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Biosimilars: impact of differences with Hatch-Waxman
Katherine Kowalchyk1, Cara Crowley-Weber
1Merchant & Gould, P.C. 3200 IDS Center, 80 South Eighth Street, Minneapolis, MN 55402, USA.
Pharmaceutical Patent Analyst
|November 19, 2013
Summary
Comparing pharmaceutical and biosimilar approval acts reveals key differences impacting biosimilar market entry and patent litigation. These differences shift settlement incentives toward patent validity and non-infringement risks.
Area of Science:
- Pharmaceutical Law
- Biotechnology Regulation
- Intellectual Property
Background:
- The Hatch-Waxman Act governs small-molecule drug approvals, while the Biologics Price Competition and Innovation Act (BPCIA) governs biosimilar approvals.
- Understanding these distinct regulatory pathways is crucial for navigating market entry and patent disputes in the biopharmaceutical industry.
Purpose of the Study:
- To compare the Hatch-Waxman Act and the BPCIA.
- To provide insights into the market entry dynamics and patent litigation strategies for biosimilars.
Main Methods:
- Comparative analysis of the Hatch-Waxman Act and the BPCIA.
- Examination of statutory exclusivity periods, litigation stays, and market exclusivity provisions.
Main Results:
- Biosimilars have longer statutory exclusivity periods compared to small-molecule drugs.
- The BPCIA lacks a 30-month stay for reference product sponsors and a 180-day market exclusivity for first-time biosimilar applicants (unless interchangeable).
- Patent litigation settlement incentives for biosimilars are primarily driven by the risk of patent invalidity or non-infringement.
Conclusions:
- Biosimilar applicants must proactively build cases for patent invalidity/non-infringement.
- Developing a freedom-to-operate strategy and seeking patents for production, formulation, or use are essential for biosimilar market success.
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