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Pharmaceutical Patents Patent Litigation Personal Jurisdiction

Robins Kaplan LLP

Janssen Prods., L.P. v. EVER Valinject GmbH

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Yondelis® (trabectedin) - Case Name: Janssen Prods., L.P. v. EVER Valinject GmbH, Civ. No. 24-7319, 2025 WL 639380 (N.D. Ill. Feb. 27, 2025) (Harjani, J.)  Drug Product and Patent(s)-in-Suit:  Yondelis® (trabectedin); U.S....more

DLA Piper

Distribution of Biosimilar Pharmaceuticals Through Third Parties is Not Enough to Avoid Personal Jurisdiction

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In Regeneron Pharms., Inc. v. Mylan Pharms. Inc., the Federal Circuit recently held that biosimilar pharmaceutical companies that filed abbreviated Biologics License Applications (aBLAs) and planned to make a single sale to a...more

McDonnell Boehnen Hulbert & Berghoff LLP

Regeneron Pharmaceuticals, Inc. v. Mylan Pharmaceuticals Inc. (Fed. Cir. 2025)

Note: This post addresses two Federal Circuit decisions issued on January 29, 2025.  Both appeals involved Plaintiff-Appellee Regeneron Pharmaceuticals, Inc., with the first appeal involving Defendant-Appellant Formycon AG...more

A&O Shearman

Federal Circuit Affirms Finding Of Personal Jurisdiction And Preliminary Injunction Against Biosimilar Applicants

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On January 29, 2025, the U.S. Court of Appeals for the Federal Circuit affirmed the grant of a preliminary injunction by the Northern District of West Virginia in favor of Regeneron Pharmaceuticals, Inc. against Samsung...more

Rothwell, Figg, Ernst & Manbeck, P.C.

Personal Jurisdiction Over Foreign Companies that File an ANDA or aBLA in the U.S.

On January 29, 2025, the Federal Circuit issued paired decisions addressing Samsung Bioepis’s (“SB”) and Formycon AG’s (“Formycon”) appeals of preliminary injunctions entered in ongoing aflibercept biosimilar litigations with...more

Goodwin

Regeneron’s Disputes with Celltrion, Samsung Bioepis, and Formcycon on Service and Personal Jurisdiction in Aflibercept BPCIA...

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As we have previously reported, in November 2023 Regeneron Pharmaceuticals, Inc. (“Regeneron”) filed complaints against Celltrion,  Samsung Bioepis and Formycon (collectively, “the Defendants”) in the U.S. District Court for...more

Goodwin

Litigation Update: AbbVie v. Alvotech hf (Adalimumab)

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We have previously reported on AbbVie’s first and second wave suits against Alvotech hf (Alvotech) in the Northern District of Illinois regarding an adalimumab biosimilar. In the first wave suit, on October 5, 2021 AbbVie...more

WilmerHale

CAFC Patent Cases - May 2021 #2

WilmerHale on

Precedential Federal Circuit Opinions - CAP EXPORT, LLC v. ZINUS, INC. [OPINION]  (2020-2087, 5/5/21) (Dyk, Bryson, Hughes) - Dyk, J. Affirming decision to set aside judgment and injunction pursuant to Federal Rule of...more

Mintz - Intellectual Property Viewpoints

In Hatch-Waxman litigation, Federal Circuit restricts venue under the TC Heartland to districts relating to ANDA filings

On November 5, 2020, the United States Court of Appeals for the Federal Circuit, in Valeant Pharmaceuticals N. Am. LLC v. Mylan Pharmaceuticals Inc., No. 19-2402, resolved a split among district courts over what constitutes...more

Morrison & Foerster LLP - Federal Circuitry

Last Week in the Federal Circuit (November 2-6): Limits on Venue in Hatch-Waxman Cases

Last week was argument week at the Federal Circuit, which as usual meant the Court issued several Rule 36 affirmances and short non-precedential decisions. But tucked in between those was at least one case—a Hatch-Waxman...more

McDonnell Boehnen Hulbert & Berghoff LLP

Valeant Pharmaceuticals North America LLC v. Mylan Pharmaceuticals Inc. (Fed. Cir. 2020)

Somewhat remarkably, there is no settled Federal Circuit precedent regarding where a patentee can bring suit against a generic competitor in Hatch-Waxman litigation under 35 U.S.C. § 271(e)(2).  While recognizing that this...more

Goodwin

Federal Circuit Narrows Venue for Patent Infringement Suits Under the Hatch-Waxman Act

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The Federal Circuit Thursday issued a decision that narrows the venue options available to patent owners bringing suit against generic drug manufacturers under the Hatch-Waxman Act. In a unanimous decision, the court held...more

Knobbe Martens

Federal Circuit Review - August 2019

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Mere Potential for Future Appeal Does Not Prevent Triggering Estoppel of Inter Partes Reexamination When Party Fails to Seek Relief in the First Instance - In Virnetx Inc. v. Apple Inc., Appeal Nos. 2017-1591, -1592,...more

Fish & Richardson

EDTX & NDTX Monthly Wrap-Up – April 2019

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A Tale of Two ANDAs: Jurisdiction and Venue in a Non-Traditional Sense - Judge Gilstrap’s recent opinion in Apicore US LLC v. Beloteca, Inc., No. 2:19-CV-00077-JRG, 2019 WL 1746079 (E.D. Tex. Apr. 18, 2019), highlights...more

Orrick, Herrington & Sutcliffe LLP

A Stealth Upheaval In Patent Personal Jurisdiction?

In 2017, the U.S. Supreme Court issued TC Heartland LLC v. Kraft Foods Group Brands LLC, which was a game changer for patent venue. The case drastically narrowed where defendants can be sued and shifted a significant amount...more

Schwabe, Williamson & Wyatt PC

Latest Federal Court Cases - December 2018 #2

PATENT CASE OF THE WEEK - Jack Henry & Associates, Inc. v. Plano Encryption Technologies LLC, Appeal No. 2016-2700 (Fed. Cir. Dec. 7, 2018) On Friday, the Federal Circuit reversed a district court’s dismissal of a...more

Schwabe, Williamson & Wyatt PC

Fresh From the Bench: Latest Federal Circuit Court Cases

Praxair Distribution, Inc. v. Mallinckrodt Hospital Products IP Ltd., Appeal Nos. 2016-2616, -2656 (Fed. Cir. May 16, 2018) - In an appeal from a inter partes review, the Federal Circuit reviewed a PTAB obviousness...more

Skadden, Arps, Slate, Meagher & Flom LLP

Supreme Court Limits Venue in Patent Litigation

In an 8-0 decision issued on May 22, 2017, the U.S. Supreme Court, in TC Heartland LLC v. Kraft Foods Group Brands LLC, restricted the available venues for patent litigation claims under 28 U.S.C. § 1400. Under Section...more

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

Practical Issues for the Pharmaceutical and Biopharmaceutical Industry in the Wake of TC Heartland

The US Supreme Court this week held that the broad venue provision of 28 U.S.C. § 1391(c) does not apply to patent law—at least, when the defendant is a domestic entity. This decision arises after years of judicial...more

Mintz - Intellectual Property Viewpoints

Supreme Court Declines to Revisit Broad Personal Jurisdiction Over ANDA Filers

On Monday, January 9, 2017, the U.S. Supreme Court denied, without comment, Mylan Pharmaceuticals’ petition for certiorari to reverse an opinion by the Court of Appeals for the Federal Circuit, which affirmed a broad scope of...more

Robins Kaplan LLP

Hatch-Waxman Venue Update: Will SCOTUS Limit Where Brands Can Sue Generics?

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Generic and branded pharma companies alike are waiting with baited breath to see if the U.S. Supreme Court will take up the issue of personal jurisdiction in Hatch-Waxman patent cases this term. After a broad ruling from the...more

Robins Kaplan LLP

Helsinn Healthcare S.A. v. Hospira, Inc.

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Case Name: Helsinn Healthcare S.A. v. Hospira, Inc., Civil No. 15-2077 (MLC), 2016 U.S. Dist. LEXIS 45826 (D.N.J. Apr. 5, 2016) (Cooper, J.) - Drug Product and Patents-in-Suit: Aloxi® (palonosetron); U.S. Patents Nos....more

Foley & Lardner LLP

Federal Circuit Finds Personal Jurisdiction Based On Plans To Market ANDA Product

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In Acorda Therapeutics Inc. v. Mylan Pharmaceuticals Inc., the Federal Circuit held that the filing of an Abbreviated New Drug Application (ANDA) and intentions to market the product across the United States–including in the...more

McDermott Will & Emery

ANDA Update - October 2015

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Federal Circuit Interprets Statutory Requirements for Biosimilar Regulatory Pathway - Amgen Inc., v. Sandoz Inc., (Fed. Cir. July 21, 2015): In a case of first impression, the U.S. Court of Appeals for the Federal...more

Morris James LLP

ANDA Case Is Dismissed For Lack Of Personal Jurisdiction

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The disputed technology is a generic rivastigmine patch. Defendant is a New Jersey corporation with a principal place of business in Vermont. Only specific jurisdiction is at issue since it is not “at home” in Delaware. ...more

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