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Generic Entry In A Rough Economy - Proposed Legislation May Ease Health Care Costs, Laura J. Grebe
Generic Entry In A Rough Economy - Proposed Legislation May Ease Health Care Costs, Laura J. Grebe
Marquette Intellectual Property Law Review
When generic drugs seek FDA approval, the pharmaceutical company files an Abbreviated New Drug Application (ANDA), in which the generic company establishes bioequivalence to its usually patented counterpart. The ANDA filer must also certify that, to the best of the filer's knowledge, the generic will not infringe on a current patent-holder's rights. This can be done by showing (1) no patent on the product exists, (2) the patent is expired, (3) the patent will expire by the time the generic is marketed, or (4) the ANDA filer believes the patent is invalid - called a Paragraph IV certification. A Paragraph …