AAM analysis shows tactics used by brand drug companies to deny market entry to life-saving lower-cost generic medicines and outlines solutions
WASHINGTON, DC (September 4, 2025) – The Association for Accessible Medicines and the Biosimilars Council today released a white paper, Serial Patent Litigation Problems and Solutions, which analyzes the increasingly common practices used by brand drug manufacturers to stymie lower-cost generic and biosimilar versions of their medicines from entering the market, denying patients options as well as significant savings.
“Serial patent litigation delays patient access to more affordable medicines,” said John Murphy III, President and CEO of AAM. “Congress should take action now to streamline patent litigation and ensure that it does not serve as a barrier to generic entry.”
The white paper outlines ten case studies of specific medications hindered by serial litigation. Serial patent litigation is a problem plaguing the pharmaceutical industry, delaying generic competition and inflating drug prices. Brand pharmaceutical companies leverage held-back or later-issued patents to file multiple successive actions against generic companies, giving them multiple opportunities to block competition. This greatly benefits brand companies, as they can readily obtain and assert a large number of related patents at a relatively low cost. Serial patent litigation significantly harms generic manufacturers, as well as patients and payors, as the availability of lower-cost, lifesaving generic medications is significantly delayed.
Serial patent litigation allows brand pharmaceutical companies to undermine the Hatch-Waxman law and one of Congress’ key goals to speed up the introduction of low-cost generic drugs to market. Legislative solutions are urgently needed to address the substantial harm that has impacted—and will continue to impact—both generic pharmaceutical companies and American patients.
White paper: Serial Patent Litigation Problems and Solutions
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About AAM
The Association for Accessible Medicines, your generics and biosimilars industry, is driven by the belief that access to safe, quality, effective medicine has a tremendous impact on a person’s life and the world around them. AAM represents the manufacturers of finished generic pharmaceuticals and biosimilars, manufacturers of bulk pharmaceutical chemicals, and suppliers of other goods and services to the generic industry. Generic pharmaceuticals are 90 percent of prescriptions dispensed in the U.S. but only 12 percent of total drug spending.
About the Biosimilars Council
The Biosimilars Council, a division of the Association for Accessible Medicines, works to ensure a positive environment for patient access to biosimilar medicines. The Biosimilars Council is the leading source for information about the safety and efficacy of more affordable alternatives to costly brand biologic medicines. Areas of focus include public and health expert education, government affairs, legal affairs, and regulatory policy. More information is available biosimilarscouncil.org.
