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Pharmaceutical Industry › Remand › Prescription Drugs

A&O Shearman

Federal Circuit clarifies presumption of obviousness for overlapping ranges

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After the Federal Circuit vacated and remanded the district court’s non-obviousness determination, the district court again found that Teva failed to show, by clear and convincing evidence, that the claims of Janssen’s patent...more

Carlton Fields

Fourth Circuit Applies Supreme Court’s Coinbase Decision Outside Context of Arbitration

Carlton Fields on

The Fourth Circuit Court of Appeals recently concluded that the U.S. Supreme Court’s decision in Coinbase Inc. v. Bielski is not limited to interlocutory appeals involving arbitration....more

American Conference Institute (ACI)

[Event] Drug & Medical Device Litigation - December 7th - 8th, New York, NY

American Conference Institute (ACI) on

The premier event for drug and medical device product liability lawyers to gain essential winning litigation strategies. ACI’s 26th Annual Flagship Conference on Drug and Medical Device Litigation is returning to New York...more

Smart & Biggar

Federal Court quashes RUZURGI NOC and returns matter to the Minister of Health for redetermination

Smart & Biggar on

Update: On redetermination, Health Canada issued a new notice of compliance for RUZURGI on June 24, 2021. Catalyst and Kye have sought judicial review (Court File No T-1047-21). On May 31, 2021, the Federal Court quashed a...more

Robins Kaplan LLP

INO Therapeutics LLC v. Praxair Distribution Inc.

Robins Kaplan LLP on

BUT FOR A CLERICAL ERROR TO BE ADDRESSED ON REMAND, THE FEDERAL CIRCUIT AFFIRMS FINDINGS OF INELIGIBLE SUBJECT MATTER AND NON-INFRINGEMENT. Case Name: INO Therapeutics LLC v. Praxair Distribution Inc., 2019 U.S. App. LEXIS...more

K&L Gates LLP

K&L Gates Triage: Recent Developments Impacting Drug Pricing and the 340B Program: Part 2

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In Part Two of this two-part series on recent developments in pharmacy law and the 340B drug pricing program, Richard Church and Ryan Severson discuss several recent developments related to the 340B drug pricing program,...more

Foley & Lardner LLP

340B Rate Cuts: DC Court Enjoins and Remands CMS’ 2018 and 2019 Reductions for Hospital Outpatients

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On May 6, 2019, a federal district court held that the Department of Health and Human Services’ (HHS) 2018 and 2019 rate reductions for 340B Program participants, including safety net On May 6, 2019, a federal district court...more

Alston & Bird

Class Action & MDL Roundup: Winter 2019

Alston & Bird on

Welcome back to the Class Action & MDL Roundup! This year has begun with cases all over the map, from California to Florida to Massachusetts. The West Coast features overbearing manufacturers, allegedly underpaid lenders,...more

Perkins Coie

Belated Government Dismissal of False Claims Act Cases: DOJ Maneuvering in Post-Escobar and Granston Memo Era

Perkins Coie on

The solicitor general filed an amicus brief in the U.S. Supreme Court last month supporting the relators’ opposition to certiorari in Gilead Sciences, Inc. v. United States ex rel. Campie, et al., No. 17-936. Yet the...more

Bass, Berry & Sims PLC

DOJ Informs Supreme Court that It Will Dismiss FCA Case if Remanded to District Court

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On November 30, 2018, the Solicitor General of the United States filed an amicus curiae brief in the closely watched False Claims Act (FCA) lawsuit, Gilead Sciences Inc. v. U.S. ex rel. Campie. In what appears to be an...more

Patterson Belknap Webb & Tyler LLP

Second Circuit Remands for New Trial Based on District Court’s Improper Exclusion of Advice-of-Counsel Testimony

Patterson Belknap Webb & Tyler LLP on

In United States v. Scully, 16-3073-cr (Pooler, Lynch, Cogan[1]), the Second Circuit vacated the defendant’s conviction for various offenses, including mail and wire fraud, conspiracy to defraud the United States, the sale of...more

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