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Patent Linkage System

Meaning

A Patent Linkage System is a critical regulatory mechanism that formally connects the market approval of generic drugs to the existing patent status of the corresponding brand-name drug, which is often an innovator hormone therapy. This system legally prevents a regulatory agency, such as the FDA, from approving a generic version until all relevant patents on the original innovator drug have either expired or been successfully challenged in court. It is a critical component of intellectual property protection designed to incentivize innovation in the pharmaceutical sector.