News & Analysis as of

Personal Jurisdiction Pharmaceutical Industry

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

Polsinelli

Personal Jurisdiction Considerations for International Biosimilars Companies

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The Federal Circuit recently issued decisions in a pair of appeals that provide guidance about when international filers of abbreviated Biologics License Applications (aBLAs) are subject to jurisdiction in the United States....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

WilmerHale

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

WilmerHale on

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

Nutter McClennen & Fish LLP

Product Liability 2023 Year in Review

Massachusetts federal and state courts issued several important product liability decisions in 2023. Nutter’s Product Liability practice group reviewed these cases and report on their significant holdings as follows ...more

Faegre Drinker Biddle & Reath LLP

5 Major Drug and Medical Device Developments in 2023

A popular New Year’s trend is to say “goodbye” to all the things that didn’t serve you in 2023, as you usher in new intentions and habits for 2024. Although there were many great trial outcomes and continuing scientific wins...more

Foley Hoag LLP

Product Liability Update - April 2023

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MASSACHUSETTS - First Circuit Holds Failure-To-Warn Claims Against Drug Manufacturer Preempted By Federal Food, Drug, And Cosmetic Act Because Animal Studies Cited By Plaintiffs Did Not Demonstrate Risks Beyond Those In...more

Faegre Drinker Biddle & Reath LLP

5 Major Drug and Device Developments of 2022

As we ring in the new year, it is time once again to reflect on some of the most significant legal developments for drug and device companies this year. The list below is by no means exhaustive (who could forget the Rule 702...more

Farrell Fritz, P.C.

Commercial Division Says, “Nope, Not Enough” When Using Local Counsel to Establish Personal Jurisdiction

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Commercial transactions often involve parties from different states.  When a dispute arises between diverse parties, the question of whether a party can obtain personal jurisdiction over a defendant becomes critical.  This...more

Faegre Drinker Biddle & Reath LLP

Top 5 Drug and Medical Device Developments of 2021

As we ring in the new year, it is time, once again, to reflect on the most significant legal developments for our drug and device clients this year. Below is a brief recap and assessment of our top-five developments impacting...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

Foley Hoag LLP

Product Liability Update - April 2021

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UNITED STATES SUPREME COURT - • United States Supreme Court Holds Due Process Permits Exercise Of Specific Personal Jurisdiction Over Out-Of-State Vehicle Manufacturer For Product Liability Claims For Harm To Forum...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

Goodwin on

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

Alston & Bird

Class Action & MDL Roundup – Summer 2020

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Welcome back to the Class Action & MDL Roundup! Our summer edition covers notable class actions from the second quarter of 2020. In this edition, the Judicial Panel on Multidistrict Litigation (JPML) weighed in on several...more

Goodwin

California Federal Court Denies Motion to Dismiss Securities Class Action Arising from Uber’s IPO

Goodwin on

California Federal Court Denies Motion to Dismiss Securities Class Action Arising from Uber’s IPO; S.D.N.Y. Dismisses Ponzi Scheme Action Against HSBC Hong Kong for Lack of Personal Jurisdiction; Delaware Court of Chancery...more

Foley Hoag LLP

Product Liability Update - May 2020

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Foley Hoag LLP publishes this quarterly Update primarily concerning developments in product liability and related law from federal and state courts applicable to Massachusetts, but also featuring selected developments for New...more

Fish & Richardson

EDTX & NDTX Monthly Wrap-Up – April 2019

Fish & Richardson on

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

Mintz - Intellectual Property Viewpoints

Dueling Declaratory Judgment Suits Result in a Dismissal and Boomerang Transfer Back to the First-filed Forum Under TC Heartland

On April 17, 2019, Judge Gilstrap of the United States District Court for the Eastern District of Texas, in Apicore v. Beloteca, No. 19-cv-00077, held that while the court could exercise personal jurisdiction over a generic...more

Orrick, Herrington & Sutcliffe LLP

Personal Jurisdiction/Forum Non Conveniens - The World in U.S. Courts: Winter 2019

Taiwanese Manufacturer of Smartphones Subject to Personal Jurisdiction in Texas in Patent Infringement Case Because of its Allegedly Purposeful Efforts to Serve the US Market Even Though all US Distribution was Orchestrated...more

Orrick, Herrington & Sutcliffe LLP

Intellectual Property - Patents - The World in U.S. Courts: Winter 2019

Taiwanese Manufacturer of Smartphones Subject to Personal Jurisdiction in Texas in Patent Infringement Case Because of its Allegedly Purposeful Efforts to Serve the US Market, Even Though all US Distribution was Orchestrated...more

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