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Getting the Facts: Drug Companies Increasingly Using Patent Games to Avoid Competition

Press Release

A recent article published by STAT highlights how Big Pharma is using continuation patents to keep lower-cost generic drugs from reaching the market.

Published Aug 15, 2023 • by AHIP

WASHINGTON, D.C. – (August 15, 2023) Everyone should be able to get the prescription drugs they need at a price they can afford. A recent article published by STAT highlights how pharmaceutical companies are using continuation patents to keep lower-cost generic drugs from reaching the market, forcing hardworking Americans to choose between paying their bills and getting the life-saving medicines they need:

“Pharmaceutical companies often file what are known as continuation patents in order to extend their window to thwart lower-cost generic competitors from reaching the market. But critics argue such patents can amount to inconsequential tweaks, which bolster bottom lines, but force the U.S. health care system to pay higher prices for medicines for extended periods.”

The STAT article cites a study published in JAMA, noting the skyrocketing use of continuation patents in avoiding competition:

“From 2000 to 2015, the Food and Drug Administration approved 1,421 new brand-name drugs. The ratio of continuation patents increased from 0.6 for drugs that were approved in 2000 to 1.8 for drugs approved in 2015, a 200% rise.”

The JAMA study authors point to the costly fight that generic competitors must undertake for their drug to gain approval:

“The study authors maintain the increased use of continuation patents makes it costlier and more time-consuming for would-be generic rivals to file patent challenges. Although they noted that continuation patents are typically invalidated at a higher rate than patents for active ingredients, lawsuits filed by brand-name drug companies can delay generic drug approvals for 30 months, even if they later fail.”

Read the STAT article (note: may require site subscription).

Read the JAMA study.

Discover more AHIP resources on High-Priced Drugs.

About AHIP

AHIP is the national association whose members provide health care coverage, services, and solutions to hundreds of millions of Americans every day. We are committed to market-based solutions and public-private partnerships that make health care better and coverage more affordable and accessible for everyone. Visit www.ahip.org to learn how working together, we are Guiding Greater Health.