News & Analysis as of

Pharmaceutical Industry Food and Drug Administration (FDA) Induced Infringement

American Conference Institute (ACI)

[Event] 15th Summit on Biosimilars & Innovator Biologics - June 20th - 21st, New York, NY

Hosted by American Conference Institute, the Summit on Biosimilars & Innovator Biologics returns to New York City, on June 20 - 21, 2024. Now in its 15th year, the 2024 conference will dive deep into the latest legal,...more

American Conference Institute (ACI)

[Event] 18th Annual Paragraph IV Disputes - April 19th - 20th, New York, NY

Hosted by ACI, 18th Annual Paragraph IV Disputes Conference returns to New York City for another exciting year with curated programming that not only addresses the hot topics, but also puts them within the context of pre-suit...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

Hogan Lovells

Federal Circuit affirms GSK labeling carve-out ruling in favor of innovator

Hogan Lovells on

Earlier this month, in GlaxoSmithKline LLC v. Teva Pharmaceuticals USA, Inc., a panel of the U.S. Court of Appeals for the Federal Circuit (CAFC) affirmed (2-1) upon rehearing its October 2020 decision that a labeling...more

McDonnell Boehnen Hulbert & Berghoff LLP

GlaxoSmithKline LLC v. Teva Pharmaceuticals USA (Fed. Cir. 2021)

Most judicial outcomes, particularly on appeal, are broadly based on varying combinations of process and outcome. The law is replete with process-based decisions (standing, jurisdiction, waiver, to name a few) and of course...more

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

Federal Circuit Panel Rehears Skinny Label Case (GSK v. Teva)

On February 23, 2021, a Federal Circuit panel of Chief Judge Prost, Judge Newman, and Judge Moore reheard oral argument in GlaxoSmithKline LLC v. Teva Pharms. USA, Inc. As discussed in our previous post, on February 9, 2021,...more

Locke Lord LLP

Federal Circuit Hints at Reversed Course on “Skinny Labels”

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On October 2, 2020, the Federal Circuit issued a precedential opinion vacating a district court’s judgment as a matter of law and reinstating a jury verdict finding of induced infringement of a patented use that had been...more

Schwabe, Williamson & Wyatt PC

Fresh From the Bench: Latest Federal Circuit Court Cases

In an ANDA applicant’s appeal from a bench trial judgment of validity and infringement, the Court affirmed the district court’s judgment on all counts. The case presented unusual procedural circumstances in a Hatch-Waxman...more

Robins Kaplan LLP

Takeda Pharms. U.S.A., Inc. v. West-ward Pharm. Corp.

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Case Name: Takeda Pharms. U.S.A., Inc. v. West-ward Pharm. Corp., Civ. No. 14-1268-SLR, 2016 U.S. Dist. LEXIS 65317 (D. Del. May 18, 2016) (Robinson, J.) - Drug Product and Patent(s)-in-Suit: Colcrys® (colchicine); U.S....more

Foley & Lardner LLP

The Promise And Pitfalls Of 3D Printing

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3D printing offers great promise for innovation and manufacturing, but this tool has expanded the scope of patented products that can be easily and cheaply copied, and may make it harder to identify and prosecute infringers....more

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