Paragraph IV Patent Certifications

For your reference here is a link to the FDA Paragraph IV Patent Certifications as well as a PDF of the certifications.

FDA Paragraph IV Patent Certifications

Paragraph IV Patent Certifications.pdf

One Response to “Paragraph IV Patent Certifications”

  1. Gary Speier says:

    The takeaway message "is to avoid 'patent profanity' at all costs" (citing Warren Woessner's blog).

    I don't disagree. The problem is that the scope of "patent profanity" seems to be expanding (by the Federal Circuit), to now cover previously considered harmless and innocuous language. The line has also been blurred.

    In deciding this case on the basis they did, the Federal Circuit is putting "form" over "funcion."