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Safe Harbors Biologics

BakerHostetler

IP Litigation Newsletter - April 2024

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The safe harbor exception in 35 U.S.C. § 271(e)(1) applies “solely for uses reasonably related to the development and submission of information” to the Food and Drug Administration (FDA). The Federal Circuit interpreted the...more

American Conference Institute (ACI)

[Webinar] 3rd Annual Passport to Proficiency on the Essentials of Hatch-Waxman and BPCIA - October 10th - 26th, 1:00 pm EST

Gain a comprehensive understanding of Hatch-Waxman and BPCIA essentials, a critical competency for legal and business professionals in the biopharmaceutical arena. Attend ACI’s Hatch-Waxman and BPCIA Proficiency Series...more

Hogan Lovells

CTGT transactions: Beware of ripples in the safe harbor

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We increasingly encounter research and development collaboration partners relying on various research tools, cell lines, and other technologies to develop products and therapies within the cell, tissue, and gene therapy...more

Kramer Levin Naftalis & Frankel LLP

Biosimilar Litigation Trends and Lessons Learned in 2019

It has been nearly 10 years since the U.S. Biosimilars Pathway (the Biologics Price Competition and Innovation Act) was enacted. The first biosimilar product in U.S. history was approved and launched in 2015. Ten biosimilars...more

Smart & Biggar

What the amendments to the USMCA mean for Canadian IP law

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On December 10, 2019, Canada, the United States and Mexico signed the Protocol of Amendment to the Agreement between the United States of America, the United Mexican States and Canada (commonly referred to as the USMCA). The...more

Knobbe Martens

Safe Harbor Defense Under 35 U.S.C. §271(e)(1) Requires That the Accused Activity Is Solely for Uses Reasonably Related to...

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AMGEN INC. v. HOSPIRA, INC. Before Moore, Bryson, and Chen.  Appeal from the United States District Court for the District of Delaware. Summary: Biological engineering activity that would otherwise constitute patent...more

Mintz - Intellectual Property Viewpoints

New revised USMCA trade deal affects intellectual property rights, but not exclusivity period for biologics

On December 10, 2019, an agreement was reached between the United States, Mexico, and Canada on amendments to the U.S.-Mexico-Canada Agreement (“USMCA”). The USMCA, if ratified by each respective country, would replace the...more

Wilson Sonsini Goodrich & Rosati

Sitting Here on Capitol Hill: Congressional Developments on Life Science and Consumer Product Issues - July 2019 #2

Legislation - Consumer Product Safety: House Committee Approves Six Bills - Responding to what they claim has been a failure of the Consumer Product Safety Commission (CPSC) to act in recent years, the House Energy and...more

Baker Donelson

OIG Advisory Opinion 17-03 Approves Pharmaceutical Manufacturer's Product Spoilage/Replacement Program

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A pharmaceutical manufacturer proposing to offer customers – at no additional cost – replacements for certain spoiled products that can no longer be administered to patients (Replacement Program) has been granted approval by...more

Patterson Belknap Webb & Tyler LLP

Following Biosimilar Trial, Jury Awards Amgen $70 Million for Pfizer’s Pre-Approval Infringement of Now-Expired EPO Patent

In one of the first Biologics Price Competition and Innovation Act (BPCIA) litigations to reach trial, a jury on Friday awarded Amgen $70 million in damages for Pfizer’s infringement of one of Amgen’s expired patents...more

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