How is patent linkage created in the U.S?
In the U.S., Patent Linkage is created through several mechanisms the Orange Book, the certification process, notice to the pioneer of a generic filing, and automatic stay of drug approval. The pioneer company reports patent information and enforces its patent, the generic company certifies the reason the patent (or patent status) is not applicable, FDA publishes information and automatically stays the approval process once notified that the pioneer company / patent holder has initiated an infringement lawsuit against the generic company. This creates a set of overlapping mechanisms that reinforce one another and prevent an accidental approval. More importantly, it does not rely solely on the pioneer company to enforce its rights, but presumes that the pioneer company’s rights are valid until proven otherwise by the generic.
