Patent 'thickets' bog down US biosimilar launches, says AAM

The Biosimilars Council, a division of the USA’s Association for Accessible Medicines (AAM), yesterday released a white paper finding that delayed biosimilar entries caused by brand-name biologic manufacturer patent accumulation or “thicketing” has cost the US health care system $7.6 billion since 2015. This includes more than $1.2 billion in lost savings to the Medicare program, it claims.

“Patients rightfully ask ‘where are all of the FDA [Food and Drug Administration]-approved biosimilars?’ The answer is: stuck in brand manufacturer patent thickets designed to thwart competition and protect monopoly pricing,” says Christine Simmon, executive director, Biosimilars Council, and senior vice president of policy and strategic alliances, at the AAM. “Our analysis demonstrates that billions in savings are lost in these brand patent thickets and we urge policymakers to act now to ensure the viability of the biosimilars marketplace so America’s patients can access these medicines,” she added.

The trade group claims that patent “thicketing” occurs when a brand-name pharmaceutical company accumulates dozens of patents near the end of the product lifecycle under the guise of “innovative” processes or development that warrant additional protections. These patent thickets chill competition by discouraging biosimilar competitors from entering a market because of the exorbitant cost and time of litigating meritless patents.