apotex Inc. v. Novartis AG, IPR2017-00854, Paper 109 (Jul. 11, 2018), the PTAB held that the claims of U.S. Patent No. 9,187,405 were not unpatentable on three separate grounds. Shortly thereafter, Novartis filed suit...more

Knobbe Martens

Federal Circuit Review - May 2018

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Priority Claims Cannot Be Incorporated by Reference - In Vanda Pharmaceuticals Inc. v. West-Ward Pharmaceuticals International Limited, Appeal Nos. 2016-2707 and 2016-2708, the Federal Circuit held that when a patent for a...more

Bradley Arant Boult Cummings LLP

A Wish for Nonexistent Cheap Drugs Is Not Standing to Sue

The recent releases of highly effective, and highly priced, drugs to treat chronic diseases has bred a spate of efforts by activists to disenfranchise drug developers of their patent rights. One recent chapter is instructive,...more

WilmerHale

Federal Circuit Patent Updates - April 2018

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01 Communique Laboratory, Inc. v. Citrix Online, LLC (No. 2017-1869, 4/26/18) (Newman, Mayer, Stoll) - Mayer J. Affirming plaintiff's motion for a new trial motion. The defendant did not improperly assert a “practicing...more

WilmerHale

Federal Circuit Patent Updates - February 2018

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Nalco Company v. Chem-Mod, LLC (No. 2017-1036, 2/27/18) (Moore, Schall, O'Malley) - O'Malley, J. Reversing district court's dismissal of patent claims for failure to state a claim. The district court's dismissal of direct...more

Knobbe Martens

Federal Circuit Review - November 2017

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Fractured Federal Circuit Holds Patent Owner Does Not Bear Burden of Persuasion in IPR Motions to Amend - In Aqua Products, Inc. v. Matal, Appeal No. 2015-1177, the Federal Circuit, sitting en banc, held that a patent...more

Troutman Pepper Locke

AIA On-Sale Bar Applies to Publicized Sales, Even When Knowledge of Sale Did Not Disclose the Underlying Invention

Troutman Pepper Locke on

The Court of Appeals for the Federal Circuit (CAFC) recently construed the on-sale bar provision of 35 U.S.C. 102(a) in a way that will make it easier for petitioners to challenge third party patents. While in an inter-partes...more

WilmerHale

Federal Circuit Patent Updates - May 2016

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Ruckus Wireless, Inc. v. Innovative Wireless Solutions (No. 2015-1425, 1438, 5/31/16) (Prost, Reyna, Stark) - May 31, 2016 3:11 PM - Reyna, J. Affirming summary judgment of non-infringement of patents based on...more

WilmerHale

Stay Versus Stay: How Litigation Stays Pending IPRs Impact the 30-Month Regulatory Stay in Hatch-Waxman Litigation

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Upon initiation of a patent infringement action between branded and generic pharmaceutical companies, the Hatch-Waxman Act (21 U.S.C. § 355(j)) provides for an automatic 30-month stay of Food and Drug Administration approval...more

WilmerHale

Federal Circuit Patent Updates - March 2016

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Clare v. Chrysler Group LLC (No. 2015-1999, 3/31/16) (Prost, Moore, Wallach) - Moore, J. Affirming summary judgment of non-infringement of patents related to storage compartment for pickup trucks. The Court rejected...more

Foley & Lardner LLP

PTAB Institutes Kyle Bass Lialda Patent IPR

Foley & Lardner LLP on

After filing over thirty petitions for Inter Partes Review of Orange Book-listed patents for various drugs, Kyle Bass and his Coalition for Affordable Drugs finally have made it over the first hurdle. The USPTO Patent Trial...more

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