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Womble Bond Dickinson

Factors Courts Commonly Consider When Deciding Motions to Transfer in ANDA Litigation

Womble Bond Dickinson on

Where the Operative Facts Occurred - In assessing this primary factor, courts have looked to the location of defendant’s principal place of business, where the ANDA application was prepared, and where the ANDA product was...more

Robins Kaplan LLP

Celgene Corp. v. Mylan Pharms., Inc.

Robins Kaplan LLP on

Case Name: Celgene Corp. v. Mylan Pharms., Inc., No. 2021-1154, 2021 WL 5143311 (Fed. Cir. Nov. 5, 2021) (Circuit Judges Prost, Chen, and Hughes presiding; Opinion by Prost, J.) (Appeal from D.N.J., Salas, J.) Drug Product...more

McDonnell Boehnen Hulbert & Berghoff LLP

Celgene Corp. v. Mylan Pharmaceuticals Inc. (Fed. Cir. 2021)

The question of the proper court for a branded pharmaceutical maker to bring suit against an Abbreviated New Drug Application filer under the Hatch-Waxman Act is surprisingly unsettled seeing as the Act was enacted in 1984. ...more

Knobbe Martens

Federal Circuit Review - August 2021

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It’s No Secret That a Related Company’s Physical Presence in a Jurisdiction May Not Be Enough For Proper Venue - In Andra Group, LP v. Victoria’s Secret Stores, LLC, Appeal No. 20-2009, The Federal Circuit held that an...more

Haug Partners LLP

Venue in Hatch-Waxman Litigation: What Courts Decided and What Litigants are Still Fighting Over

Haug Partners LLP on

Since the Supreme Court’s ruling in TC Heartland, there has been increased litigation over appropriate venue in patent litigation, including Hatch-Waxman cases. 28 U.S.C. § 1400(b) provides that venue in patent infringement...more

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

Venue Considerations for Hatch-Waxman and BPCIA Litigation

In Valeant Pharmaceuticals North America LLC v. Mylan Pharmaceuticals Inc., No. 2019-2402 (Fed. Cir. Nov. 5, 2020), the Federal Circuit clarified the venue analysis of 28 U.S.C. § 1400(b), which controls venue for patent...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

Mintz - Intellectual Property Viewpoints

District of Delaware Dismisses ANDA Applicant for Lack of Venue under TC Heartland and In re Cray

On June 17, 2019, the United States District Court for the District of Delaware, in Novartis Pharmaceuticals Corp. v. Accord Healthcare Inc., et al., No. 18-cv-01043, held that venue was not proper in Delaware over Mylan...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

Knobbe Martens

Federal Circuit Review - March 2019

Knobbe Martens on

Federal Circuit Determines Time-Barred Petitioner Joined to an IPR Has Appellate Standing - In Mylan Pharmaceuticals Inc. v. Research Corporation Tech., Appeal Nos. 2017-2088, -2089, -2091, the Federal Circuit held that a...more

Robins Kaplan LLP

Hatch-Waxman Venue: The New Narrow?

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The issue of venue—where geographically a case can be brought—and jurisdiction are a pair of principles to determine in which forum a case can properly be brought. Jurisdiction in personam concerns whether a particular party...more

Hogan Lovells

ITC Section 337 – Quarterly Highlights

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SCOTUS Narrows Opportunity For ITC Section 337 Jurisdiction Over Imported Biosimilars Based On 180-Day Notice Provision - In Amgen Inc. v. Sandoz Inc., 794 F.3d 1347, 1357-58 (Fed. Cir. 2015), the Federal Circuit held that...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

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