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Pharmaceutical Patents Patents Venue

Fenwick & West LLP

Key Takeaways: Strategies from the First Two Years of the UPC

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The Unified Patent Court (UPC) represents a transformative development in European patent litigation. Fenwick’s Ryan Johnson teamed up with Bird & Bird’s Boris Kreye and Chris de Mauny to explore important considerations and...more

WilmerHale

Managing ANDA Venue Issues As Del. And NJ Filings Rise

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In 2023, pharmaceutical patent owners filed nearly 250 infringement complaints against generic drug manufacturers. More than 90% of those cases were filed in the Districts of Delaware or New Jersey. This year's filings...more

American Conference Institute (ACI)

[Event] 17th Annual Paragraph IV Disputes Conference - April 26th - 27th, New York City, NY

Premier forum which shapes the law, policy, and proceedings of Paragraph IV Litigation is back to New York City on April 26-27! Pharmaceutical patent practitioners from across the globe attend this flagship conference to...more

Robins Kaplan LLP

Celgene Corp. v. Mylan Pharms., Inc.

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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

Haug Partners LLP

The Federal Circuit Analyzes Venue Requirements in Hatch-Waxman Cases

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Since the Supreme Court’s decision in TC Heartland (137 S. Ct. 1514 (2017)), the venue statute for patent cases, 28 U.S.C. § 1400(b), has been interpreted to mean that venue is proper only where the defendant “resides” or...more

McDermott Will & Schulte

Federal Circuit Clarifies Venue in Hatch-Waxman Case

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Addressing venue in the context of a Hatch-Waxman case, the US Court of Appeals for the Federal Circuit explained that sending a paragraph IV notice letter to a company in the district is insufficient to establish venue....more

Fish & Richardson

Federal Circuit Clarifies Venue in Hatch-Waxman Actions in Celgene v. Mylan

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The Hatch-Waxman Act provides a cause of action for infringement based on the submission of an abbreviated new drug application (ANDA) to FDA. 35 U.S.C. § 271(e)(2). Following the Supreme Court’s ruling in TC Heartland LLC v....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 - September 2021

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Arguments to the Patent Office That Contradict Information Submitted to the FDA Support an Inference of Deceptive Intent In Belcher Pharmaceuticals v. Hospira, Inc., Appeal No. 20-1799, the Federal Circuit held that a...more

Fish & Richardson

[Webinar] Life Sciences | 2020 Year in Review - January 27th, 1:30 pm - 2:30 pm ET

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2020 has been referred to as an unprecedented year for the world in so many ways—the pandemic, the California and Washington fires, the racial justice protests and calls to action—but that didn’t stop the Federal Circuit from...more

Fenwick & West LLP

Valeant v. Mylan: Restrictions on Venue in Hatch-Waxman Litigation

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For the first time since the U.S. Supreme Court’s TC Heartland decision, the U.S. Court of Appeals for the Federal Circuit addressed the issue of venue specific to Hatch-Waxman litigation, pursuant to which branded...more

Haug Partners LLP

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

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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

McDermott Will & Schulte

Venue in Hatch-Waxman Cases Limited to District Where ANDA Is Submitted

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The US Court of Appeals for the Federal Circuit found that in cases brought under the Hatch-Waxman Act, for purposes of determining venue, infringement occurs only in districts where actions related to the submission of an...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

WilmerHale

CAFC Patent Cases, 10/26/20 – 11/09/20

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Precedential Federal Circuit Opinions: In Re NITRO FLUIDS L.L.C. [ORDER] (2020-0142, 10/28/28) (REYNA, WALLACH, and CHEN)  - Reyna, J.  The Court considered a petition for a writ of mandamus seeking transfer from the...more

Schwabe, Williamson & Wyatt PC

Latest Federal Court Cases - November 2020 #2

Valeant Pharmaceuticals North America LLC v. Mylan Pharmaceuticals Inc., Appeal No. 2019-2402 (Fed. Cir. Nov. 5, 2020) - In our Case of the Week, the Federal Circuit addressed a lingering question about venue following the...more

Troutman Pepper Locke

Federal Circuit Clarifies Hatch-Waxman Venue Question

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On November 5, 2020, the Federal Circuit issued a precedential opinion deciding a patent venue question concerning Hatch-Waxman cases left open after the Supreme Court’s decision in TC Heartland LLC v. Kraft Foods Grp. Brands...more

Knobbe Martens

Venue in Hatch-Waxman Cases Tied to Acts of ANDA Submission

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VALEANT PHARMACEUTICALS v. MYLAN PHARMACEUTICALS - Before Newman, O’Malley, and Taranto. Appeal from the District Court of New Jersey - Summary: Venue in Hatch-Waxman cases is proper only in districts where actions...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

Robins Kaplan LLP

Valeant Pharms. N. Am. LLC v. Zydus Pharms. (USA) Inc.

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BECAUSE PLAINTIFFS FAILED TO SHOW SPECIFICALLY HOW DEFENDANTS COMMITTED ANY ACT OF INFRINGEMENT IN NEW JERSEY—PARTICULARLY BY FILING AN ANDA IN WEST VIRGINIA WITH THE FDA IN MARYLAND—OR THAT ANY FUTURE, INTENDED ACTS WERE A...more

Mintz - Intellectual Property Viewpoints

ANDA Applicant Dismissed for Lack of Venue Under § 1400(b) as District of New Jersey Departs from its own and the District of...

On August 13, 2019, the United States District Court for the District of New Jersey, in Valeant Pharmaceuticals N. Am. LLC v. Mylan Pharmaceuticals Inc., No. 18-cv-14305, held that venue was not proper in New Jersey over...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

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