Patent linkage may be regarded as a link between the marketing
approval of the generic product and the patent status of the
originator reference (innovator) product. Marketing Approval
ensures the safety and efficacy of a pharmaceutical product.
However, the patent gives exclusive rights to a patent holder to
prevent others from making, selling, using, importing, and offering
to sell a patented product. A patent provides exclusive rights to a
patent holder for a period of 20 years and no generic could be
brought to the market for sale until the patent of the originator
reference product is in force. Therefore marketing approval cannot
override the patent rights.
In some jurisdictions, a link between the marketing approval of
the generic product and the patent status of the new product known
as Patent linkage has been established. Patent linkage disallows
the marketing approval of the generic drug until the patent of the
originator reference drug is valid. The US is
