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Pharmaceutical Industry › Personal Jurisdiction › Biosimilars

DLA Piper

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

DLA Piper on

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

Polsinelli on

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

A&O Shearman

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

A&O Shearman on

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

Mintz - Intellectual Property Viewpoints

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

Mintz - Intellectual Property Viewpoints on

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

McDonnell Boehnen Hulbert & Berghoff LLP

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

McDonnell Boehnen Hulbert & Berghoff LLP on

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

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

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

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

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

Goodwin

Section 337 Actions at the ITC: another forum for pharma and biosimilars litigation?

Goodwin on

With the growing volume of biosimilar and pharma litigation in district courts and before the PTAB, the U.S. International Trade Commission may emerge as another forum for patent holders against imported biosimilars. Section...more

McDermott Will & Schulte

ANDA Update - Volume 2, Number 2

McDermott Will & Schulte on

180-Day Notice Period for Biosimilar Approval Is Always Mandatory and Enforceable by Injunction - Amgen Inc., v. Apotex Inc., (Fed. Cir. July 5, 2016) - A year after analyzing the patent dance and notice...more

McDermott Will & Emery

ANDA Update - October 2015

McDermott Will & Emery on

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

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