Breathing Life into Patents

Applicants wishing to extend their patents’ term of protection do not have to necessarily match up the wording of the claims and the label of the relevant drug for there to be infringement by an ANDA.

One of the great dilemmas in the pharmaceutical industry is trying to predict the language that will appear on the label of an approved drug so that there can be parity between the language of the label and that of the patent claims which cover the approved drug. Such parity is important as a means for establishing infringement during Abbreviated New Drug Administration (ANDA) litigation. This is because an ANDA applicant copies the label of the approved product as part of the application. If the approved drug product (as defined by the label) falls within a patent claim, the proposed generic product of the ANDA application must also necessarily fall within the claim.

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