Patent and Trademark Law

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The Patent Trap: The Struggle for Competition and Affordability in the Field of Biologic Drugs

By Charlotte Geaghan-Breiner

The biologic drug market in the U.S. suffers from a dearth of competition. Ten years after the passage of the Biologics Price Competition and Innovation Act (BPCIA), competition from biosimilars remains weak, and prices of branded biologics continue to increase at rates that outstrip inflation. This crisis of non-competition has resulted in billions of dollars in lost savings and reduced access to treatment, especially for vulnerable groups. Patent thickets — dense webs of overlapping patents — are one of the main barriers to biosimilar competition. By protecting their products with patent thickets, branded biologic manufacturers are able to deter competition from biosimilars and maintain periods of market exclusivity that far exceed statutory limits. This Note analyzes regulatory gaps in the BPCIA that allow patent thickets to thrive, and recommends both legislative and administrative solutions. Part II assesses the market landscape for biologic drugs in the U.S. and concludes that, of all barriers to biosimilar competition, patent thickets are the most significant. Part III evaluates the BPCIA framework in light of patent thickets and identifies aspects of the statute that allow patent thickets to block biosimilar market entry. Part IV analyzes recent legislative proposals to address the problem of patent thickets, and recommends administrative changes to strike a better balance between innovation and competition in the field of biologics.

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