News & Analysis as of

Labeling Patent Litigation

Foley Hoag LLP

Previewing Generic’s Skinny Label: Supreme Court to Rule on Teva’s Certiorari Petition

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The Supreme Court is expected to consider Teva’s pending petition for certiorari in the highly anticipated GlaxoSmithKline LLC v. Teva Pharms. USA, Inc. on May 11, 2023, a case that could carry enormous implications for the...more

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

Declaratory Judgment Jurisdiction Over Skinny Label Applications: In re: Entresto (Sacubitril/Valsartan) Patent Litigation

On September 27, 2022, Judge Richard Andrews of the District of Delaware granted Novartis’s motion to dismiss declaratory judgment (“DJ”) counterclaims raised by two generic drug manufacturers in the ongoing litigation...more

McDermott Will & Emery

Federal Circuit Divided on Whether Skinny Labeling Compliance Precludes Inducement or Supports Equitable Estoppel

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The US Court of Appeals for the Federal Circuit denied a generic drug manufacturer’s petition for en banc review of a panel opinion finding induced infringement liability despite the manufacturer’s adherence to skinny...more

Schwabe, Williamson & Wyatt PC

‎Latest Federal Court Cases - August 2021 #2

Our Case of the Week this week is a re-write of our Case of the Week on October 5, 2020. The case involves a drug that could be used for multiple therapeutic purposes. A patent covered use of the product for a specific...more

McDermott Will & Emery

The Future of Skinny Labeling in Patent Litigation Will be Reconsidered

McDermott Will & Emery on

The US Court of Appeals for the Federal Circuit has now vacated its prior ruling finding induced infringement based on so-called skinny labeling on a pharmaceutical product. GlaxoSmithKline LLC v. Teva Pharmaceuticals USA...more

King & Spalding

GSK v. Teva and Induced Infringement by AB-Rated Generics: Where Are We Now?

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The Federal Circuit’s October 2020 split decision in GSK v. Teva made waves throughout the pharmaceutical industry and among Hatch-Waxman litigators.  In the broadest reading, some see the majority opinion as rendering any...more

Fish & Richardson

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

Fish & Richardson on

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

McDermott Will & Emery

Definiteness, Drug Labels and Diclofenac, Oh My

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The US Court of Appeals for the Federal Circuit affirmed a district court’s invalidity and infringement judgments for patents directed to a topical nonsteroidal anti-inflammatory drug, finding that a patent claim reciting a...more

American Conference Institute (ACI)

[Event] Global Legal and Regulatory Summit On Biosimilars - December 3rd-4th, Munich, Germany

Legal, Regulatory and Commercial Perspectives on the International Biosimilars Marketplace - The Global Biosimilars market is expected to grow robustly. Market watchers anticipate that Europe in particular will experience...more

Hogan Lovells

Hogan Lovells ITC Section 337 Monthly Highlights

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The latest news round-up from our Hogan Lovells ITC Section 337 practice, including a new section featuring "tips from the bench" by former ITC Judge Theodore (Ted) R. Essex. ...more

McDermott Will & Emery

ANDA Update - October 2015

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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

McDonnell Boehnen Hulbert & Berghoff LLP

Eli Lilly and Company v. Teva Parenteral Medicines, Inc. (S.D. Ind. 2015) - District Court Finds Lilly Patent Infringed Based on...

Last week, in Eli Lilly and Company v. Teva Parenteral Medicines, Inc., Judge Tanya Walton Pratt of the U.S. District Court for the Southern District of Indiana determined that Eli Lilly and Company had shown by a...more

K&L Gates LLP

The Name Game Continues: AbbVie Files Supplemental Citizen Petition Raising Additional Concerns Regarding Biosimilar Labeling

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AbbVie previously filed a citizen petition to the FDA arguing against its interim labeling requirements for biosimilars under the Biologics Price Competition and Innovation Act (“BPCIA”). In its supplemental petition, AbbVie...more

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