Feature|Articles|August 4, 2026

Inside Pharma's Patent Battleground: The Policy Changes Reshaping Generic and Biosimilar Competition

Author(s)Ed Silverman

Recent changes at the U.S. Patent and Trademark Office are making it harder to challenge pharmaceutical patents, raising concerns that slower generic and biosimilar competition could undermine efforts to lower drug costs while strengthening protections for brand-name innovators.

A key Trump administration agency is drawing controversy over policies that might slow the process for bringing lower-cost medicines to market. Over the past year, the U.S. Patent & Trademark Office (PTO) has taken several steps that were billed as preserving patents from unnecessary legal challenges and strengthening the system for protecting innovation.

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