News & Analysis as of

Patent Invalidity Biosimilars Appeals

Venable LLP

Federal Circuit Affirms Preliminary Injunction Decisions for EYLEA® Biosimilars

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On March 5, 2025, the Federal Circuit affirmed the grant of a preliminary injunction against the launch of Celltrion’s proposed EYLEA® (aflibercept) biosimilar CT-P42 in CAFC Case Nos. 24-2058 and 24-2147 (appealing from...more

Smart & Biggar

PM(NOC) Regulations: Six-year anniversary of major amendments

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September 21, 2023, marked the sixth anniversary of the significant amendments to the Patented Medicines (Notice of Compliance) Regulations (Regulations). This article provides an update on activities in the sixth year...more

Smart & Biggar

Rx IP Update - April 2019

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PMPRB amendments expected to come into force no earlier than Spring 2020 - On April 1, 2019, Health Canada released Forward Regulatory Plan 2019-2021: Regulations Amending the Patented Medicines Regulations. This brief...more

Smart & Biggar

Rx IP Update - November 2018

Smart & Biggar on

In This Issue: Ontario Court of Appeal allows Sanofi and Schering to plead that Federal Court ramipril patent invalidity decision was flawed due to “promise doctrine” - In an action by Apotex for compensation from...more

Goodwin

Celltrion and Hospira Have Launched Inflectra® in U.S.

Goodwin on

This past April, the FDA approved Inflectra® (infliximab-dyyb), Celltrion and Hospira’s biosimilar of Janssen’s Remicade®. According to papers filed in the Federal Circuit this week, Celltrion and Hospira (collectively,...more

Patterson Belknap Webb & Tyler LLP

Biosimilar Litigation Update

With the U.S. biosimilar pathway created by the Biologics Price Competition and Innovation Act (BPCIA) now fully up and running, there are now seven ongoing biosimilar litigations in the U.S. Here are brief updates on recent...more

McDonnell Boehnen Hulbert & Berghoff LLP

MBHB Snippets: A review of developments in Intellectual Property Law - Volume 14, Issue 2 (Spring 2016)

Pre-AIA and Post-AIA Issues Presented by the On-Sale Bar - The “on-sale” bar to patentability refers to a sale or offer for sale of an invention that can invalidate the patent for that invention. The...more

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