Patent thicket strategy with terminal disclaimers helps block biologic competition, JAMA letter shows

2023-12-15

专利到期

Biologics developers are protecting their most lucrative assets with a particular type of patent that they can quickly pile up and drive costly litigation around, preventing competitive biosimilars from coming to the US quickly, according to a new JAMA research letter. The research points to so-called “terminal disclaimer” patents. The patents expire at the same time as the original patent and can be applied late in a biologic’s exclusivity period, but allow manufacturers to quickly build a fortress of patents around trivial changes. That “can trigger lengthy and costly litigation and add uncertainty for biosimilar manufacturers who must invalidate or design around all patents in a biologic’s portfolio,” said the researchers from the West Virginia University College of Law, Fresenius Kabi USA, and Harvard.

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