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Tony Hagen is senior managing editor for The Center for Biosimilars

The European Union makes it far more difficult to obtain patents on biologics, reducing the likelihood of patent “thickets” that stifle competition, the Matrix Global Advisors report states.

Matrix Report Identifies Shortcomings of US Patent System

Celltrion announces the launch timing for its much anticipated high-concentration formulation of adalimumab and presents trial data supporting equivalence to the reference product.

Celltrion Supports High-Concentration Adalimumab Biosimilar Launch With Phase 3 Trial Data

Biosimilar manufacturers may encounter roadblocks in the months and years ahead, and generics manufacturers will find they've hit a ceiling, according to Adam Fein, PhD, CEO of the Drug Channels Institute.

Pharmacy Economist Describes Fork in the Road for Generics and Biosimilars

Accused of unfair trade practices, AbbVie's CEO Richard Gonzalez pointed the finger at Medicare Part D. 

AbbVie's Gonzalez Is on Defense as House Members Petition FTC

The House Committee on Oversight and Reform contends AbbVie's "biosimilar defense strategy" has succeeded beyond the company's wildest imagination. 

House Committee Issues Blistering Report on AbbVie's Humira Tactics

Originator company Amgen has won another round in defending its lucrative etanercept franchise, but the decision is sure to intensify scrutiny of extended patent protections. 

Sandoz Is 0-3 in Enbrel Patent Case

When it comes to biologics, there is a constant push and pull over patent rights. Some believe this is part of a healthy market-driven economy. Others are skeptical.

Poll: Where Do You Stand on Product Exclusivity Protections?

After being sued for allegedly stealing adalimumab process information, Alvotech fires back. 

Alvotech Files Suit to Invalidate Humira Patents

Stacie Ropka, JD, PhD, is a partner at Axinn. Her practice focuses on intellectual property litigation, due diligence, and client counseling, with an emphasis on the life sciences. Ropka’s experience includes extensive counseling for product development efforts relating to biologics and reconstructive biomaterials, including products that utilize adult stem cells. Prior to attending law school, she held a faculty position at SUNY Upstate Medical University, and she also spent many years as a research scientist in the fields of neurology, virology, and immunology.

Drew Hillier, JD, is an associate at Axinn. He litigates patent cases and high-stakes commercial disputes. His experience includes advising follow-on biologic manufacturers on product development and litigation strategy. As a former federal law clerk, Hillier has litigated patent-related cases in some of the highest-profile districts in the country, including the Southern District of New York and the Eastern District of Texas.

Gabriella Mahan, JD, is an associate at Axinn’s Washington, DC office. At the time of this writing, her admission to the Washington, DC Bar is pending.

Intellectual property attorneys from Axinn discuss the limitations of the Purple Book patent disclosure requirements and the burden these impose on biosimilar developers.

Opinion: Purple Book Patent Listings Are Only a First Step

The anatomy of an interchangeability switching study. 

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